Excipient Profile of Ethanol: Ethanol is also known as ethyl alcohol, is a versatile pharmaceutical excipient used in a wide range of formulations. Here is an in-depth profile of ethanol:
Excipient Profile of Ethanol
Excipient Profile of Ethanol: Chemical Structure
Ethanol is a simple alcohol with the chemical formula C2H5OH. It is a volatile, flammable, colorless liquid that is the active ingredient in alcoholic beverages.
Physical and Chemical Properties
- Appearance: Ethanol is a clear, colorless liquid with a characteristic odor.
- Solubility: It is miscible with water and with many organic solvents, including acetic acid, acetone, benzene, carbon tetrachloride, chloroform, diethyl ether, ethylene glycol, glycerol, isopropanol, methanol, and toluene.
- Boiling Point: The boiling point of ethanol is 78.37°C (173.07°F) at a pressure of 1 atm.
- Melting Point: The melting point of ethanol is -114.1°C (-173.4°F).
- Specific Gravity: The specific gravity of ethanol is 0.789 g/cm3 at 20°C (68°F), which is lighter than water.
- Flash Point: The flash point of ethanol is 13°C (55.4°F). It is classified as a flammable liquid due to its low flash point.
- pH: The pH of a 1% aqueous solution of ethanol is approximately 7.3.
Key physical and chemical properties of Ethanol
| Property | Description |
|---|---|
| Chemical Formula | C2H5OH |
| Molecular Weight | 46.07 g/mol |
| Appearance | Clear, colorless liquid |
| Odor | Characteristic, alcohol-like odor |
| Solubility | Miscible with water and many organic solvents |
| Boiling Point | 78.37°C (173.07°F) |
| Melting Point | -114.1°C (-173.4°F) |
| Specific Gravity | 0.789 g/cm3 at 20°C (68°F) |
| Flash Point | 13°C (55.4°F) |
| pH | Approximately 7.3 for a 1% aqueous solution |
| Vapor Pressure | 5.95 kPa at 20°C (68°F) |
| Evaporation Rate | 1.7 (Butyl Acetate = 1) |
Please note that the properties of ethanol can vary slightly depending on the specific grade and the manufacturer. Always refer to the manufacturer’s data sheet for precise information
Safety Profile
Ethanol is generally safe for use in pharmaceutical applications. However, it is flammable and should be handled with care. It can also be irritating to the eyes and mucous membranes, and prolonged skin contact can cause dryness and cracking.
Applications in Pharmaceutical Formulations
Ethanol is used in a variety of pharmaceutical formulations due to its unique properties:
- Solvent: Ethanol is used as a solvent in many pharmaceutical formulations due to its excellent solvating properties. It can dissolve a wide range of substances, including drugs, preservatives, and other excipients.
- Preservative: Ethanol has antimicrobial properties and can be used as a preservative in pharmaceutical formulations.
- Antiseptic: Ethanol is used as an antiseptic in hand sanitizers and disinfectants due to its ability to kill bacteria and other microorganisms.
- Extraction Solvent: Ethanol is used as an extraction solvent in the production of herbal and botanical extracts.
- Vehicle: Ethanol is used as a vehicle in topical and oral liquid formulations, such as lotions, tinctures, and elixirs.
Ethanol is a valuable excipient in the pharmaceutical industry due to its versatility and unique properties. It plays a crucial role in many pharmaceutical formulations and continues to be a subject of extensive research and development.
Ethanol in Topical Formulations
Ethanol is widely used in topical formulations such as lotions, creams, gels, and sprays. It acts as a solvent for many active ingredients and other excipients, ensuring their uniform distribution throughout the formulation. Ethanol also has a cooling effect when applied to the skin, which can enhance the sensory appeal of the product.
In addition, ethanol can enhance the penetration of active ingredients into the skin. It does this by interacting with the lipids in the stratum corneum (the outermost layer of the skin), which can increase the permeability of the skin and facilitate the absorption of the active ingredient.
Ethanol in Oral Liquid Formulations
Ethanol is a common ingredient in oral liquid formulations such as syrups, elixirs, and tinctures. It serves as a solvent for active ingredients and can also act as a preservative, preventing the growth of bacteria and fungi in the formulation.
In tinctures, ethanol is used to extract active compounds from plants and other natural sources. The concentration of ethanol in tinctures can vary widely, but it is typically between 25% and 60%.
Ethanol in Injectable Formulations
Although less common, ethanol can also be used in injectable formulations. For example, it is used as a solvent in some injectable formulations of the anticancer drug paclitaxel.
Ethanol as a Disinfectant
Ethanol is a powerful disinfectant and is used in many hand sanitizers and surface disinfectants. It works by denaturing proteins in bacteria and viruses, which leads to their death. Ethanol-based hand sanitizers typically contain between 60% and 95% ethanol.
Safety Considerations
While ethanol is generally safe for use in pharmaceutical formulations, it can cause irritation if used in high concentrations or if it comes into contact with sensitive areas of the body. It can also cause dryness and cracking of the skin with prolonged use. Ethanol is flammable and should be stored and handled with care.
In conclusion, ethanol is a versatile and valuable excipient in the pharmaceutical industry. Its excellent solvating properties, combined with its antimicrobial activity and ability to enhance skin penetration, make it a key ingredient in many pharmaceutical formulations.
Tags: Excipient Profile of Ethanol, Excipient Profile of Ethanol for Pharmaceuticals, Excipient Profile of Ethanol Pharmaceuticals formulation.
References
- “Excipient profile and future possibilities of fucoidan: a review” – International Journal of Pharmaceutical Research (IJPR), 2020. DOI: 10.31838/ijpr/2020.12.04.517
- “Ethylenediamine, profile of a sensitizing excipient” – Pharmaceutisch Weekblad Scientific Edition, 2005. DOI: 10.1007/bf02097249
- “Profile proteins/peptides composition in zein excipient by silver staining SDS-PAGE and LC-MS/MS” – Archives of Chemical Research, 2018. DOI: 10.21767/2572-4657-c3-009
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