Aspirin EC Pellets are pharmaceutical-grade enteric-coated multiparticulate pellets containing Aspirin (Acetylsalicylic Acid) as the active ingredient. Aspirin has CAS Number 50-78-2, molecular formula C₉H₈O₄, and molecular weight 180.16 g/mol. The current USP monograph defines Aspirin as containing 98.0%–102.0% of C₉H₈O₄, calculated on the dried basis.
The enteric-coated pellet format is designed to provide resistance to acidic conditions and delayed release under suitable intestinal conditions. The formulation can consist of an Aspirin-containing pellet core with a functional enteric coating. Coating composition and coating level determine the acid-resistance and subsequent release characteristics.
Commercial Aspirin EC pellet products are available in different active loadings. Published commercial portfolios document 45% and 65%, while other commercial specifications report 40%, 45%, 60% and 65%.
For the SDP website, only the strength confirmed in the current SDP product specification or COA should be presented as an SDP-available strength.
Aspirin EC Pellets are designed for oral formulations where protection from acidic conditions and delayed release are required.
The multiparticulate format is suitable for incorporation into capsule dosage forms according to the required strength and formulation specification.
Individual enteric-coated pellets provide a flexible platform for development of oral multiparticulate formulations.
Suitable Aspirin EC Pellets can be incorporated into multiparticulate tablet systems when the coating is designed to withstand the selected compression process.
Aspirin EC Pellets can be supplied for pharmaceutical formulation requirements with product-specific loading, particle-size distribution, coating and dissolution parameters.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |