text:
|Publication number
|Publication type
|Application number
|Publication date
|12 Apr 2011
|Filing date
|21 Dec 2006
|Priority date
|20 Dec 2001
|Fee status
|Also published as
|Publication number
|Michael W. Kimball
|Original Assignee
|Watson Laboratories, Inc.
|Export Citation
|BiBTeX, EndNote, RefMan
|Patent Citations (56), Non-Patent Citations (1), Referenced by (29), Classifications (8), Legal Events (4)
|External Links: USPTO, USPTO Assignment, Espacenet
This application is a continuation-in-part of copending U.S. patent application Ser. No. 10/996,476, filed Nov. 24, 2004; which is a continuation of U.S. patent application Ser. No. 10/321,405, filed Dec. 16, 2002; which claims benefit of U.S. Provisional Patent Application Ser. No. 60/343,475, filed Dec. 20, 2001; all of which are incorporated herein in their entirety.
1. Field of the Invention
The present invention relates generally to peelable pouches for storage of transdermal patches, and methods for packaging objects or transdermal patches.
2. Related Art
Transdermal systems often include medicine or another bioactive agent that is absorbed by the user's skin over a period of time. A typical transdermal system can include an adhesive skin patch containing medicine that passes from the patch and through the user's skin. Such patches often are provided in a package formed of a pair of plies of material that are sealed together about their perimeters. A thin space is disposed between the sealed plies in which the transdermal patch is located.
One disadvantage with transdermal systems, or the packaging thereof, is the difficulty in removing the patch from the package for use. Typically, the perimeter of the package is scored or notched near a corner to facilitate breaking or tearing the sealed plies and opening the package. The user can grasp the package adjacent either side of the score or notch, and tear off a portion of the package to reveal the thin space with the transdermal patch therein.
It will be appreciated that such transdermal patches often include an adhesive used to affix the patch to the user's skin. Over time, a minimal amount of such adhesive can seep out about a perimeter of the patch, causing the patch itself to adhere to an inner surface of the package. Thus, as the user tears off a portion of the package to reveal the thin space and patch therein, the patch can be adhered to a surface of the package instead of being freely exposed within the space, resisting convenient removal of the patch. Although the packaging typically includes an inner surface of foil, or other "non-stick" surface such as a polymer coating, to resist adherence of the patch to the packaging, the adhesive often is capable of lightly adhering to such surfaces, or is capable of providing sufficient adherence to thwart or prevent removal of the patch.
It also will be appreciated that such patches, and thus such packages, can be small enough that the thin space therein is small enough to prevent or hinder the user from inserting his or her fingers and grasping the patch. In addition, as stated above, the patch can become adhered to the inner surface the package, thus further preventing or resisting the user's attempt to grasp the patch, even if sufficient space exists to insert fingers.
In addition, the user often must engage in further operations to further open the package and retrieve the patch. For example, after having torn the first portion of the package to obtain access to the space and the patch, the user often must further tear the package in order to increase the opening to the space, or further reveal the patch, in order to increase access to grasp the patch or separate it from the inner surface of the package. Such further manipulation of the packaging increases the risk of molesting or damaging the patch.
Another disadvantage with such transdermal systems, or packaging, is that the tear method of opening the package increases the risk of tearing the package across the transdermal patch itself, thus tearing or molesting the patch.
Another disadvantage with such transdermal systems is that packaging configured for one type of transdermal system may not be sufficient to package another. For example, one package configured to prevent leakage of a first type of medicine may not sufficiently prevent leakage of a second type of medicine because such packaging may not contain the second type of medicine.
The invention provides a peelable pouch, including a substantially flat enclosure formed by first and second opposing flexible plies. A seal can extend along at least a portion of a perimeter of the opposing plies. A flat, flexible transdermal patch can be disposed in the enclosure, the patch including a bioactive agent dissolved in a layer of adhesive. A release liner can be removably attached over the layer of adhesive. The patch and the release liner can together be sufficiently resilient so as to generate a spring force when displaced out of the flat configuration. The first and the second plies can each be separable along the seal and can be displaceable out of the flat configuration. The spring force generated by the patch and the release liner can be sufficient to overcome an adhesive force created by the adhesive between the patch and one of the plies.
In accordance with another aspect of the invention, a peelable pouch is provided, including a substantially flat enclosure formed by first and second opposing flexible plies. A seal can extend along at least a portion of a perimeter of the opposing plies and can couple the plies to one another. A flexible transdermal patch can be disposed in the enclosure, the patch including a bioactive agent dissolved in a layer of adhesive. A release liner can be removably attached over the layer of adhesive. The patch and the release liner can together be sufficiently rigid so as to at least partially resist bending, and can be sufficiently resilient so as to return to a substantially flat orientation after being bent out of the flat configuration. The first and the second plies can each be separable along the seal and displaceable out of the flat configuration.
In accordance with another aspect of the invention, an oxybutynin medicine system is provided, including first and second opposing flexible plies forming an enclosure. A seal can extend along at least a portion of a perimeter of the opposing plies with an enclosed cavity between the plies. First and second opposing tabs, formed by a portion of the respective first and second opposing plies, can extend beyond the seal. An oxybutynin transdermal patch can be disposed in the enclosed cavity between the first and second opposing plies. The transdermal patch can include i) a substrate; ii) an adhesive layer disposed on the substrate and configured to adhere the substrate to a user's skin; iii) oxybutynin dissolved in the adhesive layer; and iv) a release liner, removably disposed over the adhesive layer and the oxybutynin dissolved therein. The oxybutynin, and/or a permeation enhancer, can interact with the adhesive layer and can cause the adhesive therein to i) lose cohesion, ii) seep beyond a perimeter of the patch, and iii) adhere to at least one of the two plies of the pouch. The seal can include a polyacrylonitrile copolymer resin. The first and second opposing flexible plies can have: i) a closed configuration in which a majority of the two plies are disposed in a planar layer; and ii) an open configuration in which at least a portion of the two plies are separated along the seal and pulled out of the planar layer and back across the planar layer to present the oxybutynin transdermal patch between the two plies.
There has thus been outlined, rather broadly, relatively important features of the invention so that the detailed description thereof that follows may be better understood, and so that the present contribution to the art may be better appreciated. Other features of the present invention will become clearer from the following detailed description of the invention, taken with the accompanying drawings and claims, or may be learned by the practice of the invention.
Before the present invention is disclosed and described, it should be understood that this invention is not limited to the particular structures, process steps, or materials disclosed herein, but is extended to equivalents thereof as would be recognized by those of ordinarily skilled in the relevant arts. It should also be understood that terminology employed herein is used for the purpose of describing particular embodiments only and is not intended to be limiting in any way.
It must be noted that, as used in this specification and the appended claims, the singular forms "a" and "the" include plural referents, unless the context clearly dictates otherwise. Thus, for example, reference to a "medicament" includes one or more of such medicaments.
In describing and claiming the present invention, the following terminology will be used in accordance with the definitions set forth below.
"Topical formulation" means a composition in which the drug may be placed for direct application to a skin surface and from which an effective amount of drug is released. Examples of topical formulations include but are not limited to ointments, creams, gels, transdermal patches, sprays, vaginal rings, and pastes.
"Transdermal" refers to the route of administration that facilitates transfer of a drug through a skin surface wherein a transdermal composition is administered to the skin surface.
Transdermal administration can be accomplished by applying, pasting, rolling, attaching, pouring, pressing, rubbing, etc., of a transdermal preparation onto a skin surface. These and additional methods of administration are well-known in the art.
"Transdermal delivery system," "transdermal patches" or simply "patches" refer to a matrix or liquid reservoir type of delivery device which is used to transdermally deliver defined doses of a substance, over a specific application period.
One example of a transdermal patch for administering oxybutynin in accordance with this invention is a matrix-type patch which comprises an occlusive backing that is impermeable to the oxybutynin and defines the face or top surface of the patch and a solid or semisolid matrix layer comprised of a homogeneous blend of the oxybutynin, a polymeric pressure sensitive adhesive carrier, and optionally one or more skin permeation enhancers. Matrix patches are known in the art of transdermal drug delivery. Examples without limitation, of adhesive matrix transdermal patches are those described or referred to in U.S. Pat. Nos. 5,122,383 and 5,460,820, which are incorporated by reference in their entirety.
