In the pharmaceutical industry, Allopurinol is a xanthine oxidase inhibitor used as the gold standard for long-term management of hyperuricemia and gout.As a pharmacist and manufacturer, I can clarify that while Allopurinol is not strictly required to be taken at night by its molecular design, there are several pharmacokinetic and clinical reasons why a nighttime (PM) dose is often preferred.
Clinical Reasons for Nighttime Dosing
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Managing Drowsiness: One of the common, yet often overlooked, side effects of Allopurinol is drowsiness or somnolence. Taking it at night allows the patient to sleep through this effect, improving daily productivity.
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Gastrointestinal (GI) Tolerance: Allopurinol can cause gastric irritation. Taking it after a large dinner or right before bed (with a full glass of water) helps minimize the risk of nausea and stomach upset.
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Diurnal Uric Acid Variation: Uric acid levels in the blood tend to fluctuate throughout the 24-hour cycle. Some studies suggest that overnight inhibition of xanthine oxidase aligns better with the body’s natural rhythm of uric acid production and excretion.
Mechanism of Action: Uric Acid Reduction
Allopurinol blocks the production of uric acid at the source.
Enzyme Inhibition: Allopurinol and its active metabolite, Oxypurinol, inhibit the enzyme Xanthine Oxidase.
Stopping the Conversion: This enzyme is responsible for converting hypoxanthine to xanthine, and xanthine into Uric Acid.
Solubility Advantage: By blocking this path, the body keeps purines in the form of hypoxanthine and xanthine, which are more water-soluble and easier for the kidneys to flush out than uric acid.The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your WHO-GMP facility in Mumbai, Allopurinol is a high-volume “Chronic Care” asset:
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The 100 mg vs. 300 mg Strategy: Most patients start at 100 mg and titrate up to 300 mg. For your digital platform, offering both strengths in scored tablet form is a major USP, as it allows doctors to customize the dose easily.
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Hydration Guidance: As a pharmacist, your product literature must emphasize that patients should drink 2–3 liters of water daily. This prevents the formation of xanthine stones in the kidneys—a critical technical detail for B2B buyers.
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Stability & Packaging: Allopurinol is relatively stable but sensitive to high humidity. At our facility, we utilize Alu-Alu blister packaging to ensure a 36-month shelf life, which is essential for export to tropical Zone IVb regions.
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Dossier Readiness: Since gout is a growing global health concern, we provide full CTD/eCTD Dossiers to support your firm in registering this product for international insurance and government reimbursement programs.