GB2441599A - Herbal composition and method for the treatment of skin disorders and fungal infections thereof - Google Patents

Abstract

A cosmetic composition contains ghee, coconut oil, cetylalcohol, laxemul (glyceryl stearate + PEG 100 stearate), glycerol, extracts of cassia tora, centratherum anthelminticum, neem kernel oil and rose oil. Also disclosed is a method of making said cream by preparing a homogenous oil phase by heating ghee, coconut oil, cetyl alcohol, laxemul (glyceryl stearate + PEG 100 stearate), neem kernel oil and/or sesame oil, cenratherum anthelminticum, jasminum grandiflorum and rose and allowing it to cool. De-ionised water is then heated and cooled. The oil phase and the water are mixed together using a high shear stirrer and further cooled. Freeze-dried extracts of cassia tora, melia azadirachta and centratherum anthelminticum and rose oil are added to the mixture.

Description

BACK GROUND OF INVENTION

Purpose: To investigate the effect of herbal compositions suspended in a cream based on novel vehicle "Ghee" (clarified butter) and develop natural cream useful for treatment of children eczema, psoriasis, acne, and athlete's foot. This invention relates to the manufacture and use of herbal compositions in the cream form for the treatment of itchy or inf*cted skin such as in impetigo, acne (on face, forehead scalp and on the back of the body) and funga]. infection of skin and nails.

Vegetable origin emulsifiers and stabilisers are used.

Here is feasibility of preparing a cream and also by using only natural ingredients as a preservative. The base of the cream is intended for those people who have reaction to many skin sensitizers that are used in conventional creams. This is for topical application only. The use of Ghee and coconut oil in the formulation of cosmetic composition has a favourable effect on skin (soothing and cooling sensation). The cream as such it is meant as non-hydrocortisone no lanolin no fragrance cream. The high concentration of Ghee in original formula was found to be effective but smell of ghee was not tolerable by some of the customers. Now that problem is overcome and this formulation found very useful for making natural cream. Herbs and Ghee are working as protective element for cream as well as curative element in function on the skin. Acne

Acne is a disease of the pilosebaceous unit. It predominantly affects the face, back and chest.

Perioral area of the face is more vulnerable. Still acne is not a simple face skin disorder, few patients with severe acne on the back or chest who have non on the face.

Acne is a mixture of, inflammation-infection process and favoured by the presence of time oriented hormonal imbalance.

Most commonly found anaerobes and/or aerobe-bacteria in the acne are Staphylococcus albus, Staphylococcus epidermidis, Pitirosporuin ovale and Propioniibacterium acnes.

One gentleman was suffering from acne on his face and also on his back for many years. He was reluctant for antibiotics because he knew that antibiotics gave him more trouble. He came to me for natural treatment for keloids he was suffering for long time. I gave him oral compound and herbal cream to apply (one month supply), on 25th day of treatment he came to me for cream supply.

At that time I counted spots on his back out of 33 spots spots were healed. I realised that this is Propionae bacterium has disappeared.

Acne and immune response; As previously stated acne is a mixture of, inflammation-infection process and favoured by the presence of time oriented hormonal imbalance.

Pustules resolve faster than papules. In pustules natural healing process is faster because of polymorphonucleocyte activity and in papules the natural healing process is slower because here it depends on lymphocyte activity. Here this lymphocyte activity remains helpful in further growth of the comedones.

Macules are the end result of inflamed lesions, most persist for 7 days and they can linger for several weeks.

:esent invention is useful for orevention of further scarring -Facial scarring It is well recognised that facial scarring and scars on the back are associated with long standing changing guards-games played by different sorts of bacteria fungi and immune response of the body in the form of production and presentation of lymphocyte and polymorphonucleocytes.

Fungal nail infection and immune response The skin in some people react to external and internal changes very fast such as drinking alcohol, washing with alkaline soap, increased sweating in summer and more huniid skin environment. All these skin sensitising factors could bring circulatory changes on the skin and inside the nail beds.

It is well recognised that alkalinity on the skin initiates or promotes fungal infections. In long journey of antibiotics, resistance development and hide and seek games played by organisms the present invention remains most blissful.

