Kopcyclamine
It is a broad-spectrum antifungal agent that inhibits the growth of the yeast known as Pityrosporum ovale or Pityrosporum orbiculare, which is associated with conditions such as dandruff and seborrhoeic dermatitis. It also has anti-inflammatory activity. Ciclopirox is a synthetic broad-spectrum antifungal agent that inhibits the growth of dermatophytes, a type of fungus that grows on the skin, hair and nail. The FDA has approved this compound for use in the US in Dec. 1999. An 8% solution is used for topical therapy. Ciclopirox is available in the form of shampoo, nail solution, skin cream, gel or lotion.
6-Cyclohexyl-1-Hydroxy-4-Methyl-2(1H)-Pyridinone,Compound with 2-Aminoethanol (1:1)
Molecular Formula : C12H17NO2·C2H7NO
CAS # : 41621-49-2
EINECS : 255 – 464 - 2
HS Code : 29337990
Physico – Chemical Properties:
| Appearance | White to slightly yellowish white crystalline powder |
| Assay by Potentiometric titration | 97.5 – 101% |
| Solubility | Soluble in alcohol and Methylene chloride, slightly soluble in water; practically insoluble in Cyclohexane. |
| Melting point | 143° C |
| Monoethanolamine content | 223 to 230 mg per grm. |
Dosage Forms:
Nail lacquer solution : Ciclopirox olamine 8%
Topical Gel : Ciclopirox olamine 1%
Cream : Ciclopirox olamine 1%
Lotion : Ciclopirox olamine 1%
Selected Safety Data:
Ciclopirox olamine is pregnancy Category B (5). Safety and efficacy are unproven in lactating women (5). Ciclopirox olamine 1% cream is not associated with delayed hypersensitivity type contact sensitization, contact sensitizers, phototoxicity, or photo contact sensitization (2).
Packaging Sizes : 25 Kg HDPE drums
Re-test Period : Minimum 2 years
Storage Conditions : Store between 5° to 25°
Literature References:
[1] Dittmar W, Lohan G. HOE 296, a New Antifungal compound with a broad antimicrobial spectrum. Laboratory Results. Arzneim--Forsch Drug Res 1973; 23:670-676.
[2] Gupta AK. Ciclopirox: An Overview. Intern J Dermatol 40:1-7, 2001.
[3] Ceschin-Roques CG, Hanel H, Pruja-Bougaret SM, et al. Ciclopirox olamine cream 1%: In vitro and in vivo Penetration into the Stratum corneum. Skin Pharmacology 1991; 4:95-99.
[4] Bogaert H, Cordero C, Ollague W, Sayin RC, et al. Multicentre Double-Blind Clinical Trials of Ciclopirox Olamine Cream 1% in the Treatment of Tinea Corporis and Tinea Cruris. J Int Med Res 1986; 14:210-216.
[5] Loprox Cream package insert, 2002.
[6] Gupta A. The Spectrum of Utility of Ciclopirox for the Treatment of Superficial Fungal &. Bacterial infection. Ann Dermatol Venereol 2002; 129:IS607-IS842.
[7] Gupta A. Antifungal Susceptibility Testing of Dermatophytes, Yeasts and Non-Dermatophyte to Ciclopirox and other Antifungal agents. Ann Dermatol Venereol 2001; 129:IS607IS84201.
[8] Rosen T, Schell BJ, Orengo I. Anti-inflammatory Activity of Antifungal Preparations. Internat J Dermatol 1997; 36:788-792
[9] Dupuy R, Maurette C, Amoric JC, et al. Randomized placebo-controlled, double-blind study
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