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Polyethylene glycol 300 | CAS No: 25322-68-3 | GMP-certified suppliers
A medication that serves as a lubricant in ophthalmic solutions to temporarily relieve eye redness, burning, and irritation associated with dry eye conditions.
Therapeutic categories
Primary indications
- Indicated as a lubricant in over-the-counter ophthalmic solutions to temporarily relieve redness, burning and irritation of the eyes
Product Snapshot
- Polyethylene glycol 300 is supplied as an ophthalmic solution or drops formulation
- It is primarily used as a lubricant in over-the-counter ophthalmic products to relieve eye redness, burning, and irritation
- This API is approved for use in the US market
Clinical Overview
Clinically, PEG 300 is approved for use as a lubricant in over-the-counter ophthalmic solutions. It is indicated to temporarily alleviate ocular symptoms such as redness, burning, and irritation, commonly associated with dry eye conditions. Its pharmacodynamic action is largely derived from its nonionic surfactant properties, which reduce surface tension and help to condition biological surfaces such as the stratum corneum or ocular epithelium.
The mechanism of action of PEG 300 involves coating the surface of the eye, thereby enhancing lubrication and providing a protective barrier that mitigates dryness and irritation. This physical interaction supports moisture retention and surface conditioning without systemic pharmacological activity. Additionally, low molecular weight polyethylene glycols, including PEG 300, have been noted to exhibit some degree of antibacterial activity, although this is not the primary clinical indication.
Key ADME parameters for PEG 300 are characterized by minimal systemic absorption following topical ophthalmic application, with primary elimination occurring via renal excretion when administered systemically in larger doses. Toxicity profiles indicate low acute toxicity and minimal irritation potential at concentrations used in ocular formulations. However, appropriate purity and control of residual impurities, such as ethylene oxide and diethylene glycol, remain critical to ensure patient safety.
In pharmaceutical manufacturing and sourcing contexts, quality considerations for PEG 300 include compliance with pharmacopeial standards such as USP and EP monographs. The material must demonstrate consistent molecular weight distribution, low levels of volatile impurities, and endotoxin-free status for injectable or ophthalmic applications. Reliable suppliers should provide comprehensive certificates of analysis and maintain stringent quality assurance processes to support regulatory submissions and ensure patient safety.
Identification & chemistry
| Generic name | Polyethylene glycol 300 |
|---|---|
| Molecule type | Small molecule |
| CAS | 25322-68-3 |
| UNII | 5655G9Y8AQ |
| DrugBank ID | DB11161 |
Pharmacology
| Summary | Polyethylene glycol (PEG) functions as a nonionic surfactant that provides lubrication and surface protection by coating the eye, reducing irritation in dry eye conditions. It decreases surface tension and conditions epithelial barriers, facilitating enhanced diffusion of molecules across the skin or mucosal surfaces. PEG is primarily utilized in ophthalmic formulations for symptom relief related to eye dryness and irritation. |
|---|---|
| Mechanism of action | Due to their physical properties, PEG acts as a surfactant by coating the eye. It provides lubrication and surface protection in dry eyes. |
| Pharmacodynamics | PEGs act as nonionic surfactant to decrease surface tension and condition the stratum corneum, thus enhance the diffusion of other molecules or drugs through the skin . |
ADME / PK
| Absorption | PEGs can be absorbed by the gastrointestinal tract following oral administration with the fraction absorbed being dependent on the molecular weight of the compound . It is likely to display minimal absorption through the intact skin, but may penetrate through injured skin with compromised barrier function . |
|---|---|
| Half-life | No pharmacokinetic data available. |
| Protein binding | No pharmacokinetic data available. |
| Metabolism | Proportion of absorbed PEGs may be metabolized to lower oligomers, glycolic acid, hydroxyglycolic acids and the diglycolic acids homologs, carbon dioxide that is exhaled, and to a minor extent, oxalic acid . |
| Route of elimination | After oral and intravenous exposure, PEGs are excreted mainly unchanged in the urine and faeces . |
| Volume of distribution | No pharmacokinetic data available. |
| Clearance | No pharmacokinetic data available. |
Formulation & handling
- Polyethylene glycol 300 is a small molecule liquid primarily formulated for ophthalmic use.
- Its aqueous solution form facilitates ease of administration as eye drops with no noted peptide or biologic sensitivity.
- Proper storage should maintain solution stability without specific food or temperature-related handling concerns.
Regulatory status
| Lifecycle | The API is approaching patent expiry in the US, with generic competition expected to increase, indicating a transition towards market maturity and broader product availability. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | The supply landscape for Polyethylene glycol 300 features multiple originator companies producing branded products primarily in the US market. These branded formulations include various eye relief and redness treatment products, indicating established market presence. Given the absence of patent exclusivity information, generic competition is likely established or imminent, supporting a competitive sourcing environment. |
|---|
Safety
| Toxicity | Oral LD50 in rat and mouse are 27500 mg/kg and 31000 mg/kg, respectively [MSDS]. Dermal LD50 is reported to be 20000 mg/kg in rabbit [MSDS]. PEGs and their derivatives are not known to cause ocular and dermal irritation, and are associated with low acute and chronic toxicities . |
|---|
- Exhibits low acute toxicity with oral LD50 values exceeding 27,500 mg/kg in rodent models
- Dermal exposure presents minimal toxicity, with LD50 reported at 20,000 mg/kg in rabbits
- Not classified as an ocular or dermal irritant based on available toxicity data
PEG 300 is a type of Laxatives
Laxatives are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are commonly used to promote bowel movements and alleviate constipation. These medications are designed to stimulate the digestive system, facilitating the passage of stool and providing relief to individuals experiencing irregular or infrequent bowel movements.
Laxatives work through various mechanisms, including increasing intestinal motility, softening stool consistency, or promoting water retention in the intestines. They are available in different forms, such as tablets, capsules, powders, or liquids, catering to diverse patient preferences and requirements.
There are several types of laxatives, each with its unique mode of action. Bulk-forming laxatives contain fiber or other indigestible substances that absorb water, adding bulk to the stool and promoting regular bowel movements. Stimulant laxatives, on the other hand, stimulate the intestinal muscles, accelerating the passage of stool through the intestines. Osmotic laxatives draw water into the intestines, softening the stool and facilitating its movement. Additionally, stool softeners and lubricant laxatives can help ease bowel movements by making the stool easier to pass.
Laxatives are commonly used for short-term relief from constipation or to prepare for certain medical procedures or surgeries. However, their long-term use should be done under the guidance of healthcare professionals to prevent dependency or potential adverse effects.
In conclusion, laxatives are a vital subcategory of pharmaceutical APIs that aid in managing constipation and improving bowel regularity. They are available in various formulations and function through different mechanisms to provide effective relief. However, it is crucial to use laxatives responsibly and seek professional advice when necessary.
PEG 300 (Laxatives), 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.
PEG 300 API manufacturers & distributors
Compare qualified PEG 300 API suppliers worldwide. We currently have 4 companies offering PEG 300 API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, cDMF, CoA, GMP, MSDS | 229 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Germany | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Clariant Produkte | Producer | Germany | Germany | CEP, CoA, FDA, GMP | 10 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS | 144 products |
When sending a request, specify which PEG 300 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 PEG 300 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.
