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. 2023 Jan 26:17:261-272.
doi: 10.2147/DDDT.S377686. eCollection 2023.

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

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 Ming  6
Affiliations

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

Muhammad Anwar Bashir et al. Drug Des Devel Ther. .

Abstract

Background: 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: Tween 60; castor oil; olive oil; self-emulsified drug-delivery system; simvastatin.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Chemical structure of simvastatin.
Figure 2
Figure 2
(A) FTIR spectra of pure simvastatin, (B) simvastatin solution prepared in a mixture of olive oil and Tween 60, and (C) simvastatin solution prepared in castor oil and Tween 60.
Figure 3
Figure 3
Disintegration time of different formulations of simvastatin self-emulsified tablets. Disintegration time was determined according to USP for six tablets (n=6), using purified water as media held at 37°±2°C.
Figure 4
Figure 4
Dissolution rate from different formulations of simvastatin self-emulsified tablets.
Figure 5
Figure 5
Comparison of cumulative drug release after 15 (Q15 min) and 30 min (Q30 min).
See this image and copyright information in PMC

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