A transdermal patch for administering male testosterone such as Androderm™, in accordance with this invention, is a liquid reservoir system (LRS) type patch which comprises male testosterone, and other optional ingredients such as a permeation enhancer, in a carrier vehicle. The carrier vehicle comprises a fluid of desired viscosity, such as a gel or ointment, which is formulated for confinement in a reservoir having an impermeable backing and a skin contacting permeable membrane, or membrane adhesive laminate providing diffusional contact between the reservoir contents and the skin. For application, a peelable release liner is removed and the patch is attached to the skin surface. LRS patches are known in the art of transdermal drug delivery. Examples without limitation, of LRS transdermal patches are those described or referred to in U.S. Pat. Nos. 4,849,224 and 4,983,395, which are incorporated by reference in their entirety.
"Skin," "skin surface," "derma," "epidermis," and similar terms are used interchangeably herein, and refer to not only the outer skin of a subject comprising the epidermis, but also to mucosal surfaces to which a drug composition may be administered. Examples of mucosal surfaces include the mucosal of the respiratory (including nasal and pulmonary), oral (mouth and buccal), vaginal, introital, labial, and rectal surfaces. Hence the terms "transdermal" encompasses "transmucosal" as well.
The terms "formulation" and "composition" are used interchangeably herein. The terms "pharmaceutical" and "drug" are also used interchangeably to refer to a pharmacologically active substance or composition. "Bioactive agent", "medicine", "medication", "drug", "prescription" and similar terms are used interchangeably herein. These terms of art are well-known in the pharmaceutical and medicinal arts.
"Permeation enhancer" refers to anything used to assist the transdermal formulation to penetrate the skin. A wide variety of skin penetration enhancers are suitable with a transdermal device being used in the pouch of the present invention. The specific enhancer used may depend largely on the particular transdermal formulation to be employed and may be determined by one of ordinary skill in the art without undue experimentation by considering various factors such as the bioactive agent or drug to be delivered, the specific pharmaceutically acceptable carrier to be used, etc. An index of permeation enhancers is disclosed by David W. Osborne and Jill J. Henke, in their publication entitled "Skin Penetration Enhancers Cited in the Technical Literature," published in Pharmaceutical Technology (June 1998), and is incorporated herein by reference.
Examples of suitable penetration enhancers of the present invention include, without limitation: fatty acids, fatty acid esters, fatty alcohols, fatty acid esters of lactic acid or glycolic acid and their salts, amides, amines, pyrrolidones, glycerol triesters, terpenes, classical surfactants, azocyclic compounds, organic acids, complexing agents, biologics and mixtures thereof.
The term "ply" or "plies" refers to one or more layers or sheets of material.
The term "seal" refers to a closure to block access and that must be broken to gain access. Such a seal can be formed chemically, mechanically, or both chemically and mechanically. An example of a seal includes adhering portions or plies of the pouch together by an adhesive or other means. The seal can include resins or resin compositions, such as vinyl resins, polyethylene resin, hydroxyl modified, vinyl chloride-acetate, thermoplastic copolymer resin; thermoplastic materials such as polyethylene, polyvinyl chloride; a polyvinyl acetal such as polyvinyl butyral, polyvinyl acetal, polyvinyl formal; a polyester such as polyalkylene terephthalate (such as Mylar™); polyvinyl alcohol, methyl cellulose, sodium carboxymethylhydroxyethyl cellulose, polyethylene glycol, polyvinyl acetate-chloride copolymer, polyvinylidene chloride, polypropylene, polyimide, or fluorinated ethylene-propylene copolymer.
The seal can be formed by applying heat and/or pressure to the pouch or plies, causing the adhesive or other material to adhere the plies together, and seal the pouch. In addition, the seal can be formed by ultra-sonic welding. In addition, the seal can be corrugated or embossed.
The term "tab" or "tabs" refers to a flap or appendage for grasping and pulling. For example, a portion of the ply or pouch can form a tab.
As used herein, the term "substantially" refers to the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, an object that is "substantially" enclosed would mean that the object is either completely enclosed or nearly completely enclosed. The exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context. However, generally speaking the nearness of completion will be so as to have the same overall result as if absolute and total completion were obtained. The use of "substantially" is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result. For example, a composition that is "substantially free of" particles would either completely lack particles, or so nearly completely lack particles that the effect would be the same as if it completely lacked particles. In other words, a composition that is "substantially free of" an ingredient or element may still actually contain such item as long as there is no measurable effect thereof.
As used herein, the term "about" is used to provide flexibility to a numerical range endpoint by providing that a given value may be "a little above" or "a little below" the endpoint.
Distances, angles, forces, weights, amounts, and other numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of "about 1 inch to about 5 inches" should be interpreted to include not only the explicitly recited values of about 1 inch to about 5 inches, but also include individual values and sub-ranges within the indicated range. This same principle applies to ranges reciting only one numerical value and should apply regardless of the breadth of the range or the characteristics being described.
As used herein, a plurality of items, structural elements, compositional elements, and/or materials may be presented in a common list for convenience. However, these lists should be construed as though each member of the list is individually identified as a separate and unique member. Thus, no individual member of such list should be construed as a de facto equivalent of any other member of the same list solely based on their presentation in a common group without indications to the contrary.
The Invention
As illustrated in
Bioactive agents or medicines are commonly administered with transdermal patches. In one aspect, the contents of the pouch of the present invention may be a transdermal patch. A variety of transdermal patches are known to those of ordinary skill in the art. For example, U.S. Pat. Nos. 5,122,383 and 5,460,820, which are incorporated by reference in their entirety, disclose various adhesive matrix patches. Further, U.S. Pat. Nos. 4,849,224 and 4,983,395, which are incorporated by reference in their entirety, disclose various Liquid Reservoir System (LRS) type patches. Each of these general types of patches, as well as others, utilizes various structural components, which are known to those skilled in the art.
As illustrated in
Suitable materials for the backing include, but are not limited to: metal foils, metalized polyfoils, composite foils or films containing polyester such as polyester terephthalate, polyester or aluminized polyester, polytetrafluoroethylene, polyether block amide copolymers, polyethylene methyl methacrylate block copolymers, polyurethanes, polyvinylidene chloride, nylon, silicone elastomers, rubber-based polyisobutylene, styrene, styrene-butadiene and styrene-isoprene copolymers, polyethylene, and polypropylene. In one aspect of the invention, the backing layer may have a thickness of about 0.0005 to 0.01 inch.
Further, a release layer or release liner 21 may be temporarily provided upon the proximal side (side to adhere to the skin) of the adhesive layer. Such a liner provides many of the same functions as the backing layer (20) prior to adhesion of the patch to the skin (the release layer is removed prior to attaching the patch to the skin). In use, the release liner is peeled from the adhesive layer just prior to application, and then is discarded. The release liner can be made of the same materials as the backing layer, or other suitable films coated with an appropriate release surface. Thus, while the backing layer/substrate remains as an integral part of the patch (whether or not the patch is attached to the skin), the release layer must be removed prior to attaching the patch to the skin.
A wide variety of materials known to those skilled in the art of transdermal drug delivery may be used as pharmaceutically acceptable carriers for a transdermal patch. In one aspect the carrier may be a biocompatible polymer. In another aspect, the carrier may be an adhesive. In the case of an adhesive matrix patch, the carrier may be a biocompatible adhesive polymer. The carrier, in some aspects, may contain the drug to be transdermally delivered and a penetration enhancer and other ingredients, such as emollients, etc. In the case of a Liquid Reservoir System (LRS) patch, the carrier forms a gel, or other viscous form suitable for use in an LRS patch, as is known in the art. Such a viscous carrier may contain both the drug to be transdermally delivered as well as a penetration enhancer and other ingredients.
In one aspect, the pressure-sensitive adhesive of the pharmaceutically acceptable carrier is suitable for long-term (e.g., greater than 1 day, about 3-4 days, or for longer periods such as 1-4 weeks) contact with the skin. In another aspect, the pressure-sensitive adhesive of the carrier is suitable for a short-term administration (e.g., for a few minutes to a few hours, less than or equal to 1 day). Such adhesives must be physically and chemically compatible with the particular drug and enhancer, and with any carriers and/or vehicles or other additives incorporated into the drug/enhancer composition. In one aspect of the invention, the adhesives of the pharmaceutically acceptable carrier include, without limitation, acrylic adhesives including cross-linked and uncross-linked acrylic copolymers; vinyl acetate adhesives; natural and synthetic rubbers including polyisobutylenes, neoprenes, polybutadienes, and polyisoprenes; ethylenevinylacetate copolymers; polysiloxanes; polyacrylates; polyurethanes; plasticized weight polyether block amide copolymers, and plasticized styrene-rubber block copolymers or mixtures thereof. In yet another aspect of the invention, contact adhesives for use in the pharmaceutically acceptable carrier layer are acrylic adhesives, such as DuroTak 87-2888 adhesive (National Starch & Chemical Co., Bridgewater, N.J.); and polyisobutylene adhesives such as ARcareJ MA-24 (Adhesives Research, Glen Rock, Pa.) and ethylene vinyl acetate copolymer adhesives.
