Strengthens hair from root to tipPromotes hair thicknessCeases hair lossAccelerates hair growthReinforces hair anchoring
Hair Growth ProcessThe scalp has at an average 100,000 hairs. A healthy scalp sheds hair continuously and new hair replacesthem. Hair growth follows a series of cycle. Normal Cycle Normal A:T 1. Anagen: Multiplication of group of cells at the base of the hair. Typically lasts from 2 to 6 years. 2. Catagen: The growth in the hair follicles stops and degeneration begins. This phase lasts about 2 to 3 weeks. 3. Telogen: The hair rests and no growth is experienced which lasts 2 to 3 months. Shedding of hair from the follicle. 4. Return to Anagen: The hair follicle re-enters the growth phase. The shed hair is then replaced by a new one.
Hair LossAny change in Hair growth cycle leads to hair loss, also called as alopecia, is a commonproblem affecting both men and women.The most common type of hair loss is androgenetic alopecic (AGA) both in men (Male pattern baldness) andwomen (Female pattern hair loss) and is caused by heredity hormones and genetics. • Shrinkage of hair follicles. • Gradual increase in telogen phase • Reduction in A:T ratio Results in hair loss and visible baldness
KOPEXIL R egulates ebalances KOPEXIL einforces Hair Regrowth Clinically proven to be effectiveKOPEXIL increases the volume of hair in the growth stage by working on the deepstructure of the roots. It rejuvenates the hair roots so that healthy hair growth can persist.The perifollicular fibrosis is a condition in which collagen around the roots becomes rigid,tightens, and pushes the hair out; KOPEXIL helps in softening of the collagen. History: 2, 4 Diamino-pyrimidine-3-oxide (Aminexil) is a patented chemical molecule developed by L’Oreal and is claimed to help prevent prefollicular fibrosis (scarring of the hair follicles).
Product SpecificationTrade Name KOPEXILINCI Name Diamino Pyrimidine OxideChemical Name 2,4-diamino pyrimidine-3-OxideMolecular Formula C4H6N4O Molecular StructureCAS NO 7438-76-9Harmonized Tariff No. 29335995Appearance White to off white crystalline powderAssay by HPLC (on dried basis) 98.0-102.0%Solubility 1. 1gm Kopexil, soluble in 30 ml water 2. 1gm Kopexil, soluble in 10ml of Propylene glycol 3. 1gm Kopexil ,soluble in mixture of 25ml water & 5ml Ethanol 4. 1gm Kopexil, soluble in mixture of 30 ml Ethanol and 12 ml water. The above solubility observed with sonication at RT. Generally, solubility of Kopexil is poor in all solvents.Suggested use level 0.2-1.5%Storage Store in tight sealed container, avoid light and heat
KOPEXIL Mechanism of ActionLysyl hydroxylase (LH), an enzyme catalyzes the formation of hydroxylysine, which contributes to the maturation ofcollagen synthesis. Increased level of collagen causes hardening and shrinking to occur around hair follicles greatlyretarding their growth. Over time, the hair follicles die and the scalp becomes visible. Diaminopyrimidine oxide * KOPEXIL is not intended to treat, cure, diagnose or prevent any disease. Kopexil is not a drug. Kopexil is a cosmetic product. This product and its statements have not been evaluated by the FDA.
Clinical Efficacy as per available literatureTest Protocol: 35 volunteers between 20-40 years with moderate to severe hair loss. Twice daily application of identically packed KOPEXIL Hair gel for a period of 6 months. Visual examination & counting of total number of hair in a defined area with magnifying lens Pattern of increase in new hair after 6 months of treatment % of people responding % No. of people not responding KOPEXIL induces a strong KOPEXIL induces a visible increase in reduction in the hair loss, new hair formation, which clearly demonstrating its anti-hair indicates stimulation of hair growth loss efficacy. process. Conclusion: Clinical trials of KOPEXIL hair gel shows statistically that, the active ingredient KOPEXIL in hair gel exhibits its anti hair loss property and results in remarkable increase in hair growth, measured by hair counts.
