WO2020084458A1

WO2020084458A1 - Topical formulation and process for preparing the same

Info

Publication number: WO2020084458A1
Application number: PCT/IB2019/058973
Authority: WO
Inventors: Shreyas Narendrakumar SHAH; Urmil Gunvantrai DESAI; Anish Mahendrabhai AMIN; Yogendra Kanubhai PATEL; Suketu SHAH
Original assignee: Shah Shreyas Narendrakumar; Desai Urmil Gunvantrai; Amin Anish Mahendrabhai; Patel Yogendra Kanubhai; Shah Suketu
Priority date: 2018-10-25
Filing date: 2019-10-22
Publication date: 2020-04-30

Abstract

The present disclosure relates to a topical formulation comprising at least one amine, at least one emulsifier and at least one fluid medium. The amines are monoethyl amine and diethyl amine. The emulsifier is selected from Glycerol mono stearate and Glycerol di stearate. The fluid medium is water. The topical formulation also comprises pharmaceutically acceptable excipients. The topical formulation of the present disclosure provides a significant effect against Eczema and Palmoplantar crack. The present disclosure also relates to a process for preparing topical formulation.

Description

TOPICAL FORMULATION AND PROCESS FOR PREPARING THE SAME

FIELD

The present disclosure relates to a topical formulation and a process for preparing the same.

DEFINITIONS As used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which they are used indicate otherwise.

Palmoplantar Keratoderma - A dermatological condition causing marked thickening of the skin. Palmoplantar Eczema (Atopic dermatitis) - A dermatological condition caused by unknown factors where the skin becomes inflamed, itchy, red, cracked and rough.

Palmoplantar crack - Cracks or fissures affecting both the palms of the hands and the soles of the feet.

BACKGROUND The background information herein below relates to the present disclosure but is not necessarily prior art.

Topical diseases such as Palmoplantar keratoderma are often caused by hereditary factors or acquired factors. Hereditary factors are result of gene abnormalities that results in abnormal skin protein (keratin) formation. Acquired factors include changes in health or environment of the affected person. Palmoplantar crack are caused by the environmental factors affecting moisture levels in palms or feet. Several formulations are available for the treatment of topical diseases. However, these formulations may fail to completely eradicate the disease from the body and it may lead to repeated occurrence. Topical formulations that can combat these conditions are essential for the treatment of topical diseases. There is, therefore, felt a need for a topical formulation that overcomes the above mentioned limitations. OBJECTS

Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:

It is an object of the present disclosure to ameliorate one or more problems of the prior art or to at least provide a useful alternative.

An object of the present disclosure is to provide a topical formulation.

Another object of the present disclosure is to provide topical formulation for treatment of topical diseases.

Still another object of the present disclosure is to provide a process for preparing a topical formulation.

Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY

The present disclosure relates to a topical formulation for treatment of topical diseases, comprising:

a) at least one amine in the range of 1 wt% to 15 wt% of the total weight of the topical formulation;

b) at least one emulsifier in the range of 25 wt% to 35 wt% of the total weight of the topical formulation; and

c) at least one fluid medium in the range of 50 wt% to 70 wt% of the total weight of the topical formulation.

The amine is selected from monoethyl amine and diethyl amine and a ratio of monoethyl amine and diethyl amine is in the range of 9:1 to 1:9.

The emulsifier is at least one selected from glycerol mono stearate, glycerol di stearate. The fluid medium is water. The topical formulation comprises at least one pharmaceutically acceptable excipient selected from antioxidant, buffering agent, binder, wetting agent, microbial preservative, stabilizer, fragrance and mixtures thereof.