While the pharmaceutically acceptable carrier of an LRS patch may be of any suitable viscous material known to those skilled in the art of transdermal drug delivery, in one aspect of the present invention, the pharmaceutically acceptable carrier of the liquid reservoir forms a gel.
In addition to containing the drug and penetration enhancer, the pharmaceutically acceptable carrier may comprise a number of other additives, such as diluents, excipients, emollients, plasticizers, skin irritation reducing agents, or a mixture thereof. These types of components, as well as others not specifically recited, are well known in the art for inclusion in various transdermal formulations, and may be added as desired to the transdermal drug delivery system of the present invention in specific types and amounts in order to achieve a desired result.
For example, suitable diluents can include mineral oil, low molecular weight polymers, plasticizers, and the like. Many transdermal drug delivery formulations have a tendency to cause skin irritation after prolonged exposure to the skin, thus addition of a skin irritation reducing agent aids in achieving a composition that is better tolerated by the skin. In one aspect, the skin irritation reducing agent may be glycerin, as disclosed in U.S. Pat. No. 4,855,294, which is incorporated by reference in its entirety.
As described above, such patches are commonly provided in tear packages that are ripped or torn open to obtain access to the patch.
It will be appreciated that while the release layer covers most of the surface of the adhesive layer, the patch or adhesive layer can have a perimeter that is exposed to the surrounding environment. The exposed perimeter sometimes allows a minimal amount of the adhesive to escape from the patch beyond the release liner. The escaped adhesive can cause the patch to adhere to the interior of the packaging, thus thwarting or hindering efforts to remove the patch from the packaging for use.
In addition, it has been discovered that certain bioactive agents or medicines, or other ingredients thereof, can cause the adhesive in which it is dissolved to lose cohesion, and seep out of the perimeter of the patch (between the patch and the substrate/backing layer), to a greater extent, thus further aggravating or exasperating the problem of seepage of adhesive. For example, it has been discovered that oxybutynin, and/or a permeation enhancer, causes certain adhesives to lose cohesion and seep or flow more so than other bioactive agents or medicines. Thus, it has been observed that oxybutynin transdermal patches have more frequent occurrences of seepage, and thus adherence to packaging, and/or greater adhesion to the packaging. As discussed above, such adhesion hinders removal of the patch from the packaging, and can result in molestation of the patch as the user rips, tears, or otherwise mutilates the packaging to remove the patch.
In one aspect, the peelable pouch 14 of the present invention advantageously is configured to facilitate opening and removal of a transdermal patch contained therein, and to accommodate the tendency of transdermal patches, such as those with oxybutynin, to adhere to the packaging. Referring again to
A seal 32 is formed along at least a portion of a perimeter of the plies 22 and 24 sealing at least a portion of the plies together. In one aspect, the seal 32 extends along nearly the entire perimeter of the plies. An enclosed cavity 36 is formed between the opposing plies 22 and 24, and the seal 32. The transdermal patch 18 is received within the enclosure 28 or cavity 36. The peelable pouch 14, enclosure 28, and/or plies 22 and 24 have a closed configuration, as shown in
The transdermal patch 18 preferably is flexible to conform to the contours of the user's body or skin, but initially is flat to reduce space for packaging and shipping. In addition, the plies 22 and 24 and the enclosure 28 may define a substantially or mostly flat, planar layer containing the patch 18, and the plies 22 and 24. In one aspect, the patch 18 and the plies 22 and 24 have a rectangular or square shape to facilitate manufacturing and packaging, but it is contemplated that the patch and plies can have any desired shape.
In one aspect of the invention, portions of the plies 22 and 24 can extend beyond the perimeter or the seal 32 to form first and second opposing tabs 40 and 42. The tabs 40 and 42 are sized large enough to facilitate being grasped by the user. Thus, the tabs 40 and 42 can have a size approximately equal to the tips of a user's fingers. As stated above, the seal 32 can extend around a majority of the perimeter of the plies 22 and 24 or the enclosure 28. A portion 46 of the seal 32, however, can be indented from, or formed away from, a portion of the perimeter of the plies 22 and 24 to form the tabs 40 and 42. In one aspect, the portion 46 of the seal 32 transverses a corner of the plies 22 and 24, leaving the corners of the plies unsealed, to form the tabs 40 and 42.
As stated above, typical packaging can make removing the patch difficult and increases the risk of molesting the patch. In addition, patches often have a tendency to adhere to one side of the packaging, frustrating removal of the patch. The peelable pouch 14, enclosure 28, and/or plies 22 and 24 of the present invention advantageously have an open configuration, as shown in
To open the pouch 14, the user grasps the opposing tabs 40 and 42 with fingers of opposite hands, and pulls the tabs 40 and 42, and thus the plies 22 and 24, in a natural direction, which is outwardly approximately perpendicularly or orthogonally to the planar layer of the plies 22 and 24, indicated by arrows 56 and 58 in
As the user continues to pull, the tabs 40 and 42, and the open portions 50 and 52, extend back across the pouch 14 or plies 22 and 24. The inventor has found that the outward and backward movement of the open portions 50 and 52 of the plies 22 and 24 tends to cause the open portions 50 and 52 to pull away from any portions of the patch 18 that may be adhered to one or both of the plies.
Although the patch 18 can be flexible, it also is resilient enough to develop a spring force if it is bent backwardly along with one of the plies, such that the developed spring force overcomes any adherence to the ply, and causes the patch 18 itself to pull away from the plies, as shown in
In addition, it is believed that the backward movement of the open portion 50 and 52 of the plies 22 and 24 is in a direction along the plane of the patch 18 where the patch is most rigid, causing the plies to separate from the patch, rather than tending to bend the patch. Therefore, when the plies 22 and 24 are separated, a portion of the patch 18 extends outwardly from the pouch 14, enclosure 28, and/or plies 22 and 24, substantially in the planar layer, and presented between the plies 22 and 24 such that it can be easily grasped by the user.
This concept is illustrated schematically in the progression shown from
The spring force created in the patch 18 can be induced in a number of manners. In one aspect of the invention, the material of the patch and/or the liner is selected to provide sufficient rigidity to overcome any adhesion caused by adhesive leeching from the patch. In another aspect, a geometric configuration, including a width, of the patch can be selected to provide the proper spring force for the adhesive being used. The adhesive used can also be varied to ensure that the proper restoring spring force is provided.
In one embodiment of the invention, the patch is formed of an adhesive containing oxybutynin and a permeation enhancer, and a polyester-ethylene vinyl acetate backing layer with an overall thickness on the order of 4 mils, and the liner is formed of a polyester material with a thickness on the order of 3 mils. The plies can be formed of paper, low-density polyethylene, foil, adhesive, and/or Barex with a thickness on the order of 4 mils. In this embodiment, it has been found that spring force generated by deflecting or bending the patch is sufficient to overcome any adhesive force applied when utilizing an adhesive material comprising hexamethyleneglycol dimethacrylate, 2-ethyl hexylacrylate and N-vinyl pyrrolidone.
Generally, however, the patch will be presented between the plies that have each been displaced outwardly from the patch, so that the patch is not "stuck" to any one ply and need not be peeled by hand from the particular ply. Attempting to peel the patch by hand from a ply to which it is adhered is a procedure that can result in contamination of the user's fingers, and can risk damaging the patch in the event the patch is relatively securely attached to the particular ply.
In accordance with one aspect of the present invention, the transdermal system can be an oxybutynin medicine system, and the transdermal patch can be an oxybutynin transdermal patch. Oxybutynin can be used to treat urinary incontinence, or overactive bladder. The oxybutynin is dissolved in the adhesive layer of the patch. As stated above, it has been found that oxybutynin, and/or the associated permeation enhancer or other ingredients, can cause the adhesive to lose cohesion, seep beyond a perimeter of the patch, and adhere to the plies of the pouch (but still satisfy its specifications with respect to the FDA). Thus, the configuration of the pouch 14 of the present invention is well suited to facilitate opening.
