MIGLYOL® 812 N

Description

Neutral, stable, penetration enhancer, drug carrier, solvent, oral use, dermal use.

Liquid lipids are neutral oils for a wide spectrum of pharmaceutical applications. They possess superior solvent
characteristics for lipophilic actives, an advantageous dietary profile, and high stability against stress factors and ageing.

Chemical Description / Monograph Name:

• Ch.P.: Medium-Chain Triglycerides, NMPA Registration: F20230000391
• Ph. Eur. / B.P. (current version): Triglycerides, Medium-Chain
• USP (current version): Medium-Chain Triglycerides
• MIGLYOL® 812 N also available as API Grade: NMPA registration Y20190009085; CEP R1-CEP 2012-410

Description:

MIGLYOL® 812 N is a triglyceride ester of saturated caprylic and capric fatty acids, made from plant-based raw materials. MIGLYOL® 812 N is a clear, virtually colorless, low viscosity liquid with a neutral odor and taste.

Major considerations for using MCTs as drug carriers:

Solubilization capacity: MCTs are highly lipophilic compounds, meaning they have a strong affinity for
other lipophilic molecules, including many APIs. This property allows MCTs to solubilize and stabilize
lipophilic APIs, enhancing their bioavailability.

Low viscosity: MCTs typically have a low viscosity compared to other oils and fats. This characteristic
makes them suitable for formulating liquid and semi-solid dosage forms such as oral solutions,
suspensions, emulsions and topical creams, where easy dispersion and administration are desired.

Rapid absorption: MCTs are metabolized differently than long chain triglycerides (LCTs). They are
absorbed directly into the portal circulation without the need for bile salts or pancreatic enzymes.
This rapid absorption can lead to faster delivery of the API to systemic circulation, potentially improving
the onset of action and overall efficacy of the pharmaceutical product.

Stability: MCTs are generally stable under various processing and storage conditions. They have a low
susceptibility to oxidation, which helps maintain the stability and shelf-life of pharmaceutical formulations
containing MCTs as carriers for APIs.

Compatibility: MCTs are compatible with a wide range of pharmaceutical excipients and APIs. They
can be easily incorporated into various formulations without causing compatibility issues or affecting the
stability of other ingredients.

Taste and odor neutrality: MCTs are relatively neutral in taste and odor, which makes them suitable for
use in oral dosage forms where palatability is important. They can mask the unpleasant taste or odor of
certain APIs, improving patient acceptance and compliance.

Biodegradability and safety: MCTs are metabolized by the body into ketone bodies or utilized as a
source of energy, making them readily biodegradable. They are generally regarded as safe (GRAS) for use
in pharmaceutical formulations and have a low risk of adverse effects when administered orally or topically