Esomeprazole EC Pellets / MUPS / Granules
Esomeprazole EC Pellets / MUPS / Granules 8.5%, 22.5% – Suitable for Capsules, Tablets (dose: 20 mg, 40 mg)
- Esomeprazole is the chiral form of omeprazole. The product is manufactured as enteric coated pellets by aqueous technology to match with Innovator without use of organic solvent.
- The product developed is comparable with innovator with respect to dissolution profile of the marketed product.
- The quality of the pellets is based on the in-vitro dissolution test besides the assay and the impurity profile. The time dissolution values are direct measures of the coating efficiency and hence optimum therapeutic efficacy as it has a co-relation with in-vivo behaviors.
- We do offer development services in case of a requirement for different formulation/dosage/strength
- Offer complete technical package for registrations in all regulated/semi regulated markets
- Products protected by ongoing Patents are not offered by MKPPL.
Esomeprazole is also proton pump inhibitor and is one of the blockbuster molecule that is used in the treatment of ulcer.
Esomeprazole is the chiral form of omeprazole. The product is also manufactured as enteric coated pellets. The API is manufactured under MKPPL’s control and has a low impurity profile. MKPPL is currently developing a non-infringing process along with with a J.V. partners for API and pellets.
The quality of the pellets is based on the in-vitro dissolution test besides the assay and the impurity profile. The time dissolution values are direct measures of the coating efficiency and hence optimum therapeutic efficacy as it has a co-relation with in-vivo behaviors.
Additional Information
| Percentage | 8.5%, 22.5% |
|---|---|
| Mesh Size | 14#18, 16# 20, 18#24, 24#30, 30#50 |
| Release Type | Delayed Release |
| Quality Standard | USP43 |
| Documentation Available: | DMF in CTD Format |
| Forms of PFI | Pellets/Micro pellets (for capsules) |
| Target Formulations | Capsules, Premix, Tablets |
