High drug load solid oral dosage forms of dexamethasone
AssigneeJubilant Pharma Holdings Inc.
InventorIndranil Nandi
Life of this patent
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Abstract
The present invention relates to high drug load solid oral pharmaceutical compositions comprising dexamethasone or its pharmaceutically acceptable salts or solvates thereof. The present invention also relates to a process for preparing high drug load solid oral pharmaceutical compositions comprising dexamethasone or its pharmaceutically acceptable salts or solvates thereof. The preferred drug load in the compositions of the present invention is from about 26% to 50% by weight based on the total weight of the composition. The prepared compositions of dexamethasone as per the present invention exhibit desirable technical attributes.
Claims20
A high drug load solid oral pharmaceutical composition comprising:
- i) about 26% to about 50% by weight of dexamethasone or its pharmaceutically acceptable salts or solvates thereof;
- ii) from 0 to about 70% by weight of one or more diluents;
- iii) from 0 to about 30% by weight of one or more binders;
- iv) from 0 to about 20% by weight of one or more disintegrants;
- and
- v) from 0.1% to about 5% by weight of one or more lubricants.
A high drug load immediate-release tablet composition comprising:
- i) about 26% to about 35% by weight of dexamethasone or its pharmaceutically acceptable salts or solvates thereof;
- ii) from about 50% to about 70% by weight of one or more diluents;
- iii) from about 0.01% to about 10% by weight of one or more disintegrants;
- and
- iv) from about 0.1% to about 5% by weight of one or more lubricants;
- wherein the composition is free of a binder.
A high drug load immediate-release tablet composition comprising:
- i) about 26% to about 35% by weight of dexamethasone or its pharmaceutically acceptable salts or solvates thereof;
- ii) from about 50% to about 70% by weight of one or more diluents;
- iii) from about 0.01% to about 10% by weight of one or more binders;
- and
- iv) from about 0.1% to about 5% by weight of one or more lubricants;
- wherein the composition is free of a disintegrant.
Dependencies are inferred from the claim text.