Topical pharmaceutical gel composition of diclofenac sodium

摘要

Topical pharmaceutical gel compositions of diclofenac sodium are provided. The topical gel compositions contain at least about 10% w/w diclofenac sodium and are suitable for once-a-day topical application.

主权项

1. A topical pharmaceutical gel composition of diclofenac comprising:
at least about 10% w/w of diclofenac sodium; about 5-25% w/w of a glycol solvent; about 1-6% w/w of at least one gelling agent; about 0.01-0.75% w/w of at least one preservative; about 0.01-1% w/w of at least one antioxidant; about 1-10% w/w of a salicylic acid ester; about 0.05-1% w/w of menthol; at least 50% w/w of water; and at least one acidic and/or basic agent to adjust the pH of the composition to 4-8, wherein the ratio of the amount of diclofenac sodium to the amount of the salicylic acid ester is about 1:0.1 to about 1:0.5 and/or the ratio of the amount of diclofenac sodium to the amount of menthol is about 1:0.01 to about 1:0.05.