An Overview of In Vitro Release Test Methods Used In The Study of Nanoparticular Drug Delivery Systems

Year 2023, , 78 - 98, 01.03.2023

Ece Çobanoglu , Sevda Şenel

https://doi.org/10.52794/hujpharm.1181365

Abstract

The in vitro release tests which examine the release properties of the drug from the dosage form provide the opportunity to investigate the in vitro availability of the drug product as well as to compare its equivalency to other products. In order to obtain accurate and reliable results from in vitro release tests, it is crucial to select the right release test method and suitable release conditions (such as temperature, release medium, pH, agitation/flow rate, etc.). Although there are compendial in vitro release test methods available for various dosage forms, up to date there are no tests described for nanoparticulate systems in any pharmacopeia. In this review, the methods (such as sampling and separation, membrane diffusion, continuous flow, etc.) applied to test the in vitro drug release from nanoparticulate systems will be reviewed. The recent applications of these methods in different particulate systems will be summarized and the advantages and limitations of these test methods will be discussed.

Keywords

nanoparticulate systems, in vitro release test methods, sample and separate method, membrane diffusion method, continuous flow method

Nanopartiküler İlaç Taşıyıcı Sistemlerinin İncelenmesinde Kullanılan İn Vitro Salım Testi Yöntemlerine Genel Bir Bakış

Abstract

Bir ilacın dozaj şeklinden salım özelliklerinin incelenmesinde kullanılan in vitro salım testi sayesinde hem ilacın in vitro yararlanımı hakkında bilgi edinilmesi hem de diğer ürünlerle eşdeğerliğinin karşılaştırması mümkün olmaktadır. Doğru ve güvenilir sonuçlar elde edilmesi için uygun salım testi yönteminin ve uygun salım koşullarının (sıcaklık, salım ortamı, pH, karıştırma /akış hızı vb.) seçilmesi esastır. Farmakopelerde birçok dozaj şekli için in vitro salım testi yöntemleri ve koşulları tanımlanmış olmasına karşın hâlihazırda nanopartiküler ilaç taşıyıcı sistemler için bir test yöntemi farmakopelerde mevcut değildir. Bu derlemede, nanopartiküler sistemlerden ilaç salımının incelenmesinde kullanılan test yöntemleri (örnek alma ve ayırma, membran difüzyon, sürekli akış vb.) ve güncel uygulamalarından bahsedilecek ve birbirlerine olan üstünlükleri ve sakıncaları tartışılacaktır.

Keywords

nanopartiküler sistemler, in vitro salım test yöntemleri, örnek alma ve ayırma yöntemi, membran difüzyon yöntemi, sürekli akış yöntemi

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