Formulation and Evaluation of Sacubitril/Valsartan Tablets Using Solid Dispersion Technique

Abstract

The present study is an attempt to develop immediate release tablets of Sacubitril/Valsartan using solid dispersion technique to achieve rapid release in GIT which might result in enhanced absorption and thereby improved bioavailability. Various batches of Sacubitril/Valsartan solid dispersion (SD1-SD6) were prepared using solid dispersion technique. Crospovidone and PVP K 30 were used as polymeric carrier in (drug: carrier) 1:0.5 ratio for all the formulations. Crospovidone and PVPK 30 was used as dissolution inhancer. Drug-excipients interactions were carried out for pure drug and optimized formulations using FTIR studies. Six batches of Sacubitril/Valsartan  immediate release tablets (F1 to F6) were developed by wet granulation method using its solid dispersion. All the batches of immediate release tablets were evaluated for different pre-compression and post-compression parameters including stability study of the optimized formulation. Among all formulations, F6 preparared by solid dispersion method with a high quantity of dissolution enhancer content showed the greatest drug release (101.49% ± 0.31%). The stability studies (formulation F6) showed there was no major differences in physical parameters and was stable even after a period of 3 months. % CDR of the accelerated time stability batch was 94.41% ± 0.265% of its content in 30 min which is showing immediate release and the drug content of the same stability batch was 99.87% ± 0.119%.