Referring to
In accordance with another aspect of the present invention, the transdermal system can be an estradiol medicine system, and the transdermal patch can be an estradiol transdermal patch. Estradiol, such as Alora�, can be used in female hormone replacement therapy, and to treat osteoporosis. The plies can be formed of an outer layer of coated paper, a core layer of foil, and a laminate of polyethylene (PE). In one aspect, the seal includes a layer of Surlyn� because it has been found to adequately contain estradiol.
In accordance with another aspect of the present invention, the transdermal system can be a liquid reservoir system (LRS), as opposed to a matrix patch, and can include male testosterone, such as Androderm™. Male testosterone can be used to treat male hypogonadism or testosterone deficiency. Again, the plies can include an outer layer of coated paper, a core of foil, and a laminate of polyethylene (PE). The seal can include a low density polyethylene (LDPE) because it has been found to adequately contain Androderm™.
It is of course understood that other bioactive agents can be accommodated. For example, the transdermal patch can include a female testosterone patch for treating women with a hormone replacement therapy regiment. As another example, the transdermal patch can include an anti-fungal agent for toenails or fingernails, such as fluconazole. As another example, the transdermal patch can be used in pain relief, and can include medicines such as fentanyl, morphine, and others. In one aspect of the invention, the bioactive agent can include pramipexole, a dopamine agonist indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
In general, drugs for use in the present composition include therapeutic agents in all of the therapeutic areas including, but not limited to: antibiotics (including antimicrobials, antibacterials, antimycobacterials, antimalerials, antiamebics, anthelminics, antifungals, and antivirals), neoplastic agents, agents affecting the immune response (including steroidal and non-steroidal anti-inflammatory agents), blood calcium regulators, peptide and protein hormones, agents useful in glucose regulation, antithrombotics and hemostatics, antihyperlipidemic agents, thyromimetic and antithyroid drugs, antiulcer agents, histamine receptor agonists and antagonists, inhibitors of allergic response, local anesthetics, analgesics and analgesic combinations, antipsychotics, anti-anxiety agents, antidepressants agents, anorexigenics, bone-active agents, diagnostic agents, and a mixture thereof. Additional examples include: antidiarrheals, antimigraine preparations, antimotion sickness agents, antinauseants, antiparkinsonism drugs, antipruritics, antipyretics, antispasmodics (including gastrointestinal, urinary, skeletal, and smooth-muscle), anticholinergics, sympathomimetics, xanthine derivatives, cardiovascular preparations (including calcium channel blockers, beta-blockers, antiarrythmics, antihypertensives, diuretics, vasodilators including general coronary, peripheral and cerebral), central nervous system stimulants including cough and cold preparations, decongestants, diagnostics, hormones, immunosuppressives, parasympatholytics, parasympathomimetics, sedatives, tranquilizers and mixtures thereof.
Examples of specific drugs include without limitation: antibiotics: amoxicillin, cloxacillin sodium, penicillin G potassium; antimicrobials: benzalkonium chloride, chlorohexidine, gluconate hexachlorophene; antibacterials: sulfabenzamide, sulfadiazine, sulfasalazine; antimycobacterials: chlofazimine, ethambutol, isoniazid; antimalerials: chloroquine hydrochloride, quinine sulfate, pyrimethamine; antiamebics: arsthinol, bialamicol, carbarsone; anthelminics: ivermectin, bithionol, piperazine; antifungals: clotrimazole, griseofulvin, miconazole; antivirals: acyclovir, foscarnet sodium, ribavirin; neoplastic agents: adriamycine, cyclophosphamide, methotrexate; immune response steroidal anti-inflammatory agents: hydrocortisone, dioxyanthranol, betamethasone; non-steroidal anti-inflammatory agents (NSAIDs): choline salicylate, diflunisal, ibuprofen, acetaminophen; blood calcium regulators: parathyroid hormone, calcifediol, calcitonin; peptide and protein hormones: insulin, glucagon, vasopressin; glucose regulators: tolazamide, tolbutamide, chlorpropamide; antithrombotics: aspirin, sulfinpyrazone, dipyridamole; hemostatics: thrombin, microfibrillar collagen, absorbable gelatin powder; antihyperlipidemic agents: pravastatin sodium, simvastatin, clinofibrate; thyromimetic and antithyroid drugs: methimazole, propylthiouracil, potassium iodide; antiulcer agents: metoclopramide, histidine hydrochloride, famotidine; histamine receptor agonists and antagonists: astemizole, clemastine fumarate, cyclizine; allergic response inhibitors: astemizole, clemastine fumerate, diphenhydramine hydrochloride; local anesthetics: chloroprocaine hydrochloride, lidocaine hydrochloride, lidocaine base, procaine hydrochloride; analgesics and analgesic combinations: acetaminophen, aspirin, ibuprofen; antipsychotics: acetophenazine maleate, chlorprothixene, droperidol; anti-anxiety agents: diphenhydramine, phenobarbital, chlordiazepoxide; anti-depressants: amitriptyline hydrochloride, amoxapine, fluoxetine hydrochloride; anorexigenics: amphetamine, methamphetamine, chlorphentermine; bone-active agents: parathyroid hormone, calcitonin; diagnostic agents: benzylpeniclloyl polylysine, iocetamic acid, aminohippurate sodium; antidiarrheals: diphenoxylate hydrochloride, loperamide hydrochloride, fennel oil; antimigraine preparations: dihydroergotamine mesylate, ergotamine tartrate, methysergide maleate, sumatriptin succinate; antimotion sickness agents: buclizine hydrochloride, diphenidol, meclizine hydrochloride; antinauseants: benzquinamide hydrochloride, dronabinol, dimenhydrinate; antiparkinsonism drugs: amantadine hydrochloride, pramipexole, ropinirole, rotigotine benztropine mesylate, biperiden hydrochloride; antipruritics: camphor, menthol, pramoxine; antipyretics: acetaminophen, aspirin, ibuprofen; antispasmodics (including gastrointestinal, urinary, skeletal and smooth-muscle): flavoxate, flavoxate hydrochloride, ethaverine hydrochloride, oxybutynin chloride, dicyclomine; anti-cholinergics: propantheline, oxybutynin, oxybutynin hydrochloride, adiphenine hydrochloride, aminopentamide, atropine; sympathomimetics: dopamine hydrochloride, epinephrine, ephedrine sulfate; xanthine derivatives: caffeine, theophylline, aminophylline; calcium channel blockers: amlodipine, felodipine, isradipine, diltiazem, nifedipine; beta blockers: propanolol, pindolol, labetalol, betaxolol; anti-arrythmics: procainamide, prajmaline, disopyramide; antihypertensives: clonidine hydrochloride, clonidine base, guanabenz acetate, methyldopa; diuretics: ammonium chloride, mannitol, urea, hydrochlorothiazide, bumetanide; vasodilators: (general) diazoxide, minoxidil, pinacidil; (Coronary) amotriphene, bendazol, benfurodil hemisuccinate; (Peripheral) bamethan, bencyclane, betahistine; (Cerebral) bencyclane, cinnarizine, citicoline; central nervous system (CNS) stimulants cough and cold preparations: dextromethorphan hydrobromide; decongestants: pseudoephedrine hydrochloride, diphenhydramine hydrochloride; chlorpheniramine maleate; hormones: estradiol, norelgestromin, corticosteroids, hydrocortisone; testosterone, progesterone; immunosuppressives: cyclosporin, mizoribine, brequinar sodium; parasympatholytics: atropine sulfate, belladonna, cyclopentolate hydrochloride; parasympathomimetics: pyridostigmine, physostigmine, scopolamine; sedatives: buspirone hydrochloride, chloral hydrate, disulfuram; tranquilizers: chloropromazine, promazine, fluphenzaine, other CNS stimulants: methylphenidate, cholinergics: rivastigmine.
In some aspects, the drug may be oxybutynin, buspirone, fentanyl, testosterone, progestin, estradiol, propentofylline, or a mixture thereof. It should be appreciated that one or more of these and other drugs described herein exist in many pharmaceutically acceptable salts. Examples of such salts include those generated by using inorganic agents (i.e., inorganic cations such as sodium, potassium, calcium, etc., and inorganic anions such as chloride, bromide, etc.) and organic agents (i.e., organic cations such as piperazinyl, triazinyl, etc., and organic anions such as citrates, tartarates, tosylates, etc). In addition, these drugs are also present as polymorphs and/or isomers. Examples of polymorphs include monohydrates, dihydrates, hemi-hydrates, etc., as well those high-melting and low-melting polymorphs. These polymorphs can be characterized using X-ray crystallographic techniques or other well-known techniques in the art. Examples of isomers include geometric and optical isomers. Further, the pharmaceutical art has recognized that such salts, isomers, and polymorphs, as well as prodrugs, analogs, and metabolites for these drugs can be therapeutically effective as well and can be substituted with ease.
