Topical herbal formulation for treating acne and skin disorders

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to an herbal formulation of topical nanoemulsion for treating acne-related skin disorders. The above formulation contains an aqueous phase comprising a therapeutic agent, rose water and/or lemon juice, and an oil phase containing an essential oil, a non-ionic surfactant and an accessory surfactant. The aqueous and oil phases are related within the range of 1:1 to 1:2, while a particle size of the herbal formulation is less than 5 nm. The essential oil is presented by tea tree oil, basil oil, rosemary oil, lavender oil, jojoba oil, bergamot oil, clove oil and peppermint oil. The invention also refers to a method for preparing the herbal formulation which involves providing the aqueous and oil phases, mixing the above phases to produce a mixture to be emulsified with the non-ionic surfactant to prepare a macroemulsion. The prepared macroemulsion is mixed with ethanol to produce a nanoemulsion with a particle size less than 5 nm.

EFFECT: invention provides the herbal formulation with good penetration, prolonged effect causing no irritation.

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The scope of the invention

This invention relates to herbal compositions for local application on the basis of nanotechnology that have therapeutic properties. More specifically, it relates to nano-emulsion-based local synergistic herbs that are effective against acne and other skin disorders, and method of producing the same in a pharmaceutically acceptable dosage forms. Additionally, more specifically, the invention relates to prophylactic and therapeutic local treatment of skin disorders of all types of acne, eczema, psoriasis, aging, scarring and such. More specifically, this invention is associated with the local processing having improved penetration, long action, low irritation, better efficacy, synergistic bacteriostatic activity and controlled delivery of therapeutic agents.

Background of the invention

Acne is the most common skin disorder of multifactorial origin with the prevalence of 70-85% in adolescents. According to statistics, approximately 85% of people aged 12-25 years, approximately 8% of adults aged 25-34 years and 3% of adults aged 35-44 years have acne to some extent [Befd W F, J Am Acad Dermatol 1995: 32; 552-556]. In the USA alone it is estimated that 40 to 50 million people with radauth from some form of acne, approximately 17 million have clinical acne [Thiboutot D, Arch Fam Med; 2000; 9; 179-187]. Although acne and other skin disorders such as eczema, psoriasis, aging, scarring and the like, are not diseases, life-threatening, but they have significant physical and psychological consequences, such as permanent scarring, low self-esteem, social inhibition, depression, anxiety and suicidal tendencies [Gupta et al., Br J Dermattol; 1998; 78; 457-456]. Therefore, they can be regarded as a serious medical disorder. Moreover, there are increasing reasons to believe that genetic factors and stress play an important but indirect role in acne and these skin disorders. Recently also found that Smoking is associated with these diseases. Local therapy is inevitable in the treatment of acne and mainly manifests itself in a weak - moderate manifestation of acne. In more acute forms recommend a combination of local and systemic therapy [Date et al. Skin Pharmacol Physiol; 2006; 19; 2-16].

Available topical products have a direct or indirect influence on the pathogenetic factors and selected according to the predominant type of lesion of acne. Therapeutic success for acne and related skin disorders is strongly dependent on regular depositing local use for a long period of time is Yeni. However, the disadvantages normally used by local applications, significantly affect the degree of agreement of the patient with the prescribed regime and prevent the treatment. Currently available for the treatment of acne and related skin disorders mainly on the basis of antibiotics and retinoids. Antibiotics have many limitations due to development of resistance in bacteria. Retinoids are vysokochastotnymi.

Most anti-acne practically insoluble in water, and thus they are difficult to enter aquatic systems. Thus, the strategy of combining many existing anti-acne in a single composition for the treatment of acne is not new, for example, such a combination is disclosed in U.S. patent No. 5976565 in the form of strips. Another combination is described in U.S. patent No. 4428933, where the combination of oatmeal, powdered sulfur, zinc gluconate, mustard seed, boric acid powder, beer yeast, hydrogen peroxide, isopropyl alcohol, water, methyl-p-hydroxy-benzoate and egg yolks described for the treatment of acne. Patent WO/2003/030816 discusses the composition against acne, obtained from natural products, in particular polysaccharides from red algae.

Known application of salicylic acid in the treatment of normal or teenage acne. For example, U.S. patent No. 4665063 describes the application is the development of topically applied aspirin (acetylsalicylic acid) for the treatment of common acne; and U.S. patent No. 4891227 describes the use of pads for applying acne products containing salicylic acid for oily skin. These patents describe compositions of the prior art, which emphasizes the importance of aggressive chemical and physical treatment, suitable for teenage acne, without consideration of suitability for adult acne and/or necessary in the smoothness of the action.

