Bioavailable solid dosage forms of metaxalone

Bioavailable solid dosage forms of metaxalone

  • CN 103,284,965 A
  • Filed: 03/08/2005
  • Published: 09/11/2013
  • Est. Priority Date: 03/08/2004
  • Status: Active Application
First Claim
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1. pharmaceutical solid dosage forms, it comprises metaxalone, at least a being selected from is slightly soluble in water or water-fast, natural or synthetic substantially hydrophilic colloid and powder excipients and at least a non-volatile liquid of polymer,The method preparation of described dosage form by may further comprise the steps:

  • The metaxalone of effective dose is provided;

    At least a powder excipients that is selected from sodium alginate, ammonium alginate, sodium carboxymethyl cellulose, microcrystalline Cellulose, pregelatinized Starch, Explotab, methacrylic acid copolymer or its combination is provided;

    Metaxalone and the described at least a powder excipients dry blending that is selected from sodium alginate, ammonium alginate, sodium carboxymethyl cellulose, microcrystalline Cellulose, pregelatinized Starch, Explotab, methacrylic acid copolymer or its combination with described effective dose;

    With described at least a non-volatile liquid and at least a volatile liquid with metaxalone/powder blend moistening to form mixture;

    With described granulating mixture to form granule;

    Drying is also ground described granule;

    Mix with at least a other non-activity powder excipients;

    And compacting is in flakes to prepare described pharmaceutical solid dosage forms;

    Wherein said at least a non-volatile liquid is selected from propylene glycol, glycerol, liquid macrogol, semi-solid Polyethylene Glycol, pharmasolve, liquid polysorbate, semi-solid polysorbate, this dish of liquid, semi-solid this dish, liquid cremophors, semi-solid cremophors, liquid pluronics, semi-solid pluronics, liquid myglyols, semi-solid myglyols, expressed oi, vitamin E, lecithin or its combination;

    Described at least a volatile liquid is selected from methanol, ethanol, acetone, water or its combination;

    And wherein;

    (i) fill 1000mL and purified waste water, remain on 25 ℃ and

    the peak glass stripping containers back of stirring with 100rpm oar speed with USP II type (oar method) device about 30 minutes in that described dosage form is put into, 29 weight % or more described metaxalone dissolving are arranged;

    Perhaps(ii) fill 1000mL and purified waste water, remain on 35 ℃ and

    the normal glass stripping containers back of stirring with 100rpm oar speed with USP II type (oar method) device about 30 minutes in that described dosage form is put into, 40 weight % or more described metaxalone dissolving are arranged;

    Perhaps(iii) at the aqueous solution of described dosage form being put into the sodium lauryl sulphate that fills the every volume water 0.1 weight % of 500mL, remained on 37 ℃ and

    the peak glass stripping containers back of stirring with 50rpm oar speed with USP II type (oar method) device about 30 minutes, 30 weight % or more described metaxalone dissolving are arranged.

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