Diclofenac Potassium EC Pellets are pharmaceutical drug-loaded pellets containing diclofenac potassium and designed with an enteric-coating system for applications where protection of the drug from the acidic gastric environment and release at a higher intestinal pH are required. Diclofenac potassium is the potassium salt of diclofenac and is classified as a non-steroidal anti-inflammatory drug (NSAID). Its chemical identity is established as potassium 2-[2-(2,6-dichloroanilino)phenyl]acetate.
Pellet-based dosage forms provide a multiparticulate approach in which numerous small units can be incorporated into pharmaceutical dosage forms such as capsules or other suitable oral solid dosage systems. Commercial pharmaceutical-pellet manufacturers currently list Diclofenac Potassium EC Pellets alongside sustained-release and other modified-release pellet technologies. Public product catalogues show commercially offered Diclofenac Potassium EC Pellets in strengths including 30%, 33%, 40% and 50%, although the available strength depends on the individual manufacturer and product specification.
Enteric-coated pellets are designed with a functional coating system that provides resistance to the acidic stage of the gastrointestinal environment and allows drug release under the conditions specified for the formulation. The exact coating composition, coating weight gain, dissolution profile and release conditions are product-specific and should be established through the approved product specification and validated testing.
Diclofenac Potassium EC Pellets can be used as an intermediate pharmaceutical material for the development of multiparticulate oral dosage forms. Pellet systems can provide formulation flexibility because the individual units can be combined into capsules or other dosage forms and can be engineered using different coating and release technologies.
Diclofenac potassium has the molecular formula C14H10Cl2KNO2 and molecular weight approximately 334.24 g/mol. Its CAS Registry Number is 15307-81-0. PubChem and the FDA Substance Registration System identify 15307-81-0 as the CAS number for diclofenac potassium; 15307-86-5 is the related CAS for the parent diclofenac compound, not the potassium salt.
Diclofenac potassium is recognized in the USP as a compendial substance. The USP monograph defines diclofenac potassium as containing 99.0%–101.0% of diclofenac potassium on the dried basis for the API substance. This API assay should not be confused with the drug-loading percentage of a finished pellet product.
The "EC" designation refers to Enteric Coated. In pharmaceutical pellet manufacturing, an enteric coating is applied to the drug-loaded pellet to modify its release behavior.
Important technical parameters for an enteric-coated pellet product can include:
The actual acceptance criteria should be established according to the approved product specification and intended finished dosage form.
Diclofenac Potassium EC Pellets are suitable for consideration in multiparticulate drug-delivery development where an enteric-coated diclofenac potassium pellet system is required. Pharmaceutical pellet manufacturers commonly describe pellets as small multiparticulate units used for modified-release and controlled-release dosage forms and for incorporation into capsules, tablets and other oral dosage forms.
The multiparticulate approach can provide flexibility in formulation design because multiple pellets are administered as a population of individual units rather than as one single matrix. The final release characteristics depend on pellet composition, drug loading, coating system, coating level and finished dosage-form design.
Potential applications include:
The suitability of a particular grade should always be evaluated against the intended formulation, regulatory requirements and approved technical specification.
Quality control for Diclofenac Potassium EC Pellets should address both the diclofenac potassium drug component and the finished pellet system.
Relevant quality attributes may include identification, assay/drug loading, related substances, moisture, particle-size distribution, pellet morphology, friability, bulk density and dissolution performance.
For an enteric-coated product, dissolution testing is particularly important because the coating is intended to provide a defined release behavior. The exact acid-stage and buffer-stage acceptance criteria should not be copied from another manufacturer's specification; they should correspond to the validated SDP product specification.
Diclofenac Potassium EC Pellets are commercially listed by multiple Indian pharmaceutical-pellet manufacturers. Public catalogues from Pel Pharma India, Salius Pharma, SM Pharma, Gliesse Pharmaceuticals and Pelltech Healthcare list Diclofenac Potassium EC Pellets, demonstrating established commercial terminology for this product category.
Swapnroop Drugs and Pharmaceuticals can position this product within its pharmaceutical pellets and granules portfolio, with the page targeting pharmaceutical formulation developers, manufacturers and B2B buyers searching for Diclofenac Potassium EC Pellets in India.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| pH (1% Solution) | 7.0–8.5 |
| Individual Impurity | NMT 0.1% |
| Total Impurities | NMT 0.3% |