U.S. patent No. 4800197 describes the combination of salicylic acid and anionic surfactants of the Bible, in particular of sodium methylcholanthrene or sodium of metropoiltan. U.S. patent No. 5296476 describes a specific application of salicylic acid in combination with calcium citrate. Also these treatments made for aggressive, physical cleansing, which assumes that individual indicators are normal, young and oily skin.

Currently available forms of salicylic acid tend to exacerbate relatively dry acne in adults, and they, in particular, unsuitable for people with the condition of sensitive skin, such as irritant folliculitis. Known preparations of salicylic acid also poorly tolerated by patients suffering from acne in combination with rosacea.

Therefore, it is necessary to study and develop alternative acne treatment and others who can use disorders. This creates a great interest in the possible effect of natural substances on antibacterial, anti-inflammatory, reduces oxidative stress effect in these diseases. New strategies of drug delivery also serve as a tool in optimizing the effectiveness of therapeutic agents or through the regulation of their physicochemical and biopharmaceutical properties, or by minimizing/eliminating side effects associated with them, reducing the time of treatment, thus, offering the best level of agreement of the patient with the prescribed regime.

In prior art well-lit that essential oils are valuable tools for skin care. Essential oils play a very important role in the treatment of acne, because they dissolve through the lipids in the skin and easily absorbed, but also because of their ability to dissolve sebum, kill bacteria and protect the acid mantle of the skin. Used concentrated or diluted with carrier oil essential oil can be applied topically to alleviate weak - moderate acne. Some essential oils are usually used to treat acne are rose geranium essential oil, jojoba oil, bergamot oil, clove oil, lavender oil, tea tree oil, Basil oil, rosemary oil, lavender mA is lo, mint oil, etc.

Tea tree oil is a great antibacterial treatment, which makes it a great wrestler with acne, as well as the purifier of the RAS General purpose. Biju et al. [Pharmazie 2005; 60: 208-211] developed a micro-emulsions with the use of tea tree oil by applying isopropylmyristate, Polysorbate 80, glycerin with water, and U.S. patent No. 6464989 B2 discloses an emulsion with tea tree oil, but without the aqueous phase with the use of rose water and lemon juice as therapeutic agents captured in an oil phase, one or more essential oils, as used in this invention.

Irritant folliculitis caused epithelial irritation, is another condition sensitive skin, which is found in the form of erythematous papules and follicular pustules. Repeating from time to time episodes irritant folliculitis sometimes incorrectly diagnosed as normal acne and treat physical abrasives and exfoliants, which injure and exacerbate the initial state.

Acne is the most common skin disorder of multifactorial origin with the prevalence of 70-85% in adolescents. According to statistics, approximately 85% of people aged 12-25 years, approximately 8% of adults aged 25-34 years and 3% of adults aged 35-44 years have acne to some extent. Follow the consequently, it can be regarded as a serious medical disorders that require a superior solution.

Therefore, there is an urgent need for the development of such compositions that are effective for all skin types and have numerous synergistic effects, have good penetration, long-term action to avoid re-introduction, do not cause irritation and include both water and lipid phases in a specific ratio to provide medicines for the treatment of skin, in order to minimize negative effects and maximize efficiency.

A brief description of the invention

According to this invention provided with new herbal formulations based on nano-emulsion, their composition and method of production, which are used for local application to process and treat all types of acne and other skin disorders, including eczema, psoriasis, aging, scarring and such. Herbal formulations include one or more essential oils in a specific weight ratio as the oil phase and rose water and/or lemon juice in a specific ratio as the aqueous phase, which contains the drug with at least one or more non-ionic surfactants. The compositions exhibit excellent synergistic efficacy when processing the e and the treatment of acne and other skin disorders with improved percutaneous penetration, excellent thermodynamic stability, ensuring a long shelf life, low skin irritation and effect of the reservoir that contributes to the localization of the drug in the skin, enabling controlled delivery of therapeutic agents. Disclosed herbal formulations can additionally be used as a carrier to transport any other lipophilic/lipophobic drugs for effective treatment of skin disorders.

The objects of this invention

The object of this invention is the provision of new herbal compositions for local application, for processing and treating all types of acne and other skin disorders, including eczema, psoriasis, aging, scarring and such.

Another object of this invention is the disclosure of herbs with a new delivery system based on nanotechnology.

Another object of this invention is the Association of rose water and/or lemon juice in a specific ratio as therapeutically active aqueous phase of these compounds.

Also another object of this invention is the stabilization of the aqueous phase by capturing it in a lipid phase comprising one or more essential oils to form a stable, synergistic nanoemulsion local application.

Friend the m object is the disclosure compositions and method of producing these compounds.

Another object is the provision of herbal formulations of local applications that have enhanced percutaneous penetration, excellent thermodynamic stability, ensuring a long shelf life, low skin irritation, bacteriostatic/bactericidal activity and the effect of the reservoir that contributes to the localization of the drug in the skin, enabling controlled delivery of therapeutic agents.

