Description

Metformin Hydrochloride and Glimepiride SR Tablets

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 Metformin Hydrochloride and Glimepiride SR Tablets in India. This is a synergistic Anti-Diabetic Combination designed for the management of Type 2 Diabetes Mellitus. It combines the insulin-sensitizing action of Metformin (Sustained Release) with the insulin-releasing capability of Glimepiride.

We offer Contract Manufacturing (Third Party) services for this complex Bilayer Tablet. The formulation technology ensures that Metformin is released slowly over 24 hours (reducing gastrointestinal irritation), while Glimepiride is released immediately to manage post-prandial glucose spikes. Healthy Inc manages the export logistics, supplying this essential chronic care medication to pharmacy chains and government tenders across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Producing a stable bilayer tablet requires advanced machinery.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Bilayer Compression: We use specialized double-rotary presses to compress two distinct layers.

    • Layer 1 (Metformin SR): Formulated with Hydrophilic Matrix polymers (HPMC) to sustain drug release.

    • Layer 2 (Glimepiride IR): Formulated for immediate disintegration.

  • Content Uniformity: Glimepiride is potent in small doses (1-2mg). We use Geometric Mixing and high-shear granulation to ensure it is evenly distributed, preventing “hot spots” that could cause hypoglycemia.

  • Moisture Control: Both APIs are sensitive. We manufacture in Dehumidified Suites (< 30% RH) to prevent degradation.

• The Exporter: Healthy Inc

  • Packaging: We strongly recommend Alu-Alu Cold Form Blisters for this product. This provides the necessary barrier against tropical humidity and light, ensuring the Glimepiride remains stable for the full shelf life.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution Profiling: We perform Dual-Release Testing.

  • Glimepiride: Must release >85% in 15 minutes.

  • Metformin: Must follow a specific curve (e.g., <30% in 1 hr, >85% in 10 hrs) to ensure 24-hour coverage.

• Assay: We confirm the precise content of both actives (90-110%).

• Related Substances: We strictly monitor for Cyanoguanidine (Metformin impurity) and Glimepiride sulfonamide impurities.

5. Why Use Metformin SR + Glimepiride?

It provides comprehensive blood sugar control.

• Mechanism:

  • Metformin: Reduces glucose production in the liver and improves insulin sensitivity.

  • Glimepiride: Stimulates the pancreas to release more insulin.

• Key Indications:

  • Type 2 Diabetes: For patients uncontrolled on Metformin alone.

• Advantages: The SR formulation reduces gastrointestinal side effects (nausea, diarrhea) common with plain Metformin and allows for convenient Once-Daily Dosing.

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 Metformin Glimepiride SR Tablets?

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

• Q: Can I break the tablet?

  A: No. Breaking or crushing the tablet destroys the “Sustained Release” matrix, which can cause all the Metformin to be released at once, leading to stomach upset or lactic acidosis.

• Q: Does this cause weight gain?

  A: Glimepiride can cause mild weight gain, but Metformin helps counteract this by promoting weight neutrality or loss.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet daily, usually taken with breakfast.

• Titration: Dosage is adjusted based on HbA1c levels.

• Administration: Swallow whole with water.

9. Side Effects and Precautions

• Hypoglycemia: Because it contains Glimepiride, low blood sugar can occur if meals are skipped.

• Gastrointestinal: Nausea, vomiting, diarrhea (usually transient).

• Lactic Acidosis: Rare but serious risk associated with Metformin accumulation; avoid in renal failure.

• Contraindications: Diabetic Ketoacidosis, Severe Renal/Hepatic Impairment.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.