THE PHARMACEUTICAL PROFILE CHARACTERIZATION OF TELMISARTAN HYDROCHLORIDE CRYSTAL HYDRATE AND ANHYDRATE
Telmisartan is an antihypertensive drug belonging to the Angiotensin Receptor Blockers (ARB) class, categorized as Class II in the Biopharmaceutical Classification System (BCS). This means the drug has high permeability but low solubility. Telmisartan was converted into its HCl salt form and t...
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| Format: | Final Project |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/78413 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | Telmisartan is an antihypertensive drug belonging to the Angiotensin Receptor Blockers (ARB) class,
categorized as Class II in the Biopharmaceutical Classification System (BCS). This means the drug
has high permeability but low solubility. Telmisartan was converted into its HCl salt form and then
formed into an anhydrate. This study aims to characterize the pharmaceutical profile of telmisartan
HCl anhydrate compared to telmisartan HCl trihemihydrate. The anhydrate salt obtained was
characterized using thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), and
powder X-ray diffractometry (PXRD) to determine its characteristics. Subsequently, tests were
conducted to evaluate solubility, intrinsic dissolution rate, particle size distribution, tabletability,
and flow rate. The instrumental analysis confirmed the formation of telmisartan HCl anhydrate.
Telmisartan HCl anhydrate increased solubility by 1,4 times compared to the hydrate form and 18,9
times compared to telmisartan, improving the intrinsic dissolution rate by 4,3 times compared to
the hydrate form. However, the flow rate was poorer than the hydrate form, and tabletability did
not show a significant difference (P>0,05) compared to the hydrate form.
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