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Tyloxapol | CAS No: 25301-02-4 | GMP-certified suppliers
A medication that aids clearance of thick bronchopulmonary secretions and supports respiratory management in conditions such as mucus‑laden airway disease and investigational cystic fibrosis.
Therapeutic categories
Primary indications
- Tyloxapol is an inhaled surfactant that assists in removing and liquefying and removing bronchopulmonary secretions with mucus and pus
- Tyloxapol is administered either through nebulized solution or a stream of oxygen
- Also investigated for use/treatment in cystic fibrosis and pediatric indications
Product Snapshot
- Tyloxapol is supplied as an inhaled surfactant API for nebulized solution delivery
- It is used for reducing and mobilizing bronchopulmonary secretions and is under investigation for cystic fibrosis and pediatric respiratory applications
- It has approval in certain markets and remains investigational for additional indications
Clinical Overview
Pharmacologically, Tyloxapol lowers surface tension within airway fluids, promoting dispersion and mobilization of mucus and pus. This surfactant action supports expectoration in patients with impaired mucociliary clearance. Beyond its pulmonary use, Tyloxapol demonstrates systemic effects when administered intraperitoneally in experimental models, specifically inhibition of plasma lipolytic activity. It acts as an inhibitor of lipoprotein lipase, reducing the hydrolysis of triglyceride-rich lipoproteins and limiting cellular triglyceride uptake. These metabolic effects are not central to inhaled clinical use but are relevant to its characterization.
Absorption, distribution, metabolism, and elimination characteristics for inhaled Tyloxapol are not comprehensively defined in public reference sources. Systemic exposure from therapeutic inhalation is generally understood to be low, consistent with its high molecular weight and detergent-like properties, although precise kinetic parameters are not established.
Safety considerations include potential airway irritation, coughing, or bronchospasm in sensitive individuals. As with other surfactants, the risk of hypersensitivity reactions is low but possible. Data on chronic toxicity are limited, and systemic lipid-modulating effects are primarily observed in nonclinical studies using non-inhalation routes.
Tyloxapol has been used in various expectorant and cough-related formulations, though contemporary availability varies by region.
For API procurement, suppliers should provide verified identity, control of polymer distribution characteristics, and assurance of residual solvent and impurity profiles appropriate for inhalation-grade materials. Regulatory documentation should align with local requirements for surfactant APIs intended for pulmonary administration.
Identification & chemistry
| Generic name | Tyloxapol |
|---|---|
| Molecule type | Small molecule |
| CAS | 25301-02-4 |
| UNII | Y27PUL9H56 |
| DrugBank ID | DB06439 |
Pharmacology
| Summary | Tyloxapol is a nonionic surfactant that reduces surface tension within the airways to help mobilize viscous bronchopulmonary secretions. It also inhibits lipoprotein lipase, blocking plasma lipolytic activity and slowing the breakdown of triglyceride‑rich lipoproteins. Its pharmacodynamic profile reflects combined surfactant action and enzymatic inhibition. |
|---|---|
| Mechanism of action | Tyloxapol, when injected IP, blocks plasma lipolytic activity, and thus the breakdown of triglyceride-rich lipoproteins. It has also been shown to be inhibitor of lipoprotein lipase, thus preventing triglyceride uptake. |
| Pharmacodynamics | It is used as a surfactant to aid liquefaction and removal of mucopurulent (containing mucus and pus) bronchopulmonary secretions. Tyloxapol also blocks plasma lipolytic activity, and thus the breakdown of triglyceride-rich lipoproteins. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Lipoprotein lipase | Humans | inhibitor |
Formulation & handling
- Liquid nonionic surfactant API typically formulated for inhalation or topical use, with good aqueous solubility aiding dispersion in respiratory or other aqueous systems.
- Chemically stable under normal conditions but can undergo degradation with strong oxidizers; store and handle to avoid oxidative stress.
- Viscous liquid form may require heating or dilution to achieve uniform mixing during formulation processing.
