Pellet Technology
HiGlance existing plant has a manufacturing capacity of 150 Metric Ton pellets annually (Immediate/ Controlled Release).
HiGlance Pelleting Technology and Processes
Pellet (or bead) technology allows a variety of different drug delivery profiles to be achieved by coating a ‘core’ of drug and excipient with various polymers. The drug cores are generally spheroidal in shape and have a diameter in the range of 300 to 1,700 µm. In order to generate the spheroidal particles, there are two main types of processes used:
- The first, extrusion granulation, granulates API with excipients, which is extruded to form a core then coated by polymers. This process allows drug potencies up to 90%.
- The second process is known as spheronization, where drug particles are fixed to the outside of a seed core, typically sugar, with the aid of a binder. The core is coated with a polymer. This process provides a very tight size distribution of pellets. Drug potencies up to 60% are possible.
The drug delivery system is then achieved by coating these particles with a polymer coat. Depending on the type of polymers used various release profiles can be achieved such as sustained-, targeted- or pulsed-release.
Controlled Release Delivery System
HiGlance specializes in the formulation and production of technologies that permit controlled-release of active pharmaceutical ingredients (APIs) in pellets. We focus on all drugs in pellet form achieving a highly desired physicochemical and pharmacokinetic profile, which ensures finely controlled dosing and optimal drug efficacy.
Pellets as a dose form have many advantages including maintained blood plasma levels over entire intestinal transit time and reduced gastrointestinal (GI) side effects. Spreading the therapeutic dose over many hundreds of individual particles reduces the variability sometimes seen with larger singular dose forms (which are more susceptible to variable GI transit times). The particles generated by pellet technology are generally spheroidal in shape and can have a diameter ranging from 300 to 1,700µm. The rate and site of active drug release is dictated by specifically formulated polymer coatings applied to active drug cores that can have drug loadings of up to 90%. The controlled-release pellets can be filled into hard gelatin capsules and/or sachets, or incorporated into a compressed tablet.
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