Method of making the Cream Oil Phase: In a sterile vessel first take "Ghee" 12 Kg and add coconut oil 12 kg, Cetyl alcohol 4Kg, Laxemul Glyceryl stearate + PEG 100 stearate) 5kg, vegetable Glycerine 1Kg and Neem kernel oil 0.500 kg. Neat all, of the above ingredients up to 98 C melt it completely until it becomes homogenous oil phase mixture. Let it cool down up to temperature 75 C. and then it will be ready for mixing with water phase.

Water Phase: litres of deionised water (sterile water) heat it up to 100 C and let it cool down up to temperature 75 C.

then it will be ready mixing with oil phase.

Mix oil Phase and water by high shear mixing with automatic stirrer for 2-3 minutes continuously stirring until it reaches 30 C. Now add 5 milligrams of freeze dried water extracts of herbs Cassia tora, Centratherum anthelminticum and Melia azadirachta 0.005% each dissolved in 485 millilitres of deionised water and add ml of rose oil and mix well. Then take out the cream in to a separate vessel and allow it to settle down. Ph will be in range of 5.5 to 6.5.

Example 1 and Example 2 are from the priority date US Patent Application No. 10/129,794.

Example 3, Example 4 and Example 5 are in the present application CONTINUATION-IN-PART.

Example 1

A preferred embodiment of the present invention is a cream made up as follows: Ghee 3kg Water boiled and cooled freezing temperature 3litres Freeze dried extract of Centratherum anthelminUcum 5 gins (2 kilogram raw material of the seeds provided 100 grams of freeze dried powderj Medicated Sesame oil 500 ml (500 ml sesame oil treated with Centratherum anthelminticum seeds 100gm, Rose petals 100gm, Melia azadirachta leaves 100 gm, Cassia tora seeds 50 gin and some water to make a paste}.

To make up the cream, the ghee is first hydrolysed in a clean stainless steel vessel with three litres of water (boiled and cooled freezing temperature.) then add 500 ml of medicated oil.

Example 2

A preferred embodiment of the present invention is a cream made up as follows: Ghee 3kg Water boiled and cooled freezing temperature 3litres Freeze dried extract of Centratherum anthelminticum 5 gins (2 kilogram raw material of the seeds provided 100 grams of freeze dried powder) Medicated Sesame oil 500 ml (azadirachta leaves 100 gin, and some water to make a paste).

To make up the cream, the ghee is first hydrolysed in a clean stainless steel vessel with three litres of water (boiled and cooled to freezing temperature) then adds 500 ml of medicated oil. (500 ml sesame oil treated with Centratheruzn anthelmintjcwn seeds 100gm, Rose petals 100gm, Melia azadirachta leaves 100 gm, and some water to make a paste).

Laboratory Results: Test for_total viable count The above sample was tested for total viable count by pour plate. Aerobic, anaerobic and fungal methods were employed. A dilution rate of 1 in 10 was used.

Results Aerobic Tryptone Anaerobic Tryptone Saboraud Dextrose Soya Agar @ 35 C for Soya Agar @ 35 C for 7 Agar @ 35 C for 7 7 days days days 0.0 0,0 0,0 Co=ents As the test employed a dilution rate of 1:10 the theoretical sensitivity of the test, using duplicate plates is 5 colony-forming units per ml.

The sample passes the BP guidance for preparations for topical use (A316).

Additional testing that should be considered for the future would be the absence of Pseudomonas aurigenosa and Staphylococcus au.reus.

Due to absence of bacteria in this sample it is safe to assume that both the above have been satisfied.

