In the pharmaceutical industry, the combination of Glibenclamide (a second-generation sulfonylurea) and Metformin Hydrochloride SR (a biguanide in Sustained Release form) is a powerful Fixed-Dose Combination (FDC) for managing Type 2 Diabetes Mellitus. As a pharmacist and manufacturer, I view this pairing as a “Synergistic Glycemic Controller”—it simultaneously addresses insulin deficiency and insulin resistance.

At your WHO-GMP facility in Mumbai, where you likely produce various strengths (e.g., 5mg/500mg), this FDC is a staple for B2B export, especially for chronic disease management programs in emerging markets.

Primary Clinical Indications

This combination is indicated for patients with Type 2 Diabetes Mellitus whose blood glucose levels are not adequately controlled by diet, exercise, and single-drug therapy (Metformin alone):

• Dual Action Control: It is used to lower both fasting and post-prandial (after-meal) blood glucose levels.

• HbA1c Reduction: It is highly effective at bringing down long-term blood sugar markers (HbA1c) in patients with a long history of hyperglycemia.

Mechanism: The Two-Pronged Attack

This FDC works through two distinct biological pathways to restore glucose balance:

Glibenclamide (The Secretagogue): It binds to ATP-sensitive potassium channels in the Pancreatic Beta Cells. This triggers the release of stored insulin into the bloodstream, helping the body process sugar immediately after a meal.

Metformin SR (The Sensitizer): It works primarily in the liver to reduce Gluconeogenesis (the production of new sugar). It also increases the sensitivity of peripheral tissues (muscles) to insulin, allowing them to use glucose more efficiently.

The “SR” Advantage: The Sustained Release (SR) technology allows Metformin to be released slowly in the gut, reducing the gastrointestinal side effects (bloating, diarrhea) commonly associated with immediate-release versions.

The Pharmacist’s “Technical Warning”

• Hypoglycemia Risk: Because of the Glibenclamide component, there is a significant risk of “Low Blood Sugar.” Patients must be taught the signs (sweating, shaking, confusion) and should always carry a source of glucose.

• The “Meal-Time” Rule: This tablet must be taken with a meal (usually breakfast). Taking it on an empty stomach drastically increases the risk of severe hypoglycemia.

• Lactic Acidosis: A rare but serious complication of Metformin, especially in patients with kidney impairment. Periodic Renal Function Tests (RFTs) are mandatory.

• Vitamin B12 Deficiency: Long-term Metformin use can interfere with B12 absorption. Supplementation may be required for chronic patients.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “Matrix Tablet” USP: On your digital marketplace, emphasize the Hydrophilic Matrix Technology used for the Metformin SR component. This ensures a consistent, zero-order release profile that international B2B buyers look for.

• Stability for Export: Glibenclamide is stable, but Metformin is hygroscopic (absorbs moisture). For export to Zone IVb tropical regions, utilizing Alu-Alu blister packaging is essential for a 36-month shelf life.

• Dossier Support: We provide full WHO-standard CTD/eCTD Dossiers to support your firm’s registration in international tenders for diabetes management and primary healthcare.