MIGLYOL 812 N
Triglycerides, Medium-ChainProduct Application: Capsule,Injectables,Suspensions,Syrup,Tablet,Topical,Veterinary
Product Certification: GMP,Halal,OU Kosher
Pharmaceutical Category: Liquid lipids
MIGLYOL 812 N is part of the C8/C10 triglyceride (MCT oil) line from IOI Oleochemical. It is a triglyceride ester of saturated coconut/palm-kernel oil derived caprylic and capric fatty acids and plant derived glycerol. MIGLYOL® 812 N is a Medium-Chain Triglycerides (ratio ~ 60:40%)
IOI is the holder of the first CEP (Certificate of suitability) ever granted for a Medium-Chain Triglyceride and has filed US-DMF Type II. MIGLYOL 812 N has been used in enteral and parenteral nutrition for decades. From a regulatory point of view, the ingredients in some of these formulations are classified as API.
MIGLYOL® 812 N has the following advantages compared to edible oils:
- Low in impurities (as a result of production according to EU GMP guidelines)
- High stability against oxidation
- Liquid at 0°C
The Drug Substance version is a lipid component in parenteral nutrition. Neutral, stable, solubilizer and carrier for oil-soluble actives.
The Excipient version is a neutral, stable, penetration enhancer, drug carrier as well as solvent for oral and dermal use.
Viscosity [mPa·s] ~30 Pa·s
MIGLYOL 812 N Applications
- Tablets, dragees: Anti-sticking, polishing agents.
- Soft gelatine capsules: Chemically neutral, low-viscosity carrier oil, absorption promoter.
- Drops: Carrier, solvent, and absorption promoter.
- Suspensions, syrups: Carrier and absorption promoter for antibiotics etc.
- Aerosol products: Carrier and solvent (glycerol trinitrate etc.).
- Dietetic products & Nutraceuticals: Medium chain triglycerides (MCT) differ from natural fats (LCT). With regard to these essential properties: quick metabolism, not stored as body fat.
- Physiological caloric value = 8,2 kcal/g (34,3 kJ/g) compared with LCT = 9,2 kcal/g (38,5 kJ/g).
- Different absorption and metabolism properties: MCT is partially utilized if fat resorption disorders exist.
- Topical therapeutics – Psoriasis Treatment and Antipruritics: Readily absorbent, scale-detaching and keratin softening oil component, particularly in combination with Vitamin A.
- Ointments: Non-oxidizing, absorption-promoting, non-occlusive oil component with excellent spreadability.
- Rectal products Anti-nucleating and dispersing aid for active ingredients in Hard Fat (WITEPSOL) suppositories.
Azelis Canada is a supplier of MIGLYOL and all other Pharmaceutical lines from IOI Oleochemical. Speak with your Azelis Canada representative to find the best option for your formulation!