Mesalamine SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets containing Mesalamine (5-Aminosalicylic Acid / 5-ASA) as the active ingredient. Mesalamine has CAS Number 89-57-6, molecular formula C₇H₇NO₃, and molecular weight 153.14 g/mol. The active ingredient is incorporated into a pellet system designed to provide a controlled release profile over an extended period.
Sustained-release Mesalamine pellets can be developed using suitable matrix or polymer-coating technologies to regulate the release of the active ingredient. The multiparticulate format provides flexibility for capsule-filling and other oral dosage-form applications. Published formulation research has demonstrated highly loaded Mesalamine pellets with polymer-controlled extended release, showing that pellet coating and formulation composition have a major influence on release characteristics.
Commercially available Mesalamine SR pellet products are reported in different active loadings. A pharmaceutical pellet manufacturer lists 70%, 80% and 90% w/w Mesalamine SR Pellets, while another manufacturer reports 75% and 90%. These are commercial reference strengths and should not automatically be treated as SDP-approved strengths unless confirmed against the current SDP product specification.
Mesalamine SR Pellets can be used as a formulation intermediate for sustained-release oral multiparticulate products. The final release profile, active loading, pellet size, coating level and other critical quality attributes should be controlled according to the approved product specification.
Sustained-Release Oral Formulations
Mesalamine SR Pellets are designed for formulations requiring an extended release profile of Mesalamine.
Capsule Filling
The multiparticulate format is suitable for incorporation into capsule dosage forms, subject to the final formulation design.
Multiparticulate Formulation Development
Individual pellets can be engineered with controlled release characteristics to achieve the required dissolution profile.
Pharmaceutical Manufacturing
Mesalamine SR Pellets can be supplied as a formulation intermediate for pharmaceutical manufacturers developing sustained-release oral products.
Bulk Supply
The product can be supplied for bulk formulation requirements with active loading and quality parameters defined according to the applicable specification.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Water Content | NMT 1.0% |