Medium chain triglyceride excipient | Uses, suppliers and specifications (2023)


Medium chain triglycerides are a type of lipid material composed of aGlycerinVertebral column to which three fatty acids are attached. Fatty acids have different numbers of carbon atoms forming their respective aliphatic tails. Medium chain triglycerides are found naturally in many foods, but most notably coconut oil, palm kernel oil, butter, milk, yogurt, and cheese. Coconut and palm kernel are the richest sources, with the former containing 60-70% medium chain triglycerides.

However, excipient grade medium chain triglycerides are produced by fractional distillation of coconut and palm kernel oils, both extracted from the dry, hard fraction of the endosperm of Cocos nucifera L. or the dry endosperm of Elaeis guineensis. Jack, respectively. The fatty acids are then re-esterified to produce highly defined medium chain triglycerides.

Heeuropean pharmacopoeiaspecifies the type of medium chain triglycerides in relation to the vegetable source and the composition of saturated fatty acids. The total amount of saturated fatty acids should not be less than 95%, while the 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 medium chain triglycerides are rapidly digested when ingested and do not require the formation of chylomicrons for absorption and transport, instead going directly to the liver bypassing the liver. the hepatic portal system. This allows for faster utilization as an energy source and is the basis on which medium chain triglycerides are used clinically and experimentally in health and disease management.

Medium Chain Triglycerides exist as a colorless to slightly yellowish oily liquid that is virtually odorless and tasteless. It freezes around 0oC.

Chemical structure and identifiers

Medium chain triglyceride excipient | Uses, suppliers and specifications (1)

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chemical nameCapril-/Caprinsäure-Triglycerides
CAS registry number[73398-61-5]]
empirical formulaC10Hsixteeno2y C10H20o2
molecular weight≈500
eg number277-452-2

regulatory status

Medium Chain Triglycerides is an approved excipient and is listed on theUSP-NF,Ph.Eurand J.P. It is alsoGRASS listedand is listed on the FDA's database of inactive ingredients (topical preparations). Medium Chain Triglycerides are approved for use in a variety of pharmaceutical formulations, including oral, parenteral, and topical products, and are generally considered essentially non-toxic and non-irritating materials.

Physicochemical properties

acid number≤ 0,1
cloud point≤ 50C-100C
Color≤ 60 – 100 (Hazen Color Index)
density0,94–0,96 g/cm3and 200C
freezing point-50C
hydroxyl solution≤8
iodine number≤ 0,5 – 1,0
moisture content≤ 0,15 % – 0,15 % p/p
peroxido≤ 1,0
refractive index1,44 -1,450 a 20°C
solubilitySoluble in all proportions at 200C-Ethanol miscible with long chain hydrocarbons and triglycerides; practically insoluble in water
surface tension31.0 – 33 mN/m to 200C
Viscosity (dynamic)20 – 35 mPa s between 20 and 250C

Pharmacopeia Specifications

charactersColorless or slightly yellowish oily liquidUSP-NF/PhEur
alkaline contaminants³0,15ml HCl
Relative density0,93 – 0,96USP-NF/PhEur
refractive index1.440 – 1.452USP-NF/PhEur
goo25 – 33 mPasUSP-NF/PhEur
acid number≤0,2 %USP-NF/PhEur
hydroxyl solution≤1,0 %USP-NF/PhEur
iodine value≤1,0 %USP-NF/PhEur
Verseifungswert≤0,5 %USP-NF/PhEur
unsaponifiable matter≤0,5 %USP-NF/PhEur
compositioncaproic acid ≤ 2%; caprylic acid 50-80%; capric acid 20-50%; lauric acid ≤ 3%; myristic acid ≤1%USP-NF/PhEur
heavy metals10 ppmUSP-NF/PhEur
Agua0,2 %USP-NF/PhEur
total ashes0,1 %USP-NF/PhEur
chrome0,05 ppmUSP-NF/PhEur
copper0,1 ppmUSP-NF/PhEur
lead0,1 ppmUSP-NF/PhEur
Nickel0,1 ppmUSP-NF/PhEur
Zinn0,1 ppmUSP-NF/PhEur

Applications in formulations or pharmaceutical technologies

Medium chain triglycerides are emulsifiers; Solvent;suspending agent, Ytherapeutic 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 are used as a base for the preparation of oral emulsions, microemulsions, self-emulsifying systems, solutions or suspensions of drugs that are unstable or insoluble in aqueous media, e.g. calciferol. Medium-chain triglycerides have also been studied as enhancers of intestinal absorption and have also been used as a bulking agent in capsules and dragees and as a lubricating or anti-adherent agent in tablets.

