Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL DISPERSIBLE FILMS OF EMPAGLIFLOZIN

Budida Hema Kiranmayi*, Adathakula Sree Geetha, Vuyyuri Bhaargavi, T. Prasanthi, Dr. J. Anu Pravallika and K. Keerthi Sai

ABSTRACT

Empagliflozin, an anti-diabetic drug that selectively inhibits sodium-glucose co-transporter-2 (SGLT-2) in the kidneys has low solubility. The present research work aims to formulate and evaluate empagliflozin fast dissolving oral dispersible films. A fast-dissolving oral dispersible film (FDOF) of empagliflozin offers an elegant route for systemic drug delivery. They may improve systemic bioavailability as a result of bypassing the first-pass effect and better permeability due to high vascular and lymphatic drainage. Also, the large surface area of absorption, easy ingestion, and swallowing make the oral mucosa a very attractive and selective site for systemic drug delivery. All the formulations (F1- F6) of Empagliflozin oral films were prepared by the solvent casting method using the polymers HPMC 50 cps, HPMC 100 cps, and the plasticizers PEG and propylene glycol.The sodium starch glycolate used in the formulation, made the film disintegrate quicker and dissolute faster, which may result a rapid onset of action. Compatibility studies conducted using FTIR have shown the presence of no interactions between the drug and the excipients. The films of all the formulations exhibited uniform thickness. The near neutral surface pH of the films ensured the absence of irritation to the oral mucosal lining. In the in-vitro dissolution studies F4 has shown 98.4% drug release. Since F4 has proven its capability to release more drug, it can be concluded that this formulation may have improved bioavailability.

Keywords: glycolate used in the formulation, made the film disintegrate quicker and dissolute faster, which may result a rapid onset of action. Compatibility studies conducted using FTIR have shown the presence of no interactions between the drug and the excipient