The cream was made in June 2002: the Batch No. AFCJI, Report date 5 July 2002, Tested by Craig Hughes BSc. Microbiologist at Pharmaceutical Quality Assurance Services Edgware Community Hospital Edgware Middlesex HA8 OAD Example 3 EAND CREAN and iniantile-eczema or skin preparation-moisturi.zer weiart tor weigtLt 1i Ccosita.on Ingredient. mci Name Amount Purpose Water Aqua bq.9U Ghee Ghee" 12% Base, Preservative Coconut oil Cocos nucifera 12% Excipient Cetyl alcohol Cetyl alcohol 4% Emulsifier Laxemul Glyceryl stearate 5% Stabilizer 4-PEG 100 stearate Glycerine Glycerol 1% Binding Agent Vitamin E Tocoferol 0.1% Binding agent Jasmine, Rose, Neern and Herbs Black cumin oil 0.5% Herb Grape Fruit seeds extract 0.5% Laboratory Results: B? challenge Test-5 organisms for total viable count Method: MMOO2b Units: cfu/g or ml Batch: 04Y04B6 Date received 29 May 2003 testing finished 14 July 2003 Organisms tested: Recovery cfu g or ml 28 days: Pseudomonas aeruginosa ATCC 9027 <10 Staphylococcus aureus NCTC 10788 <10 Escherichia coil NCTC 845 <10 Aspergillus niger IMI 149007 <10 Candida albicans NCTC NCPF 3179 < 10 Recovery cfu g or ml was monitored at interval of 2 days, 7 days, 14 days and 28days.

Results: Initial microbial status: Bacteria<l0cfu/g; Yeast/moulds<l0cfu/g.

At the completion of testing, this sample fulfils the requirements of the BP (1999) for the adequate preservation of topical products.

Cents: BP (1999) criteria Bacteria: 2]og and 3log reduction after 48 hours and 7days respectively, with no increase thereafter.

Microbiologist John Reed performed the Test at Donnington Laboratories Limited. Unit 3, Donnington Park, Birtham Road, Chichester, West Sussex P020 7DU ci Example 4 Eczema, psoriasis, lichen pianus For skin preparation-moisturizer % weight for weight S (i) Ccosit.iori Ingredients mci Name Amount Purpose Water Aqua 65% Ghee "Ghee" 12% Base, Preservative Coconut oil Cocos nucifera 12% Excipient Cetyl alcohol Cetyl alcohol 4% Emulsifier Laxemul Glyceryl stearate 5% Stabilizer +PEG 100 stearate Glycerine Glycerol 1% Binding Agent Vitamin E Tocoferol 0.1% masking smell Black cumin seed (Freeze dried extract) Centzatherwa anthelminticum 0.005% Herb "Neem" Melia azadirachta (Freeze dried whole plant extract) 0.005% Herb De-ionised water 0.37% Neem kernel oil 0.5 % Iqelia azadirachta Grape fruit seeds Extract Citrus grandis 0.5% Vitamin E Tocopherol 0.1% Rose oil Rosa Edward 0.02% Good smell (0 Laboratory Results: BP Challenge Test-5 organisns for total viable count Hethod: MMOO2b Units: cfu/g or ml Batch: 04V0485/PC Manufactured 23 April 2003 Date received 29th May 2003 Testing finished 14 July 2003 Organisms tested: Recovery cfu g or ml. 28 days: Pseudomonas aeruginosa ATCC 9027 <10 Staphylococcus aureus NCTC 10788 <10 Escherichja coli NCTC 8545 <10 Aspergillus niger IMI 149007 70 Candida albicans NCTC NCPF 3179 <10 Recovery cfu g or ml was monitored at interval of 2 days, 7 days, 14 days and 28days.

Results: Initial microbial status: Bacteria<locfu/g; Yeast/moulds<l0cfu/g.

At the completion of testing, this sample fulfils the requirements of the BP (1999) for the adequate preservation of topical products.

Ccnts: BP (1999) criteria Bacteria: 2 log and 3 log reduction after 48 hours and 7 days respectively, with no increase thereafter; Yeasts/moulds: 2 log reduction within 14 days, with no increase thereafter.

Microbiologist John Reed performed the Test at Donnington Laboratories Limited.

