IRImmediate releaseCommercial manufactureOpen Part DMF in preparation
Itraconazole Immediate Release Pellets
Active ingredient Itraconazole
Immediate-release pellets of Itraconazole layered onto neutral starter sugar spheres with a protective seal coating for capsule filling.
Supply form: semi-finished, ready-to-fill pellets. Not for direct patient dispensing.
Formulation and monograph
- Potency / drug load
- 22.5% w/w
- Validated strengths
- 22.5% w/w, 20.0% w/w (dev), 30.0% w/w (dev), 32.5% w/w (dev), 35.0% w/w (dev), 40.0% w/w (dev), 44.0% w/w (dev)
- Pharmacopoeia
- IP / USP / BP monograph
- Starter core
- Neutral Sugar Spheres
- Film coating
- Drug Layer + Protective Seal Coat
- Appearance
- Beige to light brown spherical pellets
- Therapeutic category
- Anti-Fungal
Dissolution and release
Immediate release compliant with IP/USP/BP dissolution standards.
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.
