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Corticosteriod containing foam compositions

a foam composition and corticosteroid technology, applied in the field of foamable compositions including corticosteroid, can solve the problems of corticosteroid degradation over the shelf life of the composition, the conventional method of manufacturing corticosteroid foam, degradation and inactivation, etc., and achieve the effects of enhancing stability, stable ph, and adding manufacturing complexity

Inactive Publication Date: 2018-05-24
MAYNE PHARMA LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006]The manufacturing method and foamable compositions produced by such method as presented herein do not utilize a traditional buffer system which adds manufacturing complexity. However, compositions manufactured by the presently described method exhibit a stable pH, enhanced stability of cortico steroids, and enhanced efficacy in treatment as compared to other treatment options.
[0007]The compositions of the present invention demonstrate a clinical efficacy which is superior to comparable corticosteroid containing compositions. In addition, it has been found that the compositions of the present invention are stable and demonstrate very good long term storage stability.
[0008]As will be further explained herein below, compositions manufactured by the presently described method achieve a high level of clinical efficacy without appreciably reducing transepidermal water loss (TEWL). Skin conductance studies have also demonstrated that the compositions of the present invention do not appreciably increase skin hydration. The compositions of the present invention comprise particular combinations of ingredients which interact synergistically to produce the enhanced results described herein without increasing skin hydration or reducing transepidermal water loss.
[0009]Accordingly, in one aspect, the present invention provides a method for single-stream manufacture of a foamable composition including a corticosteroid. The method includes forming a homogenous solution which includes: i) an aliphatic alcohol; ii) a can corrosion inhibitor; iii) a polyol; iv) at least one foam structuring agent comprising one or more fatty alcohols, non-ionic surfactants, or combinations thereof; and v) water. In embodiments, the solution is formed in a single batch vessel at a constant temperature of between about 55°−75° C. while minimizing evaporative losses. Subsequently, the mixture is cooled to a temperature of between about 40°−55° C. and a corticosteroid is then added to the solution and mixed to homogeneity while maintaining a temperature of between about 40°-55° C. The solution is then filled into dispensing canisters while the solution is maintained at a temperature of between about 40°−50° C. The filled canisters are then charged with a propellant thereby forming a single-phase foamable composition.

Problems solved by technology

However, a number of problems exist in conventional methods of manufacturing cortico steroid foams, such as degradation and inactivation of the corticosteroid during manufacture and canning of the foam composition.
Additional problems include cortico steroid degradation over the shelf life of the composition.
The manufacturing method and foamable compositions produced by such method as presented herein do not utilize a traditional buffer system which adds manufacturing complexity.

Method used

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  • Corticosteriod containing foam compositions
  • Corticosteriod containing foam compositions
  • Corticosteriod containing foam compositions

Examples

Experimental program
Comparison scheme
Effect test

example 1

Foamable Halobetasol Propionate Composition

[0067]A composition was prepared in accord with the present invention utilizing the formulation of Table VI above. Listed in Table VI is a specific composition based upon the ranges set forth hereinabove in Table I.

[0068]In this procedure as described in detail herein, a carrier solution is prepared by mixing and heating ethyl alcohol to between about 65°−70° C., adding benzoic acid, propylene glycol, Polyoxyl 20 cetostearyl ether, cetostearyl alcohol, and emulsifying wax and mixing to uniformity while maintaining a temperature of between about 65°−70° C. Water is added in multiple aliquots to maintain a temperature greater than 55° C. and the completed carrier solution is heated to 65°-70° C. The carrier solution is prepared in a vessel with a pressure and / or vacuum rated lid that seals onto the vessel in order to minimize evaporative losses during compounding. Then the carrier is cooled to about 45°−50° C. and the halobetasol propionate i...

example 2

Skin Hydration and Transepidermal Water Loss (TEWL)

[0069]A series of studies was carried out to evaluate the properties and advantages of the composition of the present invention. These studies were carried out utilizing a preparation having a formulation in accord with Table VI as prepared by the procedure set forth above. In a first study, skin hydration was determined by use of an IBS Skicon-200 Conductance Meter equipped with a Measurement Technologies probe [unit 2283, probe A] to further enhance its ability to measure changes in skin surface hydration.

[0070]The data confirm that the composition of the present invention did not increase skin hydration when applied to shaved skin and was not considered to be occlusive. In fact, the composition decreased skin hydration (i.e., dehydrated) when applied to shaved skin.

[0071]A further study was carried out measuring transepidermal water loss (TEWL) of skin treated with the composition of the present invention. Computerized evaporimet...

example 3

Clinical Efficacy

[0075]A further experimental study evaluated the clinical efficacy of the composition of the present invention having the formulation of Table VI, described above, in the treatment of subjects with plaque psoriasis.

[0076]Results

[0077]52% of psoriasis subjects treated with the composition of the present invention having the formulation described above, and 0.0% of subjects treated with an identical composition void of halobetasol (Control Vehicle), achieved “treatment success”.

Definitions

[0078]Overall Disease Severity (ODS): At every visit, the overall severity of a subject's psoriasis in the Treatment Area, taking into consideration the three individual clinical signs of psoriasis (scaling, erythema, and plaque elevation) was assessed using a five-point scale ranging from 0=clear to 4=severe / very severe. To be enrolled in the study the subjects had to have at least a moderate ODS score (≥3).

Clear (0)ScalingNo evidence of scaling.ErythemaNo erythema (hyperpigmentatio...

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Abstract

The present invention provides a method of manufacturing foamable, corticosteroid containing compositions as well as methods for treating various skin diseases.

Description

RELATED APPLICATION DATA[0001]This application is a divisional of U.S. patent application Ser. No. 15 / 365,152, filed Nov. 30, 2016; which claims the benefit of priority under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No. 62 / 267,773, filed Dec. 15, 2015, the entire contents of which is incorporated herein by reference in its entirety.BACKGROUNDField of Invention[0002]This invention relates to foamable compositions including a corticosteroid, and more particularly to a method of manufacturing stable foamable compositions.Background Information[0003]Corticosteroids are well known anti-inflammatory compounds, which are recognizably utilized in the treatment of inflammatory diseases such as allergic contact dermatitis, eczema, asteatotic eczema, discoid eczema, infantile eczema and diaper dermatitis, psoriasis; including plaque psoriasis, palmoplantar psoriasis, etc., seborrheic dermatitis, atopic dermatitis, dermatitis herpetiformis, neurodermatitis, lichen simplex ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/573A61K47/10A61K9/12A61K31/58B65D83/14A61K47/44B65B63/08A61K9/00A61K47/06A61K47/12B65B31/00
CPCA61K47/10A61K9/122A61K31/573A61K31/58B65D83/752A61K47/44B65B63/08A61K9/0014A61K47/06A61K47/12B65B31/003A61P17/00A61P17/04A61P17/06A61P29/00A61P37/08A61K47/08
Inventor GAUTHIER, ROBERT T.HAMMER, JAMES D.
Owner MAYNE PHARMA LLC
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