Pharmaceutical Quality of Glibenclamide Products A Multinational Postmarket Comparative Study

Abstract

A multinational postmarket comparative study of pharmaceutical quality of glibenclamide products was performed in cooperation with large number of laboratories and under anspices of the Section of Official Laboratories and Medicines Control Services of FIP and World Health Organization. 28 countries from Europe, Africa, North and South America, Asia and Australia participated in this study. Altogether 142 glibenclamide tablet formulations of the respective countries were investigated. The products were tested for identity, purity, content, uniformity of content and in-vitro dissolution properties. Most products tested fulfilled the pharmacoepial requirements concerning identity, purity and content (95 -115 %). Marked differences were recorded in respect of in-vitro dissolution behaviour. This applies not only to the products of different countries but also among products of the same country. It is anticipated that Drug Dev Ind Pharm Downloaded from informahealthcare.com by McMaster University on 12/08/14 For personal use only. Drug Dev Ind Pharm Downloaded from informahealthcare.com by McMaster University on 12/08/14 For personal use only. Drug Dev Ind Pharm Downloaded from informahealthcare.com by McMaster University on 12/08/14 For personal use only. Drug Dev Ind Pharm Downloaded from informahealthcare.com by McMaster University on 12/08/14 For personal use only. 4 4 e Drug Dev Ind Pharm Downloaded from informahealthcare.com by McMaster University on 12/08/14 For personal use only. Drug Dev Ind Pharm Downloaded from informahealthcare.com by McMaster University on 12/08/14 For personal use only. Drug Dev Ind Pharm Downloaded from informahealthcare.com by McMaster University on 12/08/14 For personal use only. Hoechst Portugesa SA Boehringer Mannheid Lab lberfar Boehringer Mannheid Lab M a r Hoechst Iberia S.A. Kabi Vitnun AG Drug Dev Ind Pharm Downloaded from informahealthcare.com by McMaster University on 12/08/14For personal use only.

Toward Global Standards for Comparator Pharmaceutical Products: Case Studies of Amoxicillin, Metronidazole, and Zidovudine in the Americas

“…The study hypothesis was that the different drug products would meet the criteria for in vitro equivalence. The dissolution studies presented in this report repeat the type of studies conducted by Blume et al with the difference that BCS criteria were incorporated into the study design (14)(15)(16). With the understanding arising from the BCS, the studies in the present report can also signal bioequivalence, which is termed in vitro equivalence where applicable.…”

SMEDDS of Glyburide: Formulation, In Vitro Evaluation, and Stability Studies

“…The poor water solubility of GLY is responsible for its poor dissolution rate, which ultimately leads to variable absorption of GLY. Furthermore, there are reports which have documented that GLY shows large variations in interindividual bioavailability and bioequivalence of the marketed products (3,4). Thus, it can be concluded that the bioavailability and in vivo performance of GLY is dependent on its dissolution rate.…”

Glibenclamide: proven facts, perspectives, discussions

“…Растворимость глибенкламида в желудочном соке и pH в желудочно-кишечном тракте влияют на всасывание препарата [11]. Срав-нительные постмаркетинговые исследования гли-бенкламида продемонстрировали вариации в био-доступности и зависимость адсорбции при перо-ральном приеме от лекарственной формы [13]. Для повышения растворимости и биодоступности гли-бенкламида применялись различные подходы, ко-торые включали добавление сурфактантов, образо-вание комплексов с циклодекстринами, приготов-ление твердых дисперсионных систем, микрониза-ция и преобразование кристаллической решетки соединения [11,14].…”