ECEnteric coatedCommercial manufactureOpen Part DMF in preparation
Rabeprazole Sodium Enteric Coated Pellets
Active ingredient Rabeprazole Sodium
Enteric coated pellets engineered with protective barrier sub-coating and enteric polymer layering for capsule formulations.
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, 8.5% w/w (DMF list), 11.5% w/w (dev), 15.0% w/w (dev), 20.0% w/w (dev)
- Pharmacopoeia
- IP / USP monograph
- Starter core
- Neutral Starter Core
- Film coating
- Protective Sub-Coat + Enteric Polymer Barrier
- Appearance
- Light yellow to yellowish-white spherical beads
- Therapeutic category
- Anti-Ulcer
Dissolution and release
Gastro-resistant release compliant with IP/USP 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.
