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Aluminum hydroxide | CAS No: 21645-51-2 | GMP-certified suppliers
A medication that provides relief from heartburn and acid indigestion by neutralizing excess stomach acid to restore gastric balance and protect mucosal integrity.
Therapeutic categories
Primary indications
- For relief of heartburn and acid indigestion
Product Snapshot
- Aluminum hydroxide is available in multiple oral and topical formulations including tablets, suspensions, gels, ointments, capsules, and injections
- It is primarily used as an antacid for relief of heartburn and acid indigestion
- This API holds approved status in key regulatory markets such as the US and Canada
Clinical Overview
Pharmacologically, aluminum hydroxide exerts its effect through a gradual reaction with gastric hydrochloric acid, producing aluminum chloride and water, which raises the gastric pH. This rise in pH reduces the activity of pepsin, a proteolytic enzyme that contributes to mucosal damage. Additionally, aluminum hydroxide may increase the secretion of bicarbonate ions and prostaglandins, which contribute to mucosal protection and repair, thereby providing potential cytoprotective effects.
The mechanism of action involves both chemical neutralization of gastric acid and adsorption of pepsin, leading to reduced aggressive factors in the gastric environment. The balance between aggressive factors like hydrochloric acid and pepsin, and protective factors such as mucus and bicarbonate, is critical in the pathogenesis of gastric acid-related disorders. Aluminum hydroxide, through its alkalinity and modulation of gastric secretions, contributes to restoring this balance.
Key absorption, distribution, metabolism, and excretion (ADME) characteristics of aluminum hydroxide are not notable for systemic bioavailability, as it acts locally within the gastrointestinal tract. Minimal systemic absorption occurs due to its inorganic nature and low solubility under physiological conditions.
Safety considerations include the potential for aluminum accumulation in patients with impaired renal function, as aluminum ions may not be adequately excreted, leading to toxicity. Cautious use is therefore recommended in such populations. Also, aluminum hydroxide can interfere with the absorption of certain concomitantly administered medications, necessitating appropriate dosing intervals.
Aluminum hydroxide is commonly found in combination formulations with magnesium-containing antacids. It is approved for medical use in multiple jurisdictions and is listed under various drug categories related to gastrointestinal acid management.
For API procurement, quality considerations include ensuring compliance with pharmacopeial standards such as USP or Ph. Eur., confirming the absence of heavy metal contaminants, maintaining appropriate particle size distribution for consistent antacid activity, and verifying chemical purity to avoid variability in neutralizing capacity. Reliable sourcing should also consider the stability and storage conditions to prevent degradation or contamination.
Identification & chemistry
| Generic name | Aluminum hydroxide |
|---|---|
| Molecule type | Small molecule |
| CAS | 21645-51-2 |
| UNII | 5QB0T2IUN0 |
| DrugBank ID | DB06723 |
Pharmacology
| Summary | Aluminum hydroxide is a basic inorganic compound that neutralizes gastric hydrochloric acid, reducing acidity in the stomach. It raises gastric pH, inhibits pepsin activity, and may enhance mucosal protection through increased bicarbonate and prostaglandin production. These pharmacodynamic effects support its use in managing symptoms related to gastric acidity imbalance. |
|---|---|
| Mechanism of action | Aluminum hydroxide is a basic inorganic salt that acts by neutralizing hydrochloric acid in gastric secretions. Aluminum hydroxide is slowly solubilized in the stomach and reacts with hydrochloric acid to form aluminum chloride and water. It also inhibits the action of pepsin by increasing the pH and via adsorption. Cytoprotective effects may occur through increases in bicarbonate ion (HCO<sub>3</sub><sup>-</sup>) and prostaglandins. |
| Pharmacodynamics | Gastric-peptic disease occurs as a result of an imbalance between protective factors, such as mucus, bicarbonate, and prostaglandin secretion, and aggressive factors, such as hydrochloric acid, pepsin, and Helicobacter pylori (H. pylori). Antacids work by restoring acid-base balance, attenuating the pepsin activity and increasing bicarbonate and prostaglandin secretion. |
ADME / PK
| Absorption | Approximately 17-30% of the aluminum chloride formed is absorbed. |
|---|---|
| Metabolism | Not metabolized. |
| Route of elimination | Absorbed aluminum chloride is rapidly eliminated by the kidneys in patients with normal renal function. |
Formulation & handling
- Aluminum hydroxide is primarily formulated for oral administration in various solid and liquid forms, with additional topical and injectable presentations.
- This small molecule inorganic compound requires careful handling to avoid interaction with citrate-containing foods, which can enhance aluminum absorption and toxicity risk.
- Formulations should consider its stability as a suspension or tablet and avoid strong complexing agents to maintain efficacy and safety.
Regulatory status
| Lifecycle | The API’s primary patents have expired in both the US and Canada, leading to increased availability of generic formulations. The product is in a mature market phase with established usage and multiple suppliers. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Aluminum hydroxide is supplied by multiple originator companies, with branded formulations available primarily in the US and Canadian markets. The presence of several branded antacid products indicates established market demand. Patent expiry status is not specified, but the availability of multiple branded options suggests either existing generic competition or potential for its entry. |
|---|
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
Aluminum hydroxide 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.
Aluminum hydroxide (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.
Aluminum hydroxide API manufacturers & distributors
Compare qualified Aluminum hydroxide API suppliers worldwide. We currently have 6 companies offering Aluminum hydroxide API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Chemizo Enterprise | Distributor | India | India | CoA | 19 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
When sending a request, specify which Aluminum hydroxide 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 Aluminum hydroxide 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.
