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Miglitol | CAS No: 72432-03-2 | GMP-certified suppliers
A medication that improves glycemic control as an adjunct to diet in patients with type 2 diabetes mellitus inadequately managed by diet alone.
Therapeutic categories
Primary indications
- For use as an adjunct to diet to improve glycemic control in patients with non-insulin-dependent diabetes mellitus (NIDDM) whose hyperglycemia cannot be managed with diet alone
Product Snapshot
- Miglitol is an oral small molecule available in various tablet formulations including film-coated and effervescent forms
- It is primarily used as an adjunct therapy for glycemic control in non-insulin-dependent diabetes mellitus
- Miglitol is approved for use in the US market
Clinical Overview
Pharmacologically, miglitol belongs to the class of alpha-glucosidase inhibitors. It is a desoxynojirimycin derivative that acts by reversibly inhibiting membrane-bound intestinal alpha-glucosidase enzymes in the brush border of the small intestine. These enzymes are responsible for breaking down complex carbohydrates—including disaccharides, oligosaccharides, and polysaccharides—into absorbable monosaccharides such as glucose. By inhibiting these enzymes, miglitol delays carbohydrate digestion and absorption, thereby reducing postprandial blood glucose excursions.
Unlike sulfonylurea antidiabetic agents, miglitol does not stimulate insulin secretion, and its glucose-lowering effect results primarily from decreased glucose absorption. This distinct mechanism allows for additive glycemic control when combined with insulin secretagogues while mitigating associated weight gain and insulinotropic effects. Minor inhibition of lactase is reported, but at therapeutic doses, miglitol is not expected to cause lactose intolerance.
In terms of absorption, distribution, metabolism, and excretion (ADME), miglitol is minimally metabolized and largely excreted unchanged via the kidneys. This renal elimination necessitates caution in patients with impaired renal function to avoid accumulation and potential adverse effects.
Safety considerations include gastrointestinal side effects such as flatulence, diarrhea, and abdominal discomfort resulting from fermentation of undigested carbohydrates in the colon. Continuous monitoring is advised due to the risk of hypoglycemia when used concomitantly with other glucose-lowering agents.
Notable marketed formulations of miglitol are used internationally as part of comprehensive diabetes management regimens. For formulation scientists and API sourcing professionals, it is essential that miglitol API complies with pharmacopeial standards for purity, assay, and impurity profiles. High-quality API procurement should ensure consistent physicochemical properties, free from degradation products, and originate from manufacturers with validated processes adhering to current Good Manufacturing Practices (cGMP).
Identification & chemistry
| Generic name | Miglitol |
|---|---|
| Molecule type | Small molecule |
| CAS | 72432-03-2 |
| UNII | 0V5436JAQW |
| DrugBank ID | DB00491 |
Pharmacology
| Summary | Miglitol is an oral alpha-glucosidase inhibitor that targets intestinal membrane-bound enzymes responsible for carbohydrate hydrolysis, delaying glucose absorption and reducing postprandial hyperglycemia. Its antihyperglycemic effect is achieved without stimulating insulin secretion, contributing to improved glycemic control in type II diabetes mellitus. The mechanism complements other antidiabetic agents by producing additive reductions in blood glucose levels through modulation of carbohydrate digestion. |
|---|---|
| Mechanism of action | In contrast to sulfonylureas, miglitol does not enhance insulin secretion. The antihyperglycemic action of miglitol results from a reversible inhibition of membrane-bound intestinal a-glucoside hydrolase enzymes. Membrane-bound intestinal a-glucosidases hydrolyze oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in delayed glucose absorption and lowering of postprandial hyperglycemia. |
| Pharmacodynamics | Miglitol, an oral alpha-glucosidase inhibitor, is a desoxynojirimycin derivative that delays the digestion of ingested carbohydrates, thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of plasma glucose reduction, miglitol reduce levels of glycosylated hemoglobin in patients with Type II (non-insulin-dependent) diabetes mellitus. Systemic nonenzymatic protein glycosylation, as reflected by levels of glycosylated hemoglobin, is a function of average blood glucose concentration over time. Because its mechanism of action is different, the effect of miglitol to enhance glycemic control is additive to that of sulfonylureas when used in combination. In addition, miglitol diminishes the insulinotropic and weight-increasing effects of sulfonylureas. Miglitol has minor inhibitory activity against lactase and consequently, at the recommended doses, would not be expected to induce lactose intolerance. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Lysosomal alpha-glucosidase | Humans | antagonist |
