Description

Gliclazide Tablets (80mg / 30mg MR / 60mg MR)

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 Gliclazide Tablets in India. Gliclazide is a Second-Generation Sulfonylurea used for the treatment of Type 2 Diabetes Mellitus. It is widely preferred over older sulfonylureas (like Glibenclamide) because it carries a significantly lower risk of hypoglycemia and offers unique Hemovascular Benefits, helping to prevent the microvascular complications of diabetes (retinopathy and nephropathy).

We offer Contract Manufacturing (Third Party) services for both the conventional Immediate Release (80mg) and the advanced Modified Release (30mg MR / 60mg MR) formulations. Our WHO-GMP certified facility in Mumbai utilizes specialized Hydrophilic Matrix Technology for the MR formulation, ensuring a smooth, 24-hour release profile that mimics the body’s natural insulin secretion pattern. Healthy Inc manages the export logistics, supplying diabetic care centers and pharmacy chains across the UK, Europe, Australia, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Advanced “Smart Release” technology.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Matrix Technology (MR): For the 30mg/60mg MR tablets, we do not simply compress the drug. We embed Gliclazide in a Hypromellose (HPMC) Matrix. Upon contact with stomach fluid, this matrix forms a gel barrier. The drug diffuses through this gel slowly over 24 hours. This technology is critical for ensuring the drug covers the “dawn phenomenon” (morning sugar spikes) without causing night-time lows.

  • Particle Engineering: Gliclazide has poor solubility. We use Micronized API to ensure that even the Immediate Release (80mg) tablets dissolve fully and act consistently.

  • Bioequivalence: Our MR formulation is designed to be bioequivalent to the innovator, ensuring seamless switching for patients.

• The Exporter: Healthy Inc

  • Compliance Packs: We offer calendar-blister packs (days printed on the foil) to help elderly patients track their daily medication, improving adherence.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution (MR): We test release profiles at multiple time points (e.g., 2h, 6h, 12h) to verify the sustained release mechanism is functioning correctly.

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

• Related Substances: We strictly monitor for degradation impurities (Gliclazide sulfonamide and methyl derivatives).

5. Why Use Gliclazide?

Sugar control plus blood vessel protection.

• Mechanism: Gliclazide binds to the Sulfonylurea Receptor (SUR1) on pancreatic beta cells, closing potassium channels and triggering insulin release. Uniquely, it restores the “First Phase” Insulin Secretion (the immediate burst of insulin after eating), which is often lost in early Type 2 Diabetes.

• Vascular Benefit: Unlike other sulfonylureas, Gliclazide inhibits platelet aggregation and increases fibrinolysis. This “anti-clotting” effect helps protect the tiny blood vessels in the eyes and kidneys from diabetic damage.

• Key Indications:

  • Type 2 Diabetes: Adult-onset diabetes controlled by diet and oral meds.

  • Renal Safety: Can be used (with caution) in mild-to-moderate kidney disease, unlike Glibenclamide.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Studies for MR) 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 Gliclazide Tablets?

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

• Q: Is it Diamicron MR?

  A: Diamicron MR is the brand name (Servier). We manufacture the Generic Equivalent (Gliclazide MR), which uses the same matrix technology.

• Q: Does it cause weight gain?

  A: Yes, but less. While all insulin-boosting drugs can cause weight gain, Gliclazide is generally weight-neutral or causes less gain compared to Glibenclamide or Insulin.

• Q: Can I crush the MR tablet?

  A: NEVER. Crushing the MR tablet destroys the matrix, dumping 24 hours of medicine into your body at once. This can cause severe, life-threatening hypoglycemia. Swallow whole.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Immediate Release (80mg): 40mg to 320mg daily (divided doses with meals).

• Modified Release (30mg/60mg): 30mg to 120mg Once Daily at breakfast.

• Administration: Swallow whole with water during breakfast.

9. Side Effects and Precautions

• Hypoglycemia: Low blood sugar. Less common than with other sulfonylureas but possible if meals are skipped.

• Gastrointestinal: Nausea, indigestion, diarrhea.

• Hematological: Rare blood disorders (anemia, thrombocytopenia).

• Renal/Hepatic: Contraindicated in severe liver or kidney failure.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.