Development and pharmaceutical evaluation of sacubitril sodium loaded oral fast dissolving films Shaik Firoz*, Karnatham Padmini, Dugganpalli Rishmitha, Panga Swarnalatha, Akepati Lakshmi Prasanna Department of Pharmaceutics, Sree Vidyanikethan College of Pharmacy, Sree Sainath Nagar, A. Rangampet -517102, Chandragiri Mandal, Chittoor District, Andhra Pradesh *Corresponding Author E-mail: firoz.kallur@gmail.com
Online published on 16 September, 2020. Abstract Fast dissolving oral film is used as a novel approach, as it dissolve rapidly in mouth and directly reaches to the systemic circulation. The main aim of the research work was to develop the oral fast dissolving films of an anti hypertensive drug Sacubitril sodium in order to improve the drug release and to avoid the first pass metabolism. Eight formulations (F1-F8) were prepared using solvent casting method. Films were formulated by using HPMC-E5 as water soluble polymer and propylene glycol as a plasticizer. The drug polymer compatibility was studied using FTIR and DSC studies. Formulated films were characterized for their physicochemical parameters like weight variation, surface pH, drug content, folding endurance, disintegration time, dissolving time, in vitro dissolution studies. The surface pH was found to be in the range of 6.35 to 6.75 which is close to salivary pH, which indicates that films may have less potential to irritate the oral mucosa, thereby they are comfortable. FT-IR and DSC studies revealed that the polymer is compatible with the drug. Drug content of films was estimated and the results were found to be satisfactory. In vitro dissolution studies revealed a good drug release from the films. The drug release was higher in formulation F5 and lower in F1, F2, F3, F4 formulations. From the present study, it was concluded that these films represent a promising route to oral drug delivery for fast drug release in the management of hypertension. Top Keywords Polymer, Films, Formulation, Concentration, Drug, Release, Hypertension. Top |