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Development and Optimization of HP-β-CD Inclusion Complex-Based Fast Orally Disintegrating Tablet of Pitavastatin Calcium

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Abstract

Purpose

The objective of the present study was to develop HP-β-cyclodextrin inclusion complex-based rapid orally disintegrating tablets of pitavastatin calcium by unique sublimation technique for enhancing solubility and dissolution profile of anti-lipidemic class II drug.

Methods

The inclusion complex was prepared by a physical mixing method containing HP-β-cyclodextrin and pitavastatin calcium. The inclusion complex formation between the guest and host was confirmed by molecular docking studies. The developed inclusion complex was further characterized using differential scanning calorimetry (DSC), Fourier transform-infrared spectroscopy (FT-IR), powder X-ray diffraction study (PXRD), and scanning electron microscopy studies. Fast orally disintegrating tablets of pitavastatin calcium inclusion complex were developed by a unique sublimation technique employing full factorial design (24) using the Design Expert® software. Independent factors, namely, type of super disintegrants and sublimating agents at varying concentrations, were studied for effect on disintegration time, hardness of the tablet, and in vitro drug release.

Results

Molecular docking studies showed a score of −8.08. Optimized formulation containing 5% Ac-di-sol, 10% camphor showed hardness of about 3.37 ± 0.11 kg/cm2, least disintegration time 15.31 ± 0.32 s, and highest in vitro drug release of 99.11 ± 0.23% at the end of 15 min.

Conclusion

The employed complexation method enhanced solubility and increased in vitro dissolution of pitavastatin calcium. It was concluded that fast orally disintegrating tablets containing inclusion complex gave desired characteristics which provided rapid onset of action by fast disintegration and could improve patient compliance.

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Acknowledgements

The authors are grateful to the management for offering the requisite technical help to accomplish this study. The authors would like to thank MSN Laboratories Pvt. Ltd, Telangana for providing a gift sample of drug.

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Authors and Affiliations

  1. Department of Pharmaceutics, SVKM’s Dr., Bhanuben Nanavati College of Pharmacy, SVKM Campus, V. M. Road, Vile Parle (W), Mumbai, 400056, India

    Prachi Pimple, Prabha Singh & Sonika Gupta

  2. Department of Pharmaceutical Chemistry, SVKM’s Dr., Bhanuben Nanavati College of Pharmacy, SVKM Campus, V. M. Road, Vile Parle (W), Mumbai, 400056, India

    Arati Prabhu

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  1. Prachi Pimple
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  2. Prabha Singh
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Correspondence to Prabha Singh.

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Pimple, P., Singh, P., Prabhu, A. et al. Development and Optimization of HP-β-CD Inclusion Complex-Based Fast Orally Disintegrating Tablet of Pitavastatin Calcium. J Pharm Innov 17, 993–1010 (2022). https://doi.org/10.1007/s12247-022-09661-x

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