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Magaldrate | CAS No: 74978-16-8 | GMP-certified suppliers
A medication that provides rapid symptomatic relief from acid-related gastrointestinal conditions such as esophagitis, ulcers, and gastroesophageal reflux disease by neutralizing stomach acidity.
Therapeutic categories
Product Snapshot
- Magaldrate is available in multiple oral formulations including gel, tablet, chewable, and suspension forms
- It is primarily used as an antacid agent for gastrointestinal conditions
- The product has approval status in the US and Canada, with some formulations currently withdrawn
Clinical Overview
The pharmacological action of magaldrate stems from its ability to neutralize gastric acid through the chemical interaction of its hydroxide ions with hydrochloric acid in the stomach. This neutralization elevates intragastric pH, thereby reducing acidity and relieving symptoms associated with hyperacidity. Unlike single-component antacids, magaldrate provides a balanced combination whereby magnesium ions exert a laxative effect while aluminum ions tend to have constipating properties, potentially minimizing gastrointestinal motility side effects.
Absorption of magaldrate is minimal due to its localized action in the gastrointestinal tract, with API components largely remaining unabsorbed. Metabolism and systemic distribution are negligible, positioning magaldrate as a topical agent with limited systemic exposure. Excretion primarily occurs through the feces of unabsorbed material. The onset of action is generally rapid, suitable for symptomatic relief in acid-related disorders.
Safety considerations include the potential for electrolyte imbalances upon extensive or chronic use, particularly in patients with renal impairment due to accumulation risk of aluminum and magnesium ions. Long-term administration necessitates monitoring to avoid complications such as phosphate depletion or altered bowel habits. The drug’s profile contraindicates use in severe renal dysfunction and patients prone to developing milk-alkali syndrome.
Magaldrate has been approved and marketed internationally but has been withdrawn from the US market. Current availability varies by region, with usage diminishing due to the development of more targeted acid-suppressive therapies.
For API sourcing, it is critical to ensure pharmaceutical-grade magaldrate meets stringent purity criteria, with low heavy metal contamination and consistent particle size to optimize suspension stability and bioavailability. Certification under relevant pharmacopeial standards and compliance with Good Manufacturing Practices (GMP) is essential to support reliable supply for formulation development or compounding applications.
Identification & chemistry
| Generic name | Magaldrate |
|---|---|
| Molecule type | Small molecule |
| CAS | 74978-16-8 |
| UNII | 6V88E24N5T |
| DrugBank ID | DB08938 |
ADME / PK
| Route of elimination | Aluminium oxide: absorbed Al ions are eliminated in the urine (0.1-0.5 mg of Al in aluminium-containing antacid is absorbed from standard daily doses of antacid) while insoluble or poorly absorbed Al salts in the intestines are excreted through the feces. Magnesium oxide: absorbed Mg ions (up to 30%) are eliminated in the urine, unabsorbed is excreted in the feces. |
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Formulation & handling
- Magaldrate is a small molecule primarily formulated for oral administration in various dosage forms including tablets, gels, and suspensions, with an additional otic suspension formulation.
- Its negative LogP value indicates hydrophilicity, suggesting formulation strategies should ensure adequate dissolution and bioavailability in the gastrointestinal tract.
- Avoidance of alcohol is recommended due to potential interactions impacting stability or efficacy during oral administration.
Regulatory status
| Lifecycle | The API's primary patents have expired in both Canada and the US, leading to increased availability of generic versions and a mature market environment in these regions. Product competition is established, reflecting standard lifecycle progression post-patent expiry. |
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| Markets | Canada, US |
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Supply Chain
| Supply chain summary | Magaldrate is marketed primarily in North America, with branded products available in Canada and the US under various Riopan formulations. The presence of multiple branded dosage forms indicates established originator companies managing the product. Pending or recent patent expiries in this category typically enable generic manufacturers to enter the market, suggesting existing or upcoming generic competition. |
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Magaldrate is a type of Antacids
Antacids are a crucial subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used to alleviate symptoms of acid reflux, heartburn, and indigestion. These over-the-counter medications work by neutralizing excessive stomach acid, providing relief and promoting comfort.
The primary active ingredients in antacids include aluminum hydroxide, magnesium hydroxide, calcium carbonate, and sodium bicarbonate. These compounds counteract the acidic pH in the stomach, forming salts and water, thereby reducing gastric acidity.
Antacids are available in various forms, such as tablets, liquids, and chewable tablets, allowing consumers to choose the most suitable administration method. The selection of an antacid is often based on factors like personal preference, effectiveness, and speed of relief.
By neutralizing stomach acid, antacids help relieve symptoms associated with gastrointestinal disorders, such as heartburn, sour stomach, and acid indigestion. Additionally, they can provide temporary relief from gastroesophageal reflux disease (GERD) and peptic ulcers.
It is important to note that antacids are primarily symptomatic treatments and do not address the underlying causes of acid-related conditions. Individuals with chronic or severe symptoms should consult healthcare professionals for a comprehensive diagnosis and appropriate treatment.
In summary, antacids play a vital role in managing and alleviating symptoms associated with excess stomach acid. Their availability in various forms and ease of use make them popular choices for individuals seeking quick relief from acid-related discomfort.
Magaldrate (Antacids), classified under Gastrointestinal Agents
Gastrointestinal Agents belong to the pharmaceutical API category that focuses on treating disorders and ailments related to the digestive system. These agents play a crucial role in addressing various gastrointestinal conditions, such as acid reflux, ulcers, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD).
One of the key types of gastrointestinal agents is proton pump inhibitors (PPIs), which work by reducing the production of stomach acid. PPIs help in treating conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. Another essential class of agents is antacids, which neutralize excessive stomach acid, providing relief from heartburn and indigestion.
Gastrointestinal agents also include antispasmodics that alleviate abdominal cramps and spasms associated with conditions like IBS. These drugs work by relaxing the smooth muscles of the digestive tract. Additionally, there are drugs categorized as laxatives that aid in relieving constipation by promoting bowel movements.
Moreover, certain gastrointestinal agents act as antiemetics, effectively reducing nausea and vomiting. These drugs are particularly useful for patients undergoing chemotherapy or experiencing motion sickness.
Pharmaceutical companies develop and manufacture a wide range of gastrointestinal agents in various forms, including tablets, capsules, suspensions, and injections. These agents are typically formulated using active pharmaceutical ingredients (APIs) and other excipients to ensure their efficacy and safety.
In conclusion, gastrointestinal agents form a vital category of pharmaceutical APIs, providing relief from digestive disorders and improving overall gastrointestinal health. The availability of diverse agents catering to different conditions ensures that patients can receive targeted treatment for their specific gastrointestinal needs.
Magaldrate API manufacturers & distributors
Compare qualified Magaldrate API suppliers worldwide. We currently have 3 companies offering Magaldrate API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Spi Pharma | Producer | United States | France | CoA, GMP | 3 products |
| Taurus Chemicals | Producer | India | India | CoA, WC | 5 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Magaldrate 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.).
Use the list above to find high-quality Magaldrate API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
