Advanced topical hair care
EUCAPIL ® - New cosmetic approach to hairloss
How does it works? •
Eucapil is an original topical cosmetic solution against hair-loss
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Eucapil works locally, without side effects
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Eucapil protects the hair-follicle against androgens and stops hair-loss
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In healthy hair follicles, the hair may start to regrow
What comes new with Eucapil? •
Original active ingredient – fluridil •
new patented molecule
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discovered in Biophysica Laboratories, CA
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protects hair-follicles against androgens, which otherwise cause the hair-loss
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solves directly the problem, acts only locally, without any systemic side effects
Effectiviti of Eucapil® in men •
Clinical study in 43 men for 12 months - Judged as effective by both users (>90 % positive response) and dermatologists - Number of hair in growing phase increased from 76 % to 89 % after 3 months - The hair loss has stopped - Hair diameter increased, the scalp got thicker
Published in Dermatological Surgery, 2002
Advanced topical hair care
Effectiviti of Eucapil® in women •
Clinical study in 11 women, 9 months - hair diameter increased in 80 % users after 6 months, in 100 % users after 9 months - hair loss stopped in 60 % users after 6 months
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Results presented at EADV London 2005
What results can be expected •
After 4-6 weeks the hair-loss stops
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Then hair-diameter increases, the scalp gets thicker
• After 5-6 months, in the functional hair follicles a new hair-growth may be seen individually Eucapil® advantages •
Higher effectivity, in at least 90 % users
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After 4-6 weeks stops the hair-loss
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Is effective in both men and women
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Acts only locally, without side effects
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Its active ingredient is water sensitive and is safely decomposed if accidentally swallowed
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Eucapil is an OTC cosmetic
Advanced topical hair care
Structure of skin
Eucapil® (fluridil): a new cosmetic approach to hair loss Our lives depend on hormones. Of those, the sex hormones are of major importance, influencing almost every part of our physiology and our social life. Their levels change with age. In men, after reaching a peak in the twenties, their levels continuously decline. Women also produce male sex hormones, and inversely, men produce female hormones – initially in very small quantities, but with years the levels increase so that after menopause, women actually may produce about as much male sex hormone as men do at that age. Hair loss in both men and women is most often caused by the effects of male hormones. This condition is to be distinguished from other much more rare hair loss syndromes. After age 25, for reasons not yet explained, in genetically predisposed males, the male hormones start affecting the hair roots which slowly degenerate. This results in thinner hair which ultimately is pushed out of the hair follicle. A similar phenomenon occurs in predisposed women in a stage of life when they produce substantial levels of male hormones [Price, 1999]. Hair loss ultimately results in baldness. There are also other reasons for baldness which dermatologists diagnose and often can treat, but by far the most prevalent is the condition caused by male hormones. One approach to the treatment of hair loss has been to inhibit conversion of male hormone into its very active form by a drug. Such a drug Propecia® (finasteride), however must be
Advanced topical hair care
taken daily and orally. The effectiveness of Propecia® has been reported as varying from 30-50% in arresting hair loss, while side effects such as loss of libido in males were minimal and reversible. Propecia® is a pill requiring a long term administration. The few studies with topical Propecia® have found very little effect, and if there was any, it was attributable to systemic resorption from the scalp skin [Price et al., 2000; Rushton et al., 1996]. Although the current clinical studies do not indicate adverse effects, nobody knows for sure what a systemic manipulation of normal hormonal turnover might produce after a very extended use. Another drug, minoxidil, originally developed for high blood pressure, was found to induce upon longer use some hair growth in the bald vertex. The overall efficacy of its topical application to the scalp was reported around 30%; the effect was attributed to a number of factors, including an increase of scalp blood flow. Various vitamins, plant extracts as food supplements or topical preparations were also developed, but no studies consistently prove that such products affect the hair follicles. A substance capable of improving the state of hair follicles, thus reversing or arresting the thinning of hair, must be a cosmetic agent, which means that it must act only on the skin, and not be systemically resorbed. The researchers Sawaya and Hordinsky, 1993, have stated that an “ideal compound would have to be safe and effective to prevent hair loss and/or stabilize hair quality and growth and should act only on the skin and not penetrate into
the
body”.
