Capsule Formulation of Pirfenidone and Pharmaceutically Acceptable Excipients
First Claim
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1. A capsule comprising a pharmaceutical formulation of 5-methyl-1-phenyl-2-(1H)-pyridone, wherein said pharmaceutical formulation comprises, by weight, 5-30% of pharmaceutically acceptable excipients and 70-95% of 5-methyl-1-phenyl-2-(1H)-pyridone.
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Abstract
A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.
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36 Claims
- 1. A capsule comprising a pharmaceutical formulation of 5-methyl-1-phenyl-2-(1H)-pyridone, wherein said pharmaceutical formulation comprises, by weight, 5-30% of pharmaceutically acceptable excipients and 70-95% of 5-methyl-1-phenyl-2-(1H)-pyridone.
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20. A method for treating-a pulmonary fibrotic condition, comprising administering to a patient suffering said condition a capsule comprising by weight 70-95% of 5-methyl-1-phenyl-2-(1H)-pyridone and 5-30% of pharmaceutically acceptable excipients.
- 21. A capsule comprising an effective amount of 5-methyl-1-phenyl-2-(1H)-pyridone and pharmaceutically acceptable excipients, wherein said capsule is capable of sustaining a measurable pharmacokinetic response in a patient, wherein said pharmacokinetic response is characterized by a one or more fold increase in the Tmax values compared to a capsule of 5-methyl-1-phenyl-2-(1H)-pyridone containing no pharmaceutically acceptable excipients.
- 22. A capsule comprising an effective amount of 5-methyl-1-phenyl-2-(1H)-pyridone and pharmaceutically acceptable excipients, wherein said capsule is capable of sustaining a measurable pharmacokinetic response in a patient, wherein said pharmacokinetic response is characterized by a one or more fold increase in the AUC values compared to a capsule of 5-methyl-1-phenyl-2-(1H)-pyridone containing no pharmaceutically acceptable excipients.
Specification