Lidose® is the denomination of a hard gelatine capsule with
liquid or semi-liquid contents, which is the result of mixing of active
ingredient and selected lipidic excipients. This mixture has the propriety of melting at body temperature although
the two individual ingredients melt at a higher temperature (eutectic
mixture).
The drug is simply mixed with the melted excipient where it disperses
or disolves. The mixture is then filled into hard gelatine capsules and
then cooled under specific and constant conditions.
This technology offers the possibility to use hard gelatine capsules for
applications such as :
- low dosing substances so as to obtain a uniform blend.
- unstable light, air or humidity sensitive substances.
- slightly soluble drugs so as to obtain a solid dispersion (ex: peptide).
S.M.B. exports products based on Lidose® technology in more than 15 countries on the 5 continents.
Lidose® is a trademark of S.M.B.
Main advantages of S.M.B.’s lidose capsule :
- Greater tolerability especially for NSAIDs
- Less risk of gastric irritation
- Rapid absorption
- Better protection of the active ingredient against oxidation
- Suprabioavailable properties (increased bioavailibility between 20% and 80%)
- Less food dependence
- Lower variability of inter-subject absorption
Example : Fenofibrate
It is suggested that Lidose® technology improves the safety/efficacy
profile of the active ingredient by offering a lower fluctuation of inter-subject
plasma profiles in comparison with the comparator capsule.
The suprabioavailability properties of Lidose® formulation
is due to the superior dissolution of the active ingredient in the mass
(I.e : electronic micrograph of Fenofibrate 200mg Lidose® versus
a micronized formulation).
Electronic micrograph of Fenofibrate 200 mg Lidose®Vs.
Fenofibrate 200 mg Micronized Caps
The electronic
micrographs of Fenofibrate 200 Caps and Fenofibrate 200 Lidose®
were obtained using the environmental scanning electronic microscopy (ESEM).
They confirm the finely micronised structure of the powder.
The mapping of the chloride anion (Cl-), representative of Fenofibrate,
allows to localize the repartition of the active ingredient in the Fenofibrate
200 Caps formulation. It appears that some areas of the samples contain
more Fenofibrate than others, suggesting a non optimal homogeneity of
the active ingredient in the formulation. Indeed, the Fenofibrate particles
seem to be more localised on the surface of the coarse particles.
The ESEM pictures obtained on Fenofibrate 200 Lidose® have
been performed on a transversal slide of the capsule. The mapping of the
chloride anion allows to observe a very homogeneous repartition of Fenofibrate
in the mass of excipients and no coarse crystals of Fenofibrate are observed.
This suggests that the process of manufacturing and the galenic form of
Fenofibrate 200 Lidose® lead to a very homogeneous formulation
of Fenofibrate.
