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LMPs consist of spherical, smooth 50- to 300-µm particles, typically with embedded drug substance. They are produced by a continuous spinning-disk process, amenable to fluid-bed coating for ultimate control of drug release.
Bioavailability can be improved through drug solubilization (full or partial) in an LMP matrix or through the addition of amphiphilic excipients to promote solubilization in the GI tract.
Crystalline drugs facilitate good drug chemical stability and high drug loadings, and yield immediate- and extended-release functionality for even hydrophilic drugs. Taste-masking can be achieved through the encapsulation of the API in a lipid matrix and further enhanced with functional capsule delivery.
Various excipients, alone and in combination, are used to tailor functionality, providing:
The range of excipients with which LMP functionality can be tailored is represented below:
|Fatty alcohols||Cetyl alcohol, Stearyl alcohol|
|Fatty acids||Stearic acid, Palmitic acid|
|Polyglycerol fatty acid esters||Tetraglycerol pentastearate (TGPS), Tetraglycerol monostearate (TGMS)|
|Glycerol fatty acid esters||Glyceryl monostearate, Glyceryl monobehenate, Glyceryl behenate, Glyceryl palmitostearate, Glyceryl ditristearate, Glyceryl tripalmiate, Glyceryl tristearate|
|Hydrogenated fatty acid esters||Hydrogenated hardened castor oil|
|Polar waxes||Complex mixture containing, e.g. esters of acids and hydroxyacids|
|Others||Saturated polyglycolized glycerides, Beeswax, Paraffin wax, Cholesterol, Phospholipids, Microcrystalline wax|
LMPs have market precedence and are produced using a simple melt-spray-congeal (MSC) process, which is solvent-free but does accommodate the use of surfactants, if desired.
LMP production scales at our Bend, Oregon, site range from laboratory scale (20 gram to 1 kg) to clinical / pilot / launch scale (1 kg to 100 kg). Commercial-scale LMP production is being installed at our Greenwood, South Carolina, production site and will be on line in the 4th quarter of 2014.