In the pharmaceutical industry, Prednisolone 5 mg is a synthetic Glucocorticoid and a derivative of cortisol. As a pharmacist and manufacturer, I view the 5 mg strength as the “titration gold standard.” It is the most versatile dose for long-term maintenance therapy, allowing clinicians to taper patients down to the lowest effective dose to minimize side effects.
Primary Clinical Uses
Prednisolone is a systemic anti-inflammatory and immunosuppressant used across almost every medical specialty:
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Allergic Conditions: Management of severe asthma, drug hypersensitivity reactions, and serum sickness.
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Dermatological Diseases: Treatment of severe Psoriasis, Pemphigus, and exfoliative dermatitis.
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Rheumatic Disorders: Used as adjunctive therapy for short-term administration in Rheumatoid Arthritis, Gouty Arthritis, and Ankylosing Spondylitis.
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Autoimmune Disorders: Management of Systemic Lupus Erythematosus (SLE) and acute exacerbations of Multiple Sclerosis.
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Endocrine Disorders: Primary or secondary adrenocortical insufficiency (Addison’s disease).
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Ophthalmology: Control of severe acute and chronic allergic and inflammatory processes involving the eye.
Mechanism of Action: Genomic Modulation
Prednisolone works by entering the cell nucleus and altering gene expression.
Cytoplasmic Binding: Prednisolone diffuses across cell membranes and binds to specific Glucocorticoid Receptors (GR).
Translocation: The drug-receptor complex moves into the cell nucleus.
Inhibition of Inflammatory Mediators: It inhibits the transcription of genes that code for pro-inflammatory cytokines (like IL-1, IL-6, and TNF-alpha).
Annexin-1 Production: It stimulates the synthesis of lipocortin-1 (Annexin-1), which inhibits phospholipase A2—the enzyme responsible for releasing arachidonic acid (the precursor to prostaglandins and leukotrienes).
The Manufacturer’s Perspective: Formulation & Export
From a production and global trade standpoint at your WHO-GMP facility in Mumbai, Prednisolone 5 mg involves specific technical considerations:
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The “Tapering” USP: On your digital platforms, you should highlight that your 5 mg tablets are cross-scored (quadrisected). This is a major selling point for B2B clients because it allows patients to accurately take 1.25 mg or 2.5 mg doses during the critical “tapering off” phase to avoid adrenal crisis.
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Stability and Photosensitivity: Prednisolone is sensitive to light. At our facility, we utilize Alu-Alu or Amber-colored PVC/PVDC blisters to ensure a 36-month shelf life, especially for export to Zone IVb regions where high UV index and humidity are factors.
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Bioavailability: As a BCS Class I drug (high solubility, high permeability), the 5 mg tablet must meet strict dissolution profiles. Our Mumbai facility ensures that >80% of the API is released within 30 minutes to ensure rapid clinical onset.
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Dossier Support: This is a core “Essential Medicine.” We provide full CTD/eCTD Dossiers to support international registration and participation in government and NGO tenders.