1/ Introduction
Ethyl oleate is an ester of oleic acid and ethanol, appearing as a colorless or pale yellow liquid. In pharmaceuticals, ethyl oleate is commonly used as an oily vehicle in various dosage forms such as oil-based injections, emulsions/microemulsions, topical preparations, soft capsules, and film-coated tablets.
2/ Key Advantages
- Good solvent properties: effectively dissolves many poorly water-soluble drugs (e.g., steroids, fat-soluble vitamins), thereby improving oral and injectable bioavailability.
- High safety profile: recognized by the FDA as a safe excipient (GRAS); exhibits no significant toxicity and causes minimal local irritation.
- Good compatibility with a wide range of active ingredients and excipients.
- Low viscosity: facilitates the preparation of injectable solutions and ensures ease of administration.
- Chemical stability: less prone to oxidation compared to certain other oils.
- Product complies with USP/EP/BP
- The manufacturer has EXCIPACT GMP Certificate for Pharma application
- Stock available at GSP/ GDP warehouse, prompt delivery, competitive price
3/ Applications
- Injectable preparations: serves as a solvent for oil-based injections administered intramuscularly or subcutaneously.
- Emulsions, microemulsions, and self-emulsifying systems for oral or topical use: functions as the oil phase, enhancing the solubility of lipophilic or steroidal active ingredients.
- Soft capsules: acts as a vehicle for the fill material and as a plasticizer for the soft gelatin shell.
- Tablets: used as a taste-masking or sustained-release agent.
- Film-coated tablets: functions as a plasticizer in film-coating formulations.
- Transdermal patches: utilized as a component in transdermal delivery systems.
- May serve as a substitute for almond oil or peanut oil in certain formulations, offering advantages such as lower viscosity for easier handling and faster absorption.