Regulatory status
Supply Chain
| Supply chain summary | Tyloxapol is an older nonionic surfactant used primarily as a component in ophthalmic formulations, and no single originator company currently defines its supply landscape. Branded products containing Tyloxapol have had global distribution, including in the US and other markets, but they are limited in number and are typically formulation‑specific. Patent protections on the material have long expired, so supply is unrestricted and generic or multi‑source availability is already established. |
|---|
Safety
| Toxicity | Acute oral LD50 in 1000 mg/kg in mouse and 5000 mg/kg in rat. |
|---|
- Acute toxicity is low
- Reported oral LD50 values are approximately 1000 mg/kg in mouse and 5000 mg/kg in rat, indicating limited systemic hazard under standard handling conditions
- Inhalation-use history notes potential for airway irritation and transient cough during exposure to aerosolized material
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Tyloxapol is a type of Surfactants
Surfactants play a crucial role in the pharmaceutical industry as an essential subcategory of active pharmaceutical ingredients (APIs). These compounds, known as surface-active agents, are widely used for their unique properties in pharmaceutical formulations. Surfactants possess both hydrophilic (water-loving) and hydrophobic (water-repelling) regions, allowing them to reduce surface tension and enhance solubility.
In pharmaceutical applications, surfactants serve multiple purposes. They are utilized as emulsifiers, aiding in the creation of stable emulsions by dispersing immiscible substances such as oil and water. This property is particularly valuable in the production of oral suspensions and topical creams.
Surfactants also act as wetting agents, facilitating the uniform distribution of a liquid across solid surfaces. This property is beneficial for drug manufacturing processes, as it ensures consistent dissolution and optimal bioavailability of the active ingredient.
Furthermore, surfactants serve as foaming agents in various pharmaceutical products, such as liquid soaps and mouthwashes. They enhance foam formation and stability, improving the cleansing and emollient effects of these formulations.
Additionally, surfactants are used to modify the permeability of biological membranes, enabling the enhanced absorption of drugs through the skin or mucosal surfaces. This property is particularly valuable in transdermal drug delivery systems and nasal sprays.
The pharmaceutical industry relies on surfactants due to their versatile properties, including emulsification, wetting, foaming, and membrane permeability modification. Their incorporation in various formulations enhances the performance, stability, and therapeutic efficacy of pharmaceutical products.
Tyloxapol (Surfactants), classified under Additives
Additives in the pharmaceutical API category refer to a group of chemical substances that are incorporated into pharmaceutical products to enhance their stability, functionality, or performance. These additives play a crucial role in ensuring the quality, safety, and efficacy of medications.
One common type of additive used in pharmaceuticals is preservatives. Preservatives are added to prevent microbial growth and maintain the integrity of the product throughout its shelf life. They help to safeguard against contamination and maintain the potency of the active pharmaceutical ingredient (API). Some commonly used preservatives include benzyl alcohol, phenol, and parabens.
Another important group of additives is antioxidants. Antioxidants are added to pharmaceutical formulations to prevent or delay the oxidation of APIs, which can lead to degradation and loss of potency. Examples of antioxidants commonly used in pharmaceuticals include ascorbic acid (vitamin C) and tocopherols (vitamin E).
In addition to preservatives and antioxidants, other additives like flavorings, colorants, and sweeteners may be incorporated into pharmaceutical products to improve their palatability and patient acceptability.
It is crucial to note that the use of additives in pharmaceuticals is strictly regulated by health authorities to ensure their safety and efficacy. Manufacturers must comply with stringent quality control standards and guidelines to guarantee the proper use and appropriate levels of additives in pharmaceutical products.
Overall, additives play a vital role in the pharmaceutical industry by enhancing the stability, functionality, and patient acceptability of medications. Their careful selection and incorporation contribute to the overall quality and effectiveness of pharmaceutical products.
Tyloxapol API manufacturers & distributors
Compare qualified Tyloxapol API suppliers worldwide. We currently have 1 companies offering Tyloxapol 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 |
|---|---|---|---|---|---|
| Curia | Producer | United States | United States | CoA, GMP, MSDS, USDMF | 106 products |
When sending a request, specify which Tyloxapol 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 Tyloxapol 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.
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