Mesalamine SR Pellets / Granules 

Mesalamine is a drug used for treating ulcerative colitis. Although the exact mechanism of mesalamine is not known it is believed to be reducing the inflammation in the colon through systemic action.

  • Mesalamine is an anti-inflammatory agent used to treat ulcerative colitis. Mesalamine comes as a Delayed-release tablet, Delayed-release capsule, Controlled-release capsule, Extended-release capsule, Suppositories.
  • Mesalamine ER Pellets have dissolution time of 8 hours and are released as per the USP Monograph.
  • 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.

 



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Additional information
Percentage

60%, 70%, 90%, 96.38%

Mesh Size

14#20, 16#80

Release Type

Extended Release

Quality Standard

USP43

Documentation Available:

DMF in CTD Format

Forms of PFI

Granules (for Tablets), Pellets/Micro pellets (for capsules)

Target Formulations

Capsules, Suppositories, Tablets

Description

Ulcerative colitis and other inflammatory diseases cause excessive production of bio-chemicals, for example, prostaglandins, that produce inflammation in the colon. Prostaglandins are produced by the enzymes, cyclooxygenase and lipoxygenase. These enzymes are over-active in individuals with ulcerative colitis. Mesalamine may work by blocking the activity of cyclooxygenase and lipoxygenase, thereby, reducing the production of prostaglandins. Reduced production of prostaglandins decreases inflammation in the colon and the symptoms associated with ulcerative colitis. Available forms of mesalamine differ in their route of administration and how often they are administered.

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