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

• Published in: Journal of pharmaceutical innovation Vol. 18; no. 4; pp. 2131 - 2144
• Main Authors: Dangre, Pankaj, Gundre, Navnath, Meshram, Satish, Madia, Dilip, Godbole, Mangesh
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.12.2023
• Subjects: Biochemical Engineering; Biomedical and Life Sciences; Biomedicine; Biotechnology; Industrial and Production Engineering; Original Article; Pharmacology/Toxicology; Floating osmotic drug delivery system; Pioglitazone hydrochloride; Gastro-retentive drug delivery system; Diabetes mellitus; Optimization
• ISSN: 1872-5120; 1939-8042
• DOI: 10.1007/s12247-023-09779-6

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 3 2 -full factorial design to investigate the influence of HPMC-K4M and NaHCO 3 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.