Another object of this invention is the disclosure of herbs that can be used as a carrier or base for the transfer of any other lipophilic/lipophobic drugs for effective treatment of skin disorders.

A detailed description of the preferred option implementation

This invention describes a new herbal composition, their new delivery mechanisms, composition and method for producing the same in a pharmaceutically acceptable dosage forms for the treatment of acne and other skin disorders, including eczema, psoriasis, aging, scarring and such.

The application of fresh lemon juice and rose water for acne treatment firmly established, but the composition is not available commercially as a pharmaceutically acceptable dosage form, as the combination is unstable after more than two-is yireh hours at room temperature, what limits the use of this combination and indicates the need for a stable structure.

The idea of this invention is not only to overcome the stability problem of the combination of rose water and lemon juice to treat acne and other skin disorders, but also to ensure the improvement of technology. Inventors can successfully stabilize the combination of rose water and/or lemon juice in a specific ratio. This combination or just lemon juice can be used as therapeutically active aqueous phase compositions by capturing this aqueous phase in lipidil layer so as to form a form a controlled release local application in a new delivery system based on nanotechnology, i.e. nano-emulsion, which additionally contributes to the synergic effect of one or more essential oils selected as the oil phase for the specified compositions. Thus, the invention not only provides a stable variant existing in prior art compositions of rose water and/or lemon juice, but also has a lot of technological improvements by making it more effective, with long-lasting effects with enhanced percutaneous penetration, low skin irritation and controlled delivery of therapeuti the Eski active phytochemicals funds by converting them into a nanoemulsion with synergistic anti-inflammatory, analgesic, bacteriostatic/bactericidal, antioxidant, immunomodulatory effects of local application.

The novelty of this invention consists in the development of new herbal formulations comprising one or more therapeutically active ingredients as the aqueous phase, which have strong antibacterial activity, but weak stability, which is made stable by capturing them in one or more essential oils, used as oil phase and mixing in such proportions so as to provide therapeutic synergy and compatibility of the composition, proizvoda, so, W/O (water in oil) nano-emulsion, made of therapeutically active phytochemicals for the treatment of acne and other related skin disorders. Due to the increased surface section and the reduced surface tension of local delivery nano-emulsion is more efficient and stable compared with other microemulsion or creams.

Inventive step of the present invention is to select specific components for a new system of delivery, using rose water and/or lemon juice as the aqueous phase, and stabilization of therapeutically active phytochemicals funds present in the specified aqueous phase together with one or more essential oil is mi in a specific ratio so that in order to ensure complete synergy to form a nano-emulsion, which will allow the slow release of the aqueous phase, captured in an oil phase, and the rapid penetration into the skin by reducing the size of the particles through the formation of nano-emulsion.

One of the embodiments of the present invention is the disclosure of a method of obtaining a new system of delivery of drug that is present as nano-emulsion for topical application.

Another embodiment of this invention is the provision herbal formulations with increased efficiency, enhanced percutaneous penetration, excellent thermodynamic stability, ensuring a long shelf life, low skin irritation and effect of the reservoir that contributes to the localization of the drug in the skin, enabling controlled delivery of therapeutic agents with synergistic anti-inflammatory, analgesic, bacteriostatic/bactericidal, antioxidant, immunomodulatory effects of local application.

Commercial applicability: the product has a very good commercial potential for the treatment of very large numbers of patients suffering from acne and other skin disorders, including eczema, psoriasis, aging, rubs is improving and the like.

Another embodiment of this invention is the disclosure compositions compositions composed of one or more essential oils in a specific ratio as the oil phase and rose water and/or lemon juice in a specific ratio as the aqueous phase with at least one or more non-ionic surfactants and additional surface-active agent.

Essential oils used in the compositions selected from the group comprising tea tree oil, Basil oil, rosemary oil, lavender oil, rose geranium essential oil, jojoba oil, bergamot oil, clove oil, peppermint oil and the like. Because essential oils can be a little dry the skin when applied undiluted, they should be thinned using oil media to keep skin hydrated. Adding the aqueous phase instead of oil-carrier provides a solvent for essential oils, selected for the compositions of this invention.

One preferred implementation of the present invention contains one or more essential oils such as tea tree oil, Basil oil, rosemary oil, lavender oil and peppermint oil, in specific ratios. The choice was based on the individual effectiveness of these ingredients for the specified specific examples from the texts. Skin damaged by acne, is very sensitive to tea tree oil, which is mainly used at a concentration of 5-7%. However, in these compositions, the inventors have successfully used to 15-36% tea tree oil without any skin irritation at first.

