CURRENT REQUIREMENTS OF LEADING PHARMACOPOEIAS FOR CHARACTERIZATION, CLASSIFICATION AND QUALITY CONTROL OF SEMISOLID DOSAGE FORMS
DOI:
https://doi.org/10.11603/2312-0967.2021.4.12633Keywords:
semisolid dosage forms, quality indicators, pharmacopoeiaAbstract
The aim of the work. Comparative studies of the requirements of leading pharmacopeias for the definition, characteristics of semisolid dosage forms (SDF), and the parameters by which their quality are controlled.
Materials and Methods. Pharmacopeia articles and quality indicators for SDF are given in the State Pharmacopoeia of Ukraine (SPU) and in some foreign pharmacopoeias. Methods of information search, analysis of literature sources, comparison and generalization were used in the research.
Results and Discussion. A comparative analysis of pharmacopeias of leading countries and SPU on the characteristics, classification and quality indicators of SDF. In several pharmacopoeias (SPU, Ph. Eur., BP, SPRB) SDF is considered in general pharmacopoeia articles "Semisolid drugs for dermal use", in Pharmacopoeias of the USA, Japan and Russia (USP, JP, SPRF) SDF described in the general article on dosage forms (DF). Based on the analysis of the relevant monographs, approaches to the classification of SDF (by the type of DF, type of dispersed systems, and an affinity for water) are considered. The approaches of SPU and foreign pharmacopoeias to the SDF manufactured in pharmacies have been studied. The requirements of pharmacopoeias regarding the quality indicators, according to which SDFs should be monitored, depending on the method of their application, are analyzed. The main quality indicators that are determined for different SDFs are description, identification (API, antimicrobial preservatives, other excipients if necessary), homogeneity of dosage units (except for drugs of plant origin), pH or acid and peroxide value, consistency, viscosity, container tightness, microbiological purity or sterility, quantification.
Conclusions. The obtained results of the analysis show some differences of the studied pharmacopoeias in relation to SDF and indicators of their quality, which indicates the expediency of harmonization of pharmacopoeia requirements for SDF in order to unify the approaches to confirming their quality.
References
Koritnyuk RS, Zagoriy GV, Tarasenko VO, Cheenamere Ukadike [Technological and physical-chemical properties of gels]. Farmatsevt. zhurn. 2012;3:38-42. Ukrainian.
Glushchenko OM, Polova ZhM [Market analysis of wound healing semisolid drugso]. Farmatsevt chasop. 2019;4:51-6. Ukrainian. DOI: 10.11603/2312-0967.2019.4.10684
Vons BV, Chubka MB, Groshovyi TA, Stechyshyn IP. [Comparative analysis of medications for local treatment of burns on national and foreign markets]. Farmatsevt. zhurn. 2019;4:4-11. Ukrainian. DOI: 10.32352/0367-3057.4.19.01
The State Pharmacopoeia of Ukraine: 1 vol. Kharkiv: Ukrainian Scientific Pharmacopoeia Center of Quality of Medicinal Products. Ed.2. Vol.1 [Державна Фармакопея України: в 3 т./ Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів». – 2- е вид.]: Kharkiv: Ukrainian Scientific Pharmacopoeia Center of Quality of Medicinal Products; 2015. Ukrainian.
Guidance. Good manufacturing practice. [Настанова СТ-Н 42-4.0:2020. Лікарські засоби. Належна виробнича практика]. Кyiv, 2020. Ukrainian.
European Pharmacopoeia. 10th ed. Strasbourg: Council of Europe, 2019.
The British Pharmacopeia. 13th ed. London: The Stationery Office, 2016.
The United States Pharmacopoeia, 36th ed., NF 31., New York, 2013.
The Japanese Pharmacopeia. 17th ed. Tokio, 2016.
State Pharmacopoeia of Belarus Republiс: in 2 vol. [Государственная фармакопея Республики Беларусь: в 2 т.] Vol.1. General methods of drug control. Center for Expertise and Testing in Health Care, 2012. Russian.
State Pharmacopoeia of Russian Federation: in 3 vol. [Государственная фармакопея Российской Федерации: в 3 т.] Vol. 2. Moscow, 2018. Russian.