The existing oral or injectable drugs employed in endocrine therapies once topically applied on the scalp were found to be resorbed into the body. This is why none of these drugs could ever be utilized as a cosmetic product. The laboratories Biophysica, Inc. California, developed a novel class of substances which affect the skin only, and are not resorbed topically. The structure of the promising molecule precludes its resorption, and further, should it accidentally be digested, even the smallest amount of water would cause its decomposition. This innovative drug design represents an effective safety feature. In order to prove that this substance called fluridil, EU registration (through French Environmental Ministry) VII-B, 02010743-00, CAS 260980-89-0 is not resorbed, a number of experimental studies were conducted using rats and rabbits, who are known to have the capability to take up substances through their skin 6 to 10 times more
effectively
than
humans.
Numerous studies ascertained the low systemic and topical toxicity in animals. In human
Advanced topical hair care
volunteers at the Experimental Dermatology Institute of the University of California, San Francisco (Professor Howard Maibach) no skin irritation whatsoever was observed. Evaluation of Eucapil®, applied daily by male and later female volunteers, was conducted at the University Medical School, Department of Dermatology ( Olomouc, Czech Republic). As a measure of efficacy, a change in the number of growing versus dying hairs was determined by phototrichograms. In most subjects, increase in anagens (growing hair) and decrease in telogens (dying hair) was substantial. In the study of female hair loss, a significant increase of hair diameter was found. With daily application of 2 ml Eucapil® there were no changes in the hematological or hormonal profiles and no adverse systemic effects were observed. Using sophisticated equipment of high sensitivity (5 nanograms/ml) not even traces of fluridil or its decomposition fragments could be found in the blood. For a complete description of the clinical data, please refer to the articles and abstracts listed below. Preliminary feedback from post-marketing following its authorization as a cosmetic product in Czech Republic, as well as the ongoing studies show that Eucapil® induces a substantial reduction or cessation of hair loss, seen after only a few weeks of use. Upon longer use, an increase in average hair diameter, giving the impression of greater scalp hair fullness, may be seen. The best results seem to be achieved in those subjects who have not been suffering from hair loss for a long time and who have viable hair follicles. When hair has been missing from the scalp for a long time and the hair follicles were obliterated by the ingrowth of connective tissue, there is very little chance for growing new hair. Here only transplants can reasonably work. Eucapil® can be active only when the hair follicles are active. The best results so far were reported by subjects who started using Eucapil® at the time they first encountered hair loss. In men, this can start any time after 20 years of age; in women, dramatic hair loss sometimes appears concurrently with menopause. We observed that hair loss ceases after 3 to 6 weeks of once-a-day Eucapil® application, while strengthening of existing hair (increase of hair diameter) usually can be seen after 3 months. In some subjects who had been hairless for many years we found that after 3 to 4 months use, new hair growth (“peach fuzz,” i.e., the appearance of baby hair) was induced in the scalp. With time, imposed by the hair growth cycle (it may be several years), the hair may strengthen, but it is uncertain whether later the baby hair would gradually transform into hair of normal appearance.
Advanced topical hair care
The synthesis and formulation of Eucapil® was confined to Interpharma Praha, a pharmaceutical producer. Eucapil® as 2% solution of fluridil in rubbing alcohol, is filled into 2 ml ampoules under GMP (good manufacturing practice) rules. Fluridil has been registered, as a substance, in the EU by notification VII-B, 02010743-00 of the Ministry of Environment of France, with CAS 260980-89-0. Eucapil® has been authorized by the Czech and Slovak Republics’ health authorities as a cosmetic product aiming at the hair loss and improving the hair growth. Thus, Eucapil® can be used in all other European Union countries. In conclusion, in Eucapil® , we have an effective and safe topical cosmetic agent for advanced hair care. References Price TM, Allen S, Pegram GV. 2000. Lack of effect of topical finasteride suggests an endocrine role for dihydrotestosterone. Fertil Steril 74:414-415. Price VH. 1999. Treatment of hair loss. N Engl J Med 341:964-973. Rushton DH, Norris MJ, Ramsay ID. 1996. Topical 0.05% finasteride significantly reduces serum DHT concentrations, but had no effect in preventing the expression of genetic hair loss in men. In: D. Van Neste and V. Randall, D. Van Neste and V. Randall. Hair Research for the Next Millenium, Amsterdam: Elsevier. p. 359-362. Sawaya ME, Hordinsky MK. 1993. The antiandrogens. When and how they should be used. Dermatol Clin 11:65-72. Seligson AL, Campion B, Brown JW, Terry RC, Kucerova R, Bienova M, Hajduch M, Bucek M, Sovak M. 2003. Development of fluridil, a topical suppressor of the androgen receptor in androgenetic alopecia. Drug Dev Res 59:292-306).