Examples of useful testosterone and related compounds include without limitation: testosterone, methyltestosterone, androstenedione, adrenosterone, dehydroepiandrosterone, oxymetholone, fluoxymesterone, methandrostenolone, testosterone, methyltestosterone, androstenedione, adrenosterone, dehydroepiandrosterone, oxymetholone, fluoxymesterone, methandrostenolone, testolactone, pregnenolone, 17α-methylnortestosterone, norethandrolone, dihydrotestosterone, danazol, oxymetholone, androsterone, nandrolone, stanozolol, ethylestrenol, oxandrolone, bolasterone and mesterolone, testosterone propionate, testosterone cypionate, testosterone phenylacetate, testosterone enanthate, testosterone acetate, testosterone buciclate, testosterone heptanoate, testosterone decanoate, testosterone caprate, testosterone isocaprate, and combinations thereof.
These testosterone compounds can be present in subsaturated concentrations, or low concentrations. Examples of compositions comprising subsaturated testosterone are known in the art. See, for example, U.S. Pat. Nos. 5,164,190, and 5,152,997, which are incorporated by reference in their entirety. These testosterone compositions and/or other sex hormones, such as estrogen, progestin, etc. can also be provided using carriers that are stable over long-term storage. Such compositions may comprise ethylhexylacrylate polymers, as described in U.S. Pat. No. 5,780,050, which is incorporated by reference herein. Methods for providing such hormones to males and females are also well known. See, U.S. Pat. Nos. 5,460,820, 5,152,997, and 5,783,208, which are incorporated by reference in their entirety. It is appreciated that using the disclosure of the present invention, one skilled in the art can readily accomplish the objective of the above-referenced patents.
Examples of useful estradiol and related compounds include without limitation 17β-estradiol, 17α-estradiol, conjugated equine estrogen, esterified estrogen, micronized estradiol, sodium estrogen sulfate, ethinyl estradiol, estrone, tibolone, selective estrogen receptor modulator (SERM), phytoestrogen, and mixtures thereof. Examples of useful progestin and related compounds include without limitation: progesterone, medroxy-progesterone acetate, norethindrone, and norethindrone acetate.
Examples of useful oxybutynin compounds include without limitation: N-desethyloxybutynin, (R)-oxybutynin, (S)-oxybutynin, (R)—N-desethyloxybutynin, and (S)—N-desethyloxybutynin. Particularly, it has been noted that the oxybutynin metabolite, N-desethyloxybutynin, as well as it (R)- and (S)— optical isomers exert an anticholinergic action that is equal to or greater than oxybutynin, and can be readily delivered for such a purpose. See, U.S. Pat. Nos. 5,411,740, 5,500,222, 5,532,278, 5,677,346, 5,686,097, 5,736,577, 5,747,065, 5,750,137, and 5,900,250, which are incorporated by reference in their entirety.
Transdermal delivery of oxybutynin using triacetin as a penetration enhancer has been described by U.S. Pat. Nos. 5,834,010, and 5,601,839, which are incorporated by reference in their entirety. Oxybutynin can be administered in low concentrations, such that the serum concentrations of one or more of its metabolites can be significantly lowered with the beneficial effect of reduced adverse drug reactions, such as anticholinergic effects (including dry mouth, constipation, blurred vision, etc.).
Examples of propentofylline compositions, which can be used in connection with the present invention, are described in U.S. Pat. No. 5,762,953, which is incorporated by reference in its entirety. It is appreciated that the transdermal penetration of such compositions may be further enhanced using the quaternary ammonium salt compounds of the present invention.
It is appreciated that any combination of any of the above drugs (that is one or more of any of the above drugs) may be used in this invention. The present invention also contemplates the use of such salts, isomers, polymorphs, prodrugs, analogs, and metabolites, including substances not specifically recited above.
It should also be recognized that the term "drug" as used herein refers to practically any chemical substance that has pharmacological activity or biological activity, as well as those substances that can be used for diagnostic or cosmetic purposes. Thus, vitamins, such as vitamin A, C, E, K, and various B complexes, veterinary drugs, and cosmetic agents such as wrinkle-reducing agents (including anti-oxidants, for example, ascorbic acid, ascorbyl palmitate, catechins, an polyphenol compounds), depilating agents (including calcium salt, thioglycolic acid, and calcium hydroxide), hair-growing agents (including relaxin, cyproterone acetate, spironolactor, flutamide, and minoxidil), depigmenting agents (including sulfites, bisulfites, and metabisulfites, and alkaline earth, and alkaline earth metal compounds thereof), are also included. Further, the term "drug" includes peptides, proteins, carbohydrates, fats, etc that are known to exert biological and or pharmacological effects.
It is appreciated that the above categories of drugs are not rigidly described and that one drug may be described accurately in more than one category or sub-category. For example, insulin may be described as a hormone, as an anti-diabetic agent and also as a macromolecule.
Referring to
The pouches described above have rectangular or square shapes with four sides, while the seals form a pentagon shape or polygon with five sides within the perimeter of the rectangular shape of the pouch. Forming the five sided polygon seal within the perimeter of the rectangular pouch creates the tabs.
Referring to
Referring to
Referring to
Referring to
Referring to
As illustrated in
Referring to
Referring to
With the patches disposed between the webs or plies, at least a portion of the webs or plies are sealed together to form the enclosures about the patches. In one aspect, a seal is formed entirely around each patch. The plies are sealed by applying heat and pressure against the plies for a predetermined time period. The mechanisms can include a heat seal station 132 in which a press is movably disposed to selectively contact the plies. The press can be shaped and sized similar to a mold or blank of the seal. Thus, when the press contacts the plies, the seal is formed in the desired shape and size. The press can be configured to form numerous seals at the same time.
As shown in
Portions of the plies that extend beyond the seal or enclosure are left unsealed in order to form the tabs. The numerous pouches can be separated from one another and the webbing to form individual pouches with individual patches therein. The mechanisms can include a shearing station 150 for separating or cutting individual pouches from the webbing. As shown in
It is to be understood that the above-described arrangements are only illustrative of the application of the principles of the present invention. Numerous modifications and alternative arrangements may be devised by those skilled in the art without departing from the spirit and scope of the present invention and the appended claims are intended to cover such modifications and arrangements. Thus, while the present invention has been described above with particularity and detail in connection with what is presently deemed to be the most practical and preferred embodiments of the invention, it will be apparent to those of ordinary skill in the art that numerous modifications, including, but not limited to, variations in size, materials, shape, form, function and manner of operation, assembly and use may be made without departing from the principles and concepts set forth herein.
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|U.S. Classification
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|International Classification
|Cooperative Classification
|European Classification
|25 Jan 2007
Owner name: WATSON LABORATORIES, INC., UTAH
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:KIMBALL, MICHAEL W.;REEL/FRAME:018803/0756
Effective date: 20070109
|13 Oct 2014
|Fee payment
Year of fee payment: 4
|4 Mar 2015
Owner name: ACTAVIS LABORATORIES UT, INC., UTAH
Free format text: CHANGE OF NAME;ASSIGNOR:WATSON LABORATORIES, INC.;REEL/FRAME:035127/0305
Effective date: 20140917
|26 Sep 2016
Owner name: ALLERGAN SALES, LLC, CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ACTAVIS LABORATORIES UT, INC.;REEL/FRAME:039857/0661
Effective date: 20151231


text:
The Custom Installer: CEDIA Showstoppers
People often ask me, "How do you keep up with all the new technologies? The market changes so fast." One of the best ways to stay current is to attend trade shows where the latest gear is on display and you can actually talk with the folks who designed it.
My favorite show is the CEDIA (Custom Electronics Design & Installation Association) Expo, which features products geared toward custom installation. The Expo takes the coolest ingredients from the Consumer Electronics Shows, simmers them over low heat to steam away nonessentials like car audio, cellphones, batteries, and appliances, and tosses in tons of brand-new technologies for spice, creating a mélange that's irresistible to the techno-geek in us all. The Expo is like Mecca for custom installers, and this year's pilgrimage attracted nearly 25,000 pros from around the world.
