Methodological aspects of the development of an anthelmintic drug in the form of tablets

Authors

DOI:

https://doi.org/10.24959/sphhcj.20.187

Keywords:

methodology, development, medicines, anthelmintic drugs

Abstract

Aim. To substantiate the methodology for developing a domestic original highly effective medicinal product in the form of tablets for the treatment of helminthiasis of the digestive system in accordance with the existing standards.

Materials and methods. The scientific publications, electronic databases of the Ministry of Health of Ukraine and the own research, as well as methods of generalization, systematization of theoretical and practical material, bibliosemantic and system analysis, were used.

Results. The main approaches to the pharmaceutical development of original domestic medicines have been analyzed, in particular drugs for the treatment of helminthiasis of the digestive system in accordance with the requirements of the Manual ST-N MH 42-3.0:2011 “Medicines. Pharmaceutical Development (ICH Q8)”. The general scheme for the pharmaceutical development of tablets has been described taking into account the requirements of the current norms and standards of Ukraine and foreign experience. A decision tree has been proposed for choosing an active pharmaceutical ingredient for the development of anthelmintic drugs. The main stages of the development of an anthelmintic drug in the form of tablets have been described.

Conclusions. The feasibility of developing a domestic original drug in the form of tablets for the etiotropic treatment of helminthiasis of the digestive system in order to provide the needs of the population in high-quality, affordable and safe anthelmintic drugs, which is especially important in the context of import substitution policies, has been substantiated.

Author Biographies

K. V. Semchenko, National University of Pharmacy

Candidate of Pharmacy (Ph. D.), associate professor of the Department of Pharmaceutical Technology of Drugs

L. I. Vyshnevska, National University of Pharmacy

Doctor of Pharmacy (Dr. habil.), professor, head of the Department of Pharmaceutical Technology of Drugs

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Published

2020-06-09

Issue

Section

Social medicine and pharmacy: past, present and development prospects