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Medium-Chain Triglyceride Excipient | Uses, Suppliers, and Specifications

Medium Chain Triglycerides is a non-volatile oil obtained from palm endosperm or coconuts. It consists of a mixture of triglycerides of saturated fatty acids, mainly of caprylic acid (C10H16O2) and of capric acid (C10H20O2), and is supplied  as a colourless or slightly yellowish, oily liquid that is practically odourless and tasteless.

Pharmacopoeial Compliance: USP-NF; Ph.Eur; J.P; B.P; I.P

Synonyms and Trade Names: Medium-Chain Triglycerides; Triglycerides, Medium-Chain; MCT; MCT Oil; Caprylic/Capric Triglyceride; Glyceryl Tricaprylate/Caprate; Captex® 300; Crodamol® GTCC-PN; Labrafac® CC; Miglyol® 810; Miglyol® 812; Neobee® M5; Nesatol®; Waglinol® 3/9280

Uses and Applications: Emulsifying Agent; Solvent; Suspending Agent; and Therapeutic Agent

Universal product match by Pharmacentral.com

MIGLYOL® 812 N - IOI Oleo GmbH

WITARIX® MCT 60/40 - IOI Oleo GmbH

Captex™ Medium Chain Triglycerides - Abitec Corporation

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Labrafac™ Lipophile WL1349 - Gattefossé

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Description

Medium-chain triglycerides is a type of lipid material composed of a Glycerol backbone to which are bound three fatty acids. The fatty acids have different numbers of carbon atoms which form the respective aliphatic tails. Medium-chain triglycerides are naturally present in  many foods, but mainly coconut oil, palm kernel oil, butter, milk, yoghurt and cheese. Coconut and palm kernel represent the richest sources, and with the former containing 60-70%% Medium-chain triglycerides.

The excipient-grade Medium-chain triglycerides, is however, prepared by fractional distillation of coconut and palm kernel oils, both of which are respectively extracted from the hard, dried fraction of the endosperm of Cocos nucifera L. or from the dried endosperm of Elaeis guineensis Jacq. The fatty acids are subsequently re-esterified to produce highly defined Medium-chain triglycerides.

The European Pharmacopoeia specifies the nature of Medium-chain triglycerides in terms of plant source and composition of saturated fatty acids. The total amount of saturated fatty acids must not be less than 95% while concentrations of specific saturated fatty acids are as follows: ≤2.0% caproic acid (C6), 50-80% caprylic acid (C8), 20-50% capric acid (C10), ≤3.0% lauric acid (C12), and ≤1.0% myristic acid (C14).

A key difference between Medium-chain triglycerides and long-chain triglycerides is that upon ingestion, Medium-chain triglycerides are quickly digested and do not require chylomicron formation for absorption and transport, and instead, they travel directly to the liver bypassing the hepatic portal system. This allows for quicker utilisation as an energy source, and is the basis upon which Medium-chain triglycerides are used clinically and experimentally in health and disease management.

Medium-chain triglycerides exists as a colourless or slightly yellowish oily liquid that is practically odourless and tasteless. It solidifies at about 0 oC.

 

Chemical Structure & Identifiers

 


Chemical Name Caprylic/Capric Acid Triglyceride
CAS Registration Number [73398-61-5]]
Empirical Formula C10H16O2 and C10H20O2
Molecular weight ≈500
EC Number 277-452-2
UNII Code C9H2L21V7U

 

Regulatory Status

Medium-chain triglycerides is an approved excipient and is listed in the USP-NF, Ph.Eur, and JP. It is also GRAS listed and included in the FDA Inactive Ingredients Database (topical preparations). Medium-chain triglycerides is approved for use in a variety of pharmaceutical formulations including oral, parenteral, and topical products, and is generally regarded as essentially nontoxic and non-irritant material.

