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Comparative in vitro dissolution study of Atorvastatin calcium delayed release nanoparticles using USP I and USP IV dissolution apparatus
EP24081
Poster Title: Comparative in vitro dissolution study of Atorvastatin calcium delayed release nanoparticles using USP I and USP IV dissolution apparatus
Submitted on 11 Jun 2016
Author(s): sandip gite, Vandana Patravale, Amit Mirani
Affiliations: Senior research fellow
This poster was presented at DissoAsia Conference Mumbai
Poster Views: 1,099
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Poster Information
Abstract: The Biopharmaceutics Classification System groups drugs into four classes (1).Atorvastatin Calcium belongs to Class II (low solubility/high permeability), and its absorption in the GIT is limited by the dissolution rate. For Class II drugs, it is imperative to establish a significant in vitro/in vivo correlation (IVIVC). Hence, an appropriate selection of dissolution apparatus and study conditions is essential in order to discriminate between products with potential bioavailability problems.
Flow-through cell system (USP Apparatus IV) is presented as an alternative dissolution apparatus to the conventional USP Apparatus 1 and 2 because of several advantages (2-3). The USP Apparatus IV simulates the absorption into the systemic circulation, generating intermittent flow of dissolution medium into the dissolution cell where the dosage form is placed (4). It is possible to use it as an open loop system that can work under sink conditions which facilitates the dissolution of poorly soluble drugs as well as by changing the dissolution medium within a range of physiological pH values throughout the test (5). Despite the advantages of flow-through cell system over the USP Apparatus 1 and 2, information of the dissolution of Atorvastatin calcium delayed-release oral dosage forms using USP Apparatus IV is not available.
The objective of this study was to evaluate the dissolution characteristics of Atorvastatin calcium delayed-release nanoparticles (NP) under the hydrodynamic environment generated by the flow-through cell system and to compare it with the results obtained with the USP Basket method.

Summary: Atorvastatin calcium delayed release nanoparticle shows less than 60% release in 1h in USP IV dissolution apparatus, hence it can used in discriminating method
References: 1. Amidon, G.L., Lennerna ¨ s, H., Shah, V.P., Crison, J.R., 1995. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharmaceutical Research 12, 413–420.
2. Chevalier, E., Viana, M., Artaud, A., Chomette, L., Haddouchi, S., Devidts, G., Chulia, D., 2009. Comparison of three dissolution apparatuses for testing calcium phosphate pellets used as ibuprofen delivery systems. AAPS PharmSciTech 10, 597–605.
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