Unit 3, Donnington Park, Birtham Road, Chichester, WEST SUSSEX P020 7D0 UK xampie 5 impetigo, acne, athietes root r sxin preparation-moisturizer weight for weight (i) Caaposi.tion Ingredients mci Name amount Purpose Water Aqua 65% Ghee "Ghee" 12% Base, Preservative Coconut oil Cocos nucifera 12% Excipient Cetyl alcohol Cetyl alcohol 4% Emulsifier Laxemul Glyceryl stearate 5% Stabilizer +PEG 100 stearate Glycerine Glycerol 1% Binding Agent Vitamin E Tocoferol 0.1% Binding agent Grape Fruit seeds Extract Citrus grandis 0.5% Cassia tora seeds Freeze dried extract 0.005 Herb Black cumin seed Freeze dried extract Centratherum anthelminticuin 0.005% Herb "Neem" Melia azadirachta (Freeze dried whole plant extract) 0.005% Herb De-ionised water 0.365% Neem kernel Oil 0.5 % Rose oil Rosa Edward 0.02% Good smell Laboratory Results: BP challenge Test-S organisms for total viable count Method: MMOO2b Units: cfu/g or ml Batch: 040499/FC Manufactured 23 April 2003 Date received 29" May 2003 testing finished 14 July 2003 Organisms tested: Recovery cfu g or ml 28 days: Pseudomonas aeruginosa ATCC 9027 <10 Staphylococcus aureus NCTC 10788 <10 Escherichja coli NCTC 8545 <10 Aspergillus niger IMI 149007 90 Candida albicans NCTC NCPF 3179 <10 Recovery cfu g or ml was monitored at interval of 2 days, 7 days, 14 days and 28days.

Results: Initial microbial status: Bacteria<l0cfu/g; Yeas t/moulds<l0cfu/g.

At the completion of testing, this sample fulfils the requirements of the BP (1999) for the adequate preservation of topical products.

Cn'to: BP (1999) criteria Bacteria: 2log and 31og reduction after 48 hours and 7days respectively, with no increase thereafter.

Yeasts/moulds: 2 log reduction within 14 days, with no increase thereafter.

Microbiologist John Reed performed the Test at Donnington Laboratories Limited Unit 3, Donnington Park, Birtham Road, Chichester, WEST SUSSEX P020 7DU UK.

Laboratory Results CO)PABISON OP THE BACT&P.ICIDAL PROPERTIES OF

NJLI PACE CEW AGAINST PROPIONIHCTERIUM

ACHES MJD STAPHYLOCOCCUS EPIDEP.MIDIS -Obj ective To evaluate in vitro the bactericidal activity of the Anjali Face cream in the respect of the two organisms most commonly reported as being implicated in acne vulgaris and to compare this with an appropriate benchmark product with claimed efficacy against spots and acne.

Test Products Anjali Face Cream; Pharma}Ierbeli, batch BN 0470498/FC, manufactured 23 March 2003 Benchmark: Oxy 10 Lotion: Glaxo Smithcline, batch 213A, expiry date Dec 2005, was containing 10% w/w benzyl peroxide.

Results Under experimental conditions employed, Anjali Face Cream reduced both the Propionibacterium acnes and Staphylococcus epiderinidis innocula by >99% within 10 minutes.

Comments /Conclus ions Under in vitro conditions, Anjali Face Cream demonstrates bactericidal activity against Propionibacterium acnes NCTC 737 and Staphylococcus epiderznidis ATCC 12228 representing the two micro-organisms most commonly reported as implicated in acne vulgaris. Activity against these organisms was comparable to a benzyl peroxide based benchmark product, marketed as maximum strength treatment for stubborn spots and acne".

Microbiologist John Reed performed the Test at Donnington Laboratories Limited Unit 3, Donnington Park, Birtham Road, Chichester, WEST SUSSEX P020 7DU UK .xamp.Le b For skin preparation-moisturizer % weight for weight 1) (i) Composit.on Znqredients mci Name Amount Water Aqua 51.388% Ghee "Ghee" 18% Coconut oil Cocos nucifera 20% Cetyl alcohol Cetyl alcohol 5% Laxemul Glyceryl stearate 4% +PEG 100 stearate Glycerine Glycerol 0.2% Vitamin E Tocoferol 0.1% Grape Fruit seed extract Citrus arandis 0.5% Slack cumin seed extract Centratherum anthelminticum 0.012% "Neem" kernel oil Melia aadirachta 0.1 % Mixed oil Neem Melia azadirachta Rose Rosa Edward 0.7% Seeds of black cumin

C

Example

- r * 1I*-I 1P weight -- (i) Composition Ingredients mci Name Amount Water Aqut Ghee "Ghee" 6% 1-1 -O4..OflU._. OCj Cetyl alcohol Cetyl alcohol 5% Laxemul Glycery]. stearate 4% +PEG 100 stearate Glycerine Glycerol 0.2% Vitamin E Tocoferol 0.1% 25, Grape Fruit seed extract Citrus grandis 0.5% Black cumin seed extract Centratherum antheirninticum 0.012% "Neem" kernel oil Melia azadirachta 0.]. % Mixed oil Neem Melia azadirachta Rose Rosa Edward 0.7% Seeds of black cumin Example 6 was successful in concern of stability.