| Neutral alpha-glucosidase AB | Humans | antagonist |
| Neutral alpha-glucosidase C | Humans | antagonist |
ADME / PK
| Absorption | Absorption of miglitol is saturable at high doses with 25 mg being completely absorbed while a 100-mg dose is only 50-70% absorbed. No evidence exists to show that systemic absorption of miglitol adds to its therapeutic effect. |
|---|---|
| Half-life | The elimination half-life of miglitol from plasma is approximately 2 hours. |
| Protein binding | The protein binding of miglitol is negligible (<4.0%). |
| Metabolism | Miglitol is not metabolized in man or in any animal species studied. |
| Route of elimination | Miglitol is not metabolized in man or in any animal species studied. It is eliminated by renal excretion as an unchanged drug. |
| Volume of distribution | * 0.18 L/kg |
Formulation & handling
- Miglitol is a small molecule piperidine available exclusively for oral administration in tablet and effervescent tablet forms.
- High water solubility and low LogP indicate good aqueous dissolution properties, suitable for oral formulation.
- Administration with food is critical to optimize therapeutic effect, requiring formulation considerations for dosing at meal onset.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently marketed in the United States with patent protection recently expired, allowing for generic competition and indicating a mature market phase. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Miglitol is manufactured by originator companies including Pharmacia and Upjohn Co., with packaging support from firms such as Bayer Healthcare and Kaiser Foundation Hospital. Its branded products, primarily marketed under the name Glyset, are present in the US market. Patent expiry has led to or indicates the presence of generic competition within this region. |
|---|
Safety
| Toxicity | Unlike sulfonylureas or insulin, an overdose will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdomi-nal discomfort. Because of the lack of extra-intestinal effects seen with miglitol, no serious systemic reactions are expected in the event of an overdose. |
|---|
- 1
- Overdose is unlikely to cause hypoglycemia, differentiating it from sulfonylureas and insulin
- 2
Miglitol is a type of Glycemic Agents
Glycemic agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are widely used in the treatment of diabetes mellitus. These agents play a crucial role in managing blood glucose levels and improving glycemic control in individuals with diabetes.
One of the key classes of glycemic agents is oral hypoglycemic agents, which are taken by mouth and help lower blood sugar levels. This class includes various subclasses such as sulfonylureas, biguanides, meglitinides, and alpha-glucosidase inhibitors. Sulfonylureas stimulate the release of insulin from the pancreas, while biguanides decrease the production of glucose in the liver and improve insulin sensitivity. Meglitinides work by stimulating insulin secretion, and alpha-glucosidase inhibitors slow down the absorption of carbohydrates from the intestine.
Another important class of glycemic agents is injectable insulin. Insulin is a hormone that regulates glucose metabolism in the body. It is administered via subcutaneous injections and comes in different forms, including short-acting, intermediate-acting, and long-acting insulin. These different formulations allow for precise control of blood glucose levels throughout the day.
Glycemic agents are prescribed based on various factors such as the type of diabetes, severity of the condition, and individual patient characteristics. They are typically used in combination with dietary modifications and lifestyle changes to achieve optimal glycemic control.
Overall, glycemic agents are vital components in the management of diabetes, helping individuals maintain stable blood sugar levels and reducing the risk of complications associated with uncontrolled diabetes.
Miglitol API manufacturers & distributors
Compare qualified Miglitol API suppliers worldwide. We currently have 1 companies offering Miglitol API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 757 products |
When sending a request, specify which Miglitol API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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