THE EFFECT OF COCRYSTALLIZATION ON METOCLOPRAMIDE HYDROCHLORIDE TABLETS DISSOLUTION
From a pharmaceutical perspective, the monohydrate form of metoclopramide hydrochloride (MCPHCl) has preformulation problems, which is a transformation of the hydrate-anhydrous form when heated or exposed to moisture. Cocrystallization with gallic acid (GAL) co-former reduced the hydration deg...
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| Format: | Final Project |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/78410 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | From a pharmaceutical perspective, the monohydrate form of metoclopramide hydrochloride
(MCPHCl) has preformulation problems, which is a transformation of the hydrate-anhydrous form
when heated or exposed to moisture. Cocrystallization with gallic acid (GAL) co-former reduced the
hydration degree of MCPHCl to hemihydrate form and produced new materials with modified
characteristics. Previous studies found that the intrinsic dissolution of the metoclopramide
hydrochloride-gallic acid (MCPHCl-GAL) cocrystal was decreased compared to its monohydrate form.
In this study, MCPHCl-GAL tablets will be prepared and compared with MCPHCl tablets to determine
the effect of physicochemical changes in cocrystals on the tablet dissolution rate. MCPHCl cocrystals
were prepared with gallic acid co-former (GAL) using the slurry method with methanol for 2 hours at
room temperature. The cocrystals formed were then characterized using SEM, DSC, TG/DTA, and PXRD.
The tablet formulas were determined for the direct compression and wet granulation methods. Then,
an evaluation of the flowability of the granules for the wet granulation method was carried out,
including determining the Hausner ratio and compressibility index. Tablet evaluation includes weight
uniformity, size uniformity, hardness test, friability test, disintegration time, and dissolution profile. It
was found that MCPHCl-GAL, which decreased by 2.2-fold in the intrinsic dissolution test, produced a
tablet dissolution profile similar to MCPHCl tablets. This study found that the physicochemical changes
in the MCPHCl-GAL cocrystal did not significantly change the dissolution performance of the tablets.
However, with thermodynamically more stable characteristics and its similarity in tablet dissolution
performance to MCPHCl, MCPHCl-GAL can effectively handle MCPHCl preformulation problems. It can
be considered in MCPHCl tablet preparations in the pharmaceutical industry.
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