Example 7 was a failure in concern of stability.

While I tried to reduce the amount of Ghee it did not work perfectly. It could not protect the cream from growth of fungus in the cream. At last I came with solution that adding more amount of Vitamin E Tocoferol I',, can mask smell of Ghee and Grape fruit seeds extract oil Citrus grandis.

SUMMARY OF THE INVENTION

According to a first aspect of the present invention, there is provided a base material for medicated cream and also for cosmetic creams. The base material with herbal Composition for use in the treatment of skin disorders itchy or infected skin such as impetigo, acne (on face, forehead scalp and on the back of the body) and fungal infection of skin and nails, which composition comprises extracts derived from the seeds of the plant Centratherum anthelminthicurn. Example 1 According to second aspect of the present invention, there is provided a base material for medicated cream and also for cosmetic creams. The base material with herbal Composition for use in the treatment of skin disorders itchy or infected skin such as children eczema, achrodermatitis (those ladies on HRT treatment are more vulnerable). Example 3 According to third aspect of the present invention, there is provided a base material for medicated cream and also for cosmetic creams. The base material with herbal Composition for use in the treatment of skin disorders such as acne and br fungal infection and! or fungal infections of the nails, which composition comprises extracts derived from the seeds of the plant Centratherum anthelminthicum fruitoil and extract from leaves, bark, roots of the plant Melia azadirachta and extracts derived from the seeds of the plant Cassia

tora. Example 5

According to fourth aspect of the present invention, there is provided a base material for medicated cream and also for cosmetic creams. The base material along with herbal Composition for use in the treatment of skin disorders such as lichen planus, lichen scierosus, lichen simplex. To develop natural cream useful for treatment of children eczema, psoriasis. Example 4 According to fifth aspect of the present invention, there is provided a base material for medicated cream and also for cosmetic creams. The base material with herbal Composition for use in the treatment of skin disorders such as itchy skin or infected skin through the administration of extracts derived from at least one member of the group consisting of the plants Centra therum anthelmin ticum, Melia azadirach ta, Cassia

tora. Example 2

The base material for medicated cream and also for cosmetic creams of the present invention may be dispersed in a suitable carrier for topical application as a cream, gel, ointment or lotion, or may be in the form of soap, shampoo. Alternatively, the composition may be formulated in a tablet form, or composition may be formulated and made spray dried extract.

Preferably, the composition spray dried extract is dispersed in a carrier suitable for topical application comprising ghee, which is clarified butter.

The compositions of the present invention help to break the cycles of pruritus-inflamation-pruritus, and of infection-inflamation-pruritus, thereby promoting faster healing of acute, sub-acute and chronic bacterial and fungal infection of the skin and fungal of nails. The compositions of the present invention are additionally useful in reducina the effects of stress and reinrorcLng 4 -iv.o Extracts from Cent.ratherum anthelminticum, Melia azadirachta disperse in a sesame oil and cream was formulated with ghee and antimicrobial preservative efficacy test was performed using Propionibacteriwn acnes NCTC 737 was introduced in a cream Inoculum count cfufml 2.1 x 10 and significant results were seen logarithm reduction unto 5.32 was achieved at the 7 days inoculation test and 14 days inoculation tests.

Extract from Cassia tora dispersed well with yogurt and heated and then applied on impetigo worked well. The activity was dose dependent.

RuiL, uU Cuzieiuiuzi: 1. Ghee and Coconut oil blended together nicely also Cetyl alcohol and Laxemul, when heated together all mixing well.

2. Phase one, phase two and mixing of herbal extract was done nicely. Stability of cream is achieved perfectly.

3. Life of the cream is very long lasting as effectiveness of herbs also maintained for longer period than other conventional creams.