The aqueous phase selected for nanoemulsions, contains the drug and includes one or more therapeutically active phytochemical components of herbal/natural origin instead of using water, which is usually used as the preferred choice for the aqueous phase in the emulsion, made from herbal/natural products. These contain the drug therapeutically active components of the aqueous phase include rose water and/or lemon juice in a ratio of 1:1 or just lemon juice. Phytochemical tools present in the specified aqueous phase of rose water and/or lemon juice are unstable after more than 2-4 hours and, thus, pose a technical obstacle for use as therapeutically active components. Components, therefore, are caught inside a lipid bilayer essential oils, thus resulting in obtaining microemulsion. This emulsion had some inherent disadvantages because it irritated my skin was sticky, making the oil phase rancid. Uh what about the is also a task to solve, which was solved by changing the ratios used essential oils and the use of surfactants and additional surface-active substances.

Surfactant used in these compositions is non-ionic in nature and selected from the group comprising polyoxyethylene esters of sorbitol and fatty acids, Tween, such as Tween 80, Tween 20, glycols, polyoxyethylene-stearates, colloidal silicon dioxide, phosphates, sodium dodecyl sulphate, calcium carboxymethylcellulose, sodium carboxymethylcellulose, methylcellulose, hydroxyethyl cellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose phthalate, microcrystalline cellulose, magnesium aluminium silicate, triethanolamine, polyvinyl alcohol and polivinilpirolidon (PVP), and the like. Commonly used ionic surfactants are surface-active substances of animal origin and was not chosen specifically by the inventors. Apply additional surfactant selected from the group comprising alcohols with short and medium chain, such as ethanol, methanol, isopropyl alcohol and the like. The compositions can optionally include one or more emollients selected from the group comprising cetyl alcohol, softeners, cocoa butter, isopropyl-myristate, isopropyl-Lano is at, lanolin acid, stearic acid and the like. Softeners are used to avoid any burning or hardening of the skin.

Active phytochemicals funds in the aqueous phase include citric acid, ascorbic acid, quercetin 3-O-rutinozide-7-O-glucoside, chrysoeriol 6,8-di-C-glucoside (Stellaris-2), apigenin 6,8-di-C-glucoside (vicenin-2), eriodictyol 7-O-rutinozide, 6,8-di-C-glucosyl diosmin, hesperetin 7-O-rutinozide, homoeroticism 7-O-rutinozide and diosmin 7-O-rutinozide, vitamin a, water-soluble elements of rose oil and the like and essential oils include terpinen-4-ol, γ-terpinene, α-terpinene, 1,8-cineole, α-terpinolene, α-terpineol, α-pinene and p-cYmen, eugenol, cinnamal, citronellol, geraniol, linalool, MIRCEN, pinene, aciman, terpineol, methyl-chavicol, citral, camphor, camphene, limonene, α-pinene, 1,8-cineole (eucalyptol) and camphor, camphene, limonene, borneol, verbena, β-MIRCEN, β-pinene, linalool, α-terpineol, γ-terpineol, borneol, ISO-borneol, terpinen-4-ol, nerol, Lavandula, terpenes, esters of terpene, linalyl-acetate, geranyl-acetate, neryl-acetate, octene-3-yl-acetate, lavandulyl-acetate, MIRCEN, α-pinene, β-pinene, camphene, E-β-Ozimek, Z-β-Ozimek, β-phellandrene, eucalyptol (1,8-cineole), β-caryophyllene, β-farnesene, germacrene, α-Humulin, ketones, camphor, octanone, krypton, L-menthol, Mentone, Menton, alpha-pinene, a-1 lemon, to refilled (carophyllene), and kademan (cademene), and the like.

The choice of surface-active agents, additional surfactants and emollients used in the compositions, and their ratios, ranges can change specialist in this prior art, and the results can be modified without departing from the essence and scope of this invention.

One of the preferred embodiments discloses the use of 20±5% of tea tree oil, 5±5% rosemary oil and 1±5% peppermint oil as an oil phase component of the total amount of essential oils 25±5% as the oil phase, and 25+5% freshly squeezed lemon juice mixed in equal quantities, as the aqueous phase. Used preferred surfactants are non-ionic long chain polymers, and the ratio of Tween 20:Tween 80 is 88:12. Apply additional surface-active substance is preferably ethanol, and the ratio without surfactant:with additional surface-active agent is 1.5:1 with a value of HLB (hydrophilic-lipophilic balance) of 16.7. Manufactured nano-emulsion compositions are energy efficient and made in the form of nano-emulsions W/O (water in oil) type using the ratio of oil:water phase 1:1. Constructed in this way part of the ima is t the particle size ≤0.5 nanometer, Zeta-potential is ≤-0,0326, and the index polydispersity (PDI) is ≤0,169. The negative Zeta-potential and PDI≤1 shows thermodynamic stability of the nano-emulsion.

