Jun.5,2003  25  US 2003/0104041 Al  -continued  Keto-5 (containing no ketoprofen, no NaOH)  Keto-6 (containing ketoprofen, no NaOH)  Keto-7  Keto-8  Keto-9  Keto-10  Control (containing petrolatum)  mg/cm 2  when the calculated excess NaOH concentration in  the dried patch was increased from 0.20% to 2.62% (PPA-4),  i.e., up to about 4-fold more flux was obtained than in the  absence of NaOH. The cumulative amount of PPA-HCl  across human cadaver skin at 24 hours from the formulation  with an excess NaOH concentration of 1.33% (PPA-3, 5.2  mg/cm 2 )  is about 4 times higher than that from the formu› lation with an excess Na OH concentration of 0.20% (PPA-2,  1.35 mg/cm 2 ).  [0297]  A  human skin irritation study was performed using  seven transdermal systems, which are listed below:  [0298]  The Control was an occlusive chamber (Hilltop,  Cincinnati, Ohio) containing petrolatum held in place with  paper tape. The following procedures were used to prepare  the systems with the exception of the system containing  petrolatum. The formulations used to prepare these systems  are listed in Table 10, which include weight and weight  percent of each component in the formulations. Round disc  samples were prepared as described in the Methods section,  except that the discs has a diameter of  ‰  inch. The theo› retical percent weight for each ingredient after drying is  listed in Table 11, which was calculated assuming all the  volatile ingredients were completely removed during drying.  [0299]  TABLE  11  TABLE  10  Example 4  Ketoprofen  NaOH  DI water  Tetraglycol  Component Weight and Weight Percent Based on  Total Solution Weight  Keto-7  Keto-8  Keto-9  Keto-10  g(wt%)  g (wt%)  g(wt%)  g(wt%)  2.4 (14.0)  2.4 (14.0)  2.4 (13.9)  2.4 (13.8)  0.6 (3.5)  0.65 (3.8)  0.69 (4.0)  0.73 (4.2)  0.6 (3.5)  0.65 (3.8)  0.69 (4.0)  0.73 (4.2)  0.5 (2.9)  0.5 (2.9)  0.5 (2.9)  0.5 (2.9)  Isopropylmyristate  0.4 (2.3)  0.4 (2.3)  0.4 (2.3)  0.4 (2.3)  Methyl salicylates  0.6 (3.5)  0.6 (3.5)  0.6 (3.5)  Methylal  4 (23.4)  4 (23.3)  4 (23.3)  PIE adhesive  8 (46.8)  8 (46.5)  8 (46.3)  (30% solid)  0.6 (3.5)  4 (23.0)  8 (46.1)  Ketoprofen  NaOH  PIE adhesive  Tetraglycol  Isopropylmyristate  Methyl salicylates  Weight and Theoretical Weight Percent Based on  Dried Film Weight  Keto-7  g(wt%)  2.4 (34.8)  0.6 (8.7)  2.4 (34.0)  0.5 (7.2)  0.4 (5.8)  0.6 (8.7)  Keto-8  g (wt%)  2.4 (34.5)  0.65 (9.4)  2.4 (34.5)  0.5 (7.2)  0.4 (5.8)  0.6 (8.6)  Keto-9  g(wt%)  2.4 (34.3)  0.69 (9.9)  2.4 (34.3)  0.5 (7.2)  0.4 (5.7)  0.6 (8.6)  Keto-10  g(wt%)  2.4 (34.1)  0.73 (10.4)  2.4 (34.1)  0.5 (7.1)  0.4 (5.7)  0.6 (8.5) 