4. Personal skincare base material useful in cosmetic and pharmaceutical industry containing Natural preservative, natural harmless vehicle and providing treatments for many skin conditions. jq

5. Free from steroids, free from lanolin and totally free from all potential skin sensitizers.

1ah .ti. 23-o7-1; 2OO6-t78-i copyright 2.0

Claims (10)

L

1. A method of making the cosmetic and/ or Pharmaceutical cream comprising "Ghee", Coconut oil, Cetyl alcohol, Laxemul ( Glyceryl stearate + PEG 100 to stearate) Glycerol, Freeze dried extracts of Cassia tora, Centratheruxn anthelminticum, "Neem" kernel oil and Rose oil.

A method of making the cosmetic and! or Pharmaceutical cream comprising of first step preparing oil phase in a stainless steel vessel by adding Ghee, coconut oil, Cetyl alcohol, Laxemul C Glyceryl stearate + PEG 100 stearate) Glycerol, "Neem" kernel oil and or sesame oil containing mixture of Centratherum anthelminticum, Jasminum grandiflorurn and Rose. Heat all of the above ingredients up to 98 C and melt it completely until it becomes homogenous oil phase mixture. Let it cool down up to temperature 75 C. Second step comprising of preparing the water phase 65 litres of deionised water (sterile water) heated up to 100 C. and then let it cool down up to 750 c* Third step comprising of mixing oil Phase and water phase by high shear mixing with automatic stirrer for 2- 3 minutes continuously stirring until it reaches 30 C. Forth step comprising of adding freeze dried water extracts of Cassia tora 5mg, Melia azadirachta 5mg and Centratherum anthelminticum 5mg. 0.005% each dissolved in 485 millilitres of deionised water and add 20 ml of rose oil and mix well. Ph will be in range of 5.5 to 6.5.

2. Method of making cream in claim ONE where in inclusion of "Ghee" would be range of 7% to 12% and for nasty cases of skin problems it can go up to 50%.

Inclusion of coconut oil 12%, Cetyl alcohol 4%, Laxemul (Glyceryl stearate+PEG100 stearate) 5%, Glycerol 1% and "Neem" kernel oil 0.1%.

3. Method of making cream in Claim ONE where in mixing of oil phase and water phase should be carried out at temperature 75 C.

4. Method of making cream in Claim ONE where in ph of the ready cream should be in range of 5.5 to 6.5.

5. Method of making cream in claim ONE where in Cassia tora freeze dried extract of seeds 0.005% and Centratherum anthelminticum freeze dried extract of seeds 0.005, Melia azadirachta freeze dried extract of whole plant 0.005 be included in the cream by dissolving all above in deionised water 0.485 %, also included Rose Oil 0.02%.

6. Method of making cream in CLAIM ONE where in by using Freeze dried extract of Cassia tora, Centratherum anthelmint.zcwn and Freeze dried extract of Melja azadirachta in CLAIM ONE where in the product treats skin disorders such as acne vulgaris and spots, infection due to Propionibacteriuzn acnes and br fungal 2Z infection and/ or furigal infections of the nails and impetigo.

7. Method of using Freeze dried extract of Centratherum anthelminticum and Freeze dried extract of Melia azadirachta in CLAIM ONE where in the product treats eczema in children (age above 6 months), psoriasis, lichen planus and all sorts of itchy skin disorders.

8. Method of using mixed oil-sesame oil treated with leaves of Melia azadirachta, seeds of Centratherum anthelminticum and rose petals in CLAIM ONE where in the product treats skin disorders such as infantile eczema, achrodermatitis, very dry flaiky, and itchy seborrhoeic dermatitis.

9. Method of making cream in CLAIM ONE where in by using Freeze dried extract of Cassia tora, Centratherum anthelminticum and Freeze dried extract of Melia azadirachta where in CLAIM SIX effectiveness of the product is compared with BENCHMARK OXY1O LOTION (GLAXO SMITHKLINE, BATCH 213A CONTAINING 10% W/W BENZYL PEROXIDE.

10. Method of making cream in CLAIM ONE where in by using Freeze dried extract of Cassia tora, Centratherum anthelminticum and Freeze dried extract of Melia azadirachta where in CLAIM SIX effectiveness of the product is SEEN CLINICALLY.