Another preferred implementation of the present invention discloses the use of 18±5% tea tree oil, 4±5% Basil oil, 2±5% rosemary oil, 5±5% lavender oil and 7±5% peppermint oil together as an oil phase, an exciting mixture of lemon juice and rose water in a ratio of 1:1 as the aqueous phase, where the ratio of oil phase:aqueous phase is 2:1, thus forming a nanoemulsion using Tween 20:Tween 80 in the ratio of 70:30, more specifically 80:20 more specifically, 88:12, together with ethanol as additional surfactants, where the ratio of surfactant additional surfactant is 1.2:1, with the addition of 0.75 g lanolin acid and 1.5 g of stearic acid as softening agents. Nanoemulsion formed thus has a particle size ≤5 nm, the Zeta-potential is ≤-0,0500, and the index polydispersity (PDI) is ≤0,200.

Another embodiment of the present invention is the formation of nano-emulsion W/O (water in oil) type, in which the ratio of water:the oil is from 1:1 to 1:2 that I have is thermodynamically stable and provides compositions a long shelf life. The particle size specified nano-emulsion ranges from 0.5 to 50 nm with PDI index 0,100-0,200 and Zeta-potential from -0,0100 to -0,0500, more preferably the particle size is ≤5 nm, PDI index is ≤0,200, and Zeta-potential is ≤-0,0500. The ratio of surfactant to apply additional surfactant in the compositions vary from 1.5:1 to 1:1,5. So manufactured nano-emulsion with the use of one or more phytochemicals funds include containing drug to the aqueous phase, which has strong antibacterial properties, which is made stable by capturing this aqueous phase into the lipid layer of essential oils so as to form a composition of controlled release, with increased efficiency, enhanced percutaneous penetration, excellent thermodynamic stability, ensuring a long shelf life, low skin irritation and the effect of the reservoir that contributes to the localization of the drug in the skin, enabling controlled delivery of therapeutic agents with synergistic anti-inflammatory, analgesic, bacteriostatic/bactericidal, antioxidant, immunomodulatory action for preventive and therapeutic local application used when processing Leche and the research Institute of all types of acne and other skin disorders including eczema, psoriasis, aging, scarring and such. Made so the composition can also be used as a carrier or base for the transfer of any other lipophilic/lipophobic drugs for effective treatment of skin disorders.

Nano-emulsion increase the degree of absorption, enhance percutaneous penetration, eliminates the variability of absorption, help dissolve lipophobia therapeutic agent/phytochemicals funds, increase bioavailability, help rapid and effective penetration of the active component, provide protection from hydrolysis and oxidation of the drug in the oil phase, as this type of emulsion is not exposed to air and water, increase the degree of consent of the patient with the prescribed regime and require less energy, thus making the invention technically advanced compared to other drugs for local application in the prior art.

The method of obtaining applied for nano-emulsion, as described below, includes the following steps:

Stage 1A: take rose water and/or fresh lemon juice in a ratio of 1:1 or just lemon juice as the aqueous phase and filtered with a filter of 0.2 micron;

Stage 1b: mix 30±7% of essential oils and 20+7% aqueous phase and indicate (A);

This is the section 2A: mix suitable surfactant in the ratio of 70:30, more specifically 80:20, more specifically, 88:12, and denote ();

Stage 2b: emuleret (A) through 28±5% mixture of a suitable surfactant ();

Stage 3A: is stirred for 15 minutes, getting the final microemulsion whitish color, which indicate (S);

Step 4: take the ethanol as additional surfactants, which separately indicate (D);

Step 5: mix 20±5% (D) in (C). The mixture stand for (E);

Step 6: add the appropriate softeners after heating the above mixture is optional, depending on the requirements of the stock;

Step 7: apply a colloid mill and filtered the resulting nanoemulsion appropriate filters, and fill in the appropriate containers.

Nano-emulsion thus obtained have a particle size ≤5 nanometers. The stages involved in the preparation include, but are not limited to, disclosures made above.

