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product

Esomeprazole EC Pellets / MUPS / Granules

PRODUCT NAME: Esomeprazole Pellets
PRODUCT CODE: ATM006PLES
Class of Drugs: Proton Pump Inhibitor
Action: Delayed release drug
Percentage Strengths: 8.5%, 22.5%
Mesh Size:  14#18, 16# 20, 24#30, 30#50, 18#24

 

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  • Description
  • Packaging details

Description

The chiral version of omeprazole is called esomeprazole. In order to comply with Innovator, the product is produced as enteric coated pellets using aqueous technology without the need of an organic solvent.

The produced product is similar to the innovator in terms of the marketed product’s dissolving profile.

In addition to the assay and the impurity profile, the in-vitro dissolution test determines the quality of the pellets. Due to their correlation with in-vivo behaviors, the time dissolution values provide direct measurements of coating efficiency and, consequently, optimal therapeutic efficacy.

We do provide development services in the event that a modified formulation, dosage, or strength is needed.

Provide a full technical package for registrations in all markets that are regulated or partially regulated.

 

Packaging details

Packaging details: 25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.
Storage: Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat