Jun.5,2003  38  US 2003/0104041 Al  TABLE  56  TABLE  57  TABLE  59  TABLE  58  [0389]  Since testosterone is not expected to react with  NaOH, the NaOH concentration listed in Table 57 equals the  excess NaOH concentration, calculated as described in  Example 2.  [0390]  The  pH  of the patches was measured as described  in the Methods section. The  pH  of the testosterone patch  increased from 7.14 to 10.32 when the calculated excess  NaOH  concentration in the dried patch was increased from  0% to 3.6%.  [0392]  The cumulative amount of testosterone across  human cadaver skin at 24 hours increased from 7.4  µg  /cm 2  to 199.4  µg/cm 2  when the calculated excess NaOH concen› tration in the dried patch was increased from 0% to 3.6%.  The cumulative amount of testosterone across human  cadaver skin at 24 hours from the system containing 1.0%  NaOH (Test-2) was 49.9  µg/cm 2 ,  which was about six times  higher than that from the formulation without NaOH (7.4  µg!cm 2 ,  Test-1). This result indicated that the permeation of  testosterone could be enhanced with an excess NaOH con› centration as low as 1.0%.  [0393]  The formulation of Test-P92 provided up to 7-fold  more testosterone flux than in the absence ofNaOH (Test-1).  The formulation of Test-3 provided up to 19-fold more flux,  while the highest  pH  formulation evaluated, Test-4, pro› vided up to 40-fold more flux than in the absence of NaOH.  [0391]  The in vitro permeation of testosterone through  human cadaver skin from these discs was measured as  described in the Methods section. Three diffusion cells were  used for each formulation. The cells were filled with 10%  ethanol/90% water solution. The receiver solution was com› pletely withdrawn and replaced with fresh ethanol/water  solution at each time point. The samples taken were ana› lyzed by an  HPLC  for the concentration of testosterone in  the receiver solution. The cumulative amount of testosterone  across human cadaver skin was calculated using the mea› sured testosterone concentrations in the receiver solutions.  [0394]  An in-vitro skin permeation study was conducted  using four diclofenac sodium transdermal systems, desig› nated Diclo-9, Diclo-10, Diclo-11, and Diclo-12, the com› positions of which are set forth in Table 60. Round disc  samples were prepared as described in the Methods section.  The theoretical percent weight for each ingredient after  drying ( calculated assuming all the volatile ingredients were  completely removed during drying) is listed in Table 61.  Example 19  Component Weight and Weight Percent Based on  Total Solution Weight  Test-1  Test-2  Test-3  Test-4  g(wt%)  g(wt%)  g(wt%)  g(wt%)  Testosterone  0.3 (4.8)  0.3 (4.7)  0.3 (4.7)  0.3 (4.7)  Ethyl alcohol  0.5 (7.9)  0.5 (7.9)  0.5 (7.8)  0.5 (7.8)  PG  0.5 (7.9)  0.5 (7.9)  0.5 (7.8)  0.5 (7.8)  NaOH  0  0.02 (0.3)  0.04 (0.6)  0.D75 (1.2)  DI water  0  0.02 (0.3)  0.04 (0.6)  0.D75 (1.2)  PIE adhesive  4 (63.5)  4 (63.1)  4 (62.7)  4 (62.0)  (30% solid)  Heptane  1 (15.9)  1 (15.8)  1 (15.7)  1 (15.5)  [0388]  Component Weight and Weight Percent Based on  Dried Film Weight  Test-1  Test-2  Test-3  Test-4  g(wt%)  g(wt%)  g(wt%)  g(wt%)  Testosterone  0.3 (15.0)  0.3 (14.9)  0.3 (14.7)  0.3 (14.5)  PG  0.5 (25.0)  0.5 (24.8)  0.5 (24.5)  0.5 (24.1)  NaOH  0  0.02 (1.0)  0.04 (2.0)  0.D75 (3.6)  PIE adhesive  1.2 (60.0)  1.2 (59.4)  1.2 (58.8)  (30% solid)  1.2 (57.8)  Cumulative Amount of Testosterone (µg/cm 2 )  Time  Test-1  Test-2  Test-3  Test-4  5 hours  1.9  7.3  36.1  76.1  16.25 hours  4.3  28.5  78.0  147.8  20 hours  5.3  36.6  89.5  168.8  24 hours  7.4  49.9  108.0  199.4  Excess NaOH Concentration (wt % ) and pH  Excess NaOH  Concentration  pH  Test-1  0  7.14  Test-2  Test-3  1.0  2.0  9.17  10.04  Test-4  3.6  10.32 