JP-2022516099-A5 -

Dates

Publication Date

20221212

Application Date

20191204

Description

In various embodiments, the first component may contain an immunosuppressant in a mass concentration range of about 0.05% to about 1.0% by weight, for example, about 0.08% to about 0.8% by weight, about 0.1% to about 0.6% by weight, about 0.2% to about 0.5% by weight, or preferably about 0.25% to about 0.4% by weight. In various embodiments, the amount of immunosuppressant is about 0.3% by weight. Sodium mycophenolate, chondroitin sulfate, disodium edetate dihydrate , polyvinylpyrrolidone, polysorbate-80, and PLURONIC® F-127 were combined with approximately 90% buffer salt solution and stirred until completely dissolved. While continuing to stir, METHOCEL® E4M was added, followed by glycerol. The pH of the solution was then adjusted to approximately 5.6 to 5.8 using sodium hydroxide solution, and the remaining buffer salt solution was added. Example 3 Preparation of Pharmaceutical Composition No. 3 A pharmaceutical composition was prepared as described below. The following components were used in the amounts indicated: (a) Approximately 0.321 g of sodium mycophenolate powder; (b) Approximately 0.01 g of betamethasone sodium phosphate powder; (c) Approximately 0.25 g of chondroitin sulfate (bovine); (d) Approximately 0.25 g of powdered dextran 70,000; (e) Approximately 0.30 g of powdered sodium thiosulfate pentahydrate; (f) Approximately 0.20 g of PLURONIC® F-127; (g) Approximately 1.0 mL of glycerol; (h) Approximately 1.17 g of anhydrous disodium phosphate; (i) Approximately 0.4 g of anhydrous monosodium phosphate; (j) Approximately 0.10 g of METHOCEL® E4M; (k) Approximately 40 mL of buffer salt solution; and (l) Approximately 100 mL of sterile water for injection.