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Precision Engineering: Unveiling the Superiority of Atorvastatin 40 mg Film-Coated Tablets
- Mastered by Walter Healthcare
Strategic Product Overview
Product Name: Atorvastatin 40 mg Film-Coated Tablets
Generic Name: Atorvastatin Calcium Trihydrate (equivalent to Atorvastatin)
Strength: 40 mg
Dosage Form: Film-Coated Tablet
Pharmacological Class: HMG-CoA Reductase Inhibitor (Statin)
Therapeutic Indication: Adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for treatment of primary dysbetalipoproteinemia or hypertriglyceridemia. Adjunct to diet to reduce LDL-C in Primary hyperlipidemia, Heterozygous familial hypercholesterolemia (HeFH)
Market Relevance: A cornerstone in cardiovascular therapy, demanding uncompromising quality and consistent efficacy due to long-term patient use.
Solid Dispersions: Enhances dissolution rate by dispersing the drug in a hydrophilic polymer matrix (amorphous form). Examples: Atorvastatin solid dispersions with polyvinylpyrrolidone (PVP) or poloxamers have shown improved solubility. Spray-dried dispersions with HPMC (hydroxypropyl methylcellulose) have been studied.
Salt Formation: Increases solubility by forming a more water-soluble ionic form. Examples:Atorvastatin calcium (the most common commercial form, used in Lipitor® and generics). Atorvastatin magnesium (also used in some formulations). Effect: While salts improve solubility compared to the free acid form, further enhancements (e.g., solid dispersions) are still needed for optimal bioavailability.
Physicochemical Mastery: The Walter Healthcare Standard
API Characterization: Safe and efficacious
Source & Qualification: WHO-GMP approved API vendors for Atorvastatin Calcium. Our rigorous multi-point qualification process includes comprehensive impurity profiling (LC-MS/MS), residual solvent analysis (GC-MS), heavy metal screening (ICP-MS), and crucial polymorphic form identification (XRD, DSC, FTIR) for every incoming batch. This guarantees purity exceeding 99.8%.
Polymorphic Form & Crystallinity (Critical for Bioavailability & Stability):
· Precisely control Atorvastatin's polymorphic form (Form I) and crystallinity, verified through X-Ray Diffraction (XRD), Differential Scanning Calorimetry (DSC), and Fourier-Transform Infrared (FTIR) spectroscopy. This prevents conversion to less stable or bioavailable forms.
· Unlike generic suppliers with variable forms, our strict polymorphic control eliminates stability issues, ensures batch-to-batch consistency in dissolution, and safeguards against unexpected bioavailability changes, which are common challenges for Atorvastatin.