Further, the present disclosure relates to a process for preparing a topical formulation. The process steps are as follows. a) a predetermined amount of at least one amine is dissolved in at least one fluid medium to obtain a solution.

b) an emulsifier is added in a predetermined amount to the solution and mixed to obtain an emulsion.

c) the emulsion is blended to obtain the topical formulation.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING

The present disclosure will now be described with the help of the accompanying drawing, in which:

Figure 1 illustrates a) subject suffering from Eczema before treatment, b) effect of topical formulation of group El (MEA 11.2% and water 88.8%) after treatment, c) subject suffering from Eczema before treatment, and d) effect of topical formulation of group E2 (DEA 1% and water 99%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 2 illustrates a) subject suffering from Eczema before treatment, b) effect of topical formulation of group E3 (GMS 33.3% and water 66.7%) after treatment, c) subject suffering from Eczema before treatment, and d) effect of topical formulation of group E6 (MEA 0.7%, DEA 0.2%, GMS 33.3% and water 65.8%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 3 illustrates a) subject suffering from Eczema before treatment, b) effect of topical formulation of group E4 (MEA 11.2%, GMS 33.3% and water 55.5%) after treatment, c) subject suffering from Eczema before treatment, and d) effect of topical formulation of group E4 (MEA 11.2%, GMS 33.3% and water 55.5%) after treatment, in accordance with one embodiment of the present disclosure. Figure 4 illustrates a) subject suffering from Eczema before treatment, b) effect of topical formulation of group E4 (MEA 11.2%, GMS 33.3% and water 55.5%) after treatment, c) subject suffering from Eczema before treatment, and d) effect of topical formulation of group E4 (MEA 11.2%, GMS 33.3% and water 55.5%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 5 illustrates a) subject suffering from Eczema before treatment, b) effect of topical formulation of group E5 (DEA 1%, GMS 33.3% and water 65.7%) after treatment, c) subject suffering from Eczema before treatment, and d) effect of topical formulation of group E5 (DEA 1%, GMS 33.3% and water 65.7%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 6 illustrates a) subject suffering from Eczema before treatment, b) effect of topical formulation of group E5 (DEA 1%, GMS 33.3% and water 65.7%) after treatment, c) subject suffering from Eczema before treatment, and d) effect of topical formulation of group E7 (MEA 11.2%, DEA 1%, GMS 18% and water 69.8%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 7 illustrates a) subject suffering from Eczema before treatment, b) effect of topical formulation of group E8 (MEA 11.2%, DEA 1%, GMS 33.3% and water 54.5%) after treatment, c) subject suffering from Eczema before treatment, and d) effect of topical formulation of group E8 (MEA 11.2%, DEA 1%, GMS 33.3% and water 54.5%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 8 illustrates a) subject suffering from Eczema before treatment, b) effect of topical formulation of group E8 (MEA 11.2%, DEA 1%, GMS 33.3% and water 54.5%) after treatment, c) subject suffering from Eczema before treatment, and d) effect of topical formulation of group E8 (MEA 11.2%, DEA 1%, GMS 33.3% and water 54.5%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 9 illustrates a) subject suffering from Eczema before treatment, b) effect of topical formulation of group E8 (MEA 11.2%, DEA 1%, GMS 33.3% and water 54.5%) after treatment, c) subject suffering from Eczema before treatment, and d) effect of topical formulation of group E8 (MEA 11.2%, DEA 1%, GMS 33.3% and water 54.5%) after treatment, in accordance with one embodiment of the present disclosure. Figure 10 illustrates a) subject suffering from Eczema before treatment, b) effect of topical formulation of group E8 (MEA 11.2%, DEA 1%, GMS 33.3% and water 54.5%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 11 illustrates a) subject suffering from Palmoplantar crack before treatment, b) effect of topical formulation of group Cl (DEA 11.2% and water 88.8%) after treatment, c) subject suffering from Palmoplantar crack before treatment, d) effect of topical formulation of group C2 (MEA 1% and water 99%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 12 illustrates a) subject suffering from Palmoplantar crack before treatment, b) effect of topical formulation of group C3 (GMS 33.3% and water 66.7%) after treatment, c) subject suffering from Palmoplantar crack before treatment, d) effect of topical formulation of group C3 (GMS 33.3% and water 66.7%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 13 illustrates a) subject suffering from Palmoplantar crack before treatment, b) effect of topical formulation of group C4 (DEA 11.2%, GMS 33.3% and water 55.5%) after treatment, c) subject suffering from Palmoplantar crack before treatment, d) effect of topical formulation of group C4 (DEA 11.2%, GMS 33.3% and water 55.5%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 14 illustrates a) subject suffering from Palmoplantar crack before treatment, b) effect of topical formulation of group C4 (DEA 11.2%, GMS 33.3% and water 55.5%) after treatment, c) subject suffering from Palmoplantar crack before treatment, d) effect of topical formulation of group C5 (MEA 1%, GMS 33.3% and water 65.7%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 15 illustrates a) subject suffering from Palmoplantar crack before treatment, b) effect of topical formulation of group C5 (MEA 1%, GMS 33.3% and water 65.7%) after treatment, c) subject suffering from Palmoplantar crack before treatment, d) effect of topical formulation of group C6 (DEA 0.7 %, MEA 0.2%, GMS 33.3% and water 65.8%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 16 illustrates a) subject suffering from Palmoplantar crack before treatment, b) effect of topical formulation of group C7 (DEA 11.2%, MEA 1%, GMS 18% and water 69.8%) after treatment, c) subject suffering from Palmoplantar crack before treatment, d) effect of topical formulation of group C8 (DEA 11.2 %, MEA 1%, GMS 33.3% and water 54.5%) after treatment, in accordance with one embodiment of the present disclosure.

