Negara: Bangladesh
Bahasa: Inggris
Sumber: DGDA (Directorate General of Drug Administration)
Esomeprazole
The ACME Laboratories Ltd.
Esomeprazole
20 mg
Mups Tablet
COMPOSITION Each MUPS (Multiple-Unit Pellet System) tablet contains 133.333 mg Esomeprazole 15% w/w enteric coated pellets (as Esomeprazole Magnesium Trihydrate USP) equivalent to 20 mg Esomeprazole. MUPS MUPS is abbreviation for Multiple-Unit Pellet System. However, from pharmaceutical industry and research perspective, the term in general refers to MUPS compacted into tablets. Thus, the resulting tablets prepared by compaction of modified release coated multiparticulates of pellets are called as MUPS. It is the more recent and challenging technologies that combine the advantages of both tablets and pellet-filled capsules in one dosage form. PHARMACOLOGY Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+- ATPase in the gastric parietal cell thus reducing gastric acidity. After oral administration, peak plasma levels (C max ) occur at approximately 1.5 hours (T max ). At repeated once- daily dosing with 40 mg, the systemic bioavailability is approximately 90%. Esomeprazole is 97% bound to plasma proteins. Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. Approximately 80% of an oral dose of Esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the feces. CLINICAL ADVANTAGE OF ESOMEPRAZOLE MUPS TABLET COMPARED TO CONVENTIONAL MODIFIED- RELEASE ESOMEPRAZOLE TABLETS AND PELLET- FILLED ESOMEPRAZOLE CAPSULES Ensures greater bioavailablility Ensures uniform emptying of micro pellets from stomach into small intestine facilitates rapid dissolution of enteric coating and drug release resulting in early T max and C max (peak time and peak plasma concentration) Ensure lesser possibility of dose dumping Is a combination of fast acting and sustained action Ensures uniform drug release Once daily dosing Ensures lesser chance of localized irritation Ensures better and more uniform drug absorption Is better than capsules i Baca dokumen lengkapnya