PRECLINICAL STUDIES OF THE STABILITY OF SUSPENSIONS PREPARED FROM READY-MADE DRUGS

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DOI: https://doi.org/None
Issue: 
3
Year: 
2017

S.V. Gushchina (1), V.M. Kosman (2), M.N. Makarova (1), A.N. Shikov (2), PhD 1 - Pharmacy House, Research-and-Production Association; 245, Kuzmolovsky Urban-Type Community, Kuzmolovsky Settlement, Vsevolozhsky District, Leningrad Region 188663, Russian Federation; 2 - Saint Petersburg Institute of Pharmacy; 245, Kuzmolovsky Urban-Type Community, Kuzmolovsky Settlement, Vsevolozhsky District, Leningrad Region 188663, Russian Federation

Introduction. Preclinical studies using laboratory animals are one of the most important stages of drug registration. When using an object in the carrier, its homogeneity, concentration, and stability in this medium should be established in accordance with the regulatory document «Principles of Good Laboratory Practice» [1]. Thus, organizations involved in preclinical studies should carry out chemical analyses of the suspensions given to animals to confirm their suitability for administration. Objective: to assess the stability of the suspensions for preclinical studies, which are prepared from ready-made formulations. Materials and methods. The investigation object was 1% starch suspensions from 6 ready-made medicines belonging to 3 biopharmaceutical classification system groups. The stability of the suspensions was assessed using the following indicators: organoleptic characteristics; permeability through a probe for intragastric administration; pH value; supernatant layer height; dry residue; and the content of the active ingredient determined by HPLC with UV detection. Results. The 4-hour stability of the active ingredient in the carrier medium (1% starch gel) was confirmed for each test drug. The basic methods for analysis to determine supernatant layer height and dry residue could assess the stability of suspensions themselves. Conclusion. The stability of the active ingredient during 4-hour storage was confirmed for all the test drugs as a suspension in an aqueous medium. It is best to calculate pH values, to carry out an organoleptic analysis, and to determine the height of the settled layer when estimating the shelf-life of a suspension during a test.
Keywords: 
stability
suspension for animal usage
biopharmaceutical classification
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