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TOPICAL PHARMACEUTICAL COMPOSITIONS OF BENZOYL PEROXIDE AND A TETRACYCLINE ANTIBIOTIC

IP.com Disclosure Number: IPCOM000237117D
Publication Date: 2014-Jun-03

Publishing Venue

The IP.com Prior Art Database

Abstract

The present disclosure relates to topical pharmaceutical compositions comprising a hydrogel composition of benzoyl peroxide and an oleaginous gel composition of a tetracycline antibiotic. It also relates to processes for the preparation of the topical pharmaceutical compositions, and dispensing systems for their administration. It further relates to a method of treating topical conditions by administering the topical pharmaceutical compositions.

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TOPICAL PHARMACEUTICAL COMPOSITIONS OF BENZOYL PEROXIDE AND A TETRACYCLINE ANTIBIOTIC

Abstract

The present disclosure relates to topical pharmaceutical compositions comprising a hydrogel composition of benzoyl peroxide and an oleaginous gel composition of a tetracycline antibiotic.  It also relates to processes for the preparation of the topical pharmaceutical compositions, and dispensing systems for their administration.  It further relates to a method of treating topical conditions by administering the topical pharmaceutical compositions.

Reported herein is a topical pharmaceutical composition comprising:

(a)          a hydrogel composition of benzoyl peroxide; and

(b)         an oleaginous gel composition of a tetracycline antibiotic.

Reported herein is a dispensing system for administering a topical pharmaceutical composition comprising:

(a)          a hydrogel composition of benzoyl peroxide; and

(b)         an oleaginous gel composition of a tetracycline antibiotic.

Also reported herein is a process for the preparation of topical pharmaceutical composition, wherein the process comprises the steps of:

(a)     dispersing benzoyl peroxide, one or more gelling agents, and one or more pharmaceutically acceptable excipients in an aqueous vehicle to form a hydrogel composition; and

(b)     dispersing a tetracycline antibiotic, one or more thickening agents, and one or more pharmaceutically acceptable excipients in a non-aqueous vehicle to form an oleaginous gel composition.

Further, reported herein is a method of treating a topical condition by administering a topical pharmaceutical composition comprising:

(a)          a hydrogel composition of benzoyl peroxide; and

(b)         an oleaginous gel composition of a tetracycline antibiotic.

Preferably, the tetracycline antibiotic as disclosed herein is minocycline.

To overcome the incompatibility and stability related problems of combinations of benzoyl peroxide and minocycline, separate compositions for both benzoyl peroxide and minocycline were prepared.  By preparing the topical composition in two separately maintained components, the individual components would remain stable and allow long-term storage of the compositions at room temperature without degradation.

The hydrogel composition and oleaginous gel composition, as disclosed herein, have substantially similar specific gravities to achieve the desired consistency so as to provide a cosmetically elegant and a patient complaint product.

“Topical”, as used herein, means the composition for application to the skin, nail, or mucosal tissue.

“Topical condition”, as used herein, means a disease or disorder selected from acne, infection, inflammation, pruritis, psoriasis, seborrhea, contact dermatitis, skin cancers, skin photoaging, pigmentation, redness, rosacea, and combinations thereof.

“Hydrogel”, as used herein, means a semisolid composition that consists of an aqueous vehicle constrained within a three dimensional polymeric network.  The hydrogel composition comprise...