Diclofenac Sodium EC Pellets Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Diclofenac Sodium EC Pellets (CAS No: 15307-79-6)
Pharmaceutical-Grade Enteric Coated Pellets for Oral Dosage Forms

Diclofenac Sodium EC Pellets are pharmaceutical-grade enteric-coated multiparticulate pellets containing Diclofenac Sodium, formulated to resist dissolution in gastric acid and release the drug in the intestinal environment. This enteric-coating approach is used to reduce direct gastric mucosal exposure to the drug and support gastro-resistant oral dosage forms. Diclofenac Sodium has the molecular formula C₁₄H₁₀Cl₂NNaO₂ and a molecular weight of approximately 318.1 g/mol (source: PubChem).

Enteric-coated Diclofenac Sodium pellets are typically produced by layering the drug onto an inert or drug-crystal core, followed by application of a pH-dependent enteric polymer coat, with the coating level and polymer system determined by the target gastro-resistance and dissolution profile.

Key Features

  • Diclofenac Sodium enteric-coated (gastro-resistant) multiparticulate formulation
  • Resists drug release in acidic (gastric) media as per applicable pharmacopeial gastro-resistance test
  • Suitable for pharmaceutical capsule filling and oral dosage-form development
  • Flexible formulation platform for defined drug loading and coating level
  • Product-specific pellet size, drug loading and release characteristics
  • Appropriate for bulk pharmaceutical formulation applications

Applications

  • Hard gelatin capsule filling for enteric/gastro-resistant oral dosage forms
  • Multiparticulate oral dosage-form manufacturing
  • Gastro-resistant formulations for musculoskeletal pain and inflammatory conditions
  • Pharmaceutical formulation development
  • Drug-loaded pellet applications
  • Bulk pharmaceutical pellet supply

Why Choose Diclofenac Sodium EC Pellets?

  • Enteric-coated multiparticulate platform for Diclofenac Sodium
  • Designed to meet gastro-resistance formulation requirements
  • Suitable for capsule-based multiparticulate dosage forms
  • Flexible drug loading and coating-level options, subject to product specification
  • Quality evaluation can include identification, assay/drug content, related substances, moisture, gastro-resistance and dissolution testing
  • Available formulation characteristics can be established according to customer and product requirements

Packaging & Supply
Diclofenac Sodium EC Pellets can be supplied in suitable pharmaceutical packaging for formulation development and bulk manufacturing applications. Packaging configuration, drug loading, coating level, and storage requirements should be confirmed according to the applicable product specification and customer requirements.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 1.0%
Heavy Metals NMT 10 ppm
Individual Impurity NMT 0.2%
Total Impurities NMT 0.5%
Water Content NMT 2.0%
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