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Topical compositions of apremilast

A composition, topical medicine technology, applied in the field of treating skin diseases

Inactive Publication Date: 2019-02-05
TORRENT PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, there remains an unmet need to develop suitable formulations with favorable properties to provide desired efficacy at reduced dosage and frequency of administration

Method used

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  • Topical compositions of apremilast
  • Topical compositions of apremilast
  • Topical compositions of apremilast

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0149] Embodiment 1 (Apremilast topical foamable composition)

[0150] Table 1

[0151]

[0152]

[0153] Process for preparing apremilast topical foamable formulation

[0154] Apremilast was dissolved in isosorbide dimethyl ether and / or diethylene glycol monoethyl ether (Transcutol) to obtain a drug solution. Polyethylene glycol (15)-hydroxystearate, ceteareth 20, cetyl alcohol, PEG-400, glyceryl monocaprylate, polysorbate and phenoxyethanol according to Table 1 Melt and mix to make the oil phase. The previously prepared drug solution was added dropwise to the oil phase and stirred to obtain a mixture. PVP-K30 in Example 1a was added to water to prepare an aqueous phase, and water was used as the aqueous phase in Example 1b. Add the aqueous phase to the prepared mixture and stir slowly to obtain a microemulsion. The microemulsion thus prepared was filled in an aluminum can, and a propellant (deodorized liquefied petroleum gas (LPG)) was added in Example 1b to obtain ...

Embodiment 2

[0155] Embodiment 2 (Apremilast topical foamable composition)

[0156] Table 2

[0157]

[0158] Process for preparing apremilast topical foamable formulation

[0159] Apremilast was dissolved in isosorbide dimethyl ether and / or diethylene glycol monoethyl ether (Transcutol) to obtain a drug solution. Melt and mix other excipients such as polyethylene glycol (15)-hydroxystearate, ceteareth 20, cetyl alcohol, PEG-400, glyceryl monocaprylate and phenoxyethanol to prepare the oil Mutually. The previously prepared drug solution was added dropwise to the oil phase and stirred to obtain a homogeneous mixture. Add PVP-K30 to water to prepare an aqueous phase. Add the aqueous phase to the prepared homogeneous mixture and stir slowly to obtain a microemulsion. The microemulsion thus prepared was filled in an aluminum can, and finally a propellant (deodorized liquefied petroleum gas (LPG)) was added to obtain a topical microemulsion foam of Apremilast.

Embodiment 3

[0160] Embodiment 3 (Apremilast topical foamable composition)

[0161] table 3

[0162]

[0163] The compositions of Examples 3a-3d were prepared according to the method described in Example 2.

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Abstract

The present invention relates to topical pharmaceutical compositions comprising Apremilast in an amount of about 0.1 to 5 % w / w of the total composition and one or more pharmaceutically acceptable excipients and process for their preparation. The present invention further relates to method for treatment of skin diseases using topical pharmaceutical compositions comprising Apremilast.

Description

technical field [0001] The present invention relates to a topical pharmaceutical composition comprising apremilast and one or more pharmaceutically acceptable auxiliary materials and a preparation method thereof. The present invention also relates to methods of treating skin disorders using topical pharmaceutical compositions comprising apremilast. Background technique [0002] Apremilast is chemically known as N-{2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl base]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acetamide, which can be characterized by the following chemical formula: [0003] [0004] In the United States and Europe, apremilast is approved as It is a selective phosphodiesterase 4 (PDE4) inhibitor and increases intracellular cyclic adenosine monophosphate (cAMP), thereby reducing inflammatory cytokines such as tumor necrosis factor and interleukin-23 (IL-23 )expression. It is indicated for the treatment of active psoriatic arthritis and plaque p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/08A61K47/10A61K9/06A61K9/12A61K31/4035
CPCA61K47/08A61K47/10A61K9/06A61K9/122A61K31/4035A61K9/0014A61P37/08A61K47/22
Inventor 贾亚·亚伯拉罕维韦克·米什拉基兰·乔杜里卫普·米塔尔
Owner TORRENT PHARMA LTD
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