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Design of Dual Principles Floating Osmotic Drug Delivery System of Pioglitazone Hydrochloride for Gastro-retention: In Vitro-In Vivo Evaluation

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Abstract

Background

This work aimed to design and optimize the gastro-retentive drug delivery system (GRDDS) by employing dual principles, i.e., floating and osmotic for pioglitazone hydrochloride (PGH). PGH is commonly prescribed for chronic type II diabetes mellitus (DM).

Method

Floating osmotic drug delivery system (FODDS)–based tablet was prepared to employ a 32-full factorial design to investigate the influence of HPMC-K4M and NaHCO3 on floating lag time and in vitro drug release. Furthermore, graphical optimization was carried out to get the optimal combination based on desirability. The excipients-drug interaction was performed by using DSC and FTIR studies.

Results

The optimized bath (OF-O) showed floating lag time (s) = 35.55 ± 2.5 and in vitro drug release (%) = 93.27 ± 2.2. The OF-O showed prolonged release of PGH over 8 h in 0.1 N HCl (pH 1.2). The in vivo estimation of buoyancy in human volunteers in fasted and fed conditions revealed that tablets stayed buoyant in gastric fluid for 8 h. The study concluded that the developed formulation could enhance gastric retention and provide prolonged delivery of PGH.

Conclusion

The implementation of dual principles further widens the scope of gastro-retentive drug delivery (GRDDS) for prolonging the drug release in the gastric cavity.

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Data Availability

All data generated or analyzed during this study are included in this article.

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Acknowledgements

The author sincerely acknowledges radiologist Dr. Nilay S. Nimbarkar for his help in carrying out the X-ray study.

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Authors and Affiliations

  1. Department of Pharmaceutics, DMIHER (DU), Datta Meghe College of Pharmacy, Wardha, 442001, MH, India

    Pankaj Dangre

  2. Department of Pharmaceutics, Kamla Nehru College of Pharmacy, Butibori, 441108, MH, India

    Pankaj Dangre & Navnath Gundre

  3. Department of Pharmacognosy, Kamla Nehru College of Pharmacy, Butibori, 441108, MH, India

    Satish Meshram

  4. Department of Pharmacology, Datta Meghe College of Pharmacy, DMIHER (DU), Wardha, 442001, MH, India

    Dilip Madia

  5. Department of Quality Assurance, Dadasaheb Balpande College of Pharmacy, Besa, Nagpur, 440037, MH, India

    Mangesh Godbole

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  1. Pankaj Dangre
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Contributions

Pankaj Dangre: conceptualization, software, validation, formal analysis, writing—reviewing and editing, project administration. Navnath Undre: methodology, formal analysis, data creation. Satish Meshram: formal analysis. Dilip Madia: supervision, resources: Mangesh Godbole: reviewing of original draft preparation, visualization, investigation, project administration.

Corresponding authors

Correspondence to Pankaj Dangre or Mangesh Godbole.

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Dangre, P., Gundre, N., Meshram, S. et al. Design of Dual Principles Floating Osmotic Drug Delivery System of Pioglitazone Hydrochloride for Gastro-retention: In Vitro-In Vivo Evaluation. J Pharm Innov 18, 2131–2144 (2023). https://doi.org/10.1007/s12247-023-09779-6

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