Process for preparing tannate liquid and semi-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 ingredient from the group of an antihistamine, a decongestant, an antitussive or anticholinergic is dissolved in a suitable solvent and added to a dispersion of tannic acid in water to form the tannate salt complex of the active ingredient. The active ingredient tannate salt complex without isolation or purification is then added to a liquid or semi-solid medium composed of thickening, suspending, coloring, sweetening and flavoring agents, with stirring. Thereafter, preservatives, pH-adjusting and anti-caking agents in a suitable solvent are mixed with the liquid or semi-solid medium to generate a therapeutic dosage form.
Claims18
A manufacturing process for the in-situ conversion and incorporation of a salt or free base of an active pharmaceutical ingredient selected from the group consisting of an antihistamine, a decongestant, an antitussive and an anticholinergic for incorporation into a therapeutic liquid or semi-solid dosage form, the process comprising the steps of:
- (a) dissolving the salt or free base of the active pharmaceutical ingredient in a pharmaceutically acceptable liquid to form a solution;
- (b) separately adding a dispersing agent and tannic acid to a pharmaceutically acceptable liquid to form a dispersion;
- (c) transferring the solution from step (a), to the dispersion in step (b) to form a precipitate of a tannate salt complex of the active pharmaceutical ingredient;
- and
- (d) combining the tannate salt complex of the active pharmaceutical ingredient without isolation or purification with a pharmaceutically acceptable excipient to generate a therapeutic dosage form.
A process for converting a salt or free base of an active pharmaceutical ingredient selected from a group consisting of an antihistamine, a decongestant, an antitussive and an anticholinergic into a therapeutic liquid or semi-solid dosage form, the process comprising the steps of:
- (a) dissolving the salt or free base of the active pharmaceutical ingredient in a pharmaceutically acceptable liquid to form a solution;
- (b) adding tannic acid to a pharmaceutically acceptable liquid to form a dispersion;
- (c) transferring the solution from step (a), to the dispersion in step (b) to form a precipitate of a tannate salt complex of the active pharmaceutical ingredient;
- and
- (d) achieving more consistent therapeutic dosing by directly combining the tannate salt complex of the active pharmaceutical ingredient with a pharmaceutically acceptable excipient without isolation and purification.
A process for preparing a tannate salt complex of an active pharmaceutical ingredient selected from a group consisting of an antihistamine, a decongestant, an antitussive and an anticholinergic, comprising:
- reacting a salt or free base of the active pharmaceutical ingredient with tannic acid in a pharmaceutically acceptable liquid to form a reaction solution;
- directly combining said reaction solution with a pharmaceutically acceptable excipient without isolation or purification to generate a therapeutic dosage.
Dependencies are inferred from the claim text.