Example 1: the Test composition 1: each 100 ml contains (XLP01)

NameTrack
Tea tree oil20.2 ml volume/volume
Basil oil8,2 ml volume/volume
R is Marinova oil 1.9 ml volume/volume
Lavender oil5,4 ml volume/volume
Rose water:citrus juice in the ratio of 1:1of 17.8 ml volume/volume
Surfactant 88% Tween 20 and 12% of Tween 80 (hydrophilic-lipophilic balance = 16,7)25 ml
Additional surfactant 95% ethanol21 ml
Softeners lanolin and stearic acidenough

Example 2: Testing part 2: each 100 ml contains (XLP02)

NameTrack
Tea tree oil23,5 ml volume/volume
Basil oilof 9.4 ml volume/volume
Rosemary2,8 ml volume/volume
Rose water:citrus juice in the ratio of 1:1of 17.8 ml volume/volume
Surfactant 88% Tween 20 and 12% Tween 8 (hydrophilic-lipophilic balance = 16,7) 25 ml
Additional surfactant 95% ethanol21 ml
Softeners lanolin and stearic acidenough

Example 3: Testing part 3: each 100 ml contains (XLP03)

NameTrack
Tea tree oil23,7 ml volume/volume
Basil oil12.0 ml volume/volume

Rose water:citrus juice in the ratio of 1:1of 17.8 ml volume/volume
Surfactant 88% Tween 20 and 12% of Tween 80 (hydrophilic-lipophilic balance = 16,7)25 ml
Additional surfactant 95% ethanol21 ml
Softeners lanolin and stearic acidenough

Example 4: Test part 4: each 100 ml contains (XLP04)

NameTrack
Tea tree oil35,7 ml volume/volume
Rose water:citrus juice in the ratio of 1:1of 17.8 ml volume/volume
Surfactant 88% Tween 20 and 12% of Tween 80 (hydrophilic-lipophilic balance = 16,7)25 ml
Additional surfactant 95% ethanol21 ml
Softeners lanolin and stearic acidenough

Example 5: Testing part 5: each 100 ml contains (XLP05)

NameTrack
Tea tree oilof 17.8 ml volume/volume
Basil oil3.6 ml volume/volume
Rosemary1.8 ml volume/volume
Lavender oil5,4 ml volume/volume
Mint oil,7 ml volume/volume
Rose water:citrus juice in the ratio of 1:1of 17.8 ml volume/volume
Surfactant 88% Tween 20 and 12% of Tween 80 (hydrophilic-lipophilic balance = 16,7)25 ml
Additional surfactant 95% ethanol21 ml

Softeners lanolin and stearic acidenough

Example 6: Test part 6: each 100 ml contains (XLP06)

NameTrack
Tea tree oil21,4 ml volume/volume
Rosemary1.8 ml volume/volume
Lavender oil5,4 ml volume/volume
Mint oil7,1 ml volume/volume
Citrus juiceof 17.8 ml volume/volume
Surfactant 88% Tween 20 and 12% of Tween 80 (hydrophilic-lipoyllysine = 16,7) 25 ml
Additional surfactant 95% ethanol extract Azarichata indica21 ml
Softeners lanolin and stearic acidenough

Example 7: Testing part 7: each 100 ml contains (XLP07)

NameComposition (100 ml)
Tea tree oil19,11 ml volume/volume
Rosemary4,55 ml volume/volume
Mint oilof 0.91 ml volume/volume
Citrus juicea 24.57 ml volume/volume
Surfactant 88% Tween 20 and 12% of Tween 80 (hydrophilic-lipophilic balance = 16,7)30,94 ml
Additional surfactant ethanol20 ml

Experiment 8: the inhibitory effect XLP-07 on acne and related conditions in people

Category miliums/ acne/papules/ pustules/ nodules/cysts
Number of patientsAge (in years)The duration of treatment and time easier with XLP-07The duration of treatment and time of relief with standard ClonazelamPercentage faster healing with XLP07 compared with Clonazelam
Patient 1the miliums08 years3 days33,3%
Patient 2the miliums10 years2 days
Patient 3acne12 years4 days25%
Patient 4acne15 years3 days
Patient 5papules185 days54,5%
Patient 6papules17.5 years9 days
Patient 7papules27 years5 days
Patient 8papules20 years13 days
Patient 9pustules22 years8 days61,9%
The patient 10pustules1921 days
Patient 11cysts25 years10 days60%
The patient 12cysts32 years25 days

Monitoring criteria: mild-moderate acne includes miliums, blackheads, papules and pustules. Severe acne ha is acterized nodules and cysts.

Conclusion: XLP-07 product of the present invention is significantly more effective than Clerasil (leading trademark for acne treatment in India).

Experiment 9: Microbiological examination XLP-07 and its comparison with cream Acne-n-Pimple (Himalaya&Co.)

XLP-07 compared to cream Acne-n-Pimple

The microorganismXLP-07Standard cream Acne-n-Pimple
S.epidermidis (MTCC435) (120 ál)17,17±1.4 mm17,10±1.5 mm
S.epidermidis (MTCC435) (dilution 1:4)for 11.55±1.3 mmnull
S.aureus (MTCCIZI) (100 μl)16,90±1.2 mm16,27±1.4 mm
S.aureus (MTCC 737) (dilution 1:3)11,88±1.0 mm clear zoneAn intermediate zone with a dense growth

Conclusion

1. The zone of inhibition S.epidermidis and S.aureus was more XLP-07 compared to the standard cream Acne-n-Pimple.

2. Found that XLP-07 more effective even at very low concentrations, thus showing the effect of slow release of therapeutically active means having strong bactericidal and the efficiency.

