Home Products Omeprazole Enteric Coated Pellets EC Enteric coated Commercial manufacture Open Part DMF in preparation
Omeprazole Enteric Coated Pellets Active ingredient Omeprazole
Gastro-resistant enteric coated pellets formulated for hard gelatin capsule filling. Features a protective sub-coat barrier and enteric polymer membrane designed to protect the acid-labile active substance in gastric fluid and release it in intestinal conditions.
Supply form: semi-finished, ready-to-fill pellets. Not for direct patient dispensing.
Formulation and monograph
Potency / drug load 7.5% w/w
Validated strengths 7.5% w/w, 6.9% w/w (dev), 7.0% w/w (dev), 8.5% w/w (dev), 10.0% w/w (dev), 12.0% w/w (dev), 15.0% w/w (dev), 20.0% w/w (dev), 22.5% w/w (dev)
Pharmacopoeia IP / USP / BP monograph
Starter core Neutral Sugar Spheres
Film coating Protective Sub-Coat + Enteric Polymer Membrane
Appearance Off-white to pale cream spherical pellets
Therapeutic category Anti-Ulcer Dissolution and release Gastro-resistant release compliant with IP/USP/BP enteric dissolution monograph criteria.
Validated on USP Apparatus 1 (basket) or Apparatus 2 (paddle) using automated eight-bowl dissolution suites.
Packaging and storage Primary moisture barrier: double virgin polyethylene liners, heat-sealed, with pharmaceutical-grade silica gel desiccants. Secondary pack: tamper-evident HDPE drums suitable for domestic transport or export freight. Store protected from direct sunlight and humidity, at the temperature specified by the active-substance monograph. Release physics
Enteric Coated / Delayed Release Pellets (EC) An alkaline sub-coating is applied over the active drug layer to prevent chemical interaction between acid-labile molecules (such as benzimidazole PPIs) and functional polymers. Subsequently, a calibrated functional layer of pH-dependent enteric polymers is uniformly applied in a Fluid Bed Coater.
Technology notes Manufactured in dedicated 200 kg, 300 kg or 500 kg fluid bed coaters with Wurster bottom-spray inserts and recirculating cleanroom air handling.
Review the coating suites 