REQUIREMENTS FOR QUALITY OF SUPPOSITORIES AS A DOSAGE FORM IN ACCORDANCE WITH THE WORLD PHARMACOPOEIAS
DOI:
https://doi.org/10.11603/2312-0967.2019.3.10443Keywords:
suppositories, pessaries, quality control, pharmacopoeiasAbstract
The aim of the work. Comparative analysis of the world pharmacopoeias data for definition the indicators and their norms and also methods that determine the quality of suppositories as dosage form.
Materials and methods. Methods of information search, analysis of literary resources, comparison, generalization are used.
Results and discussion. Definition of suppositories as dosage form in the State Pharmacopoeia of Ukraine, State Pharmacopoeias of the Republics of Belarus and Kazakhstan, European and British Pharmacopoeias are given in general pharmacopoeia articles «Drugs for rectal use» and «Drugs for vaginal use» (as pessaries). The US Pharmacopoeia, Japanese Pharmacopoeia, and the State Pharmacopoeia of the Russian Federation contain a description of suppositories in general pharmacopoeia articles on dosage forms. During the analysis established that for the suppositories and pessaries the basic quality indicators: appearance, identification, uniformity of mass, disintegration, dissolution, melting point (for lipophilic bases), content of impurities, quantitative determination, microbiological quality are determined.
Conclusions. The analysis shows some differences of the data of pharmacopoeias regarding the quality control of suppositories and pessaries. This indicates the need to harmonize the requirements of pharmacopoeias for unification of quality control methods of suppositories and pessaries as widely used dosage forms.
References
Polovko NP, Vyshnevska LI, Shpychak OS. [Evaluation of the biopharmaceutical factors at the development and production of new drugs]. Suchasni dosiahnennia farmatsevtychnoi tekhnolohii i biotekhnolohii: zb. nauk. pr. – Kh., 2017. 155-60. Ukrainian.
Orlova TV. [Modern rectal, vaginal and urethral medicinal forms]. Vestnik VGU. 2014;1:126-33. Russian.
Pankrusheva TA, Erofeeva LN, Orlova TV, Kurilova OO, Chekmareva MS. [Problems of formulation and standardization of suppositories in the modern period]. Kurskij nauch.-prakt. vestnik «Chelovek i ego zdorov'e». 2016;2: 108–12. Russian.
Hlushchenko OM,. Kanevskyi RS. [Comparative сharacteristics assortment of suppositorial medicines in the markets of Ukraine and Russia]. Liky Ukrainy. 2015;2(23):87-91. Ukrainian.
Zaychenko VS, Ruban ОА, Masliy JuS, Gerbina NA. Justification of surface-active substances choice in composition of suppositories for treatment of benign diseases of prostate gland. Ukr. biofarmatsevt. zhurnal. 2017;6(53):4-8. Ukrainian. DOI: https://doi.org/10.24959/ubphj.17.143
Dzjuba AS, Trofimova EO. The suppository market: state-of-the-art and development prospects. Farmacija. 2014;3:27-30. Russian.
Pankrusheva TA, Erofeeva LN, Orlova TV, Kurilova OO. Suppozitorii. Sovremennyj vzgljad na lekarstvennuju formu. [Suppositories. Modern view at the dosage form]. Kursk: KGMU; 2017. 212 p. Russian.
Hrabov LM, Posunko DV, Ctepanova OYe. [Application methods of thermocontact heating and discrete pulse input energy in technologies of obtaining suppositories]. Prom. teplotehnika, 2015;38(1):31-40. Ukrainian.
Kondrat'eva IA, Smehova IE. [Pharmacopoeial requirements for rectal suppositories]. Farmacija. 2012;1:54-6. Russian.
Farmatsevtychna entsyklopediia. [Electronic resource, Ukrainian.]. URL: https://www.pharmencyclopedia.com.ua. Ukranian.
Tytova AV, Sadchynkova NP/ [The role of pharmacopoeia in the context of globalization of world economics and its development prospects]. Vedomosty NCESMP. 2016;2:42-9. Russian.
State Pharmacopoeia of Ukraine: in 3 vol. [Державна Фармакопея України: в 3 т.] 2nd ed. Kharkiv State Enterprise "Ukrainian Research Center expert pharmacopoeia drug quality", 2015. Ukranian.
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.
State Pharmacopoeia Kazakhstan Republic. Vol 1. 1 ed. [Государственная фармакопея республики Казахстан], Almaty, 2015.
State Pharmacopoeia of Russian Federation: in 3 vol. [Государственная фармакопея Российской Федерации: в 3 т.] Vol.1. Mocrow, 2018. Russian.
State Pharmacopoeia of Russia: in 3 vol. [Государственная фармакопея Российской Федерации: в 3 т.] Vol.2. Mocrow, 2018. Russian.
Japanese Pharmacopoeia. 16th ed. Тоkіо, 2011.
The British Pharmacopoeia. 12th ed. London: HMSO, 2015.
European Pharmacopoeia. 8th ed. Strasbourg: Council of Europe, 2015.
The United States Pharmacopoeia 37: The National Formulary 32. New York, 2014.
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