In the pharmaceutical industry, Metformin Sustained Release (SR) 500 mg (also known as Extended-Release or ER) is a specialized formulation of the first-line biguanide used for Type 2 Diabetes Mellitus.
As a pharmacist, I classify the SR 500 mg tablet as a “compliance booster.” While the active molecule is the same as the immediate-release (IR) version, the Sustained Release technology is designed to release the medication slowly over 24 hours. This addresses the primary barrier to Metformin therapy: gastrointestinal (GI) side effects.
Primary Clinical Uses
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Type 2 Diabetes Management: Used as an adjunct to diet and exercise to lower blood glucose. It is particularly effective at reducing Fasting Plasma Glucose (FPG).
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Insulin Resistance & Prediabetes: Often the only recommended pharmacological intervention to prevent the progression of prediabetes to full-blown Type 2 diabetes.
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PCOS (Polycystic Ovary Syndrome): Prescribed off-label to manage insulin resistance, aid in weight management, and help restore regular ovulation and fertility in women.
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Patient Transition: Used for patients who cannot tolerate the nausea, bloating, or diarrhea commonly associated with Metformin IR 500 mg.
Mechanism of Action: The Dual-Polymer Matrix
From a manufacturing perspective, Metformin SR utilizes a dual hydrophilic polymer matrix system (often referred to as a “GEL” matrix).
Hydration: Upon ingestion, the tablet’s outer polymers hydrate and swell, forming a thick gel layer.
Diffusion: The Metformin is trapped in an “inner phase” and slowly diffuses through the “external phase” (the gel) into the GI tract at a steady rate.
Physiological Action: Like standard Metformin, it reduces hepatic glucose production, increases peripheral insulin sensitivity, and delays intestinal glucose absorption—but without the sudden “spike” in concentration that irritates the stomach.
The Manufacturer’s Perspective: Formulation & Export
As you develop your digital platforms and social media, highlighting the technical superiority of SR/ER technology is a major B2B selling point:
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Tolerability Advantage: Clinical studies show that the incidence of GI adverse effects is significantly lower (up to 50% less) with SR formulations compared to IR. This leads to better patient retention and higher re-order rates for your trading firm.
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Dosing Frequency: Metformin SR is typically taken once daily with the evening meal. For a multivendor marketplace, this “once-a-day” convenience makes it a preferred product for export to markets with busy urban populations.
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Packaging & Stability: We utilize Alu-Alu blister packaging at our WHO-GMP facility. This protects the polymer matrix from moisture, which is critical; if the polymers absorb moisture during storage, the “sustained release” mechanism can fail (a phenomenon known as “dose dumping”).
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Dossier Support: Our Mumbai facility provides full eCTD/CTD Dossiers for Metformin SR 500 mg, including Comparative Dissolution Profiles against the innovator (Glucophage XR) to ensure international regulatory approval.