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Therapeutic topical compositions of apremilast

A composition and topical application technology, applied in the field of topical therapeutic composition of Apremilast, can solve the problem that oral tablet composition is not suitable for swallowing difficulties or gastrointestinal side effects

Pending Publication Date: 2019-10-18
SARUDBHAVA FORMULATIONS PTE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Although apremilast can be used as an effective oral therapy for psoriasis; oral tablet compositions are less suitable for patients who have difficulty swallowing or gastrointestinal side effects that do not decrease even after titration of the recommended oral dose

Method used

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  • Therapeutic topical compositions of apremilast
  • Therapeutic topical compositions of apremilast
  • Therapeutic topical compositions of apremilast

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] Example 1: Topical Composition of Apremilast

[0083]

[0084] program:

[0085] a) Dissolve apremilast in a portion of ethanol while stirring.

[0086] b) Add isopropyl myristate and undecylenic acid to the solution of step (a) while stirring.

[0087] c) Add the remaining amount of ethanol to the solution of step (b) and mix.

Embodiment 2

[0088] Example 2: Topical Composition of Apremilast

[0089]

[0090] program:

[0091] a) Dissolve apremilast in a portion of ethanol while stirring.

[0092] b) Dissolve iodide and sodium thiosulfate in water.

[0093] c) Adding the solution obtained in step (b) to the solution of step (a) while stirring.

[0094] d) Make up the volume to the required amount by adding ethanol and water to the solution of step (c) and mixing.

Embodiment 3

[0095] Example 3: Topical Composition of Apremilast

[0096]

[0097] program:

[0098] a) Dissolve apremilast in a mixture of isopropyl myristate, mineral oil and carbitol with stirring.

[0099] b) Dissolve the acrylic acid polymer in ethanol.

[0100] c) Adding the solution obtained in step (b) to the solution of step (a) while stirring.

[0101] d) Make up the volume to the required amount by adding ethanol and mineral oil to the solution of step (c) and mixing.

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PUM

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Abstract

The present invention relates to topical compositions comprising apremilast. It also relates to processes for preparing such compositions and methods of using them in management of skin diseases or disorders such as psoriasis, dermatosis, eczema, rosacea, acne vulgaris, allergies, contact and atopic dermatitis, pruritus, seborrhea, skin cancers, inflammation and other associated skin conditions.

Description

[0001] field of invention [0002] The present application provides formulations for topical administration of apremilast. The present application also provides methods for the preparation of such compositions and methods of using them to manage skin diseases or disorders such as psoriasis, dermatosis, eczema, rosacea, acne vulgaris , allergies, contact and atopic dermatitis, pruritus, seborrhea, skin cancer, inflammation and other related skin conditions. [0003] Background of the invention [0004] Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is chemically known as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2 ,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, having the chemical structure given below: [0005] [0006] Apremilast is currently only available as a product sold by Celgene Corp under the trade name Oral formulations obtained. Tablets are supplied for oral administration in strengths of 10 mg, 20 mg and 30 mg. T...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61Q19/00
CPCA61K8/492A61K9/0014A61K31/4035A61K45/06A61P17/00A61P17/04A61P17/06A61P17/08A61P17/10A61P17/16A61P29/00A61P35/00A61P37/08A61P43/00A61Q19/00
Inventor 文卡塔·努卡拉朱·斯里达拉拉
Owner SARUDBHAVA FORMULATIONS PTE LTD
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