Shostak TA, Bilous SB, Hutz’ NI, Kalynyuk TG. [Comparative analysis of pharmacopoeias of the leading countries regarding the classification of semi-solid medicinal preparations]. Klinichna farmatsiya, farmakoterapiya ta medychna standartyzatsiya. 2014;3-4:136-9. Ukrainian.
The State Pharmacopoeia of Ukraine: 3 vol. Kharkiv: Ukrainian Scientific Pharmacopoeia Center of Qua-lity of Medicinal Products. Ed.2. Vol.3. [Державна Фармакопея України: в 3 т./ Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів». – 2-е вид., Т.3]: Kharkiv: Ukrainian Scientific Pharmacopoeia Center of Quality of Medicinal Products; 2014. Ukrainian.
The State Pharmacopoeia of Ukraine: 3 vol. Kharkiv: Ukrainian Scientific Pharmacopoeia Center of Qua-lity of Medicinal Products. Ed.2. Suppl. 5. [Державна Фармакопея України: в 3 т., 5 доповнення / Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів». – 2-е вид.]: Kharkiv: Ukrainian Scientific Pharmacopoeia Center of Quality of Medicinal Products; 2021. Ukrainian.
About the statement of Rules of production (manufacturing) and quality control of medicines in drugstores: the Order of the Ministry of Health of Ukraine of December 17, 2012. № 812. Available from: https://zakon.rada.gov.ua/laws/show/z1846-12#Text.
About the statement of documents on questions of production of medicines in the conditions of drugstores: the Order of the Ministry of Health of Ukraine of Yuli 01, 2015. № 398. Available from: http://search.ligazakon.ua/l_doc2.nsf/link1/MOZ24944.html
On repealing the orders of the Ministry of Health of Ukraine of July 20, 2006 № 500 and of September 7, 2009 № 663: the Order of the Ministry of Health of Ukraine of October 10, 2021. № 2325. URL: https://zakon.rada.gov.ua/rada/show/v2325282-21#Text
Gladukh IeV, Seguy Anael Marcelle, Nicolaychuk NO. [The rheological studies of the gel base with a dense extract from burdock]. Sotsialʹna farmatsiya v okhoroni zdorovʺya. 2017;3:21-6. Ukrainian. DOI: 10.24959/sphhcj.17.92
Davtyan LL, Vashuk VA, Polishchuk YP. [Rheological research process as the basis for creating a new drug]. Farmatsevt. zhurn. 2013;4:52-8. Ukrainian.
Shostak TA, Melnyk YuYa, Skorokhoda VY. [The study of rheological properties of treatment gel on hydrophilic basis]. Farmatsevt chasop. 2018;1:41-6. Ukrainian. DOI: 10.11603/2312-0967.2018.1.8597.
Pavliuk BV, Lukashiv OYa, Pokryshko OV, Chubka, Hroshovyi TA. [Research of the preservatives’ antimicrobic activity for the development of a new combined gel composition for the local treatment of burns]. Farmatsevt chasop. 2019;(3):35-42. Ukrainian. DOI: 10.11603/2312-0967.2019.3.10409.
Horlachova VI, Vyshnevska LI. [Investigation of the effectiveness of antimicrobial preservatives to improve the structure of the medical cosmetic cream with anti-inflammatory action]. Ukr biofarmats zhurn. 2016;1:16-20. Ukrainian. Available from: http://dspace.nuph. edu.ua/bitstream/123456789/8826/1/16-20.pdf
Rudenko VV [Comparative description of kinetic indices of operating substances from ointment for treatment of wounds in I and II phases]. Farmatsevt chasop. 2013;2:122-5. Ukrainian. DOI: 10.11603/2312-0967.2013.2.2398.
Jan Misik, Ruzena Pavlikova, Jiri Cabal, Ladislav Novotny, Kamil Kuca. Method of static diffusion cells for assessment of pesticides skin permeation. Military Medical Science Letters. 2011;80:46-51.
Chumakova VA. Development of the composition, pharmaco-technological studies of the mild dosage form of fexofenadine antihistamine action [Разработка состава, фармако-технологические исследования мягкой лекарственной формы фексофенадина антигистаминного действия [диссертация]: Pyatigorsk; 2016. Russian.
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