The custom-installer side of me loves the Expo because it offers a chance to find products that can help with upcoming projects - like a motorized, room-dividing drapery system from Electric Shade capable of making angled turns and extending more than 20 feet. And there's also the opportunity to network with other professionals to find solutions to install challenges. The S&V writer side of me loves the Expo for the chance to schmooze with manufacturers, probing them for off-the-record comments on what they think the future holds for their companies - and the open bars and goodie bags at the press events ain't bad either.
Audio Developments One trend I noticed was how fast new technologies are being adopted and brought to market at entry-level prices. People are now blasé about 5.1-channel surround sound since most A/V receivers offer at least 6.1 channels, and a majority now offer 7.1 channels. Another technology that's been fast-tracked is Dolby Pro Logic IIx, which was introduced at last year's Expo and is now in most receivers.
But there are still some developments at the "high end" that will make you want to call in for a credit-line increase. Both Denon and ADA are giving more than lip service to the idea of multiroom A/V receivers. Denon's new flagship AVR-5805 ($6,000) is literally two receivers in one with 170 watts for each of ten channels - among other amp configurations, it can drive two 5.1-channel systems simultaneously! And it offers discrete line-level outputs for up to four more zones plus DVI (Digital Visual Interface) and HDMI (High Definition Multimedia Interface) switching. ADA's HTR-2400 ($9,999 to $11,999) can drive a 7.1-channnel system with100 watts all around while at the same time powering 16 additional stereo channels in eight zones with 100 watts each! usa.denon.com, ada-usa.com
Now that the original Star Wars Trilogy has finally come to DVD, why not enjoy it the way George Lucas does - on a THX-certified home theater speaker system? The "X" used to stand for eXpensive, but not so much now that Sonance is adding a $1,000 THX Ultra2-certified model and a $475 THX Select model to its Cinema LCR Cabinet line. Both are expected to be available in December.
Proving again that great things can come in small packages, Apple's iPod quickly became the most popular portable digital music player yet. But until now there hasn't been an elegant solution for integrating an iPod into your home audio system. Sonance's iPort is an in-wall or rack-mountable docking station that gets the music out of your iPod and sends it wherever you want. Sonance plans to have it available before the end of the year at a price to be announced. sonance.com
Video Projection Systems Was it just last year that we were drooling over the new front projectors using Texas Instruments' HD2+ DLP (Digital Light Processing) chip, which offered greater contrast and adjustability? Front projectors with these chips initially fetched $10,000 and up and were on the must-have lists of well-todo home theater owners everywhere. But Sharp has now brought HD2+ performance to the masses with its $4,500 XV-Z2000. Its price should get you off the fence if you've been contemplating a front projector. sharpusa.com

subset: commoncrawl


text:
Stan Wawrinka and Jeremy Chardy, the only two seeds left standing in Den Bosch, were a pair of second- round winners Wednesday at the $545,000 Topshelf Open, a final grass- court Wimbledon tune-up.
The second-seeded Swiss Wawrinka held off game Italian Paolo Lorenzi 6-3, 7-6 (10-8), while a fifth-seeded Chardy got past Romanian wild card Marius Copil, 7-5, 6-4 on Day 4 at Autotron Rosmalen.
Wawrinka and Chardy will do battle in Thursday's quarterfinals, which means only one seed will make it through to the final four here.
In other second-round action, Belgian Xavier Malisse overcame Taiwan's Yen- Hsun Lu 3-6, 6-1, 6-4; Spaniard Roberto Bautista Agut whipped Argentine Carlos Berlocq 6-2, 6-3; Russian Evgeny Donskoy topped Dutch favorite Robin Haase 6-4, 7-5; French qualifier Nicolas Mahut bested Russian Andrey Kuznetsov 6-2, 6-4; Spain's Guillermo Garcia-Lopez grounded German Daniel Brands 7-6 (9-7), 6-2; and Czech qualifier Jan Hernych fought back to beat France's Michael Llodra 6-7 (5-7), 6-4, 7-5. Hernych was a Den Bosch finalist in 2006, while Llodra titled here in 2004 and was the 2005 runner-up.
Thursday's other quarters will pit Malisse against Bautista Agut, Donskoy versus Mahut and Garcia-Lopez against Hernych.
This week's champion will earn $94,000.


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If New Hope Church of Schuyler County, Missouri is your church, tell us more! Click here and email a detailed description of all the great things your church has to offer and we'll include it here.
- Christian Guide
- US Church Directory
- Missouri Church Directory
- Schuyler County Churches
- New Hope Church


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The goal of the International Education program is to provide Vol State students with a global perspective. It starts in the classroom with new ways of looking at academic subjects. It grows with special international events and speakers on campus. It blossoms with travel-study, which allows students to participate in academic travel to countries across the globe. Faculty members are active partners in the endeavor, through academic work, organizing special programs and in teaching travel-study classes. Ultimately, international education prepares students for active participation in the global village.
Students interested in travel-study will need to attend a meeting that will detail the programs available. The meetings are held each fall semester on Vol State campuses. Please see the "Meetings" tab on the left hand side of the page for the dates and times.
For More Information Contact:
Anne-Marie McKee


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Associated Press
His place in history assured, U.S. District Senior Judge Horace Ward has retired from the Northern District of Georgia bench _ where he has sat since 1979, when he became the first African-American appointed to a federal judgeship in Georgia.
Ward's federal judicial career has stood as "a constant visible reminder of the power of the rule of law in ensuring equal rights," said Chief Judge Julie Carnes.
"He will always be remembered as a trailblazer in the civil rights movement," she said. "He had the courage to challenge a social order that limited the opportunities of its black citizens."
A Morehouse College honors graduate with a master's degree from Atlanta University, Ward was instrumental in desegregating the University of Georgia. He was the first African-American to sue for admission to an all-white college in Georgia when, as a prospective law student in 1950, he first challenged UGA's refusal to admit him. After earning a law degree from Northwestern University in 1959, Ward joined a team of renowned civil rights lawyers who won the right for two African-American students _ Hamilton Holmes and Charlayne Hunter _ to desegregate UGA in 1961.
"His tenaciousness in attempting to be admitted to the University of Georgia law school paved the way for the later integration of Georgia's public colleges," said Carnes, who earned both her undergraduate and law degrees at UGA. "Judge Ward was a constant and visible reminder of the power of the rule of law in ensuring equal rights to all its citizens and of the importance of citizens and judges who insist that it do so."
Ward said recently that his appointment by President Jimmy Carter to the federal bench was "the crowning achievement in my legal career."
The retiring judge said his decision was prompted by his recent 85th birthday and a recognition that he had spent 50 years in public service _ as the second African-American in the state's history to be elected to the Georgia senate; as a Fulton County State Court judge; as the first African-American to become a Superior Court judge in Georgia, and, finally, as a federal judge.
Ward also practiced law with civil rights attorney Donald Hollowell and served as both an assistant county attorney in Fulton County and an assistant city attorney in Atlanta before embarking on his judicial career.
In a lecture at UGA in 2000, Ward called his unsuccessful fight to secure admission to the law school "a long and hard struggle" that played out over the course of a decade.
Said Ward's biographer, UGA professor and Dean of Social Work Maurice Daniels: "I think it took a great deal of courage to challenge the system of segregation at the time that he did because, in essence, he was challenging the governor, he was challenging the General Assembly, he was challenging the Board of Regents, he was challenging the University of Georgia. It took a great deal of courage for him and others to pursue the course of dismantling the cherished system of segregation in this state."
More than two decades later, as a U.S. senator, Talmadge would greenlight Carter's nomination of Ward to the federal bench. Ward said that when he was sworn in as a federal judge in December 1979, he took his oath in the same courtroom where his case against UGA had been litigated.
Daniels said Ward demonstrated perseverance as well as bravery in his fight to desegregate UGA. And, he observed, "I can honestly say that he never showed any kind of animosity or any kind of negative feeling with respect to those who placed obstacles and barriers in his path."


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Labor risks creating 'underclass' in Australia with new rules for asylum seekers: Cameron
Labor Senator Doug Cameron says the Gillard government has moved too far to the right on asylum seeker policy, and risks creating a new underclass by denying refugees the right to work while they await permanent visas.
Senator Cameron, a convener of Labor's Left faction, was responding to the announcement by Immigration Minister Chris Bowen on Wednesday to extend the no-advantage test to asylum seekers whose claims are processed onshore.
They will be denied permanent protection visas for as long as five years even if they are found to be genuine refugees and regardless of whether their claims are processed in Australia, Nauru or Manus Island in Papua New Guinea.
Asylum seekers allowed into the community on bridging visas will have no work rights and only limited accommodation and financial support.