XLP-07 in comparison with Clonazelam

The microorganismXLP-07Clerasil
S.epidermidis (MTSS) (18 ál)9,29 mm clear zoneNull
S.aureus (MTCC737) (18 ál)12,58 mm fuzzy area8,86 mm fuzzy area

Conclusion

1. Found that XLP-07 more effective even at low concentrations, while the zone of inhibition at Clerasil or were missing, or was not clear. Thus, showing that XLP07 has the best bactericidal activity against these pathogens.

Experiment 10: Study of the effectiveness of individual oil

IngredientS.aureus (MTCC 737)S.epidermidis (MTSS)
Tea tree oil10 mm13 mm
Rosemary7.5 mm12.6 mm
Lavender oil0ill
Basil oil0ill
Mint oil07.8 mm
Rose + lemon juice12.5 mm12.6 mm
Fresh lemon juice14 mm16 mm

Experiment 11: the Various tests hydrophilic-lipophilic balance (HLB)

HLB4HLB 14HLB 15,51HLB15,85HLB 16HLB 16,33The HLB of 16.4The HLB of 16.7 (Final)
83% Span 809% Span 8050% Tween 2050% Tween 2060% Tween 2075% Tween 2085% Tween 2088% Tween 20
17% Tween 8091% Tween 8070% Tween 8050% Tween 8040% Tween 8022% Tween 8015% Tween 80 12% Tween 80
The test was not successfulThe test was not successfulThe test was successfulThe test was successfulThe test was successfulThe test was successfulThe test was successfulThe test was successful

Experiment 12: a Comparative study of the levels of antioxidant and anti-inflammatory enzymes and related biochemical parameters in the model induced acne in rats.

Induced acne in rats, which were divided into 3 groups. Control uncultivated infected group I, group II, which were treated by Clonazelam, and group III, which were treated XLP07 within 7 days. After 7 days was studied various biochemical parameters in all groups. Cm. 3 and 4.

Conclusion: Figure 3: shows a sharp increase in MDA (malonic dialdehyde) activity in group III after treatment XLP07 compared with Group II Clerasil (the leading product for the treatment of acne in the Indian market) and infected control uncultivated group I. This indicates that XLP07 has better antioxidant activity than Clonazelam.

Figure 4: shows a sharp smart is the increased activity of the enzyme myeloperoxidase in group III after treatment XLP07 compared with Group II Clerasil (the leading product for the treatment of acne in the Indian market) and infected control uncultivated group I. This indicates that XLP07 has better anti-inflammatory activity compared with Clonazelam.

Experiment 13: Data on long-term stability XLP07

Data on long-term stability

Product: XLP-07 for external application of 5 ml vials

Lot no: RD/XLP-07/B01

Date of manufacture: 02/2006Date of experiment: 01/2008
Start date: 10.02.2006Lot size: 100 vials

Packing: filled in 5 ml vials

Test conditions: 30°C±2°C/relative humidity 65%±5%

Storage: store below 30°C

NOTES: 1. All procedures performed at standard temperature and pressure.

2. The above results show that the product is stable at 30°C±2°C/65%RH±5% within 24 months.

The above disclosure describes a method and the method of this invention and sets forth the best option considered by the inventor for his invention, but which should not be construed as limiting. Various changes and variations of the described method and system of the invention the present invention will be apparent skilled in the field of technology without deviating from the scope and sown the capabilities of the present invention. Although this invention is described in connection with specific preferred variant implementation, it should be understood that the invention as claimed should not wrong to be limited to such specific choices of implementation. Actually, various modifications and equivalents of the described embodiments of the present invention which are obvious to experts in the development of compounds or related areas will also be in the scope of this invention.

A brief description of graphic materials

Figure 1: a Graph showing the Zeta potential of the nano-emulsion (Experiment 7), where the Zeta-potential is -0,0326.

Figure 2: Graph showing the distribution of particle size and index of polydispersity nano-emulsion (Experiment 7), where the diameter of the maximum number of particles is in the range of 0.5 nanometer.

Figure 3: a Graph showing a significant increase in MDA activity group III compared with G-II and G-I.

Figure 4: a Graph showing a significant reduction in MPO activity in group III compared with G-II and G-I.

