THE EFFECT OF METOCLOPRAMIDE HYDROCHLORIDE COCRYSTALLIZATION WITH OXALIC ACID COFORMER ON TABLET DISSOLUTIONÂ PROFILE

• Main Author: Faustina Susilo, Thalia
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/82430
• Institution: Institut Teknologi Bandung

Metoclopramide hydrochloride (MCPHCl) can change to anhydrous at a temperature of 70°C and return to monohydrate at a humidity of 65%-75% RH. Previous research successfully co-crystallized MCPHCl with oxalic acid (OXA), producing a form with higher thermodynamic stability and a lower intrinsic dissolution rate. A low intrinsic dissolution rate is thought to influence the tablet dissolution rate profile. However, there has been no further research regarding the dissolution rate of tablets with MCPHCl-OXA cocrystals. The main focus of this research is to analyze the effect of co-crystallization of MCPHCl into MCPHCl-OXA on the dissolution rate profile when MCPHCl-OXA cocrystals are made into tablet preparations. MCPHCl-OXA cocrystals will be formed using the slurry method using pro-analysis methanol for 1.5 hours at room temperature and then characterized by PXRD, TG-DTA, and SEM so that their purity can be determined. MCPHCl-OXA was also tested regarding flow properties, compressibility and intrinsic dissolution rate. The manufacture of MCPHCl-OXA and MCPHCl tablets was carried out using the wet granulation method (GB) and direct compression method (KL). GB granules, KL print mass, and tablets will then be evaluated. Based on the results, it was found that MCPHCl-OXA had a significant decrease in the intrinsic dissolution rate (p-value < 0.05) compared to MCPHCl but showed a similar tablet dissolution profile to MCPHCl. It was concluded that co-crystallization of MCPHCl into MCPHCl-OXA did not produce significant changes in tablet dissolution. MCPHCl-OXA, which is thermodynamically stable and has a dissolution profile similar to MCPHCl, can be used as a solution to the MCPHCl preformulation problem. In addition, MCPHCl-OXA also has better flow properties and compressibility than MCPHCl. Thus, MCPHCl-OXA can be considered for its use in the production of tablet preparations.