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Emulsifiable paste preparation containing alclometasone dipropionate

A technology of aclomethasone dipropionate and cream, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, anti-inflammatory agents, etc. and other problems, to achieve the effect of good buffering capacity, sustained sustained drug release, and increased stability

Active Publication Date: 2018-06-15
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Alclometasone dipropionate cream preparation was first developed by Schering-Plough Company. The commercially available reference preparation is the product of FOUGERA PHARMS Company. The trade name is Alclometasone Dipropionate. This dosage form has not yet been approved for import in China
But in the preparation process of this method, the principal agent needs to be heated and stirred for a long time (about 1 hour) to dissolve in the solvent propylene glycol, which increases time cost and energy cost; the stabilizer chlorocresol has a very pungent smell, which is not conducive to Production operation; and the main drug in the finished paste exists in a solution state, and there is still a risk of degradation as the storage time prolongs or the storage conditions intensify
In addition, there are no reports on other cream compositions or preparation methods that can solve the stability of aclomethasone dipropionate

Method used

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  • Emulsifiable paste preparation containing alclometasone dipropionate
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  • Emulsifiable paste preparation containing alclometasone dipropionate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 2

[0080] The stability of embodiment 1 aclomethasone dipropionate in different states

[0081] The result is as follows:

[0082] Table 1 The stability research results of aclomethasone dipropionate in solution state and solid state

[0083]

[0084]

[0085] Test Conclusions:

[0086] The present invention finds that the stability of aclomethasone dipropionate is related to its existing state, and the stability of aclomethasone dipropionate in solid state is significantly better than that in solution state.

Embodiment 2 2

[0087] Embodiment 2 Alclomethasone dipropionate dispersion medium screening

[0088] The result is as follows:

[0089] The dispersion situation of table 2 aclomethasone dipropionate in different media

[0090]

[0091] Test Conclusions:

[0092] Different excipients have certain dispersibility to aclomethasone dipropionate.

[0093] Cetostearyl alcohol has the best wetting and dispersing ability to aclomethasone dipropionate.

Embodiment 3 2

[0094] Embodiment 3 Alclomethasone dipropionate dispersion condition screening

[0095] The result is as follows:

[0096] Dispersion of the main drug under different dispersion conditions in table 3

[0097]

[0098]

[0099] Test Conclusions:

[0100] Cetostearyl alcohol is used as the dispersion medium, the dispersion temperature is 70-80°C, and the dispersion time is 5 minutes. Alclomethasone dipropionate can be uniformly dispersed.

[0101] Prolonging the dispersion time to 60min, the crystal size did not change significantly.

[0102] Cetostearyl alcohol is used as the dispersion medium of aclomethasone dipropionate, the optional dispersion temperature range is wide, the dispersion time range is wide, and the operability is strong.

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Abstract

The invention belongs to the field of medicine preparations and particularly relates to a preparation process of alclometasone dipropionate. According to the preparation process, in order to solve a stability problem of alclometasone dipropionate, cetostearyl alcohol is adopted as a dispersing agent of alclometasone dipropionate serving as an active ingredient, and main medicine particles are evenly dispersed and not dissolved in a system to prepare a suspended type emulsifiable paste. The granularity D90 of the emulsifiable paste prepared by means of a formula and a method is smaller than orequal to 30 microns, and the emulsifiable paste is uniform, fine and smooth and easy to apply. Alclometasone dipropionate in a fine particular state in the prepared emulsifiable paste exists in the system; compared with a solution-type emulsifiable paste, the emulsifiable paste has the advantages that the chemical stability of main medicine is remarkably improved on the one hand, and on the otherhand, prolonging of medical effects is facilitated since medicine particles are stored and continuously released so that irritation caused to the skin since the concentration of partial medicine is excessively high due to fast release of medicine can be reduced at the same time. The process procedures are obtained by means of optimization, the operation is simple and feasible, and the process hasreproducibility and is applicable to industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a preparation process of aclomethasone dipropionate. Background technique [0002] Alclomethasone dipropionate is a low-to-medium-effect glucocorticoid drug that inhibits phospholipase A2 from hydrolyzing membrane phospholipids to release arachidonic acid by inducing lipocortins, thereby controlling the biosynthesis of prostaglandins and leukotrienes and other inflammatory mediators , to play the role of anti-inflammation, antipruritic and vasoconstriction, clinically used to relieve inflammation and itching symptoms of skin diseases sensitive to glucocorticoids. In addition to the anti-inflammatory, anti-proliferative, and vasoconstrictive properties of glucocorticoids, aclomethasone dipropionate can also increase skin hydration and increase skin humidity. Another treatment option, especially for elderly patients with degenerative skin function, prone to itchy, dry sk...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K9/06A61K47/10A61K31/573A61P29/00A61P17/00A61P17/04
CPCA61K9/0014A61K9/06A61K9/10A61K31/573A61K47/10
Inventor 程霞徐飞林子褀
Owner CHONGQING HUAPONT PHARMA
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