Research of quality values and stability study of vaginal suppositories containing fluconazole and chlorhexidine digluconate

Abstract

Aim of research. Stability is one of the main quality values of remedies. Biopharmaceutical properties of drugs and efficiency of pharmacodynamic and pharmacokinetic processes of active compounds in human’s organism completely depend on physico-chemical values permanence and microbiological stability of every unit of drug. The aim of research resulting in the article was to determine the main quality values stability and microbiological purity of vaginal suppositories containing fluconazole and chlorhexidine digluconate after storage under certain conditions.Materials and methods. During both storage under room temperature and keeping in cool place vaginal suppositories prepared upon hydrophilic basis were periodically verified on indicators of description, identification, average weight and homogeneity of weight, dissolution, microbiological purity and active ingredients assay in unit dose. All research tests were carried out in accordance with both the SPhU requirements and elaborated draft of quality control procedures for «Flugedyn» remedy.Results. As a result of quality values study of suppositories test samples the efficiency and reliability of developed techniques and normative documentation draft of remedy were confirmed. Samples have been kept for as long as 5 years don’t comply with the requirements of normative documentation of remedy.Conclusion. Thus, summation of research data allow recommend following optimal storage period for vaginal suppositories «Flugedyn»: keep 3 years in dry place at a temperature 2 to 25 оС