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Bioavailable Solid Dosage Forms of Metaxalone
专利权人:
发明人:
申请号:
EP09165833.6
公开号:
EP2110124B1
申请日:
2005.03.08
申请国别(地区):
EP
年份:
2013
代理人:
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.
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