Metformin Sustained Release Tablets

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Metformin Sustained Release Tablets 1 gm
Each Filmcoated Sustained Release Tablet contains:
Metformin Hydrochloride BP 1 gm

Usage: – Treat type 2 diabetes

Category: – Anti Diabetic drugs

Therapeutic category: – Anti Diabetic

 

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Description

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

Healthy Inc is a specialized global provider of advanced metabolic therapies. We provide premium Metformin Sustained-Release (SR/ER) Tablets, manufactured in WHO–GMP certified facilities using sophisticated controlled-release technology. Designed to improve patient compliance and reduce side effects, this product is a primary export for endocrinology hospitals, diabetic care centers, and Ministry of Health (MOH) tenders in Southeast Asia, Africa, and the Middle East.


Product Overview

Metformin Sustained-Release is an advanced formulation of the biguanide antihyperglycemic agent. Unlike immediate-release versions, the SR variant is engineered to release the active pharmaceutical ingredient (API) gradually over an extended period, maintaining stable plasma concentrations and significantly reducing the “GI-distress” often associated with metformin therapy.

The “Compliance-Driven” Glycemic Specialist:

  • Mechanism of Action: Metformin SR improves glucose tolerance by inhibiting hepatic gluconeogenesis, increasing peripheral insulin sensitivity, and slowing intestinal glucose absorption. By activating the AMPK pathway, it optimizes cellular energy use.
  • Gastrointestinal Tolerability: The slow-release mechanism avoids the rapid “bolus” effect in the upper GI tract, which is the primary cause of nausea and diarrhea in diabetic patients. This allows for higher dose titration with better comfort.
  • 24-Hour Efficacy: A single daily dose of Metformin SR provides consistent glycemic control throughout the day and night, reducing the pill burden for patients on complex multi-drug regimens.

Technical & Manufacturing Specifications

Formulated using advanced diffusion and erosion-controlled matrix systems.

Technical Metric Specification Standard
Active Ingredient Metformin Hydrochloride BP / USP / IP
Dosage Form Sustained-Release (SR) / Extended-Release (ER) Tablets
Available Strengths 500 mg, 750 mg, 1000 mg
HS Code 3004.90.99 (Medicaments) / 2925.29.90
Stability Validated for Zone IVb (Tropical) export climates

Manufacturing Authority

Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.

  • Dual-Polymer Matrix: Our tablets utilize a hydrophilic polymer matrix (such as HPMC) that swells upon contact with gastric fluid to form a gel layer. This gel controls the diffusion of Metformin, ensuring a zero-order or near-zero-order release profile.
  • Ghost Tablet Technology: Our SR formulation is designed to be fully absorbed; however, in some matrix systems, the insoluble tablet shell (the “ghost”) may be excreted naturally, which is a normal characteristic of advanced drug delivery systems.
  • Purity & NDMA Screening: We employ LC-MS/MS testing to ensure every batch is free from Nitrosamine impurities, meeting the most stringent FDA and EMA safety guidelines.

Therapeutic Indications & Clinical Symptoms

  • Type 2 Diabetes Mellitus: Management of hyperglycemia in adults and children where diet and exercise are insufficient.
  • Insulin Resistance: Improving metabolic parameters in patients with metabolic syndrome.
  • PCOS Management: Long-term use in Polycystic Ovary Syndrome to regulate menstrual cycles and improve fertility.

Dosage & Administration

  • Standard Dose: Usually started at 500 mg or 1000 mg once daily with the evening meal.
  • Administration: Tablets must be swallowed whole; crushing or chewing will destroy the sustained-release matrix and lead to “dose dumping.”
  • Renal Safety: $eGFR$ should be monitored regularly; contraindicated if $eGFR < 30$ mL/min.

Global Export & Contract Manufacturing Services

Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Specialty Diabetes Hospitals and National Health Tenders. We offer Third Party Manufacturing for Metformin SR with full CTD Dossier and COPP support. Our logistics network ensures streamlined delivery to Vietnam, Nigeria, Philippines, and the UAE, providing WHO-GMP quality at competitive B2B prices.

Commercial Inquiries

WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in