 

Physicochemical Properties

Acid value ≤ 0.1
Cloud point ≤ 5 0C – 10 0C
Color ≤ 60 – 100 (Hazen colour index)
Density 0.94-0.96g/cm3 at 200C
Freezing point -5 0C
Hydroxyl value ≤8
Iodine number ≤ 0.5 – 1.0
Moisture content ≤ 0.15% – 0.15% w/w
Peroxide value ≤ 1.0
Refractive index 1.44 -1.450 at 20 °C
Saponification value 325 —365
Solubility Soluble in all proportions at 20 0C ethanol, miscible with long-chain hydrocarbons and triglycerides; practically insoluble in water
Surface tension 31.0 – 33 mN/m at 200C
Viscosity (dynamic) 20 – 35 mPa s between 20 and 250C

 

Pharmacopeoeal Specifications

Test Specification Reference
Identification A, B, C, D USP-NF/PhEur
Characters Colourless or slightly yellowish oily liquid USP-NF/PhEur
Appearance +
Alkaline impurities ³0.15ml of HCl
Relative density 0.93 – 0.96 USP-NF/PhEur
Refractive index 1.440 – 1.452 USP-NF/PhEur
Viscosity 25 – 33 mPas USP-NF/PhEur
Acid value ≤0.2% USP-NF/PhEur
Hydroxyl value ≤1.0% USP-NF/PhEur
Iodine value ≤1.0% USP-NF/PhEur
Peroxide value ≤1.0 USP-NF/PhEur
Saponification value ≤0.5% USP-NF/PhEur
Unsaponifiable matter ≤0.5% USP-NF/PhEur
Composition Caproic acid ≤2%; Caprylic acid 50-80%; Capric acid 20-50%; Lauric acid ≤3%; Myristic acid ≤1% USP-NF/PhEur
Heavy metals 10ppm USP-NF/PhEur
Water 0.2% USP-NF/PhEur
Total ash 0.1% USP-NF/PhEur
Chromium 0.05ppm USP-NF/PhEur
Copper 0.1ppm USP-NF/PhEur
Lead 0.1ppm USP-NF/PhEur
Nickel 0.1ppm USP-NF/PhEur
Tin 0.1ppm USP-NF/PhEur

 

Applications in Pharmaceutical Formulations or Technology

Medium-chain triglycerides is an emulsifying agent; solvent; suspending agent, and therapeutic agent. It has been used in a variety of pharmaceutical, food and cosmetic formulations including oral, parenteral, and topical preparations.

In oral formulations, Medium-chain triglycerides is used as the base for the preparation of oral emulsions, microemulsions, self- emulsifying systems, solutions, or suspension of drugs that are unstable or insoluble in aqueous media, e.g. calciferol. Medium-chain triglycerides has also been investigated as intestinal-absorption enhancers and have additionally been used as a filler in capsules and sugar-coated tablets, and as a lubricant or antiadhesion agent in tablets.

In parenteral formulations, Medium-chain triglycerides is similarly been used in the production of emulsions, solutions, or suspensions intended for intravenous administration. In rectal formulations, it has been used in the preparation of suppositories containing labile materials. In cosmetics and topical pharmaceutical preparations, Medium-chain triglycerides is used as a component of ointments, creams, and emulsion.

Therapeutically, Medium-chain triglycerides is used as nutritional agents. Diets containing medium-chain triglycerides are used in conditions associated with the malabsorption of fat, such as cystic fibrosis, since medium-chain triglycerides arc more readily digested than long-chain triglycerides. Medium-chain triglycerides has been particularly used in total parenteral nutrition (TPN) regimens in combination with long chain triglycerides.

Medium-chain triglycerides has a number of advantages in pharmaceutical formulations, which include better spreading properties on the skin; no impedance of skin respiration; good penetration properties; good emollient and cosmetic properties; no visible film on the skin surface; good compatibility; good solvent properties; and good stability against oxidation.

 

Safety and Precautions

Medium-chain triglycerides is generally regarded as a safe and non-toxic material. In acute toxicology studies in animals and humans, no irritation or other adverse reactions have been observed; for example, when they were patch-tested on more than 100 individuals, no irritation was produced on either healthy or eczematous skin. Medium-chain triglycerides are not irritating to the eyes. Similarly, chronic toxicology studies in animals have shown no harmful adverse effects associated with Medium-chain triglycerides following inhalation or intraperitoneal, oral, and parenteral administration.

