Development and Evaluation of Self-Emulsifying Drug-Delivery System–Based Tablets for Simvastatin, a BCS Class II Drug

Autor: Bashir MA, Khan A, Shah SI, Ullah M, Khuda F, Abbas M, Goh KW, Ming LC
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Drug Design, Development and Therapy, Vol Volume 17, Pp 261-272 (2023)
Druh dokumentu: article
ISSN: 1177-8881
Popis: Muhammad Anwar Bashir,1 Amjad Khan,2 Sayyed Ibrahim Shah,3 Majeed Ullah,2 Fazli Khuda,4 Muhammad Abbas,3 Khang Wen Goh,5 Long Chiau Ming6 1Department of Pharmacy, Abasyn University, Peshawar, Pakistan; 2Department of Pharmacy, Kohat University of Science and Technology, Kohat, Pakistan; 3Department of Pharmacy, Abdul Wali Khan University, Mardan, Pakistan; 4Department of Pharmacy, University of Peshawar, Peshawar, Pakistan; 5Faculty of Data Science and Information Technology, INTI International University, Nilai, Malaysia; 6PAP Rashidah Sa’adatul Bolkiah Institute of Health Sciences, Universiti Brunei Darussalam, Gadong, Brunei DarussalamCorrespondence: Khang Wen Goh; Long Chiau Ming, Email khangwen.goh@newinti.edu.my; long.ming@ubd.edu.bnBackground: Self-emulsifying drug-delivery systems (SEDDSs) are designed to improve the oral bioavailability of poorly water-soluble drugs. This study aimed at formulating and characterization of SEDDS-based tablets for simvastatin using castor and olive oils as solvents and Tween 60 as surfactant.Methods: The liquids were adsorbed on microcrystalline cellulose, and all developed formulations were compressed using 10.5 mm shallow concave round punches.Results: The resulting tablets were evaluated for different quality-control parameters at pre- and postcompression levels. Simvastatin showed better solubility in a mixture of oils and Tween 60 (10:1). All the developed formulations showed lower self-emulsification time (˂200 seconds) and higher cloud point (˃60°C). They were free of physical defects and had drug content within the acceptable range (98.5%– 101%). The crushing strength of all formulations was in the range of 58– 96 N, and the results of the friability test were within the range of USP (≤ 1). Disintegration time was within the official limits (NMT 15 min), and complete drug release was achieved within 30 min.Conclusion: Using commonly available excipients and machinery, SEDDS-based tablets with better dissolution profile and bioavailability can be prepared by direct compression. These S-SEDDSs could be a better alternative to conventional tablets of simvastatin.Keywords: simvastatin, self-emulsified drug-delivery system, castor oil, olive oil, Tween 60
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