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 or 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.
Ensures greater bioavailability.
Ensures uniform emptying of micro pellets from stomach into small intestine facilitates rapid dissolution of enteric coating and drug release resulting in early Tmax and Cmax
Ensures 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 in reducing the esophageal residence time.
Minimizes fluctuation in plasma concentration of drug.
MUPS ensure rapid and uniform gastric emptying and subsequently uniform drug dissolution of pellets in the gastrointestinal tract due to their small size and larger surface,uniform drug absorption is facilitated which results in consistent and controlled pharmacological action.
A further reduction in inter- and intra-subject variability in drug absorption and clinical response is facilitated since the number of pellets per MUPS dosage form is much more than a conventional pellet-filled capsule and possibility of dose dumping (in stomach) and incomplete drug release is further minimized.
Indications
Nexe MUPS is indicated in:
Gastro-esophageal Reflux Disease (GERD).
Risk reduction in NSAID associated gastric ulcer.
H. pylori eradication (Triple therapy).
Zollinger-Ellison syndrome and idiopathic hypersecretion.
Erosive esophagitis-
Adult (≥18 years): 40 mg once daily for 4 weeks.
Children & adolescents (12-18 years): 40 mg once daily for 4 weeks.
Maintenance of healing of erosive esophagitis-
Adult (≥18 years): 20 mg once daily.
Children & adolescents (12-18 years): 20 mg once daily.
Risk reduction in NSAID associated gastric ulcer-
Adult (≥18 years): 20 mg once daily for 4-8 weeks.
H. pylori eradication (Esomeprazole MUPS tablet with 1000 mg Amoxicillin and 500 mg Clarithromycin)-
Adult (≥18 years): 20 mg twice daily for 7 days.
Children & adolescents (12-18 years): 20 mg twice daily for 7 days.
Zollinger-Ellison syndrome and idiopathic hypersecretion-
Adult (≥18 years): 40-80 mg twice daily.
Children 1-11 years:
Erosive esophagitis: Weight <20 kg: 10 mg once daily for 8 weeks. Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks
Maintenance of healing of erosive esophagitis: 10 mg once daily
Children below the age of 1 year: Esomeprazole MUPS tablet is not approved for use in children younger than 1 year.
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Nexe MUPS is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Nexe MUPS is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Nexe MUPS does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.
Nexe MUPS may potentially interfere with CYP2C19, the major Nexe MUPS metabolizing enzyme. Co-administration of Nexe MUPS 30 mg anddiazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Nexe MUPS inhibits gastric acid secretion. Therefore, Nexe MUPS may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Nexe MUPS.
Combination Therapy with Clarithromycin: Co-administration of Nexe MUPS, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of Nexe MUPS and 14-hydroxyclarithromycin.
The most frequently occurring adverse events reported with Nexe MUPS include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.
The manufacturer advises caution. It is not known if Esomeprazole or its metabolites appear in human breast milk.
Nexe MUPS should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Nexe MUPS may slightly increase the risk of hip, wrist and spine fracture, particularly when it is taken over a period of more than one year.