Senator Cameron said he was concerned that asylum seekers would be reliant upon charity to survive in the community.
''I don't want people to come here and starve,'' Senator Cameron told reporters in Canberra on Thursday.
''I don't want an underclass to be created in Australia.''
Senator Cameron said he did not think it was possible to stop boat arrivals.
''I don't think there's any capacity anywhere to stop the boats, full stop. We have to make sure the policies that we put in place are humane policies,'' he said.
''The political debate on refugees is at its lowest ebb and my view is we should try and get above that.
''The Labor Party is a party that has had a long history of supporting refugees. I don't want this government to end up going further and further to the right on refugee issues.''
Senator Cameron predicted there would be a robust debate about the policy when the Labor caucus meets on Tuesday during the final parliamentary sitting week of the year.
''Those policies are entitled to be subject to scrutiny from the back bench and critical analysis from the back bench,'' he said.
Opposition Leader Tony Abbott told a breakfast function in Perth on Thursday that the Coalition was concerned that asylum seekers on bridging visas would live unproductive lives on welfare. Mr Abbott said that he would be making an announcement to "rectify" the visas in coming days.
''These people [asylum seekers] will get Australian citizenship with the worst possible preparation - five years on welfare - for life in Australia,'' Mr Abbott said.
''Now I'll be making further announcements about what the coalition will be doing to rectify this situation in coming days.
Mr Abbott said that "no credible country" subcontracted part of its immigration program out to people smugglers.
Interviewed on ABC radio this morning, Immigration Minister Chris Bowen defended the policy to deny holders of bridging visas work rights. He said it was a matter of consistent treatment, because asylum seekers held on Nauru and Manus Island could not work.
He also said the policy made a journey to Australia less attractive for people who wanted to come for economic reasons.
''You can find people smugglers out there saying 'look we'll get you to Australia, you may or may not be a refugee, you'll be able to work, you'll make more money that you ever would here in Sri Lanka or elsewhere, and you can send that money home... economically it's in your interests to move'.''
Mr Bowen said Labor's approach was aimed at deterring people from risking their lives by taking perilous boat journeys to Australia.
''We are doing everything that is possible to try and deter people coming by boat. If people are arguing that we shouldn't be doing that, then they need to accept the ramifications of that, which is that they are effectively saying 'we accept that more people will drown at sea', and I don't think that's a morally sustainable position,'' he said.
''There are tough decisions to be made. I don't enjoy making them. That's my job.''
Coalition border protection spokesman Michael Keenan says Labor's immigration policies were failing because it had not adopted the full range of measures used by the Howard government.
Mr Keenan rejected the suggestion that Labor had put in place the Coalition's approach.
''They've adopted one component of it and that is offshore processing, and they've been dragged kicking and screaming to do that,'' he said on Sky News.
''What we have always said is that the whole suite of policies that the Howard government used to stop people smuggling needs to be returned. That is offshore processing on Nauru and Manus, but very importantly in conjunction with the return of temporary protection visas and turning the boats back around when it's safe and appropriate to do so.''
The president of the Australian Human Rights Commission, Gillian Triggs, acknowledged that public opinion seemed to support the tough policies pursued by both major parties, but she said Labor's policies ''run the risk of being in serious breach of international law''.
David Manne, the executive director of the Refugee & Immigration Legal Centre, said Labor's policies would effectively punish thousands of people.
''The very people that we're meant to be protecting, are going to be put into the community into a situation where they face limbo without limits, and also the real risk of destitution without work rights,'' he told Sky News.
''It's a real concern that we're revisiting the type of policy which we know harms innocent people fleeing from harm.''
St Vincent de Paul Society National Council Chief Executive Dr John Falzon expressed sadness today over the government's announcement that it would be leaving refugees on bridging visas with no right to work and very little support:
"We condemn this latest chapter in the chronicle of inhumane treatment of refugees by successive governments,'' Dr Falzon said.
"It is time for Australia to accept its international obligations and to respect the human rights and human dignity of the people who seek asylum in our country.
"People should not be forced into a life of poverty and insecurity. The current suite of policies will go down in history as a form of degradation instead of being the product of careful deliberation."
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As little as five years ago, no one had detected water in the samples returned from the Moon. The advancement of instrumentation, such as secondary ion mass spectrometry and Fourier transform infrared spectroscopy, has made it possible to detect tiny, but measurable, amounts of water in the mineral grains from Apollo samples.
In a new paper, researchers show that they have detected significant amounts of water in the samples of the lunar highland upper crust obtained during the Apollo missions. The lunar highlands are thought to represent the original crust, crystallized from a mostly molten early Moon that is called the lunar magma ocean.
According to Hejiu Hui, postdoctoral research associate at the University of Notre Dame<, "The presence of water in the early Moon needs to be reconciled with the favored formation scenario that had been supported by the volatile elements and isotopes in the samples, such as Zinc. "It's not 'liquid' water that was measured during these studies but hydroxyl groups [developed from water that did exist in the lunar magma ocean] that was distributed within mineral grain. We are able to detect those hydroxyl groups in the crystalline structure of the Apollo samples." The hydroxyl groups the team detected are evidence that the lunar interior contained significant water during the Moon's early molten state, before the crust solidified, and that they may have played a key role in the development of lunar basalts. "The presence of water," says Hui, "could imply a more prolonged solidification of the lunar magma ocean than the once popular anhydrous moon scenario suggests."
Now, I can close my eyes and see the moon crowded with people. People from the moon flying space shuttles to Earth to visit their grand parents. It will not happen in my life time. But I feel great when I think that someday it will happen.


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As I matured as a therapist, I started integrating elements of Buddhism into the psychodynamic approach in which I had been trained. (I believe Marsha Linehan did something similar in creating DBT, and I enjoyed Jack Kornfield's book, A Path With Heart.) In particular, I have always been stirred by the simple wisdom in AA's Serenity Prayer. As we stop banging our heads against the walls of things we cannot change, we have more energy to affect things we can change. I have tried to help patients find comfort and their own paths forward by accepting the many forces before which we stand helpless. I have shared that wisdom with my own children. And like Alice in Wonderland, sometimes I even try to follow my own advice.
Recently I posted a blog on my flight before the fury of Hurricane Irene on the Atlantic Coast. I didn't know it when I wrote the blog, but soon after, the worst devastation from the storm hit not along the coast, but inland—particularly with flooding in Vermont. This week Tropical Storm Lee pounded my community in Central Pennsylvania with record floods.
When I first heard about global warming, I assumed the slow process of year-by-year temperature elevations would take many decades to affect real life. But climate scientists say the short-term effect is to increase weather volatility. When I moved from the desert southwest to Wisconsin in 2007, I expected a personal climate change—but not the record-breaking snowfall that began the day I arrived in Madison. Record-breaking snow followed me to Hershey, Pennsylvania, the week I moved here after Christmas in 2009. And this week my hospital was briefly isolated, I had to wade home through serious flooding, roads and buildings collapsed, our municipal sewage system has gone down, and I worry about weekend coverage for inpatients at our psychiatric hospital.
I can make small, personal efforts to conserve energy and reduce greenhouse gases. But I am helpless against nature's fury when it appears. I can try to take reasonable steps to be prepared, and when disasters strike, I can work with colleagues and my community to help those in need. But truly we are small, and natural forces are immense. As doctors, we seldom cure, but usually we can attenuate symptoms and relieve suffering. I try to acknowledge what I can't change and focus on what I can.
The pounding I saw from two back-to-back tropical storms taught me one other thing: the necessity of the social compact we call government. My state and community have good infrastructure, and today President Obama declared this a disaster area, allowing federal assistance. While some congressional representatives and presidential candidates rail against all government as evil and unnecessary, I realize that a well-functioning government is people helping people. It's who we are, and it gives us more options and help in the face of powerful forces.
-Alan J. Gelenberg, M.D.
Editor, Biological Therapies in Psychiatry
Shively/Tan Professor and Chair, Psychiatry, Penn State University
Editor-in-Chief, Journal of Clinical Psychiatry


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Although there does not appear to be any organized effort against ballot issue 3B among Cortez residents, there is opposition to the tax increase measure for a new Montezuma-Cortez High School.
C.O. Bud Garner is really conflicted on the bond issue, but is leaning against it.
Garner, a member of the 9-12 Project/Tea Party Patriots group, emphasized he is not speaking on behalf of the organization.
There seems to be an attitude that if you dont vote for a tax increase that youre against education. That is such a specious argument, he said.
