Research Article | Open Access
Volume 2021 - 1 | Article ID 172 | http://dx.doi.org/10.51521/JPEM.2021.1104
Academic Editor: John Bose
V. Ranjith*, R. Nithya
Department of Pharmaceutics,
PSG College of Pharmacy, Coimbatore, 641 004, Tamilnadu, India.
Corresponding author: V. Ranjith, Department of Pharmaceutics, PSG College of
Pharmacy, Coimbatore, 641 004, Tamilnadu, India., E-mail: ranjithvelu1@gmail.com
Citation: V.
Ranjith*, R. Nithya (2021) Oral Dosage Form Containing Solubility Enhanced Forms of Atorvastatin
Calcium and Ezetimibe. J Pharm Exper Med, 1(1);1-8
Copyright: © 2021, V. Ranjith*, R. Nithya. This is an open-access article distributed
under the terms of the Creative Commons Attribution 4.0 International License,
which permits unrestricted use, distribution and reproduction in any medium,
provided the original author and source are credited.
ABSTRACT
The aim of the research work was to increase the
solubility of atorvastatin calcium (ATC) and ezetimibe (EZT) by preparing solid dispersion
containing tablet. Solvent evaporation method using combination of polymers [PVP
K30/HPMC E5, PEG 6000/HPMC E5] involving various drug: polymer ratio was used
to prepare solid dispersion. The prepared solid dispersion was evaluated for
its solubility. The solubility of pure drugs and optimized batch was found to
be 0.029±0.001, 0.012±0.0002 (ATC, EZT) and 0.427±0.003, 0.179±0.002 (ATC, EZT)
respectively. The optimized solid dispersion showing increased solubility (14-fold)
was selected and formulated into tablets. The tablet was subjected to various
quality control tests like content uniformity, thickness, weight variation, hardness,
friability, disintegration. In vitro drug release profile was also studied.
The formulated tablets show higher percentage of drug release in compared with marketed
tablets (Storvas®EZ10).
KEYWORDS: Atorvastatin calcium (ATC), Ezetimibe (EZT), Solid dispersion (SD), Solubility.