Lansoprazole Pellets-Suitable for filling in 15mg & 30mg Capsules, MUPS, Premix (sachet) & 30mg Tablets.
Lansoprazole is a second-generation proton pump inhibitor and is one of the blockbuster molecule that is used in the treatment of ulcers.
- Release pattern compared with innovator -Prevacid delayed-release capsules and Prevacid solutab delayed-release orally disintegrating tablets.
- A comparative dissolution was conducted for Lansoprazole capsules of Murli Krishna Pharma and prevacid capsules which compare favorably.
- The focal intent of the MKPPL was to develop a stable; pharmaceutically equivalent, robust and delayed release micro pellet formulation of Lansoprazole for both capsule and orally disintegrating tablets.
- Offer complete technical package for registrations in all regulated/semi regulated markets.
The API used for manufacture of Lansoprazole is synthesized using a non-infringing route. The use of non-infringing excipients and aqueous coatings makes it aptly suitable for the regulatory market. The quality of the pellets is based on the in-vitro time & release dissolution profile besides the assay and the impurity profile.
Dissolution studies have also been conducted at various intestinal pH ranges. The dissolution values a direct measure of the coating efficiency and also reflects on the molecules in-vivo behavior hence optimum therapeutic efficacy is assured.
The semi-finished dosage form is available in the same strengths as Omeprazole and is intended for use in capsule as well as in suspension. The micro-pellets can be employed for manufacturing tablets.
12#16, 14#18, 16#20, 18#20, 20#22, 22#24, 24#30, 30#40, 40#60
Capsules, Tablets, Premix
DMF in CTD Format