Ive not heard a definitive argument that says what our problems are with the educational outcomes here, he said, although he acknowledged that some of it has nothing to do with the actual product being offered at the school. There are solutions that have nothing to do with a new building.
The Re-1 district seems to be changing its focus as it relates to passing a bond, Garner believes.
He related that when Re-1 Superintendent Alex Carter spoke to the 9/12 group, he said he hoped that the districts education results would improve if the bond passes.
In June, Garner was defeated in the Republican primary race for county commissioner.
This is our second bite at the apple, Garner said, noting district residents overwhelmingly voted down another BEST grant-related bond that wouldve helped rehabilitate the Southwest Open School campus.
At that time, Re-1 School Board President Jackie Fisher said that there was no relationship between building new buildings and educational results, Garner recalled.
Maurine and Dale Foote felt strongly enough on the issue that they put a No on 3B neon green sign in their front yard on Mildred Road.
When asked why they dont support the bond, Maurine said that a friend who works at the high school said that the school is not that bad.
A tax increase is another reason for their opposition.
I cant afford another tax, Maurine said, noting shes not currently working. Dale Foote is working. They do not have any children in the school district, saying that their only child left the nest years ago.
If passed, the bond would expire after 20 years.


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Photographer's Note
The tribal, etnic, colorful evening market in Luang Prabang is nothing like other markets in Asia. It is clean, calm, rather quiet, and ends relatively early.
Nobody has marked this note useful
Critiques | Translate
saxo042 (38014) 2012-01-13 7:42
Hi Candra,
A very interesting picture with all these warm red colours and fine details to enjoy. The lady enhances the picture considerably. The size is of course much better here, but you still have a marginal to the upper TE limit. This photo is 747 pixels...
Kind regards
Photo Information
- Copyright: Candra Sutama (candra) (56)
- Genre: Places
- Medium: Color
- Date Taken: 2010-00-01
- Categories: Daily Life
- Exposure: f/1.4, 1/40 seconds
- More Photo Info: view
- Photo Version: Original Version
- Date Submitted: 2012-01-12 7:30
Viewed: 1984
Points: 2


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Horn: 'Nobody took accountability at all' for Rangers' late-season collapse
Catch SportsDay On Air twice per week on Fox Sports Southwest, when Dallas Morning News experts discuss hot sports topics from the Cowboys, Mavericks, Stars, Rangers and colleges (check our TV listings for air times). Here are a few highlights from Monday's episode featuring Evan Grant, David Moore and Barry Horn:
On who's to blame for Rangers' collapse:
Grant: I think you blame everybody in the organization. This organization talks about accountability, their big sign this year was "Together in Texas." Everybody shares accountability. Ron Washington didn't use the players he was given as bench players down the stretch, the general manager and front office didn't give Ron Washington established players to use, which made the manager a little more hesitant to use those guys. But mostly, it comes down to the players not performing. You're only as good as your players perform, and these guys just didn't perform over the final month of the season.
Horn: I think you can go around the room and say, "It's your fault, your fault, your fault, and your fault." But the bottom line is Jon Daniels will still be in charge, everything will still be his decision, so it will not be Jon Daniels' fault.
Grant: I think that as a GM, he's going to step up and say he's accountable as well.
Horn: He'll be
the first guy on the team this season to say he's accountable. Nobody took
accountability at all.
Grant: That's true, and when they finally won a game against the A's, when they held on to win 9-7 that Thursday in Arlington, Ian Kinsler said, "This is why we're the best team in the American League." And you kept trying to give these guys the benefit of the doubt, believing they have done it, they have been there, but they didn't back up anything. So next year, when this team talks about, "We've played in big games," the response has to be, "Yeah, and you lost them all, too."


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Brantly, William Tomlinson [Theophilus]
23 Jan. 1787–28 Mar. 1845
William Tomlinson [Theophilus] Brantly, Baptist clergyman, college president, and editor, was born in Chatham County, the son of William Brantley and the grandson of John Brantley, who settled on an 880-acre tract along Rocky River in 1749. At some unknown time he came to be called Theophilus and without actually changing his name legally, he dropped Tomlinson and substituted Theophilus. Born into a family of many children and moderate means, Brantly had little opportunity of receiving an adequate education or of escaping the small farm operated by his father. During the Second Great Awakening, however, he found a way to become a national success. Converted at a Baptist revival meeting in 1802, he began preaching throughout Chatham County. His sermons soon brought him under the notice of a wealthy neighbor who offered, on the condition that he prepare himself for the undertaking, to pay his expenses for a college education. When the doors of South Carolina College first opened in 1804, Brantly was among the initial entering class. Before he was graduated in 1808, he had found in the college's first president, Jonathan Maxcy, the man after whom he would style his life. After serving distinguished presidencies at Union College, N.Y., and at Brown University, Maxcy had come to influence a generation of southerners at South Carolina College.
Upon graduation, Brantly settled at Augusta, Ga., serving as rector of Richmond Academy. There he organized the First Baptist Church, making it within two years one of the largest in Georgia. At the same time he married Mrs. Anna McDonald Martin of Sparta, Ga., the sister of Georgia Governor Charles J. McDonald. His marriage and his apparent talents as a clergyman enabled him to become one of the most famous Baptist divines in America. In 1811 he moved to Beaufort, S.C., where he took over the important Baptist church of that town. He also created the short-lived Beaufort College. Although the college did not last beyond his departure in 1818, it numbered among its graduates Basil Manly, Sr., and Richard Fuller, two who took over the mantle of leadership among Southern Baptists after Brantly's death. After his stint in Beaufort and the death of his wife, Brantly returned to Augusta, where he served the church he had previously organized and resumed the rectorship of Richmond Academy.
In 1826 Brantly was invited to become pastor of perhaps the largest Baptist church in America, First Baptist in Philadelphia, recently left vacant by the death of Henry Holcombe. In Philadelphia he made a national name for himself as a preacher and editor. Many of his sermons were published individually, and he published a large volume of Sermons in 1837. He took over the sagging Columbian Star, the national Baptist weekly; renaming it the Christian Index, he managed it successfully until 1832, when, as a result of his heated endorsement of South Carolina in the Nullification controversy, he lost the bulk of his northern readers. Although he gave up the newspaper in 1833, he remained in Philadelphia until 1837, apparently as popular as ever with his parishioners. When his health failed that year, he was offered the pastorate of First Baptist in Charleston, S.C. Not content with a full-time pastorate alone, he accepted first the editorship of the Southern Watchman and General Intelligencer and then the presidency of the College of Charleston in 1838. Relinquishing the paper, he served his dual functions as minister and college president quite well until July 1844, when he suffered an apparent stroke that left him totally paralyzed and senseless until his death in Augusta, Ga., eight months later.
Following the death of his first wife, Brantly married Mrs. Margaret Joyner of Augusta in 1819. To the first marriage was born William Theophilus (1816–82) and to the second John Joyner (1821–1902). Both men became widely known Baptist clergymen in their own rights.
William T. Brantly Papers (Maryland Historical Society Library, Baltimore).
William Cathcart, The Baptist Encyclopedia (ca. 1880).
Encyclopedia of Southern Baptists, 3 vols. (1958–71).
Charles E. Taylor, Brief Memoir of the Reverend William T. Brantly (1846).
Additional Resources:
The twentieth century biographical dictionary of notable Americans ... The Biographical Soceity, 1904. http://books.google.com/books?id=vmlmAAAAMAAJ&dq=william+theophilus+brantley&source=gbs_navlinks_s&printsec=frontcover#v=onepage&q&f=false (accessed April 18, 2013).
Image Credits:
Boykin, Samuel. History of the Georgia Baptists, Volume 2. The Baptist Standard Bearer, Inc., 2001. http://books.google.com/books?id=BuZ8oukYIF8C&dq=william+theophilus+brantley&source=gbs_navlinks_s&printsec=frontcover#v=onepage&q&f=false (accessed April 18, 2013).
1 January 1979 | Tise, Larry Edward
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Funeral Service will be at 10 a.m. Thursday, Feb. 21, 2013, at Cornwell Funeral Home Chapel with Bro. Euel Nordin officiating and Alan Bradley reading the obituary. Visitation will be from 5-7 p.m. Wednesday, Feb. 20, 2013, at Cornwell Chapel. Interment will be in Brearley Cemetery at Dardanelle.
A complete obituary will be published in Wednesday's edition of The Courier.
Arrangements by Cornwell Funeral Home Dardanelle. Online guest book and condolences at www.cornwellfuneralhomes.com.