On the need for introducing the pharmaceutical-technological test “Uniformity of mass of subdivided tablets” in the State Pharmacopeia of Russia
https://doi.org/10.31549/2542-1174-2020-2-20-29
Abstract
The purpose of the study was to develop approaches to assessing the uniformity of mass fractions in subdividing tablets. The problem of dividing tablets into parts to provide the necessary dose is considered. A survey of 18 pediatric hospital nurses concerning practice of subdividing tablets was conducted during which we found that 78% of respondents divided tablets into 2 parts or more (up to 5). The fractions of subdivided tablets were tested for compliance with the requirements of the federal General Monograph 1.4.2.0009.15 “Mass uniformity of dosage forms” intended for non-divided tablets and the European Pharmacopoeia (article 0478 “Tablets”; section “Subdivision of tablets”). The need for regulation of methods for controlling the subdivision of tablets is established. It is proposed to introduce into the State Pharmacopoeia of Russia a pharmaceutical-technological test “Uniformity of mass of subdivided tablets” harmonized with the European Pharmacopoeia methodology (article 0478 “Tablets”; section “Subdivision of tablets”).
About the Authors
S. N. Egorova
Institute of Pharmacy, Kazan State Medical University
Russian Federation
Russian Federation
Dr. Sci. (Pharmaceut.), Professor, Deputy Director for Educational Activities,
Kazan
A. I. Pavlova
Institute of Pharmacy, Kazan State Medical University
Russian Federation
Russian Federation
Resident,
Kazan
G. F. Khafizova
Institute of Pharmacy, Kazan State Medical University
Russian Federation
Russian Federation
Resident,
Kazan
A. R. Khayatov
“Medical Equipment and Pharmacy of Tatarstan”, State Unitary Enterprise (Kazan)
Russian Federation
Russian Federation
Head, Department for Procurement of Medical Devices and Disinfectants,
Kazan
N. V. Vorobyova
Institute of Pharmacy, Kazan State Medical University
Russian Federation
Russian Federation
Cand. Sci. (Pharmaceut.), Associate Professor,
Kazan
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Review
For citations:
Egorova S.N., Pavlova A.I., Khafizova G.F., Khayatov A.R., Vorobyova N.V. On the need for introducing the pharmaceutical-technological test “Uniformity of mass of subdivided tablets” in the State Pharmacopeia of Russia. Journal of Siberian Medical Sciences. 2020;(2):20-29. (In Russ.) https://doi.org/10.31549/2542-1174-2020-2-20-29
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