Description

Metformin Sustained Release Tablets (500mg / 750mg / 1000mg)

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 Sustained Release (SR) Tablets in India. Also known as Extended Release (ER/XR), this formulation is designed to solve the biggest challenge of Metformin therapy: gastrointestinal intolerance. By releasing the drug slowly over 12-24 hours, our SR tablets significantly reduce the incidence of diarrhea and nausea compared to standard immediate-release tablets, while allowing for convenient Once-Daily Dosing.

We offer Contract Manufacturing (Third Party) services for this value-added formulation. Manufacturing a consistent SR profile requires precise polymer selection. Our WHO-GMP certified facility in Mumbai utilizes advanced Hydrophilic Matrix Technology (HPMC) to create a gel barrier around the tablet that controls drug diffusion. Healthy Inc manages the export logistics, supplying chronic care programs and pharmacy chains across the USA, Europe, the Middle East, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Patient compliance is the engineering goal.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Hydrophilic Matrix System: We use high-viscosity Hydroxypropyl Methylcellulose (HPMC) polymers. When the tablet is swallowed, the outer layer absorbs water and swells to form a thick gel. The drug slowly diffuses through this gel layer as it travels down the GI tract, ensuring a steady release without the “dose dumping” that causes stomach upset.

  • Gastric Retention (Optional): Some of our formulations are designed to swell and float or expand in the stomach, prolonging the time the drug spends in the upper GI tract (where Metformin is best absorbed), improving bioavailability.

  • Odor Masking: We apply a flavor-infused coating to mask the inherent “fishy” smell of Metformin API.

• The Exporter: Healthy Inc

  • Bulk Efficiency: SR tablets are often larger than IR tablets. We optimize blister layouts and bottle counts to ensure cost-effective shipping for bulk orders.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution (Extended Profile): Unlike IR tablets (which release in 30 mins), we test SR tablets at multiple intervals (e.g., 1hr: <30%, 4hr: 50-60%, 10hr: >85%) to prove the sustained release mechanism works.

• Assay: We confirm the potency is strictly within 95-105% of the label claim.

• NDMA Testing: Rigorous screening for Nitrosamine impurities.

5. Why Use Metformin SR?

It offers the same benefits with fewer side effects.

• Mechanism: Same as standard Metformin (reduces liver glucose production, increases insulin sensitivity).

• Key Advantages:

  • Better Tolerance: Significant reduction in diarrhea, nausea, and bloating.

  • Better Compliance: Taken once daily (usually with dinner) instead of 2-3 times a day.

  • Stable Levels: Avoids the “peaks and troughs” of drug levels in the blood.

• Indications: Type 2 Diabetes, Pre-Diabetes, PCOS.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Dissolution Profiles) 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 SR Tablets?

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

• Q: Can I crush or cut the tablet?

  A: ABSOLUTELY NOT. Breaking the tablet destroys the gel matrix. This releases 1000mg of drug instantly, leading to severe diarrhea and potential lactic acidosis. Swallow whole.

• Q: When should I take it?

  A: It is best taken once daily with the evening meal (dinner). This ensures the drug works overnight to control fasting blood sugar in the morning.

• Q: I saw a “ghost pill” in my stool. Is this normal?

  A: Yes. With some SR technologies (wax matrix), the empty shell of the tablet may pass through the body after the drug has been absorbed. This is harmless.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Starting Dose: 500mg SR once daily with dinner.

• Titration: Increase by 500mg weekly based on blood sugar.

• Max Dose: 2000mg to 2500mg once daily.

• Switching from IR: Patients usually switch to the same total daily dose (e.g., 500mg IR twice daily -> 1000mg SR once daily).

9. Side Effects and Precautions

• Gastrointestinal: Much milder than IR, but mild nausea can still occur initially.

• Lactic Acidosis: Rare risk (same as IR). Avoid in severe kidney/liver failure or excessive alcohol intake.

• Vitamin B12: Long-term use lowers B12 levels. Supplementation may be needed.

• Contrast Dye: Stop taking Metformin before any CT scan using iodine contrast dye (risk of acute kidney injury).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.