Process for preparing tannate tablet, capsule or other solid dosage forms
AssigneeKiel Laboratories, Inc.
InventorsJeffrey S. Kiel, H. Greg Thomas, Narasimhan Mani
Life of this patent
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Abstract
An active pharmaceutical ingredient is combined with tannic acid to form a tannate salt complex of the active ingredient. The active ingredient tannate salt complex without isolation or purification is then blended with pharmaceutically acceptable excipients to form a granulate which is processed into a tablet or capsule to generate a therapeutic solid dosage form.
Claims17
A process for the conversion of at least one active pharmaceutical ingredient into its tannate salt complex for incorporation into a therapeutic tablet, capsule or other solid dosage form, the process comprising:
- (a) combining, in the presence of a pharmaceutically acceptable liquid, the salt or free base of an active pharmaceutical ingredient with tannic acid to form a tannate salt complex of the active pharmaceutical ingredient and without further treatment;
- and
- (b) processing the tannate salt complex into a tablet, capsule or other solid dosage form.
A process for the conversion of at least one active pharmaceutical ingredient into its tannate salt complex for incorporation into a therapeutic tablet, capsule or other solid dosage form, the process comprising:
- (a) dissolving the salt or free base of the active pharmaceutical ingredient in a pharmaceutically acceptable liquid to form a solution at a maximum temperature and pH value that does not cause decomposition of the active pharmaceutical ingredient;
- (b) separately mixing an anti-clumping agent with tannic acid to generate a blend;
- (c) combining the solution of step (a) with the blend of step (b) to form a tannate salt complex of the active pharmaceutical ingredient;
- (d) combining the tannate salt complex of the active pharmaceutical ingredient of step (c) with a pharmaceutically acceptable excipient to form a granulate;
- and
- (e) processing the granulate into a tablet, capsule or other solid dosage form.
A process for the conversion and incorporation of a salt or free base of at least one active pharmaceutical ingredient into a therapeutic tablet or capsule dosage form, the process comprising:
- (a) dissolving the salt or free base of the at least one active pharmaceutical ingredient in a pharmaceutically acceptable liquid to form a solution at a maximum temperature and pH value that does not cause decomposition of the at least one active pharmaceutical ingredient;
- (b) separately blending an anti-clumping agent with tannic acid in a powder form to form a powder blend;
- (c) applying the solution of step (a) to the powder blend of step (b) with the tannic acid of step (b) present in an amount in excess of the at least one active pharmaceutical ingredient from step (a) to form a tannate salt complex of the at least one active pharmaceutical ingredient;
- (d) combining the tannate salt complex from step (c) after drying with a diluent, a binder, a hardness enhancer, a glidant and a lubricant to produce a granulate;
- and
- (e) forming the granulate into capsules or tablets.
Dependencies are inferred from the claim text.