Description
Acetazolamide Tablets
Therapeutic Uses, Composition, Manufacturing, and Safety Guidelines
1. Introduction
Acetazolamide Tablets are a cornerstone medication in modern healthcare, widely recognized for their ability to manage glaucoma, epilepsy, altitude sickness, and certain edematous conditions. As a carbonic anhydrase inhibitor, Acetazolamide plays a vital role in balancing fluid and electrolyte dynamics in the body.
Healthy Life Pharma Pvt. Ltd., a WHO–GMP certified pharmaceutical manufacturer in India, ensures global supply of Acetazolamide Tablets formulated in compliance with IP, BP, and USP standards.
2. Therapeutic Importance
Acetazolamide Tablets offer a multifaceted therapeutic profile across several indications:
Ophthalmology: Reduces intraocular pressure in chronic open-angle and secondary glaucoma.
Neurology: Acts as an adjunct therapy in epilepsy management due to its stabilizing effect on neuronal activity.
Nephrology: Aids in diuretic therapy by promoting bicarbonate excretion, thereby managing metabolic alkalosis and edema associated with heart failure.
Pulmonology and Sports Medicine: Prevents acute mountain sickness (altitude sickness) by enhancing respiratory drive and oxygenation.
For patients, Acetazolamide offers a clinically proven, cost-effective, and globally trusted therapy backed by decades of safety and pharmacovigilance data.
3. Scientific Insight
Pharmacologically, Acetazolamide is a nonbacteriostatic sulfonamide derivative that reversibly inhibits carbonic anhydrase, an enzyme critical for bicarbonate reabsorption in renal tubules and the ciliary body of the eye.
Mechanism of Action: Inhibition of carbonic anhydrase decreases hydrogen ion secretion, reducing sodium reabsorption and increasing diuresis.
Pharmacokinetics:
Absorption: Rapid oral absorption with 90–100% bioavailability.
Distribution: Extensively bound to plasma proteins (~90%).
Metabolism: Minimal hepatic metabolism.
Excretion: Primarily excreted unchanged via the kidneys.
Half-life: Approximately 10–15 hours.
This scientific basis underpins the broad clinical applications of Acetazolamide Tablets.
4. Manufacturing Perspective
At Healthy Life Pharma Pvt. Ltd., manufacturing follows GMP and GLP standards, ensuring purity, potency, and consistency.
Formulation: Acetazolamide blended with excipients such as microcrystalline cellulose, maize starch, and magnesium stearate for uniform compressibility.
Process: Granulation, drying, compression, and film-coating performed under HEPA-filtered environments with in-process quality checks.
Batch Traceability: Maintained through validated ERP systems and compliance with Schedule M of Drugs and Cosmetics Act (India).
Every batch undergoes microbiological testing and dissolution profiling to meet pharmacopoeial specifications.
5. Quality & Regulatory Standards
Quality compliance adheres to Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopoeia (USP) standards.
Each production site operates under WHO-GMP certification and ISO 9001:2015 quality management protocols.
Analytical control follows:
Identification tests: Infrared absorption and chromatographic profiling.
Assay: Titrimetric or HPLC-based quantification.
Uniformity: Weight and content uniformity as per IP.
Dissolution: 80% drug release in 45 minutes (USP standard).
Regulatory documentation includes CTD modules, COA, COPP, and stability data, ensuring international market readiness.
6. Analytical & Laboratory Aspect
Analytical evaluation of Acetazolamide Tablets involves precision-based laboratory techniques:
Identity confirmation: FTIR and UV spectrophotometry.
Assay: Quantification via high-performance liquid chromatography (HPLC).
Impurity profiling: Carried out through gas chromatography or LC-MS to detect degradation products.
Microbial testing: Ensures absence of pathogenic contamination.
Laboratories maintain 21 CFR Part 11–compliant data integrity systems, supporting regulatory audits.
7. Safety & Pharmacovigilance
Safety oversight for Acetazolamide Tablets is extensive:
Contraindications: Hypersensitivity to sulfonamides, hepatic impairment, or severe renal dysfunction.
Adverse Effects: Paresthesia, drowsiness, fatigue, mild metabolic acidosis, and hypokalemia.
Drug Interactions: Enhanced effects with salicylates or other diuretics; contraindicated with high-dose aspirin therapy.
Monitoring: Regular electrolyte and renal function tests recommended during long-term therapy.
Pharmacovigilance units within Healthy Life Pharma track post-marketing surveillance data globally to maintain product safety integrity.
8. Market & Trade View
Global Market Demand:
Acetazolamide Tablets are in steady demand across Asia, Africa, and Europe due to expanding ophthalmic and neurology segments.
Export Documentation Includes:
Certificate of Pharmaceutical Product (COPP)
WHO-GMP Certificate
Stability Data (Zone IV)
Free Sale Certificate
COA & MSDS
Regulatory Markets Supplied:
Latin America
ASEAN & GCC regions
African & CIS countries
Competitive pricing and adherence to international documentation standards strengthen India’s export advantage.
9. Innovation & Research
Recent research focuses on sustained-release Acetazolamide formulations, ophthalmic nano-dispersions, and combination therapies with loop diuretics.
AI-driven formulation modeling and continuous manufacturing systems (QbD-based) are revolutionizing production control and predictability.
Healthy Life Pharma’s R&D division contributes to developing patient-friendly dosage forms with enhanced bioavailability and minimal side effects.
10. Educational & Ethical View
Acetazolamide Tablets symbolize ethical manufacturing and healthcare education synergy.
Healthy Life Pharma promotes pharmaceutical literacy, advocating safe drug usage and accessibility.
The company follows an ethical manufacturing philosophy, ensuring sustainable sourcing and zero environmental discharge in compliance with ISO 14001.
11. Conclusion
Acetazolamide Tablets represent a fine balance between clinical efficacy, safety, and accessibility. Through WHO-GMP–certified facilities, globally harmonized regulatory compliance, and robust R&D initiatives, Healthy Life Pharma Pvt. Ltd. stands as a trusted manufacturer and exporter in the global pharmaceutical ecosystem.
FAQ Section (Rich Snippet Ready)
Q1. What are Acetazolamide Tablets used for?
They are used to treat glaucoma, epilepsy, altitude sickness, and certain types of edema.
Q2. Are Acetazolamide Tablets WHO-GMP certified?
Yes, manufactured under WHO-GMP and ISO 9001:2015 standards.
Q3. Can Acetazolamide be taken daily?
Only under medical supervision. Dosage depends on the indication and patient’s renal function.
Q4. What is the strength of Acetazolamide Tablets available?
Commonly available in 250 mg and 500 mg strengths.
Q5. Who is a trusted Acetazolamide Tablets manufacturer in India?
Healthy Life Pharma Pvt. Ltd., a WHO-GMP certified company exporting globally.
