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Development and Optimization of Vitamin D3 Solid Self-Microemulsifying Drug Delivery System: Investigation of Flowability and Shelf Life

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Abstract

We report herein the design of a solid self-microemulsifying drug delivery system (SMEDDS) of vitamin D3 for augmentation of its solubility and dissolution. The studies employed a 32 full factorial design by employing JMP 13.2.1, software for preparation of liquid SMEDDS. Further, the prediction profiler was utilized to optimized liquid SMEDDS-Vit.D3 (OF) formulation. The solidification of liquid SMEDDS-Vit.D3 formulation was carried out by physical adsorption over Neusilin US2 and Aerosil 200 carriers. Solid-state evaluation of SMEDDS-Vit.D3 suggested the transformation of crystalline to amorphous form of Vit.D3 which is responsible for imparting more aqueous solubility and thus enhancement in dissolution behaviour. The investigation of flow behaviours viz. flow function (FF) and effective angle of wall friction (EAWF) of solid SMEDDS-Vit.D3 was performed using powder flow tester. Solid SMEDDS-Vit.D3 prepared using Neusilin US2 showed good flow behaviour and hence was developed into tablets. The tablets showed good quality control parameters as per pharmacopeial standards. The in vitro dissolution studies demonstrated more dissolution of Vit.D3 in SMEDDS (liquid, solid, and tablet) when compared to the unprocessed drug. The shelf life (T90) of tablets was reported to be 28.12 months suggesting excellent stability of Vit.D3 in solid SMEDDS. In nutshell, our research works explore the utilization of SMEDDS for the oral delivery of Vit.D3 to gain maximum health-related benefits.

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Acknowledgements

All the authors honestly are grateful to the Gattefosse Pvt. Ltd (Mumbai, India) for providing different oils, surfactants, and co-surfactant and Gangwal Chemical Pvt. Ltd (Fuji Chemical Industries Co., Ltd) for Neusilin US2.

Funding

The authors received financial support from Department of Science and Technology-FIST Govt. of India (Grant No-SR/FST/College-2018/268).

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Authors and Affiliations

  1. Department of Pharmaceutics, Datta Meghe College of Pharmacy, DMIMS (DU), Wardha, 442 001, Maharashtra, India

    Pankaj V. Dangre

  2. Department of Pharmaceutical Quality Assurance, R C Patel Institute of Pharmaceutical Education and Research, Dist. Dhule 425405, Shirpur, Maharashtra, India

    Pankaj V. Dangre, Navya J. Gurram & Shailesh S. Chalikwar

  3. Department of Pharmacognosy, R C Patel Institute of Pharmaceutical Education and Research, Dist. Dhule 425 405, Shirpur, Maharashtra, India

    Sanjay J. Surana

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  1. Pankaj V. Dangre
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Contributions

Shailesh S. Chalikwar: reviewing of original draft preparation, visualization, investigation, project administration. Navya J. Gurram: methodology, formal analysis, data creation. Sanjay J. Surana: supervision, resources. Pankaj V. Dangre: conceptualization, software, validation, formal analysis, writing — reviewing and editing, project administration.

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Correspondence to Shailesh S. Chalikwar.

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Dangre, P.V., Gurram, N.J., Surana, S.J. et al. Development and Optimization of Vitamin D3 Solid Self-Microemulsifying Drug Delivery System: Investigation of Flowability and Shelf Life. AAPS PharmSciTech 23, 110 (2022). https://doi.org/10.1208/s12249-022-02267-z

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