Description

Glibenclamide and Metformin HCl SR Tablets (2.5mg/500mg / 5mg/500mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Glibenclamide and Metformin HCl SR Tablets in India. This Fixed-Dose Combination (FDC) is a potent anti-diabetic formulation used for the management of Type 2 Diabetes Mellitus. It combines Glibenclamide (a Sulfonylurea) with Metformin Sustained Release (SR) (a Biguanide) to provide dual-action glucose control with improved patient compliance.

We offer Contract Manufacturing (Third Party) for this complex bilayer or matrix formulation. Our WHO-GMP certified facility in Mumbai utilizes advanced polymer technology to ensure the Metformin component releases slowly over 12-24 hours, reducing gastrointestinal side effects. Healthy Inc manages the export logistics, supplying diabetes care programs and distributors across Africa, Southeast Asia, and Latin America.

2. Product Specifications

Parameter	Specification
Product Name	Glibenclamide & Metformin HCl SR Tablets
Generic Name	Glibenclamide & Metformin Hydrochloride Prolonged Release Tablets USP / BP / IP
CAS Number	10238-21-8 (Glibenclamide) / 1115-70-4 (Metformin)
Strength	Glibenclamide 2.5mg + Metformin 500mg SR   Glibenclamide 5mg + Metformin 500mg SR
Dosage Form	Bilayer Tablet / Film Coated Tablet (Sustained Release)
Standard	USP / BP / IP Compliant
Therapeutic Class	Anti-Diabetic / Hypoglycemic
Shelf Life	24 to 36 Months
Packaging	10×10 Blister / 10×15 Blister / Bulk Jar

3. Manufacturing Glibenclamide + Metformin SR

Combining immediate release and sustained release in one tablet requires precision.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  We often use Bilayer Technology or a specialized Hydrophilic Matrix system. The Glibenclamide part is formulated for immediate release to control post-meal spikes, while the Metformin HCl is embedded in a polymer matrix (like HPMC) that swells and releases the drug slowly. This reduces the “dumping” effect that causes stomach upset, a common issue with plain Metformin.

• The Exporter: Healthy Inc

  Healthy Inc ensures global reach. We use high-grade Moisture Barrier Packaging (PVDC or Alu-Alu) because Metformin is hygroscopic (absorbs moisture). We handle all regulatory filings, ensuring the product meets the specific dissolution profiles required by international health authorities.

4. Quality Assurance

We adhere to strict testing protocols for Modified Release tablets:

• Dissolution Profiling: We test the Metformin release at multiple time points (1h, 4h, 8h, 12h) to confirm the sustained release mechanism is working correctly.

• Content Uniformity: We ensure the potent Glibenclamide (milligram dose) is evenly distributed to prevent hypoglycemia risks.

• Impurity Profiling: We strictly monitor for related substances to ensure safety over the shelf life.

5. Why Use Glibenclamide + Metformin SR?

It targets two main causes of high blood sugar.

• Mechanism:

  • Glibenclamide: Stimulates the pancreas to secrete more insulin.

  • Metformin: Reduces glucose production by the liver and improves the body’s sensitivity to insulin.

• Advantages of SR: The “Sustained Release” form of Metformin significantly reduces nausea and diarrhea compared to immediate-release forms, improving long-term adherence.

• Key Indications:

  • Type 2 Diabetes: Treatment of patients whose blood sugar cannot be controlled by diet, exercise, or monotherapy alone.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Glibenclamide Metformin SR Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: What is the benefit of SR (Sustained Release)?

  A: It allows for once or twice daily dosing and minimizes stomach upset.

• Q: Can this cause low blood sugar (Hypoglycemia)?

  A: Yes, because it contains Glibenclamide. Patients should not skip meals.

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CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: Usually one tablet once or twice daily with meals.

• Titration: Dosage should be adjusted gradually based on blood glucose levels.

• Administration: Swallow whole; do not chew or crush the SR tablet.

9. Side Effects and Precautions

• Common Side Effects: Hypoglycemia (low blood sugar), nausea, metallic taste, and diarrhea (less than plain Metformin).

• Lactic Acidosis: Rare but serious risk associated with Metformin accumulation (avoid in severe kidney/liver dysfunction).

• Alcohol: Avoid alcohol as it increases the risk of Lactic Acidosis and Hypoglycemia.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture.