Description

Glimepiride, Pioglitazone and Metformin HCl 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 Triple Fixed-Dose Combination (FDC) Diabetes Tablets in India. This formulation combines three powerful anti-diabetic agents: Glimepiride (Sulfonylurea), Pioglitazone (Thiazolidinedione), and Metformin HCl Sustained Release (Biguanide). This “Triple Therapy” is designed for the management of severe Type 2 Diabetes where dual therapy has failed to control blood sugar levels.

We offer Contract Manufacturing (Third Party) for this chemically complex formulation. Our WHO-GMP certified facility in Mumbai utilizes advanced Trilayer or Bilayer Tablet Technology to ensure the chemical stability of all three active ingredients within a single dosage form. Healthy Inc manages the export logistics, ensuring consistent supply to specialized diabetic care centers and distributors across Southeast Asia, Latin America, and the Middle East.

2. Product Specifications

3. Manufacturing Triple FDC Tablets

Combining three distinct chemical entities requires formulation mastery.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  This is one of the most complex diabetes tablets to manufacture. We use Multi-Layer Compression to physically separate incompatible ingredients if necessary. The Metformin component is formulated as a Hydrophilic Matrix for 24-hour sustained release, while Glimepiride and Pioglitazone are formulated for immediate release. We maintain strict humidity controls (< 25% RH) because Pioglitazone is moisture-sensitive.

• The Exporter: Healthy Inc

  Healthy Inc ensures that the product remains stable during global transit. We exclusively use Alu-Alu Cold Form Blisters for this product to provide the highest barrier against moisture and light. This prevents degradation and ensures the tablet remains effective until the expiry date.

4. Quality Assurance

We adhere to strict testing protocols for Triple FDCs:

• Dissolution Profiling: We simultaneously track the release rates of all three drugs. Metformin must show a slow release curve, while Glimepiride and Pioglitazone must dissolve rapidly.

• Related Substances: We strictly monitor for specific degradation impurities of Pioglitazone and Glimepiride.

• Assay: We ensure precise dosing of the micro-ingredients (1mg/2mg) alongside the bulk ingredient (500mg).

5. Why Use This Triple Combination?

It attacks diabetes from three different angles.

• Mechanism:

  1. Glimepiride: Increases insulin secretion from the pancreas.

  2. Pioglitazone: Reduces insulin resistance in fat and muscle cells (makes the body use insulin better).

  3. Metformin: Reduces glucose production in the liver.

• Key Indications:

  • Uncontrolled Type 2 Diabetes: For patients who have not achieved glycemic targets on dual therapy (Metformin + Glimepiride).

  • Synergy: The combination allows for lower doses of individual components, potentially reducing side effects.

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 this Triple Diabetes Tablet?

  A: Healthy Life Pharma Pvt. Ltd. manufactures it in India using advanced multi-layer technology.

• Q: Why Pioglitazone?

  A: It is excellent for patients with high insulin resistance (often overweight patients).

• Q: Is there a risk of fluid retention?

  A: Yes, Pioglitazone can cause mild edema (swelling), so it is monitored in heart failure patients.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet daily, usually with the first main meal.

• Monitoring: Regular monitoring of Liver Function Tests (LFTs) and blood sugar is recommended.

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

9. Side Effects and Precautions

• Edema: Swelling of legs or ankles (due to Pioglitazone).

• Hypoglycemia: Risk exists due to Glimepiride; skip dose if a meal is skipped.

• Contraindications: Do not use in patients with active bladder cancer or severe heart failure (NYHA Class III/IV).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly protected from moisture.