SRSustained releaseCommercial manufactureOpen Part DMF in preparation
Domperidone Sustained Release Pellets
Active ingredient Domperidone
Sustained-release multiparticulates coated with a functional diffusion membrane to achieve extended drug release across gastrointestinal transit.
Supply form: semi-finished, ready-to-fill pellets. Not for direct patient dispensing.
Formulation and monograph
- Potency / drug load
- 30.0% w/w
- Validated strengths
- 30.0% w/w, 22.0% w/w (dev), 28.0% w/w (dev)
- Pharmacopoeia
- IP / USP / BP monograph
- Starter core
- Neutral Starter Core
- Film coating
- Polymeric Diffusion Barrier Membrane
- Appearance
- White to creamy-white spherical pellets
- Therapeutic category
- Anti-Emetic / Prokinetic
Dissolution and release
Extended release compliant with IP/USP/BP sustained-release dissolution specifications.
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.