Safety Data & Regulatory StatusSafety Data:• The safety profile of KOPEXIL supports that it is safe to use in Cosmetic Products as per SCCNFP(The SCCNFP is the scientific advisory body to the European Commission in matters of consumerprotection with respect to cosmetic and non-food products intended for consumers). At present, theSCCNFP does not recommend any specific warnings or restrictions under the currently proposedconditions of use.• Evaluation of acute toxicity (oral, dermal), skin and mucous membrane irritation, sensitization,sub-chronic toxicity (oral, dermal), chronic (oral, dermal), reproductive toxicity (oral), genotoxicity,carcinogenicity, percutaneous absorption have shown that the compound can be safely used.Regulatory Status*:Not approved by FDAEurope : Allowed for personal care applicationUSA : Allowed for personal care applicationJapan : Allowed in selected product categoryRest of world : Allowed for use in most of the Asian countries*Consult your regulatory authority for use level and restrictions.
KOPEXILFeatures BenefitsPreventing the stiffening of follicles Activation of hair follicles and No& Inhibits LH enzyme. miniaturization of folliclesEliminates the perifollicular fibrosis Increases blood flow to the root andcondition reducing inflammation Strengthens hair anchoring with maximum efficacyEnhances the anagen phase of hair Reverses the hair loss process and helps hair regrowthIt enhances m RNA synthesis in the Increases hair volume. Faster visiblematrix cells result with less concentration
Recommended Dosage & ApplicationsRecommended dosage:Recommended dosage of Kopexil which can be used safely incosmetic products at concentrations up to 1.5 %Applications:-Hair Serum -Hair Conditioner-Hair Lotion -Hair Gel-Hair Shampoo -Hair Cream
Reference Formulations Ingredients In % A Carbopol 0.70 Disodium EDTA 0.05 Methyl paraben 0.20 Water qs to 100 B Kopexil 1.00 D-Panthenol 0.20 Glycerin 2.00 Ethanol qs C Colour qs Perfume qs D Triethanolamine 2.00 E PVP 0.50 Tween 20 qs
Reference Formulations Ingredients In % A Kopexil 1.00 D-Panthenol 0.20 Disodium EDTA 0.10 Methyl paraben 0.20 Propyl paraben 0.10 Distilled water qs to 100 B Sodium lauryl sulphate 5.00 Sodium laureth sulphate 35.00 Dow corning conditioning agent 0.50 C Colour qs Perfume qs D Coco diethanolamide 2.00 Cocamido propyl betaine 8.00
Kopexil Brands in the MarketCompany: DS Laboratories Company: Glenmark Company: L’orealBrand Name: Spectral DNC Brand Name: Hair4U Brand Name: Vichy DercosLocation: USA Location: INDIA Location: Paris 2/10/2013 HGKP/MKTG/001 14
Kopexil Brands in the MarketCompany: Marico Company: UAS Pharma Company: Perox FarmaBrand Name: Hair Gain Brand Name: Neutriderm Brand Name: MussvitalTonic Location: Australia Location: SpainLocation: India 2/10/2013 HGKP/MKTG/001 15
References:• Gerhard J. Nohynek et. al. Safety assessment of personal care products/cosmetics and their ingredients. ElsevierToxicology and Applied Pharmacology 243 (2010) 239–259.• Mahé YF; Buan B; Bernard BA. A minoxidil-related compound (Aminexil) lacking a C6 substitution still exhibits strong anti-lysyl hydroxylase activity in vitro. Skin Pharmacol, 9(3):177-83 1996• TA Wynn. Cellular and molecular mechanisms of fibrosis. The Journal of Pathology 2 214(2008) 199–210.Disclaimer:The information given and the recommendations made herein are based on literature search and are believed to be accurate but no guarantee of their accuracy is made.Information is supplied upon the condition that the receivers will make their own determination as to its suitability for their purposes prior to use. In no event will KUMARORGANIC PRODUCTS LTD be responsible for the damage of any nature whatsoever resulting from the use of or upon reliance of the information