Figure 17 illustrates a) subject suffering from Palmoplantar crack before treatment, b) effect of topical formulation of group C8 (DEA 11.2 %, MEA 1%, GMS 33.3% and water 54.5%) after treatment, c) subject suffering from Palmoplantar crack before treatment, d) effect of topical formulation of group C8 (DEA 11.2 %, MEA 1%, GMS 33.3% and water 54.5%) after treatment, in accordance with one embodiment of the present disclosure.

DETAILED DESCRIPTION Embodiments, of the present disclosure, will now be described with reference to the accompanying drawing.

Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising,"“including,” and“having,” are open ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and/or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed. Conventional formulations fail to treat topical diseases due to improper penetration of drugs to the skin.

Therefore, the present disclosure provides a topical formulation for treatment of topical diseases. The topical formulation comprises a) at least one amine in the range of 1 wt% to 15 wt% of the total weight of the topical formulation; b) at least one emulsifier in the range of 25 wt% to 35 wt% of the total weight of the topical formulation; and c) at least one fluid medium in the range of 50 wt% to 70 wt% of the total weight of the topical formulation.

The amine is at least one selected from monoethyl amine and diethyl amine and a ratio of monoethyl amine and diethyl amine is in the range of 9:1 to 1:9.

In an embodiment, the amine is mixture of monoethyl amine and diethyl amine and the ratio of monoethyl amine and diethyl amine is 9:1. In another embodiment, the ratio of monoethyl amine and diethyl amine is 1:9.

The amount of monoethyl amine is in the range of 1 wt% to 15 wt% of the total weight of the topical formulation.

In an embodiment, the amount of monoethyl amine is 11.2 wt% of the total weight of the topical formulation. In another embodiment, the amount of monoethyl amine is 1 wt% of the total weight of the topical formulation.

The amount of diethylamine is in the range of 1 wt% to 15 wt% of the total weight of the topical formulation.

In an embodiment, the amount of diethylamine is 11.2 wt% of the total weight of the topical formulation.

In another embodiment, the amount of diethyl amine is 1 wt% of the total weight of the topical formulation. The emulsifier is at least one selected from glycerol mono stearate, glycerol di stearate.

In an embodiment, the emulsifier is Glycerol mono stearate.

The amount of emulsifier is in the range of 25 wt% to 35 wt% of the total weight of the topical formulation. In an embodiment, the amount of emulsifier is 33.3 wt% of the total weight of the topical formulation.

The fluid medium is water.

The amount of fluid medium is in the range of 50 wt% to 70 wt% of the total weight of the topical formulation. In an embodiment, the amount of fluid medium is 54.5 wt% of the total weight of the topical formulation.

The topical formulation comprises at least one pharmaceutically acceptable excipient selected from antioxidant, buffering agent, binder, wetting agent, microbial preservative, stabilizer and mixtures thereof. The topical formulation is used to treat dermatological disease conditions such as Acne, Palmoplantar crack, Dermatitis, Eczema, Seborrheic Dermatitis, Warts, Psoriasis and Dermatitis Valgus.

