Core formulation
AssigneeAeropharm Technology Incorporated
InventorsAkwete L. Adjei, Yaping Zhu, Anthony J. Cutie
Life of this patent
Estimating the term…
Abstract
This invention relates to a controlled release combination drug product comprising troglitazone, e.g. its hydrochloride, and a biguamide, e.g. metformin. In particular, the product comprises a core of metformin, at least a portion thereof has a layer or coat thereon of troglitazone.
Claims17
A core formulation comprising,
- (a) a first layer comprising troglitazone or a pharmaceutically acceptable salt thereof as an active ingredient,
- (b) a core, at least a portion of which is enclosed by said first layer, comprising a biguanide as an active ingredient;
- and
- (c) a polymer selected from the group consisting of a silicate;
- diatomacous earth;
- Fuller's earth, Kieselhurh, Celite;
- talc;
- attapulgite;
- micas;
- montmorilonite, kaolin, aluminum oxide, bentonite, pumice;
- silanes and siloxanes and a mixture of any of the foregoing polymers, and a mixture thereof, associated with at least one of said active ingredients.
A method for producing a controlled release formulation, which comprises:
- (a) producing a hollow outer shell comprising a gel-like material of a polymer selected from the group consisting of silica gel, fumed silica gel, silicic acid, disilicic acid, trisilic acid, metasilicic acid, and orthosilicic acid in their free or salt forms;
- silicon dioxide in either of its amporphous, crystalline, or precipitated forms;
- diatomacous earth;
- Fuller's earth, Kieselhurh, Celite;
- talc;
- attapulgite;
- micas;
- montmorilonite, kaolin, aluminum oxide (Hydrargilite), bentonite, Bentonite Magma™, pumice;
- a silane, a siloxane and a mixture of any of the foregoing polymers having a predetermined rate of medicament release to provide a predetermined delay in the time period of release of the contents destined to be enclosed by said shell;
- (b) inserting a core comprising metformin and having an outer layer comprising troglitazone partially enclosing said core, into said hollow outer shell;
- and
- (c) sealing said core within said hollow outer shell.
A method of producing a modulated release formulation of troglitazone hydrochloride medicament and metformin medicament, which comprises:
- (a) forming a core of the metformin medicament;
- and
- (b) depositing a layer of the troglitazone hydrochloride medicament on at least a portion of a surface of said core;
- and
- (c) associating a polymer selected from the group consisting of silica gel, fumed silica gel, silicic acid, disilicic acid, trisilic acid, metasilicic acid, and orthosilicic acid in their free or salt forms;
- silicon dioxide in either of its amporphous, crystalline, or precipitated forms;
- diatomacous earth;
- Fuller's earth, Kieselhurh, Celite;
- talc;
- attapulgite;
- micas;
- montmorilonite, kaolin, aluminum oxide, bentonite, pumice;
- silanes and siloxanes and a mixture of any of the foregoing with at least one of the medicaments to form the modulated release formulation.
A drug controlled-release pharmaceutical composition comprising an effective amount of troglitazone hydrochloride combined with an effective amount of metformin associated with an effective controlled-release amount of a polymer selected from the group consisting of silica gel, fumed silica gel, silicic acid, disilicic acid, trisilic acid, metasilicic acid, and orthosilicic acid in their free or salt forms;
- silicon dioxide in either of its amporphous, crystalline, or precipitated forms;
- diatomacous earth;
- Fuller's earth, Kieselhurh, Celite;
- talc;
- attapulgite;
- micas;
- montmorilonite, kaolin, aluminum oxide, bentonite, pumice;
- silanes and siloxanes and a mixture of any of the foregoing polymers.
A drug controlled-release pharmaceutical composition comprising an effective amount of troglitazone hydrochloride combined with an effective amount of phenformin associated with an effective controlled-release amount of a polymer selected from the group consisting of silica gel, fumed silica gel, silicic acid, disilicic acid, trisilic acid, metasilicic acid, and orthosilicic acid in their free or salt forms;
- silicon dioxide in either of its amporphous, crystalline, or precipitated forms;
- diatomacous earth;
- Fuller's earth, Kieselhurh, Celite;
- talc;
- attapulgite;
- micas;
- montmorilonite, kaolin, aluminum oxide, bentonite, pumice;
- silane;
- a siloxane and a mixture of any of the foregoing polymers.
A controlled-release pharmaceutical composition comprising an effective amount of troglitazone hydrochloride combined with an effective amount of buformin associated with an effective controlled-release amount of a polymer selected from the group consisting of silica gel, fumed silica gel, silicic acid, disilicic acid, trisilic acid, metasilicic acid, and orthosilicic acid in their free or salt forms;
- silicon dioxide in either of its amporphous, crystalline, or precipitated forms;
- diatomacous earth;
- Fuller's earth, Kieselhurh, Celite;
- talc;
- attapulgite;
- micas;
- montmorilonite, kaolin, aluminum oxide, bentonite, pumice;
- a silane;
- a siloxane and a mixture of any of the foregoing polymersor.
Dependencies are inferred from the claim text.