Drug Design, Development and Therapy (Jan 2023)

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

  • Bashir MA,
  • Khan A,
  • Shah SI,
  • Ullah M,
  • Khuda F,
  • Abbas M,
  • Goh KW,
  • Ming LC

Journal volume & issue
Vol. Volume 17
pp. 261 – 272

Abstract

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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 [email protected]; [email protected]: 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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