In another embodiment, the dermatological disease condition is Eczema.

In yet another embodiment, the dermatological disease condition is Palmoplantar crack. The topical formulation is in the form of cream, ointment, gel and lotion.

In an embodiment, the topical formulation is cream.

In another aspect, the present disclosure provides a process for preparing a topical formulation.

In the first step a predetermined amount of at least one amine is dissolved in at least one fluid medium to obtain a solution. In an embodiment, a mixture of monoethyl amine and diethyl amine is dissolved in water to obtain the solution. In the second step a predetermined amount of at least one emulsifier is added to the solution and mixed to obtain an emulsion. In an embodiment, glycerol mono stearate is added to the solution of amines in water and mixed to form the emulsion.

In the third step the emulsion is blended to obtain the topical formulation. Optionally, a process steps involves the addition of at least one pharmaceutically acceptable excipient to the emulsion obtained in the second step before blending of emulsion.

The foregoing description of the embodiments has been provided for purposes of illustration and not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.

The present disclosure is further described in light of the following experiments which are set forth for illustration purpose only and not to be construed for limiting the scope of the disclosure. The following experiments can be scaled up to industrial/commercial scale and the results obtained can be extrapolated to industrial scale.

EXPERIMENTAL DETAILS

Experiment 1: - Preparation of the topical formulation

A predetermined amount of monoethyl amine and diethyl amine as disclosed in table 1 and 2 were dissolved in 545 grams of water to obtain a solution. 333 grams of Glycerol mono stearate was added and mixed into the solution to obtain an emulsion. The emulsion was blended to obtain a topical formulation in cream form.

The topical formulation in accordance with the present disclosure comprised the following ingredients as disclosed in Table 1 and Table 2 Table 1: Topical Formulation 1

Table 2: Topical Formulation 2

Clinical Trials For Topical Formulation 1:

To study the effect of Formulation 1 obtained in experiment 1, against Eczema, efficacy studies were performed clinically. Formulation 1 was tested for Eczema in humans. A comparative study was also done with the individual components of the Formulation 1.

19 healthy human volunteers aged between 18 years to 60 years, having no previous history of Eczema and having mild to a moderate kind of Eczema were included in the study. Individuals having systemic diseases including diabetes, hypertension, hypercholesterolemia, and acquired immune deficiency syndrome (AIDS), thyroid disorders, and secondary infections were excluded from the studies. Individuals who were sensitive to any herbal ingredient or unknown ingredient were excluded. 19 individuals were divided in total eight groups as shown in Table 3.

Table 3: Treatment groups and Formulations used for study

100 grams of formulations were prepared and filled in wide mouth containers. The wide mouth containers were distributed to the groups and were instructed to apply 2 grams of the formulation on the affected areas twice daily. Total duration of treatment was 70+1 days. The application of the formulation was planned for 56+1 days. The safety follow up visit was planned on 70+1 day to check any reoccurrence will be occurred in a short course of time.

Procedure for topical formulation application

In case of mild eczema, the subjects were suggested for direct application of the topical formulation on the affected part of the body followed by covering it with cotton socks. However, in moderate cases the similar treatment was recommended for daytime and, further was to be combined with occlusion application at night time with the aim to increase absorption of a topical agent, prevent scratching and reducing the itchiness. Subjects were suggested for occlusion using polythene bags after application of topical formulation, and after that advised to wear cotton socks.

Evaluation parameters

A series of photographs were taken at every subject’s visit, once in a week for initial 5 visits and after that once in two weeks for remaining 2 visits. Photographs were taken in the clinic. An assessment was done by a dermatologist using predefined scoring on visit basis and grades were recorded. The Investigator Global Assessment scale for Atopic Dermatitis was used as shown in Table 4. Table 4: Investigator Global Assessment scale for Atopic Dermatitis

El group subjects received a formulation comprising only ME A 11.2% and water 88.8%. E2 group subjects received a formulation comprising only DEA 1% and water 99%. El to E2 group subjects showed a marginal effect after treatment for subjects having Eczema as illustrated in Figure 1 (a, b, c and d). E3 group subjects received a formulation comprising only GMS 33.3% and water 66.7%. E3 group subjects did not show effect after treatment for subjects having Eczema as illustrated in Figure 2 (a and b).

