THE EFFECT OF METOCLOPRAMIDE HYDROCHLORIDE COCRYSTALLIZATION WITH OXALIC ACID COFORMER ON TABLET DISSOLUTIONÂ PROFILE
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 di...
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| Format: | Final Project |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/82430 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | 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.
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