IRImmediate releaseCommercial manufacture
Atorvastatin Immediate Release Pellets
Active ingredient Atorvastatin
Immediate-release pellets containing Atorvastatin, formulated with protective barrier coating for capsule filling.
Supply form: semi-finished, ready-to-fill pellets. Not for direct patient dispensing.
Formulation and monograph
- Potency / drug load
- 10.0% w/w
- Validated strengths
- 10.0% w/w
- Pharmacopoeia
- IP / USP / BP monograph
- Starter core
- Neutral Sugar Spheres
- Film coating
- Active Drug Layer + Protective Coating
- Appearance
- White to off-white spherical pellets
- Therapeutic category
- Cardiovascular (Lipid-Lowering)
Dissolution and release
Immediate release compliant with IP/USP/BP dissolution 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.
