The present study is to develop a pharmaceutically stable and robust formulation of Acetaminophen 500mg and
Diphenhydramine Hydrochloride 25mg tablets comparable with innovator. This goal various types of superdisintegrant and excipient with different concentrations are used in various prototype trials are taken & evaluated with respect to various quality parameters like weight variation, friability, hardness, thickness and also
perform various stability studies in these formulation. The formulation shall be finalized by comparing the in -vitro dissolution profile with that of the innovator in various pH
media by using HPLC method and produce a desirable and stable tablet. The main objective of this study was to develop and evaluate the formulation of
Acetaminophen 500mg and Diphenhydramine Hydrochloride 25 mg tablets. Several trials have been taken to optimize and develop a robust formulation. Various processing problems were encountered during the formulation development and
these were overcome with proper optimization of composition of formulation ingredients and processing conditions. The reproducibility batch (T11) was taken for the finalized batch ie. T11 was charged for stability studies at accelerated and real time conditions. The stability study for 3 months shows that the formulation is stable enough at 400C/75%RH. The formulation is a robust one and the performance is less likely to be affected by the various factors studied. The stability data is found to be satisfactory and so the scale up, Exhibit as well as validation batches can be planned for further progress. So it can be concluded that the Acetaminophen 500mg and Diphenhydraminehydrochloride 25mg tablets formulation T11 is robust and stable