E4 group subjects received a formulation comprising only MEA 11.2%, GMS 33.3% and water 55.5%. E4 group showed a marginal effect after treatment for subjects having Eczema as illustrated in Figure 3 (a, b, c and d) and 4 (a, b, c and d).

E5 group subjects received a formulation comprising only DEA 1%, GMS 33.3% and water 65.7%. E5 group showed a marginal effect after treatment for subjects having Eczema as illustrated in Figure 5 (a, b, c and d) and Figure 6 (a and b).

E6 group subjects received a formulation comprising only MEA 0.7%, DEA 0.2%, GMS 33.3% and water 65.8%. E6 group showed better effect than El, E2, E4 and E5 groups after treatment for subjects having Eczema as illustrated in Figure 2 (c and d).

E7 group subjects received a formulation comprising only MEA 11.2%, DEA 1%, GMS 18% and water 69.8%. E7 group showed better effect better effect than El, E2, E4 and E5 after treatment for subjects having Eczema as illustrated in Figure 6 (c and d). E8 group subjects received formulation 1 comprising MEA 11.2%, DEA 1%, GMS 33.3% and water 54.5% showed significantly more effect as compared to E6 and E7 after treatment and showed a reduction in symptoms of Eczema as illustrated in Figure 7 (a, b, c and d), Figure 8 (a, b, c and d), Figure 9 (a, b, c and d) and Figure 10 (a and b). The formulation 1 comprising MEA 11.2%, DEA 1%, GMS 33.3% and water 54.5% in combination showed the significant effect and helped in reducing the symptoms of Eczema. The components in the formulation in the specific ratio showed synergistic effect.

Clinical Trials For Topical Formulation 2: Formulation 2 was tested for Palmoplantar crack in humans. A comparative study was also done with the individual components of the Formulation 2.

19 healthy human volunteers aged between 18 years to 60 years, having no previous history of history of crack not treated with other formulation in the previous six weeks and having mild to a moderate kind of crack were included in the study. Individuals having skin disorders affecting the foot such as infections (e.g. Athlete’s foot), dermatitis, psoriasis, un healed skin wounds, ulcers or blisters, Open heel cracks (i.e. with exposed dermis), thyroid disorders were excluded from the studies. Individuals who were sensitive to any herbal ingredient or unknown ingredient were excluded. 19 individuals were divided in total eight groups as shown in Table 5. Table 5: Treatment groups and Formulations used for study

Procedure for topical formulation application The subjects were instructed before going to bed, to mix some liquid soap in a foot tub filled with warm water and to soak their palm or feet in this warm soapy water for about 20 minutes. They were also instructed to use a pumice stone to gently scrub off the loosened dead skin cells followed by rinsing off their palm or feet with clean water and pat dry with a soft towel. Further, they were instructed to apply topical formulation 2 and wear a pair of clean cotton socks overnight. They were instructed to follow the protocol daily until their cracked palms or feet were healed completely.

Evaluation parameters

A series of photographs were taken at every subject’s visit which was planned once in a week for initial 5 visits and after that once in two weeks for remaining 2 visits. The photographs were taken in the clinic. Using CASI (Crack Area Severity Index), investigators graded the severity of the callosities and cracks clinically and photographically on a 0 to 4 scale (0=no cracks or calluses; 4=deep cracks and thick calluses).

Cl group subjects received a formulation comprising only DEA 11.2% and water 88.8% and the C2 group received a formulation comprising only MEA 1% and water 99%. Cl and C2 group subjects showed a marginal effect after treatment for subjects having palmoplantar crack as illustrated in Figure 11 (a, b, c and d).