Advanced topical hair care
Interpharma, a.s. Interpharma (IPP) is a pharmaceutical and fine chemical producer. IPP was founded in 1932 as a pharmaceutical enterprise and survived the war and 40 years of communism. Today, IPP is associated with Biophysica, Inc. a San Diego, California discovery facility. IPP reduces to practice biomedical, chemical and pharmaceutical research. In 1992, IPP underwent a major transformation. Through its affiliation with Biophysica, involved in the discovery, development and licensing of diagnostics, anti-cancer drugs and other pharmaceuticals worldwide since 1980, IPP employees gained exposure to the ways of modern management and technologies. Thanks to their efforts, the know-how and the technology transfer from the US, new research and development projects made it possible for IPP to expand from a fine chemical and bulk pharmaceutical manufacturer to a developmental company. Research and development activities at IPP are supported by an integrated modern pilot plant and an industrial scale bulk production GMP facility.
We are proud that our rebirth was financed without external assistance, solely by reinvesting all of our profits.
Our business: We seek to expand our business and are looking for opportunities to develop and market innovative biomedical pharmaceutical products. IPP offers competitive pricing and fast process development for fine chemicals, pharmaceuticals (APIs) and their intermediates. We offer rapid and professional development of manufacturing technologies and upcoming bulk generics which for legal reasons may not be developed in certain countries prior to the expiration of their patents.
Advanced topical hair care
Our products include a novel topical anti-androgen for management of androgenetic alopecia, a developmental product for resistant prostate cancer, a boron based neutron capture tumor therapy compound, a number of urologically oriented compounds addressing incontinence, benign prostatic hypertrophy and prevention of prostate cancer, and many others. They are listed and described elsewhere on this website. In the field of Nutraceuticals, IPP has a long tradition of purifying and modifying rutin, a potent antioxidant derived from plants. IPP has excellent analytical and GMP manufacturing experience with complex natural substances such as resveratrol, quercetin, boswellian acids, curcuminoids, baicalin, genistein, diindolylmethane (DIM) and many others. From our sources in Southern France, we have developed total red grape extract enriched with pharmaceutically relevant quantities of Resveratrol Complex. IPP is committed to only such nutraceuticals that are of proven biological value, manufactured under GMP and rigorously analytically controlled. Our people: The management, scientific and production staff are proficient in English and experienced in the development of new technologies for laboratory, pilot-plant and large-scale synthesis. Drawing on the human resources in the Czech Republic known for excellent education in chemistry and pharmaceutical sciences, the personnel of IPP has grown to 108 employees, of whom 18 are working in the state-of-the-art research and development laboratories. Our facilities: IPP is a GMP compliant full scale manufacturing facility with state-of-the-art laboratories and an integrated pilot plant. We export DMF-supported APIs and intermediates worldwide and are continuously audited by our customers. We are ISO-9002 certified and FDA approved for export of bulk injectables to the US. English is used as the official language of the Research, Regulatory Affairs and Manufacturing departments.
Our factory has been thoroughly renovated and, to a large degree, replaced. We have 14 production centers and a reactor volume of about 100 m3. There are 75 reactors ranging from 250 to 4000 liters and three 2500 L boilers for the recovery of solvents, a substructure of centrifuges, filter dryers, pumps and multiple drying units. We have a modern power plant authorized to cleanly burn most waste solvents. There is a modern cooling and steam generating system with a combined burner, a dedicated distilled and purified water plant
Advanced topical hair care
and a recently completed state-of-the-art automatic neutralization and biological treatment of the effluents.
Our GLP and GMP production facility is supported by Quality Assurance unit and state-ofthe-art Quality Control analytical laboratories which include a microbiology facility.
We have dedicated facilities for hydroxyethylation, reactions up to 220°C, catalytic hydrogenation up to 20 atm, iodination and preparation of iodomonochloride and sodium iodo-dichloride. We have a distinctive expertise in the technology of handling iodine, iodination, iodine recovery, and x-ray contrast media manufacturing as well as extractions and sophisticated purifications.
Interpharma Praha, a.s. Komoranska 955 143 10 Praha 12-Modrany, Czech Republic [tel.] 00420 241 773 214 (Switchboard) [tel.] 00420 241 773 242 (Main Secretariat) [fax] 00420 241 773 235 [email]
[email protected] [internet] www.interpharma-praha.com
