Kiel Laboratories, Inc.

Pernix Therapeutics, LLC

Narasimhan Mani

Jeffrey S Kiel

H Greg Thomas

Tannate compositions containing active pharmaceutical ingredients to be used for treating nausea, vomiting, pain, convulsions, and insomnia and manufacturing processes for preparing the tannate compositions.

Tannate compositions, methods of making and methods of use

The present invention relates to pharmaceutical compositions of gabapentin tannate in solid dosage form, processes for production of those compositions and methods of use of those compositions. Tannate salts of active pharmaceutical ingredients are used in sustained release applications and to improve certain organoleptic properties such as taste. The process may utilize either natural or synthetic tannic acid.

Phenolic acid salts of gabapentin in solid dosage forms and methods of use

The present invention provides a novel process for preparation of the tannate salt of gabapentin for human and veterinary pharmaceutical use. Tannate salts of active pharmaceutical ingredients are used in sustained release applications and to improve certain organoleptic properties such as taste. However, the prior art neither discloses nor suggests the preparation of gabapentin tannate. The process for preparing gabapentin tannate includes the mixing of gabapentin and tannic acid together in the presence of one or more solvents. The method may further include the step of selecting the one or more solvents from a group consisting of purified water, ethanol, glycerin, propylene glycol, diethylether, methylene chloride, acetone, isopropyl alcohol and mixtures thereof. The process may also include the steps of isolating and purifying the tannate salt. This may be accomplished by filtration, drying, centrifugation and lyophilization. The process may utilize either natural or synthetic tannic acid.

Process for preparing phenolic acid salts of gabapentin

The present invention relates to pharmaceutical compositions of gabapentin tannate, processes for production of those compositions and methods of use of those compositions. The present invention provides a novel process for preparation of the tannate salt of gabapentin in liquid or semi-solid dosage form for human and veterinary pharmaceutical use. Tannate salts of active pharmaceutical ingredients are used in sustained release applications and to improve certain organoleptic properties such as taste. The process may utilize either natural or synthetic tannic acid.

Phenolic acid salts of gabapentin in liquid and/or semi-solid dosage forms and methods of use

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.

Process for preparing tannate tablet, capsule or other solid dosage forms

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.

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Port Jefferson, NY, United States of America

Narasimhan Mani