In humans, administration of 0.5 g/kg body-weight medium- chain triglycerides to healthy individuals produced no change in blood or serum triglycerides compared to subjects receiving the same dose of the long-chain triglyceride, Triolein.

In patients consuming diets based on Medium-chain Triglycerides, adverse effects reported include abdominal pain and diarrhoea.

LD50 (mouse, IV): 3.7g/kg

LD50 (mouse, oral): 29.6 g/kg

LD50 (rat, oral): 33.3 g/kg

 

Stability and Storage Conditions

Medium-chain triglycerides is stable over the wide range of storage temperatures that can be experienced in tropical and temperate climates. However, it should be stored at temperatures not exceeding 25 °C and not exposed to temperatures above 40 °C for long periods. The material should be protected from light in a well-filled and well-dosed container. At very low temperatures, samples of Medium-chain triglycerides may become viscous or solidify. When this occurs, solidified material should therefore be well melted and mixed before use, although overheating is best avoided. When stored dry, in sealed containers, medium-chain triglycerides remain stable for many years.

In the preparation of microemulsions and self-emulsifying systems, emulsions, or aqueous suspensions in which Medium-chain triglycerides is used, care should be taken to avoid microbiological contamination of the preparation, since lipase-producing microorganisms, which become active in the presence of moisture, can cause hydrolysis of the triglycerides. Hydrolysis of the triglycerides is revealed by the characteristic unpleasant odour of free medium- chain fatty acids.

Medium-chain triglycerides may be sterilized by maintaining at 170 oC for I hour. When handling the product, you should observe precautions appropriate to the circumstances and quantity of material handled.

 

Sustainability and Environmental Impact

A sustainability score has not yet been assigned for Medium-chain triglycerides by the Excipients Forum. However, it must be noted that palm oil, one of the main raw materials for the production of Medium chain triglycerides, is mostly grown in Indonesia and Malaysia, a region with large areas of rainforest home to tigers, orangutans and other species. Some sustainability experts consider the palm oil industry unsustainable and a threat to world’s forests, wildlife and climate. Coconut-based Medium-chain triglycerides offers a more sustainable alternative since it poses less stress on the climate than palm oil.

 

Manufacturers & Suppliers

IOI Oleo GmbH

  • Miglyol® 812 N
  • Miglyol® 810 N
  • Witarix® 60/40 MCT

 

Gattefossé SAS

  • Labrafac™ Lipophile WL 1349

 

Abitec Corporation

  • Captex® Medium-Chain Triglycerides

 

Croda Inc.

  • Crodamol GTCC-PN

 

Additional Resources (Downloads)

References and Literature Used

[1] R.G. Strickley, Solubilizing excipients in oral and injectable formulations, Pharmaceutical Research, 21 (2004) 201-230.

[2] P.M. Hedberg, T. Skantze, L. Von Corswant, P. Lindfors, A. Zackrisson, U. Olsson, Aqueous dispersion comprising stable nonoparticles of a water-insoluble active and an excipient like middle chain triglycerides (mct), Google Patents, 2005.

[3] J.D.R. Schulze, D.A.I. Ashiru, M.K. Khela, D.F. Evans, R. Patel, G.E. Parsons, M.D. Coffin, A.W. Basit, Impact of formulation excipients on human intestinal transit, Journal of Pharmacy and Pharmacology, 58 (2006) 821-825.

[4] S. Fernandez, V. Jannin, J.-D. Rodier, N. Ritter, B. Mahler, F. Carrière, Comparative study on digestive lipase activities on the self emulsifying excipient Labrasol®, medium chain glycerides and PEG esters, Biochimica et Biophysica Acta (BBA)-Molecular and Cell Biology of Lipids, 1771 (2007) 633-640.

[5] S. Savić, C. Weber, M.M. Savić, C. Müller-Goymann, Natural surfactant-based topical vehicles for two model drugs: Influence of different lipophilic excipients on in vitro/in vivo skin performance, International Journal of Pharmaceutics, 381 (2009) 220-230.

 

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