What is Rosuvastatin 10mg used for?
In the pharmaceutical industry, Rosuvastatin 10 mg is a potent, synthetic HMG-CoA reductase inhibitor, commonly referred to as a “statin.” As a pharmacist and manufacturer, I classify Rosuvastatin as a “High-Intensity Statin.” Even at this relatively low 10 mg dose, it is significantly more effective at lowering LDL (bad) cholesterol than older statins like Simvastatin or Atorvastatin at comparable doses.
Primary Clinical Uses
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Hyperlipidemia: To reduce elevated Total-C, LDL-C, and Triglycerides, while increasing HDL-C (good cholesterol).
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Primary Prevention of Cardiovascular Disease: Prescribed to patients with no clinically evident heart disease but with an increased risk (based on age, hypertension, or smoking history) to prevent strokes and myocardial infarctions.
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Atherosclerosis Management: To slow the progression of plaque buildup in the arterial walls.
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Homozygous Familial Hypercholesterolemia: Used as an adjunct to other lipid-lowering treatments in patients with genetic high cholesterol.
Mechanism of Action: Cholesterol Synthesis Inhibition
Rosuvastatin works primarily in the liver, where the majority of the body’s cholesterol is produced.
Enzyme Inhibition: It competitively inhibits the enzyme HMG-CoA reductase. This enzyme is the “rate-limiting” step in the mevalonate pathway—the chemical process that creates cholesterol.
Upregulation of LDL Receptors: By reducing the internal production of cholesterol, the liver senses a “shortage.” It responds by increasing the number of LDL receptors on the surface of liver cells.
Blood Clearance: These extra receptors “grab” LDL particles from the bloodstream and pull them into the liver for processing, thereby lowering circulating cholesterol levels.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your WHO-GMP facility in Mumbai, Rosuvastatin 10 mg is a high-demand “lifestyle drug”:
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BCS Class II Challenges: Rosuvastatin has low solubility and high permeability. At our facility, we utilize specialized micronization of the API to ensure the 10 mg tablet meets strict BP/USP/IP dissolution and bioavailability profiles.
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The “Starting Dose” USP: For your digital platform, 10 mg should be marketed as the standard starting dose for most adults. It offers the best balance between efficacy and minimizing the risk of myalgia (muscle pain), a common concern for B2B buyers.
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Stability & Packaging: Rosuvastatin is sensitive to moisture and light. We utilize Alu-Alu blister packaging to ensure a 36-month shelf life, which is essential for export to Zone IVb regions where high humidity is a factor.
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Dossier Support: This is a top-tier molecule for chronic care. We provide full CTD/eCTD Dossiers to support your firm in registering this against the innovator (Crestor).