Jul.  3, 2003  11  US 2003/0124176 Al  various amino acid moieties with suitable protecting groups,  which will prevent a chemical reaction from occurring at  that site until the protecting group is ultimately removed. It  is also well known to protect the a-amino group on an amino  acid while that entity reacts at the carboxyl group, followed  by the selective removal of the a-amino protecting group to  allow a subsequent reaction to take place at that site.  Examples of suitable a-amino and side chain protecting  groups are well known in the art.  [0108]  Alternatively, the peptide, polypeptide or protein  may be prepared by employing recombinant technology via  techniques well known in the art. That is, conventional  recombinant techniques may be used, which, as will be  appreciated by those skilled in the art, involves constructing  DNA  encoding the desired amino acid sequence, cloning the  DNA  into an expression vector, transforming a host cell,  e.g., a bacterial, yeast, or mammalian cell, and expressing  the  DNA  to produce the desired peptide, polypeptide or  protein.  [0109]  Additionally, peptides, polypeptides or proteins  can be obtained from natural sources such as a human or  other animal, and may be extracted from either a living  organism or from a cadaver. The material is separated and  purified prior to incorporation into a drug delivery system or  dosage form. Techniques of separation and purification are  well known in the art and include, for example, centrifuga› tion.  [0110]  Although any peptidyl drug may be incorporated  into the delivery systems of the present invention, the drug  is generally selected from coagulation factors, cytokines,  endorphins, kinins, hormones,  LHRH  (luteinizing hormone› releasing hormone) analogs and other peptidyl drugs that  provide a desired pharmacological activity. Of course, the  categories provided are not intended to be limiting and  simply serve as a means for organization.  As  will be  appreciated, a peptidyl drug may fall into more than one  category.  [0111]  Many coagulation modulators are endogenous pro› teins that circulate in the blood and interact with other  endogenous proteins to control blood coagulation. Preferred  coagulation modulators include a $_{1 }$-antitrypsin, a $_{2}$-macro› globulin, antithrombin III, factor I (fibrinogen), factor II  (prothrombin), factor III (tissue prothrombin), factor V  (proaccelerin), factor VII (proconvertin), factor VIII ( anti› hemophilic globulin or AHG), factor IX (Christmas factor,  plasma thromboplastin component or PTC), factor X (Stu› art-Power factor), factor  XI  (plasma thromboplastin ante› cedent or  PTA),  factor  XII  (Hageman factor), heparin cofac› tor II, kallikrein, plasmin, plasminogen, prekallikrein,  protein C, protein S, thrombomodulin and combinations  thereof. When applicable, both the "active" and "inactive"  versions of these proteins are included.  [0112]  The cytokines are a large and heterogeneous group  of proteins and have a role in the function of the immune  system and the control of hematopoiesis, i.e., the production  of blood or blood cells. Preferred cytokines include colony  stimulating factor 4, heparin binding neurotrophic factor  (HBNF),  interferon-a, interferon a-2a, interferon a-2b,  interferon a-n3, interferon-~, interferon-y, interleukin-1,  interleukin-2, interleukin-3, interleukin-4, interleukin-5,  interleukin-6, interleukin-7, interleukin-8, interleukin-9,  interleukin-10, interleukin-11, interleukin-12, interleukin- 13, interleukin-14, interleukin-15, interleukin-16, interleu› kin-17, tumor necrosis factor, tumor necrosis factor-a,  granulocyte colony-stimulating factor, granulocyte-mac› rophage colony-stimulating factor, macrophage colony› stimulating factor, midkine, thymopoietin and combinations  thereof.  [0113]  Endorphins are generally peptides or small-chain  peptides that activate opiate receptors. Agonist and antago› nist derivatives of the naturally occurring endorphins are  also contemplated. Representative examples of endorphins  or pharmacologically active derivatives include dermorphin,  dynorphin, a-endorphin, ~-endorphin, y-endorphin, a-en› dorphin [Leu$^{5}$]enkephalin, [Met$^{5}$]enkephalin, substance P,  and combinations thereof.  [0114]  Peptidyl hormones may be naturally occurring or  may be pharmacologically active derivatives of known  hormones. In addition, peptidyl hormones may be human or  be derived from other animal sources. Examples of peptidyl  hormones that can be administered using the method, com› position and delivery system of the invention include, but  are not limited to, activin, amylin, angiotensin, atrial natri› uretic peptide, calcitonin ( derived from chicken, eel, human,  pig, rat, salmon, etc.), calcitonin gene-related peptide, cal› citonin N-terminal flanking peptide, cholecystokinin, ciliary  neurotrophic factor, corticotropin (adrenocorticotropin hor› mone, corticotropin-releasing factor, epidermal growth fac› tor, follicle-stimulating hormone, gastrin, gastrin inhibitory  peptide, gastrin-releasing peptide, ghrelin, glucogon, gona› dotropin-releasing factor, growth hormone releasing factor,  human chorionic gonadotropin, inhibin A, inhibin  B,  insulin  (derived from beef, human, pig, etc.), leptin, lipotropin,  luteinizing hormone, luteinizing hormone-releasing hor› mone  (LHRH),  a-melanocyte-stimulating hormone, ~-mel› anocyte-stimulating  hormone,  y-melanocyte-stimulating  hormone, melatonin, motilin, oxytocin (pitocin), pancreatic  polypeptide, parathyroid hormone, placental lactogen, pro› lactin, prolactin-release inhibiting factor, prolactin-releasing  factor, secretin, somatotropin, somatostatin, growth hor› mone-release inhibiting factor, thyrotropin (thyroid-stimu› lating hormone, thyrotropin-releasing factor, thyroxine, tri› iodothyronine, vasoactive intestinal peptide, vasopressin  (antidiuretic hormone) and combinations thereof.  [0115]  Particularly preferred analogues of  LHRH  include  buserelin, deslorelin, fertirelin, goserelin, histrelin, leupro› lide (leuprorelin), lutrelin, nafarelin, tryptorelin and combi› nations thereof.  [0116]  Other examples of hormones and hormone-related  drugs include anastrozle, betamethasone, bicalutamide, des› mopressin, desogestrel, dexamethasone, dienestrol, dro› spirenone, estradiol, estropipate, ethinyl estradiol, ethyno› diol  diaceate,  exemestane,  fludrocortisone  ( e.g.,  fudrocortisone acetate), goserelin, hydrocortisone, letrozole,  leuprolide ( e.g., leuprolide acetate), liothyronine ( e.g., lio› thyronine sodium), medroxyprogesterone ( e.g., medrox› yprogesterone acetate), methimazole, methylprednisolone  ( e.g.,  methylprednisolone  acetate),  methyltestosterone,  norethindrone ( e.g., norethindrone acetate), norgestimate,  norgestrel, octreotide acetate, oxandrolone, oxymetholone,  prednisolone, prednisone, progesterone, tamoxifen ( e.g.,  tamoxifen citrate), testosterone,  and  toremifene ( e.g.,  toremifene citrate).  [0117]  In addition, the peptidyl drug may be a kinin.  Particularly preferred kinins include bradykinin, potentiator 