Determination of the size of fat droplets in emulsions for parenteral use

DOI: https://doi.org/10.29296/25419218-2022-05-02
Issue: 
5
Year: 
2022

O.V. Gunar, A.V. Dorenskaya
Federal State Budgetary Institution Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, Petrovsky Boulevard, 8, building 2, Moscow, 127051, Russian Federation

Introduction. In medical practice, emulsions for parenteral use are widely used, which are a complex dispersed system with different quality requirements. Objective: consideration of some aspects of determining the size of fat droplets in emulsions for parenteral use. Material and methods. The objects of study are emulsions for parenteral use. For tests, a particle counter "MultisizerTM – 3 Coulter Counter" and a BX41 Olympus binocular microscope equipped with an eyepiece – micrometer were used. For additional lighting, the KL 1500 LCD illuminator. GF RF, USP, EPh. Results. The study of literary materials and pharmacopoeial documentation gives an idea of the requirements for the quality of medicines (drugs) in terms of "particle size" and methods of their analysis. For the experimental estimation of particle sizes, the methods of electrosensitive zones (ESZ) and optical microscopy were used, which, according to the results of comparative statistical calculations, can in some cases complement each other, but in fact, the instrumental method of ESZ is preferable. Conclusion. The ESZ method is applicable to the determination of particle size in emulsions for parenteral use. Studied for the period 2015-2021 the quality of the medicinal product in terms of "particle size" meets the requirements of normative documents
Keywords: 
lipid emulsions for parenteral use
particle size
size distribution of fat droplets
electrosensitive zone method (Culter).
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