Description
Glibenclamide & Metformin Hydrochloride SR Tablets
Healthy Inc is a specialized global supplier of complex metabolic therapies. We provide premium Glibenclamide & Metformin Hydrochloride Sustained Release (SR) Tablets, manufactured in WHO–GMP certified facilities. This combination is a cornerstone for 24-hour glycemic management, serving as a vital export for endocrinology hospitals, diabetes care centers, and government health tenders in Southeast Asia, Africa, and LATAM.
Product Overview
This Fixed-Dose Combination (FDC) utilizes two distinct mechanisms of action to address insulin deficiency and insulin resistance simultaneously, with the added benefit of a sustained-release matrix for the Metformin component.
The “Round-the-Clock” Metabolic Specialist:
- Glibenclamide (Glyburide): A potent second-generation sulfonylurea that stimulates the pancreatic beta cells to secrete insulin. It acts by closing ATP-sensitive potassium channels, leading to cell depolarization and calcium-mediated insulin release.
- Metformin Hydrochloride SR (Sustained Release): A biguanide that reduces hepatic glucose output and improves peripheral insulin sensitivity. The SR (Sustained Release) technology ensures a slow, steady release into the gastrointestinal tract, significantly reducing the “gastric distress” (nausea and cramping) associated with immediate-release Metformin.
- Synergistic Efficacy: By combining a secretagogue with a sensitizer, this FDC provides comprehensive coverage for both fasting plasma glucose (FPG) and post-prandial glucose (PPG) levels.
Technical & Manufacturing Specifications
Engineered for precise biphasic release and molecular stability.
| Technical Metric | Specification Standard |
|---|---|
| Active Composition | Glibenclamide (2.5mg/5mg) + Metformin HCl SR (500mg) |
| Dosage Form | Bilayered or Matrix-based Sustained Release Tablet |
| Metformin Release Profile | Gradual release over 10–12 hours |
| HS Code | 3004.90.99 (Anti-Diabetic Medicaments) |
| Packaging | Alu-Alu Blister (Mandatory to prevent Metformin hydration) |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.
- Bilayer Tableting: We utilize advanced bilayer technology where Glibenclamide is in an immediate-release layer for rapid onset, while Metformin is embedded in a hydrophilic polymer matrix (such as HPMC) for controlled, sustained delivery.
- Uniformity of Low-Dose API: Glibenclamide is a high-potency drug at low doses. We ensure 100% content uniformity through micronization and validated blending to avoid the risk of accidental hypoglycemia.
- Dissolution Integrity: Our SR tablets undergo rigorous 12-hour dissolution testing to ensure they meet the USP/BP release specifications, preventing “dose dumping.”
Therapeutic Indications & Clinical Symptoms
- Type 2 Diabetes Mellitus: Management of hyperglycemia in patients not controlled by diet, exercise, or monotherapy.
- Symptom Management: Effective in reducing polyuria, polydipsia, and unexplained weight loss associated with poorly controlled diabetes.
- HbA1c Reduction: Indicated for patients requiring a significant drop in long-term blood sugar markers.
Dosage & Administration
- Administration: Typically taken once daily with the evening meal to maximize the benefit of the sustained-release Metformin and to cover nighttime hepatic glucose production.
- Titration: Dosage should be individualized based on blood glucose monitoring.
- Contraindications: Not for Type 1 Diabetes or patients with significant renal impairment (CrCl < 30 mL/min).
Global Export & Contract Manufacturing Services
Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Institutional Tenders and B2B Pharma Marketplaces. We offer Third Party Manufacturing for Glibenclamide & Metformin SR with full CTD Dossier support. Our logistics team ensures moisture-protected transit for all metabolic exports to Vietnam, Philippines, Nigeria, and LATAM markets.
Commercial Inquiries
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
