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Topical pharmaceutical composition of adapalene and minocycline

A topical composition, minocycline technology, applied in the direction of drug combination, drug delivery, tetracycline active ingredients, etc., can solve problems such as instability, moisture, temperature and light sensitivity

Inactive Publication Date: 2020-06-26
GLENMARK PHARMACEUTICALS LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] U.S. Patent Publication No. 2014 / 0147504 discloses that the main challenge in developing a topical formulation of minocycline is its chemical nature: it is unstable in solution and is also sensitive to moisture, temperature and light
No FDA-approved topical minocycline formulations to date

Method used

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  • Topical pharmaceutical composition of adapalene and minocycline
  • Topical pharmaceutical composition of adapalene and minocycline
  • Topical pharmaceutical composition of adapalene and minocycline

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0149] Embodiment 1: Adapalene / minocycline hydrochloride preparation

[0150] Table 1

[0151]

[0152] Preparation:

[0153] 1. Dissolve magnesium chloride in water with stirring at 500-1000 RPM for about 10 minutes until a clear solution is observed.

[0154] 2. Add sodium sulfite to the above solution with stirring at 500-1000 RPM for about 20 minutes to obtain a clear solution.

[0155] 3. Add minocycline hydrochloride to the solution formed in step 2 with stirring at 500-1000 RPM for 20-30 minutes.

[0156] 4. Add adapalene to the above mixture under stirring at 500-1000 RPM for 20-30 minutes, and homogenize the resulting mixture to obtain a uniform dispersion.

[0157] 5. Add acrylamide / sodium acryloyldimethyl taurate copolymer / isohexadecane / polysorbate 80 to the mixture formed in step (4) and homogenize for about 30 minutes to obtain a uniform gel glue dispersion.

Embodiment 2

[0158] Embodiment 2: Adapalene / minocycline hydrochloride preparation

[0159] Table 2

[0160]

[0161]

[0162] Preparation:

[0163] 1. Dissolve magnesium chloride in purified water with stirring at 500-1000 RPM for about 10 minutes until a clear solution is observed.

[0164] 2. Add sodium sulfite to the above solution with stirring at 500-1000 RPM for about 20 minutes to obtain a clear solution.

[0165] 3. Add minocycline hydrochloride to the solution formed in step (2) under stirring at 500-1000 RPM for 20-30 minutes to ensure complete dissolution of the drug in the solvent.

[0166] 4. Adapalene was dispersed in a solvent system comprising glycerin and propylene glycol under stirring at 500-1000 RPM for 20 minutes to obtain a homogeneous dispersion of API.

[0167] 5. The adapalene dispersion was then added to the solution mixture formed in step (3) with stirring at 500-1000 RPM for 20-30 minutes.

[0168] 6. Add acrylamide / sodium acryloyldimethyl taurate copo...

Embodiment 3

[0169] Embodiment 3: Adapalene / minocycline hydrochloride preparation

[0170] table 3

[0171] Element %w / w adapalene 0.1-0.3 Minocycline Hydrochloride 1-4 magnesium chloride 0.1-3 Sulfite 0.1-0.2 Propylene Glycol 4-10 glycerin 4-10 Sodium hyaluronate 1-2.5 purified water 70-85

[0172] Preparation:

[0173] 1. Dissolve magnesium chloride in purified water with stirring at 500-1000 RPM for about 10 minutes until a clear solution is observed.

[0174] 2. Add sodium sulfite to the above solution with stirring at 500-1000 RPM for about 20 minutes to obtain a clear solution.

[0175] 3. Add minocycline hydrochloride to the solution formed in step (2) with stirring at 500-1000 RPM for about 20-30 minutes to ensure complete dissolution of the drug in the solvent.

[0176] 4. Add sodium hyaluronate and disperse it into the solution mixture formed in step (3) under stirring at 1000-2000 RPM for about 30-60 minutes to ob...

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PUM

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Abstract

A topical pharmaceutical composition comprises adapalene or a pharmaceutical acceptable salt thereof and minocycline or a pharmaceutical acceptable salt thereof. The composition is for topical application and used to treat acne.

Description

[0001] priority statement [0002] This patent application claims priority from Indian Provisional Patent Application IN 201721037587 filed on October 24, 2017 and Indian Provisional Patent Application IN 201721037989 filed on October 26, 2017, the contents of which are incorporated by reference way incorporated into this article. [0003] field of invention [0004] The present invention relates to pharmaceutical compositions (eg, fixed dose combinations,) comprising adapalene and minocycline. Also provided are methods of preparation and use of such compositions for the treatment of acne vulgaris. [0005] Background of the invention [0006] Acne vulgaris is an inflammatory disease of the sebaceous glands characterized by skin eruptions, usually pustular but not supportive. Acne is a common condition among adolescents and affects a small but significant proportion of the adult population. Affected acne produces unsightly lesions, especially on the face, and in some cases ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/06A61K9/10A61K31/7048A61K31/65A61P17/10
CPCA61K31/65A61P17/10A61K9/0014A61K31/192A61K9/06A61K47/34A61K2300/00A61K47/02A61K47/32A61K47/38
Inventor U·R·杜帕德M·博马加尼R·R·帕特洛拉G·班加A·肖佩德G·德赫贝M·克里希纳
Owner GLENMARK PHARMACEUTICALS LTD
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