Assessment of the destructive influence of sanitary cleansing on pharmaceutical rubber stoppers using a method of measuring the contact angle
https://doi.org/10.31549/2542-1174-2021-1-65-72
Abstract
For the first time, experimental studies of the influence of sanitary cleansing on the surface of pharmaceutical rubber (butyl- and halobutyl-based) stoppers were carried out by measuring the contact angle.
It was found that the sanitary cleansing of stoppers, carried out before the closure of sterile dosage forms of medicinal products (MP), including pre-sterilization cleaning of the stoppers (2-fold boiling for 30 min in 1% solution of trisodium phosphate or sodium hydroxide and a single boiling in 0.1% solution of hydrochloric acid for 30 min) and subsequent sterilization in an autoclave at t = 130°C, pressure p = 0.2 MPa for 60 min acts destructively on their surface and is accompanied by a decrease of the contact angle (an increase in the hydrophilicity of the stoppers’ surface), which leads to significant leaching of the components of rubber stoppers and their contamination of drug solutions.
Determination of the contact angle allows by reproducible instrumental method to identify and quantify the destruction processes of the surface of rubber stoppers used for closing of sterile solutions of MP. This indicator can be used to assess the influence of pharmaceutical and technological factors (sanitary cleansing, sterilization, contact with drug solutions, etc.) on the rubber stoppers surface, to control the corrosive resistance of closures and to predict the amount of impurities in sterile solutions of MP.
About the Authors
A. D. Khusainov
Kazan National Research Technological University
Russian Federation
Russian Federation
Khusainov Alfred Danilovich — Cand. Sci. (Techn.), Associate Professor, Department of Chemistry and Elastomer Processing Technology
S. N. Egorova
Kazan State Medical University, Institute of Pharmacy
Russian Federation
Russian Federation
Egorova Svetlana Nikolayevna — Dr. Sci. (Pharma-ceut.), Professor, Deputy Director for Educational Activities, Institute of Pharmacy.
49, Butlerova str., Kazan, 420012
A. D. Khasanova
Kazan National Research Technological University
Russian Federation
Russian Federation
Khasanova Alsu Danilovna — Post-graduate Student, Department of Chemistry and Technology of Elastomer Processing
N. N. Simonova
Kazan National Research Technological University
Russian Federation
Russian Federation
Simonova Nadezhda Nikolayevna — Senior Researcher, Department of Chemistry and Elastomer Processing Technology
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Review
For citations:
Khusainov A.D., Egorova S.N., Khasanova A.D., Simonova N.N. Assessment of the destructive influence of sanitary cleansing on pharmaceutical rubber stoppers using a method of measuring the contact angle. Journal of Siberian Medical Sciences. 2021;(1):65-72. https://doi.org/10.31549/2542-1174-2021-1-65-72
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