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Journal №11 for 2014 г.
Article in number:
Investigation of levonorgestrel and ciproterone acetate dosing homogeneity and their release from combined oral hormonal contraceptives
Keywords: ethitinilestradiol ciproterone acetate uniformity of dosing dissolution
Authors:
E.N. Kareva - Dr.Sc. (Med.), Professor, Department of Academician P.V. Sergeev Molecular Pharmacology and Radiobiology, Pirogov N.I. Russian Search National Mediacal University, Moscow
N.A. Denisova - Assistent, Department of Pharmaceutical and Toxicological Cemistry, Pharmaceutical faculty, I.M. Sechenov First Moscow State Medical University
D.A. Tikhonov - Senior Assistent, Department of Academician P.V. Sergeev Molecular Pharmacology and Radiobiology, Pirogov N.I. Russian Search National Mediacal University, Moscow
N.P. Sadchikova - Dr.Sc. (Pharm.), Professor, Department of Pharmaceutical and Toxicological Chemistry, Pharmaceutical faculty, I.M. Sechenov First Moscow State Medical University
Abstract:
The Limit of active substances content in terms of «Uniformity of dosage according to leading pharmacopoeias should be from 85 % to 115 % of the nominal content. Based on the results of quantitative evaluation of active substances by the dosinghomogeneity of ethinyl estradiol and ciproteron acetate of oral contraceptives tablets Erica-35 (Dr.Reddys) and Diana-35 (Bayer AG), we can conclude that the investigated drugs are placed in the specified limits in terms of «Uniformity of dosage». Study of the release of levonorgestrel and ciproteron eacetate from tablets Erica-35 and Diane-35 showed their conformity to requirements of normative documents in terms of «Dissolution».
Pages: 45-50
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