1. Herbal composition based on nano-emulsion topical application for treatment related to acne skin disorders, and the composition includes:
- containing drug to the aqueous phase, containing, at least, rose water and lemon juice;
- oil phase, sod is readuy, at least one essential oil selected from the group consisting of tea tree oil, Basil oil, rosemary oil, lavender oil, jojoba oil, oil of bergamot, clove oil and mint oil;
and at least one nonionic surfactant and at least one additional surfactant,
where specified containing the drug aqueous phase is captured in the lipid layer, at least one essential oil;
where the ratio specified containing the drug aqueous phase and the oil phase is in the range from 1:1 to 1:2;
and where specified herbal composition based on nano-emulsion topical application has a particle size ≤5 nm.

2. Herbal composition based on nano-emulsion topical application according to claim 1,
where the specified nonionic surfactant and a specified additional surfactant are present in a ratio of from 1.5:1 to 1:1,5; and
where this additional surface-active substance is ethanol.

3. Herbal composition based on nano-emulsion topical application according to claim 1 or 2, where the ratio specified rose water and the lemon juice is in the range of 1:1;
where specified herbal composition based on local nano-emulsion applied the I is the index of polydispersity (PDI)≤0,200 and Zeta-potential ≤-0,0500.

4. Herbal composition based on nano-emulsion topical application according to claim 1 or 2,
where the specified nonionic surfactant selected from the group comprising polyoxyethylene esters of sorbitol and fatty acids, Tween 80, Tween 20, glycols, polyoxyethylene-stearates, colloidal silicon dioxide, phosphates, sodium dodecyl sulphate, calcium carboxymethylcellulose, sodium carboxymethylcellulose, methylcellulose, hydroxyethyl cellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose phthalate, microcrystalline cellulose, magnesium aluminium silicate, triethanolamine, polyvinyl alcohol and polyvinylpyrrolidone (PVP);
where the specified nonionic surfactant is preferably at least one of Tween 20, Tween 80; and
where the value of the specified Tween 20 to the specified Tween 80 is at least 70:30 or 80:20, 88:12.

5. Herbal composition based on nano-emulsion topical use according to any one of claims 1 to 4,
where specified containing the drug aqueous phase includes lemon juice;
where indicated lemon juice includes 25±5% of specified containing the drug aqueous phase;
where the specified essential oil includes within the range percentages of the amounts specified tea tree oil in the amount of 20±5%of specified rosemary oil in an amount of 5±5% and is shown peppermint oil in quantities of 1±5% as specified oil phase;
where the specified nonionic surfactant Tween 20 includes:Tween 80 in the ratio as 88:12;
where the ratio of nonionic surfactants to the additional surfactant is 1.5:1 with a HLB value of 16.7;
where the composition is a local application is specified containing the drug aqueous phase to the said oil phase is 1:1 and the particle size ≤0.5 nm, the Zeta-potential is ≤-0,0326, and the index polydispersity is ≤0,169.

6. Herbal composition based on nano-emulsion topical application according to claim 1,
where this nanoemulsion includes a specified rose water and the specified freshly squeezed lemon juice in a ratio of 1:1, available in the range of 18±5%as specified containing the drug aqueous phase;
where specified containing the drug aqueous phase is captured in the range of percentage amounts of specified essential oils, including 18±5% tea tree oil, 4±5% Basil oil, 2±5% rosemary oil, 5±5% lavender oil and 7±5% peppermint oil together as specified oil phase, an exciting containing the specified drug aqueous phase,
where the value containing the drug aqueous phase to oil phase is 1:2;
where the specified nonionic surface is but-the active substance is the ratio of Tween 20:Tween 80 88:12;
where this additional surface-active substance is ethanol, and the ratio of the specified surfactant to the specified additional surfactant is 1.2:1 with HLB value of 16.7;
where specified herbal composition based on nano-emulsion topical application has a particle size ≤5 nm, the Zeta-potential is ≤-0,0500, and the index polydispersity (PDI) is ≤0,200.

7. The way to obtain herbal composition based on nano-emulsion topical application according to claim 1,
moreover, the method includes the steps are:
provide containing the drug aqueous phase containing, at least, rose water and lemon juice;
provide an oil phase containing at least one essential oil selected from the group consisting of tea tree oil, Basil oil, rosemary oil, lavender oil, jojoba oil, oil of bergamot, clove oil and mint oil;
where specified containing the drug aqueous phase is captured in the lipid layer, at least one essential oil;
where the ratio specified containing the drug aqueous phase and the oil phase is in the range from 1:1 to 1:2;
provide at least one non-ionic surfactant is emesto and at least one additional surfactant;
provide ethanol as additional surfactants;
mix specified containing the drug aqueous phase and the oil phase to obtain A mixture;
emuleret a mixture with the specified at least one nonionic surface-active agent to obtain microemulsion; and
mix the ethanol with the specified microemulsions to obtain herbal composition based on nano-emulsion topical application having a particle size ≤5 nm.

8. The method according to claim 7, additionally comprising adding softener.



 

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