Formulation and In-Vitro Evaluation of Gastroretentive Expandable Film of Nateglinide

Abstract

The present work was based on the development and characterization of unfolding type gastro retentive dosage form appropriate for the controlled release of Nateglinide (NAT), a drug with a narrow therapeutic window. Gastroretentive films were formulated using hydroxypropyl methylcellulose (HPMC) as a film-forming agent, and polyethylene glycol 400 (PEG) as a plasticizer. The drug-loaded polymer film of hydroxypropyl methylcellulose (HPMC) as a film-forming agent and polyethylene glycol 400 (PEG) as a plasticizer was folded into hard gelatin capsules. The prepared films were evaluated for several parameters like physical appearance, surface texture, weight variation, thickness, folding endurance, swelling index, tensile strength, unfolding behavior, drug content, and In vitro drug release studies. Drug and polymers were found to be compatible as revealed by Fourier transform infrared spectroscopy (FTIR) study revealed uniform dispersion of NAT in polymeric matrices. The best release for gastroretentive film was shown by formulation F19 (HPMC 15cps and PEG 400). Formulation F19 exhibited a good appearance, better mechanical strength with acceptable flexibility. Formulation F19 was given 90% NAT release after 12 hr, 95.15±0.18% drug content, and found to be stable.  The results indicate that the unfolding type gastro retentive drug delivery system offers a suitable and practical approach for the prolonged release of drug over an extended period and thus oral bioavailability, efficacy, and patient compliance is improved.