Home Products Rosuvastatin Immediate Release Pellets IR Immediate release Commercial manufacture
Rosuvastatin Immediate Release Pellets Active ingredient Rosuvastatin
Immediate-release pellets containing Rosuvastatin, layered with protective coatings to maintain active substance stability and batch content uniformity.
Supply form: semi-finished, ready-to-fill pellets. Not for direct patient dispensing.
Formulation and monograph
Potency / drug load 10.0% & 7.5% w/w
Validated strengths 10.0% w/w, 7.5% w/w, 3.75% w/w (dev), 15.0% w/w (dev), 20.0% w/w (dev)
Pharmacopoeia IP monograph
Starter core Neutral Core Beads
Film coating Active Drug Layer + Protective Top-Seal
Appearance Uniform off-white spherical pellets
Therapeutic category Cardiovascular (Lipid-Lowering) Dissolution and release Immediate release compliant with IP 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. Release physics
Immediate Release Pellets (IR) Active pharmaceutical ingredients are layered as a micronized or solubilized solid dispersion onto neutral starter cores using hydrophilic binders. A thin water-soluble protective seal minimizes friability while allowing dissolution medium to instantly wet and solubilize the active matrix.
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 