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Excipient monograph · مونوگراف ماده جانبی
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Medium-chain triglycerides
میگلیول
1Nonproprietary names
- BPMedium-chain Triglycerides
- Ph. Eur.Triglycerides, Medium-chain
- USP–NFMedium-Chain Triglycerides
2Synonyms and trade names
Caprylic/capric triglyceride; fractionated coconut oil; MCT oil; triglycerida saturata media; Captex 300; Captex 355; Crodamol GTCC; Labrafac Lipophile WL 1349; Miglyol 810; Miglyol 812; Neobee M-5
3Chemical name and CAS Registry Number
Mixture of triglycerides of saturated fatty acids, mainly caprylic (C8) and capric (C10) acids · [73398-61-5]
4Empirical formula and molecular weight
Polymer, mixture or material of variable composition — no single molecular formula applies.
5Functional category
Oleaginous vehicle
Typical concentrations: — · Dosage forms: Liquid, Semi-solid, Sterile (parenteral/ophthalmic)
6Applications in pharmaceutical formulation
Used as an oily vehicle and solvent in oral solutions and suspensions, soft gelatin capsule fills, self-emulsifying lipid formulations, topical creams and ointments, and parenteral lipid emulsions (commonly mixed with long-chain triglycerides). They are also used as emollients, lubricants and in clinical nutrition.
7Description
A colourless or slightly yellowish, practically odourless and tasteless oily liquid of low viscosity.
8Typical properties
- Fatty acid composition
- caprylic acid 50–80%, capric acid 20–50%, with small amounts of caproic, lauric and myristic acids
- Relative density
- 0.93–0.96
- Viscosity (dynamic, 20 °C)
- 25–33 mPa·s
- Refractive index
- 1.440–1.452
- Saponification value
- 310–360
- Solubility
- practically insoluble in water; miscible with ethanol, dichloromethane, light petroleum and fixed oils
9Stability and storage conditions
Because the fatty acids are saturated, medium-chain triglycerides are much more resistant to oxidation than vegetable oils. Store in a well-filled, airtight container, protected from light, at a temperature not exceeding 25 °C.
10Incompatibilities
Can soften or dissolve some plastics (for example polystyrene) and swell rubber; compatibility with containers, closures and capsule shells should be checked. Incompatible with strong oxidising agents.
11Method of manufacture
Made by esterifying glycerol with the C8–C10 fatty acid fraction obtained by hydrolysis and fractional distillation of coconut or palm kernel oil.
12Safety
Regarded as non-toxic and non-irritant. They are absorbed and oxidised more readily than long-chain fats and can be ketogenic; large oral amounts may cause gastrointestinal upset (nausea, diarrhoea, abdominal discomfort), and they should be used with caution in patients prone to ketoacidosis.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended; spills are slippery and should be cleaned up promptly.
14Regulatory status
Included in the FDA Inactive Ingredient Database (oral capsules and solutions; topical preparations) and in parenteral and non-parenteral medicines licensed in Europe.
15Related substances
Propylene glycol dicaprylocaprate; glyceryl monocaprylate; coconut oil; soybean oil; triacetin.
16Comments
Their good solvent capacity for many lipophilic drugs, low viscosity and oxidative stability make them a common first choice of oil in lipid-based oral formulations. Grade designations (for example 810 and 812) differ in the C8:C10 ratio.