摘要 |
AN IMMEDIATE RELEASE PHARMACEUTICAL GRANULE COMPOSITION COMPRISING (I) AT LEAST ONE DRUG BELONGING TO CLASS II OR CLASS IV OF THE BIOPHARMACEUTICAL CLASSIFICATION SYSTEM, WHEREIN THE SAID DRUG CONSTITUTES AT LEAST ABOUT 0.5% BY WEIGHT AND UP TO ABOUT 20% BY WEIGHT OF THE COMPOSITION, THE SAID COMPOSITION FURTHER COMPRISING (II) A FIRST EXCIPIENT SELECTED FROM THE GROUP CONSISTING OF: - BLENDS OF A MICROCRYSTALLINE CELLULOSE AND A SWELLABLE POLYMER IN RESPECTIVE AMOUNTS SUCH THAT THE WEIGHT RATIO OF THE SAID POLYMER TO THE MICROCRYSTALLINE CELLULOSE IN THE BLEND IS ABOVE ABOUT 2:100 AND UP TO ABOUT 30:100, - ONE OR MORE DEXTRIN-CONTAINING COMPOUNDS SELECTED FROM THE GROUP CONSISTING OF MALTODEXTRINS, CYCLODEXTRINS AND DERIVATIVES THEREOF, AND - MIXTURES OF THE SAID DEXTRIN-CONTAINING COMPOUNDS AND THE SAID BLENDS, AND (III) A WETTING AMOUNT OF A SECOND EXCIPIENT BEING A NON-AQUEOUS WETTING COMPOUND OR MELTABLE COMPOUND AND COMPRISING A SOLID FRACTION AND OPTIONALLY A LIQUID FRACTION.
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