Description

Glipizide Tablets (5mg / 10mg)

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 Glipizide Tablets in India. Glipizide is a Second-Generation Sulfonylurea used for the management of Type 2 Diabetes Mellitus. Compared to other sulfonylureas, Glipizide has a relatively short half-life, which significantly reduces the risk of long-lasting hypoglycemia, making it a preferred choice for elderly patients or those with mild renal impairment.

We offer Contract Manufacturing (Third Party) services for both the Immediate Release and Extended Release (XL/ER) formulations. Our WHO-GMP certified facility in Mumbai utilizes Advanced Granulation Technology to ensure the drug is released consistently. For the Extended Release version, we employ an Osmotic Pump or Hydrophilic Matrix system that delivers the medication over 24 hours, allowing for once-daily dosing. Healthy Inc manages the export logistics, supplying diabetic care markets across the USA, Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Fast onset for mealtime control.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Rapid Disintegration (IR): The Immediate Release tablet is engineered to disintegrate within 15 minutes. This ensures the drug reaches peak levels just as glucose from food enters the bloodstream, mimicking the body’s natural insulin spike.

  • Modified Release Technology (XL): For our XL/ER tablets, we use a specialized semi-permeable membrane coating. This allows water to enter the tablet core and push the drug out slowly through a laser-drilled pore or matrix, providing steady blood sugar control all day.

  • Uniformity: We use high-precision compression tooling to ensure weight variation is kept to an absolute minimum (< 1%), guaranteeing precise dosing in every tablet.

• The Exporter: Healthy Inc

  • Generic Branding: We can customize the tablet shape (e.g., diamond or oval) and embossing to match the innovator product in your specific target market for easier patient transition.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution:

  • Immediate Release: >80% release in 30 minutes.

  • Extended Release: Tested at 2h, 6h, and 12h to confirm sustained profile.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for specific impurities (Glipizide related compound A) to ensure safety.

5. Why Use Glipizide?

Effective control with lower risk for the elderly.

• Mechanism: Glipizide binds to the Sulfonylurea Receptor (SUR1) on the pancreatic beta cells. This closes ATP-sensitive potassium channels, leading to depolarization and the opening of calcium channels. The influx of calcium triggers the release of insulin granules.

• Key Advantage: It stimulates insulin release strictly in response to meals (postprandial). It is inactive in the body after about 12-24 hours, meaning if a patient skips a meal, the risk of dangerous low blood sugar is lower compared to long-acting drugs like Glibenclamide.

• Key Indications:

  • Type 2 Diabetes: To lower blood glucose when diet and exercise are insufficient.

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 ER) 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 Glipizide Tablets?

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

• Q: Is it Glucotrol?

  A: Glucotrol is the brand name (Pfizer). We manufacture the Generic Equivalent (Glipizide), which acts exactly the same.

• Q: When should I take it?

  A: 30 minutes BEFORE a meal (usually breakfast). This allows the drug to start working exactly when you start eating.

• Q: Is it safe for kidneys?

  A: Relatively Safer. Glipizide is metabolized by the liver into inactive products, making it a safer choice than other sulfonylureas for patients with mild kidney issues.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Starting Dose: 5mg once daily (given 30 mins before breakfast).

• Geriatric Start: 2.5mg daily.

• Max Dose: 40mg daily (Immediate Release) or 20mg daily (Extended Release).

• Administration: Swallow whole with water. Do not chew or crush XL/ER tablets.

9. Side Effects and Precautions

• Hypoglycemia: Low blood sugar (shaking, sweating, hunger).

• Gastrointestinal: Nausea, diarrhea, or constipation.

• Weight Gain: Possible, as with all insulin secretagogues.

• Allergy: Contraindicated in patients with sulfa allergies.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture and humidity.