C3 group subjects received a formulation comprising only GMS 33.3% and water 66.7%. C3 group subjects did not show significant effect after treatment for subjects having palmoplantar crack as illustrated in Figure 12 (a, b, c and d). C4 group subjects received a formulation comprising only DEA 11.2%, GMS 33.3% and water 55.5%. C5 group subjects received a formulation comprising only MEA 1%, GMS 33.3% and water 65.7%. C4 and C5 group showed a marginal effect after treatment for subjects having palmoplantar crack as illustrated in Figure 13 (a, b, c and d), Figure 14 (a, b, c, and d) and Figure 15 (a and b). C6 group subjects received a formulation comprising only DEA 0.7%, MEA 0.2%, GMS 33.3% and water 65.8%. C7 group subjects received a formulation comprising only DEA 11.2%, MEA 1%, GMS 18% and water 69.8%. C6 to C7 group showed better effect than Cl, C2, C4 and C5 after treatment for subjects having palmoplantar crack as illustrated in Figure 15 (c and d), Figure 16 (a and b).

C8 group subjects received formulation 2 comprising DEA 11.2%, MEA 1%, GMS 33.3% and water 54.5% showed significantly more effect as compared to C6 and C7 after treatment and showed palmoplantar crack healing effect as illustrated in Figure 16 (c and d) and Figure 17 (a, b, c and d). The formulation 2 comprising DEA 11.2%, MEA 1%, GMS 33.3% and water 54.5% in combination showed the significant effect and helped in reducing palmoplantar crack and produced palmoplantar crack healing effect. The components in the formulation in the specific ratio showed synergistic effect.

TECHNICAL ADVANCEMENTS The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a topical formulation capable of treating dermatological conditions. easy to use, having deep and fast penetration into the skin layers, provide early relief from dermatological disease conditions, - no reoccurrence in short duration, and gives better patient compliance and satisfaction.

Throughout this specification the word“comprise”, or variations such as“comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

The use of the expression“at least” or“at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the invention to achieve one or more of the desired objects or results. While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions. Variations or modifications to the formulation of this invention, within the scope of the invention, may occur to those skilled in the art upon reviewing the disclosure herein. Such variations or modifications are well within the spirit of this invention.

The numerical values given for various physical parameters, dimensions and quantities are only approximate values and it is envisaged that the values higher than the numerical value assigned to the physical parameters, dimensions and quantities fall within the scope of the invention unless there is a statement in the specification to the contrary. While considerable emphasis has been placed herein on the specific features of the preferred embodiment, it will be appreciated that many additional features can be added and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other changes in the preferred embodiment of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

CLAIMS:

1. A topical formulation, comprising:

a. at least one amine in the range of 1 wt% to 15 wt% of the total weight of said topical formulation;

b. at least one emulsifier in the range of 25 wt% to 35 wt% of the total weight of said topical formulation; and

c. at least one fluid medium in the range of 50 wt% to 70 wt% of the total weight of said topical formulation;

2. The topical formulation as claimed in claim 1, wherein said amine is selected from monoethyl amine and diethyl amine.

3. The topical formulation as claimed in claim 2, wherein the ratio of said monoethyl amine and diethyl amine is in the range of 9:1 to 1:9.

4. The topical formulation as claimed in claim 1, wherein said emulsifier is selected from Glycerol mono stearate and Glycerol di stearate.

5. The topical formulation as claimed in claim 1, wherein said fluid medium is water.

6. The topical formulation as claimed in claim 1, wherein said formulation comprises at least one pharmaceutically acceptable excipient selected from antioxidants, buffering agents, binders, wetting agents, microbial preservatives, stabilizers, fragrance and mixtures thereof.

7. The topical formulation as claimed in claim 1, wherein said formulation is in a form selected from cream, ointment, gel and lotion.

8. A process for preparing a topical formulation, said process comprising the following steps:

a. dissolving a predetermined amount of at least one amine in at least one fluid medium to obtain a solution;

b. adding a predetermined amount of at least one emulsifier to said solution and mixing to obtain an emulsion; and

c. blending said emulsion to obtain said topical formulation.

9. The process as claimed in claim 8, wherein at least one pharmaceutically acceptable excipient is added to said emulsion prior to step (c) of blending.