METHODOLOGICAL ASPECTS OF DRUG DEVELOPMENT IN THE FORM OF CHEWABLE TROCHES
DOI:
https://doi.org/10.11603/2312-0967.2020.2.11177Keywords:
methodology, pharmaceutical development, drug technology, chewable trochesAbstract
The aim of the work. Study of the main methodological aspects of drug development in the form of chewable troches.
Materials and Methods. The objects of study were the works of domestic and foreign authors, electronic databases of the Ministry of Health of Ukraine and the own research. During the work methods of bibliosemantic analysis, systematization of theoretical and practical material and generalization of data were used.
Results and Discussion. The basic approaches to the pharmaceutical development of the original domestic medicines, in particular, in the dosage form of chewable troches in accordance with the requirements of the Guidance 42–3.1:2004. Quality guidelines Medicines: Pharmaceutical development, are described. The general scheme of pharmaceutical development of chewable troches is presented. The decision trees for the choice of gel-forming agent and flavorings to correct the taste characteristics are proposed.
Conclusions. The feasibility of developing a domestic original drug in the form of chewable troches is substantiated. The main steps of the pharmaceutical development of this dosage form are characterized.
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