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

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Medium chain triglycerides are used therapeutically as dietary supplements. Diets containing medium chain triglycerides are used in conditions associated with fat malabsorption, such as cystic fibrosis, because medium chain triglycerides are more easily digested than long chain triglycerides. In particular, medium chain triglycerides have been used in total parenteral nutrition (TPN) regimens in combination with long chain triglycerides.

Medium chain triglycerides have a number of advantages in pharmaceutical formulations, including better spreadability on the skin; no impediment to skin breathing; good penetrating properties; good softening and cosmetic properties; no visible film on the skin surface; good compatibility; good solvent properties; and good oxidation stability.

Safety and Precautions

Medium Chain Triglycerides are generally considered a safe and non-toxic material. No irritation or other undesirable effects were observed in acute toxicology studies in animals and humans; For example, when patch-tested on more than 100 people, they did not cause irritation on healthy or eczema skin. Medium chain triglycerides do not irritate the eyes. Similarly, chronic toxicology studies in animals have not revealed harmful side effects associated with medium chain triglycerides after inhalation or intraperitoneal, oral and parenteral administration.

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

In patients on medium-chain triglyceride-based diets, reported side effects include abdominal pain and diarrhea.

LD50(Maus, IV): 3,7 g/kg

LD50(Maus, oral): 29,6 g/kg

LD50(Ratte, oral): 33,3 g/kg

Stability and storage conditions.

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

When preparing microemulsions and self-emulsifying systems, emulsions or aqueous suspensions using medium chain triglycerides, care must be taken to avoid microbiological contamination of the preparation, since lipase-producing microorganisms, which are activated in the presence of lipase-producing microorganisms, humidity, can cause hydrolysis of triglycerides. Hydrolysis of triglycerides is noted by the characteristic unpleasant odor of medium chain free fatty acids.

Medium chain triglycerides can be sterilized by keeping them at 170oC for I hour. When handling the product, you must take precautions appropriate to the circumstances and the amount of material handled.

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Sustainability and environmental compatibility

For medium chain triglycerides, the agency has not yet assigned any sustainability rating.excipients forum. However, it should be noted that palm oil, one of the main raw materials for the production of medium-chain triglycerides, is grown mainly in Indonesia and Malaysia, a region with large tracts of tropical rainforest that is home to tigers, orangutans and other species. . . Some sustainability experts consider the palm oil industry unsustainable and a threat to the world's forests, wildlife and climate. Coconut-based medium chain triglycerides offer a more sustainable alternative, as they have less of an impact on the climate than palm oil.

Manufacturers and Suppliers

IOI Audio GmbH

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

Gattefossé SAS

  • Labrafac™ Lipófilo WL 1349

Abitec Corporation

  • Captex® medium chain triglycerides

Croda Inc.

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  • Crodamol AGB-PN

Additional resources (downloads)

The use of medium chain triglycerides in gastrointestinal diseases

Review of the toxicological properties of medium chain triglycerides

Influence of formulation excipients on human intestinal transit

References and literature used

[1]RG Strickley, Solubilization of excipients in oral and injectable formulations, Pharmaceutical Research, 21 (2004) 201-230.

[2]Hedberg Hedberg, Skantze T, Von Corswant L, Lindfors P, Zackrisson A, Olsson U, Aqueous dispersion comprising stable non-particles of a water-insoluble drug and an excipient such as medium chain triglycerides (mcts), Google Patents, 2005 .

[3]JDR Schulze, DAI Ashiru, M.K. Khela, D.F. Evans, R. Patel, G.E. Parsons, M.D. Coffin, A.W. Basit, Effect 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 of digestive lipase activities with 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 skin performance in vitro/in vivo, International Journal of Pharmaceutics, 381 (2009) 220-230 .

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