SOLVING ACTIVE INGREDIENT HOMOGENEITY PROBLEM OF BENZYDAMINE HCL LOZENGES WITH MIXING METHOD MODIFICATION

• Main Author: Abdullah, Dhoni
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/56537
• Institution: Institut Teknologi Bandung

Mixing process variation of the drugs active ingredients in the granulation phase is one of the important factors in the homogeneity of drugs that contain a small amount of active ingredient, such as Benzydamine HCl tablets. Increase of method sensitivity due to analysis method update for Benzydamine HCl tablet assay from spectrophotometry to HPLC, makes the inhomogeneity issue in the parameters of content uniformity become apparent. The aim of this study was to solve the homogeneity problem of Benzydamine HCl and its primary outcome was to obtain the content uniformity of Benzydamine HCl within the range 85 - 115% for its individual data and the acceptance value (AV) ?15%. The solution approach to the homogeneity problem of Benzydamine HCl tablets was carried out using the 8-steps Plan, Do, Check, Action (PDCA) method popularized by Toyota. In this study, the mixing process of Benzydamine HCl in the tablet manufacturing process was changed from the extragranular phase to the intragranular phase. The change in the mixing phase is proven to be able to produce uniformity values for tablet content to meet the requirement, AV ?15% and 85 - 115% assay value for its individual data. These results indicate that the PDCA approach can be used to solve the issue of homogeneity of Benzydamine HCl tablets, by changing the mixing phase of active ingredients in the tablet manufacturing process.