Abstract

ORAL THIN FILMS FOR HYPERTENSION MANAGEMENT: A REVIEW OF FORMULATION, EVALUATION AND FUTURE PROSPECTS

Nisha Patel*, Nupur Patel, Mosam Patel, Maitri Patel, Anu Viral Patel

ABSTRACT

Hypertension is a serious cardiovascular disease, for which a long-term pharmacological therapy is required. The disadvantages of common oral dosage forms including difficulties in administration and the physicochemical nature of certain antihypertensive drugs have prompted the development of innovative formulations. Oral thin films (OTFs) are flexible polymeric dosage forms that rapidly disintegrate or dissolve without the need for water. This review aims to explore OTFs for hypertension treatment, including formulation components, manufacturing methods, drug release mechanisms, evaluation parameters, existing formulations and future prospects. Film-forming polymers such as hydroxypropyl methylcellulose, polyvinyl alcohol, plasticizers, solubilizing agents, and permeation enhancers are the main constituents. The preparation techniques, including solvent casting,electrospinning, hot-melt extrusion, and 3D printing are discussed. The antihypertensive drugs incorporated in OTFs were telmisartan, atenolol, enalapril, amlodipine, olmesartan, hydralazine and ambrisentan. Moreover, the development of nanocrystals, nanoplexes, and colloidal carriers such as bilosomes and niosomes for the improvement of the solubility of the drugs has been explored. Evaluation techniques such as thickness, weight variation, drug content, mechanical properties, moisture content, disintegration and dissolution tests, mucoadhesiveness and membrane permeation are presented. Nevertheless, the loading capacity, unpleasant taste, moisture sensitivity, manufacturing challenges, and limited clinical evidence are serious concerns. The fast disintegration or improvement of in vitro dissolution does not necessarily lead to better efficacy. Further research and clinical studies are needed to evaluate the safety, stability and effectiveness.

Keywords: Oral thin films; hypertension; antihypertensive drugs; buccal delivery; sublingual delivery; drug solubility.