QUALITY BY DESIGN SUPPORTED CONSTRUCTION OF ORAL FAST-DISSOLVING FILMS FOR TELMISARTAN: RECONNOITERING THE QUALITY ATTRIBUTES

Abstract

Objective: The angiotensin II receptor antagonist telmisartan (TMS) is often used to treat hypertension. The BCS class II antihypertensive drug TMS has a low solubility, poorly absorbed when taken orally. The goal of this study was to formulate an oral fast-dissolving film (OFDF) of TMS. In recent years, the concept of a rapidly dissolving dosage form as an innovative delivery system has gained popularity. By decreasing dosing frequency, maximize therapeutic effectiveness, bioavailability, and stability. It will also prevent the drugs from being metabolized in the first place. This technique allows for faster drug absorption from the gastrointestinal tract (GIT), which might result in a more rapid onset of action. Methods: An experimental design known as Box-Behnken was employed to optimize a OFDF. Mango kernel (100-300 mg), maltodextrin (200-350 mg), and propylene glycol (PG) (15-30%) were chosen as independent variables with the highest preference. Included measurements of T5 tensile strength, disintegration time, folding endurance, elongation, and drug release efficiency as dependent variables. Results: The physical properties of the films were found to be satisfactory, and Fourier transform infrared (FTIR) analysis failed to detect any drug-polymer interaction. F4 was found to have the greatest bioadhesive strength of 49.82 gm and the longest ex-vivo mucoadhesion duration of 189 min. A higher concentration of mango kernel in the formulation resulted in a greater rate of drug release. More than 60% of the drug was discharged within 10 min. Conclusion: The oral mucosa of a rat was used for ex-vivo for irritation studies. Based on the pharmacokinetic plasma parameters, which is made into quick-dissolving films that are taken by mouth, is much better absorbed than aqueous suspensions. Studies of the enhanced formulation's stability showed that F4 may be stored for up to three months without deterioration.