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Aluminium monostearate | CAS No: 7047-84-9 | GMP-certified suppliers
A medication that serves as a gel-forming agent in topical and oral formulations, supporting formulation stability and viscosity control in products addressing acid-related gastrointestinal conditions.
Therapeutic categories
Product Snapshot
- Aluminium monostearate is typically supplied as a powder for use in topical and oral formulations
- It is primarily utilized as an excipient in pharmaceutical manufacturing, including as a thickening agent and emulsifier
- The compound currently holds experimental status with no established regulatory approvals in major markets such as the FDA or EMA
Clinical Overview
Although aluminium monostearate does not have a direct clinical indication as an active pharmaceutical ingredient, it is utilized in various dosage forms, particularly topical and oral preparations, to provide structural and functional matrix properties. In pharmaceuticals, it aids in the stabilization and viscosity control of gels, creams, and suspensions. Its use in cosmetics mainly concerns the formulation of colorants and thickening agents.
Regarding pharmacology and mechanism of action, aluminium-containing compounds such as aluminium monostearate can act as antacids by neutralizing gastric hydrochloric acid through a buffering reaction, thereby raising gastric pH and alleviating acid-related irritation. Additionally, aluminium ions demonstrate biological effects including inhibition of smooth muscle contraction by interfering with calcium signaling pathways. Specifically, aluminium has been shown to bind troponin C, a regulatory muscle protein, impede voltage-dependent calcium transport, and inhibit mitochondrial voltage-gated anion channels (VDAC). These actions may collectively influence gastrointestinal motility and acid handling.
Pharmacokinetic data for aluminium monostearate as an API is limited due to its predominant use as an excipient or adjuvant rather than a systemic therapeutic agent. Aluminium absorption from the gastrointestinal tract is generally low, but chronic and extensive exposure can lead to accumulation, posing potential toxicity risks including neurotoxicity and bone disease. Careful consideration of dosage form composition and aluminium exposure levels is necessary to mitigate such risks.
Aluminium monostearate is categorized as experimental in drug approval contexts, reflecting its auxiliary rather than primary therapeutic role. Brands and commercial usage often pertain to formulation roles within complex pharmaceutical or cosmetic products rather than standalone medications.
From a sourcing and quality perspective, procurement of aluminium monostearate for pharmaceutical use requires rigorous adherence to pharmacopeial standards and regulatory guidelines. Purity, particle size, and consistency are critical parameters due to their impact on formulation performance and safety. Suppliers must provide appropriate certificates of analysis confirming compliance with International Council for Harmonisation (ICH) guidelines and relevant pharmacopeial monographs. Controlled manufacturing processes and thorough impurity profiling help ensure suitability for use in pharmaceutical grade products.
Identification & chemistry
| Generic name | Aluminium monostearate |
|---|---|
| Molecule type | Small molecule |
| CAS | 7047-84-9 |
| UNII | P9BC99461E |
| DrugBank ID | DB01375 |
Pharmacology
| Summary | Antacids therapeutically reduce gastric acidity by neutralizing hydrochloric acid through a buffering reaction, thereby raising gastric pH and mitigating mucosal irritation linked to peptic ulcers. Aluminum ions contribute to the pharmacodynamic profile by inhibiting smooth muscle contraction and delaying gastric emptying via interaction with troponin C and modulation of voltage-dependent calcium and mitochondrial anion channels. Primary molecular targets include troponin C and voltage-dependent anion-selective channel proteins involved in muscle function and cellular ion transport. |
|---|---|
| Mechanism of action | Antacids perform a neutralization reaction, ie. they buffer gastric acid, raising the pH to reduce acidity in the stomach. When gastric hydrochloric acid reaches the nerves in the gasitrointestinal mucosa, they signal pain to the central nervous system. This happens when these nerves are exposed, as in peptic ulcers. The gastric acid may also reach ulcers in the esophagus or the duodenum. Other mechanisms may contribute, such as the effect of aluminum ions inhibiting smooth muscle cell contraction and delaying gastric emptying. Aluminum is known to bind troponin C (a muscle protein) and to interfere with voltage-dependent calcium transport. Aluminum also binds to and inhibits the activity of mitochondrial voltage gated channels (VDAC). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Troponin C, slow skeletal and cardiac muscles | Humans | stimulator |
| Voltage-dependent anion-selective channel protein 1 | Humans | inhibitor |
| Voltage-dependent anion-selective channel protein 2 | Humans | inhibitor |
Formulation & handling
- Aluminium monostearate is a small molecule solid primarily used in topical or oral formulations rather than injectable forms. Its high logP and low water solubility indicate significant lipophilicity, necessitating consideration of lipid-based excipients for formulation. Stability and handling should account for potential sensitivity to moisture given its solid state and fatty acid composition.
Regulatory status
Aluminium monostearate is a type of Emulsifiers
Emulsifiers are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used in the formulation of various pharmaceutical products. They play a vital role in achieving stable and uniform emulsions, which are essential for the production of creams, lotions, and other topical formulations.
Emulsifiers are surface-active agents that possess both hydrophilic (water-loving) and lipophilic (oil-loving) properties. These unique characteristics enable them to form a bridge between water and oil phases, thereby stabilizing the emulsion system. By reducing interfacial tension, emulsifiers facilitate the dispersion of immiscible liquids, resulting in a homogeneous mixture.
The primary function of emulsifiers in pharmaceutical formulations is to enhance the stability, appearance, and texture of the final product. They prevent phase separation, coalescence, and sedimentation, ensuring uniform distribution of active ingredients. Moreover, emulsifiers improve drug delivery by aiding in the solubilization of lipophilic drugs and promoting their absorption through the skin.
In addition to their emulsifying properties, these APIs may also possess other beneficial characteristics such as antimicrobial activity or skin-conditioning properties. This makes them versatile ingredients used in various pharmaceutical and cosmetic applications.
Commonly used emulsifiers in the pharmaceutical industry include polysorbates, sorbitan esters, and fatty alcohols. Each emulsifier has its own set of advantages and limitations, making it crucial for formulators to carefully select the appropriate emulsifier based on the specific requirements of the formulation.
Overall, emulsifiers are essential pharmaceutical APIs that contribute to the stability and efficacy of topical formulations. Their multifunctional properties make them indispensable ingredients in the development of a wide range of pharmaceutical and cosmetic products.
Aluminium monostearate API manufacturers & distributors
Compare qualified Aluminium monostearate API suppliers worldwide. We currently have 3 companies offering Aluminium monostearate 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 |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Chemtura Corp. | Producer | United States | United States | CEP, CoA | 3 products |
| Ferro Corp. | Producer | United States | United States | CEP, CoA | 2 products |
When sending a request, specify which Aluminium monostearate 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 Aluminium monostearate 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.
