Osmolality quality requirements for liquid dosage forms

DOI: https://doi.org/10.29296/25419218-2022-01-03
Issue: 
1
Year: 
2022

E.L. Kovaleva, A.K. Shestakova, K.S. Arkhipova, L.V. Polteva Scientific Centre for Expert Evaluation of Medicinal Products, 8/2 Petrovsky Blvd, Moscow, 127051, Russia

Osmolality/osmolarity is one of the most important quality parameters of a number of dosage forms and medicinal products. Nevertheless, the leading pharmacopoeias have some differences in the approaches to controlling this quality parameter in medicinal products. The aim of the study was to substantiate requirements for the inclusion of the Osmolality/Osmolarity quality parameter in the specifications for some dosage forms and pharmacological classes of medicines, based on the analysis of data from scientific papers and monographs of the leading pharmacopoeias. The paper summarizes scientific papers that demonstrate the significant role of this quality parameter for medicines efficacy and safety, compares test methods recommended for osmolality determination and different pharmacopoeial approaches to controlling osmolality in some dosage forms and medicinal products.
Keywords: 
osmolarity
osmolality
parenteral
X-ray contrast
nasal
ophthalmic
orally inhaled drugs
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