Description

Metformin Hydrochloride and Pioglitazone 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 Pioglitazone SR Tablets in India. This Fixed-Dose Combination (FDC) is an advanced anti-diabetic therapy designed for patients with Type 2 Diabetes Mellitus who do not achieve adequate glycemic control with Metformin or Pioglitazone alone.

We offer Contract Manufacturing (Third Party) services for this bilayer or matrix formulation. It combines Metformin (Sustained Release), which reduces hepatic glucose production, with Pioglitazone, which significantly improves insulin sensitivity in target tissues. Our WHO-GMP certified facility in Mumbai utilizes specialized polymer technologies to ensure the Metformin releases slowly over 24 hours while the Pioglitazone releases immediately. Healthy Inc manages the export logistics, supplying diabetes care markets in Southeast Asia, Latin America, and the Middle East.

2. Product Specifications

3. Manufacturing Technology

Combining an SR profile with a moisture-sensitive drug requires precision.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Bilayer Technology: We often utilize bilayer compression to separate the two drugs physically. The Metformin layer is formulated with Hydrophilic Matrix polymers (HPMC) to sustain drug release. The Pioglitazone layer is formulated for immediate release.

  • Moisture Control: Pioglitazone is sensitive to moisture and light. We process the blend in Low-Humidity Suites (< 30% RH) to prevent degradation.

  • Uniformity: Pioglitazone (15mg/30mg) is a low-dose potent drug compared to Metformin (500mg). We use high-shear granulation to ensure perfect content uniformity.

• The Exporter: Healthy Inc

  • Packaging: We prioritize Alu-Alu Cold Form Blisters for this product. This provides the necessary barrier against humidity to ensure the Pioglitazone remains stable and effective throughout the shelf life.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution Profiling: We perform dual dissolution testing. The Pioglitazone must release rapidly (>85% in 30 mins), while the Metformin must follow a specific release curve (e.g., 25-50% in 1st hour, >85% in 8 hours) to minimize GI side effects.

• Related Substances: We strictly monitor for Pioglitazone impurities and Metformin degradation products (Melamine/Cyanoguanidine).

• Assay: We ensure 100% label claim for both actives using validated HPLC methods.

5. Why Use Metformin SR + Pioglitazone?

It targets insulin resistance and glucose production simultaneously.

• Mechanism:

  • Metformin: Reduces the amount of sugar produced by the liver and improves the body’s response to insulin. The SR form reduces nausea and diarrhea common with immediate-release Metformin.

  • Pioglitazone: A Thiazolidinedione (TZD) that works on fat and muscle cells to make them more sensitive to insulin, allowing them to pull more sugar out of the blood.

• Key Indications:

  • Type 2 Diabetes: Particularly effective for overweight patients with significant insulin resistance who are not controlled on Metformin 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 Metformin Pioglitazone SR Tablets?

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

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

  A: It allows for once-daily dosing and significantly reduces the stomach upset (gas, diarrhea) often caused by plain Metformin.

• Q: Does Pioglitazone cause weight gain?

  A: Yes, Pioglitazone can cause mild fluid retention and weight gain. It is usually not prescribed for patients with heart failure.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet daily, usually taken with the evening meal.

• Titration: Dosage may be increased after a few weeks if glycemic control is not achieved.

• Administration: Swallow whole with water; do not chew or crush the tablet (to preserve the SR mechanism).

9. Side Effects and Precautions

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

• Hypoglycemia: Low risk when used alone, but risk increases if combined with insulin or sulfonylureas.

• Contraindications: Do not use in patients with active bladder cancer or Class III/IV Heart Failure.

• Lactic Acidosis: Rare but serious risk associated with Metformin accumulation.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly protected from moisture.