Granulate Formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and Method of Making the Same
AssigneeHoffmann-La Roche Inc.
InventorSiddharthya Krishnachandan Mujumdar
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Abstract
The disclosure relates to granulate formulations of pirfenidone and methods of making such formulations.
Claims102
A granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone, comprising granules comprising:
- 5-methyl-1-phenyl-2-(1H)-pyridone and a glidant.
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A method of making a granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone, comprising:
- mixing the 5-methyl-1-phenyl-2-(1H)-pyridone and intragranular excipients in a fluid bed granulator to form granules, wherein the intragranular excipients comprise a glidant;
- and
- optionally adding one or more extragranular excipients to the granules.
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The method of claim 59, wherein, when present:
- the filler is present in an amount of about 2% to about 30% by weight based on the total weight of the formulation;
- the binder is present in an amount of about 1% to about 10% by weight based on the total weight of the formulation;
- and
- the distinegrant is present in an amount of about 0.1% to about 10% by weight based on the total weight of the formulation.
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The method of claim 59, wherein the binder is in an aqueous solution, an aqueous suspension, an alcoholic solution, an alcoholic suspension, or an aqueous-alcoholic mixture, and applied to form the granules as a wet granulation.
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Dependencies are inferred from the claim text.