| 摘要 |
A pharmaceutical solid dosage form comprises metaxalone and at least one powder excipient, wherein the metaxalone is dry-mixed with the at least one powder excipient; the metaxalone/powder blend is then wetted and granulated with at least one pharmaceutically acceptable volatile liquid; and the wet granulation is then dried, milled and subsequently mixed with other powder excipients to yield the final metaxalone/powder blend which is then compressed to produce the pharmaceutical solid dosage form, and wherein: (i) 13% by weight or greater of said metaxalone is dissolved about 30 minutes after said dosage form is placed in a peak glass dissolution vessel filled with 1000 mL of purified water, maintained at 25°C and stirred at a paddle speed of 100 rpm using a USP Type II (paddle) apparatus; or (ii) 28% by weight or greater of said metaxalone is dissolved about 30 minutes after said dosage form is placed in a standard glass dissolution vessel filled with 1000 mL of purified water, maintained at 35°C and stirred at a paddle speed of 100 rpm using a USP Type II (paddle) apparatus; or (iii) 27% by weight or greater of said metaxalone is dissolved about 30 minutes after said dosage form is placed in a peak glass dissolution vessel filled with 500 mL of an aqueous solution of 0.1 % by weight of Sodium Lauryl Sulfate per volume of water, maintained at 37°C and stirred at a paddle speed of 50 rpm using a USP Type II (paddle) apparatus. |
