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Multiparticulate Systems
Multiparticulate Systems
In multi-particulate systems the dosage of the drug substance is - in contrast to classical single-unit dosage forms - divided on a plurality of sub-units, typically consisting of thousands of spherical particles with a diameter of 0.05-2.00 mm.
Although their manufacture and design is more complex in comparison to single-unit dosage forms, multi-particulate systems offer a magnitude of differing interesting options and advantages to accomplish unique product characteristics and in particular specific drug release patterns. In contrast to single-unit forms, which retain their structure in the digestive tract, the multiparticular, i.e. multiple-unit, preparations consist of numerous sub-units, which disperse after administration. Each single sub-unit acts as an individual modified release entity. As a consequence of this property, the multiple-unit approach offers certain advantages for a modified release dosage form over single-unit, monolithic, preparations:
- Reduced variability of the gastric emptying
- As a consequence lower dependency on the nutrition state
- Minimised risk of high local drug concentrations within the GI-tract
- Reduced risk of sudden dose dumping
- Lower intra- and inter-individual variability of dissolution of the drug substance
- Lower intra- and inter-individual variability of absorption of the drug substance into the systemic circulation
- Increased residence times within the lower intestine
Glatt Pharmaceutical Services has expertise, equipment, patent protected technologies and machinery for the development and commercial manufacture of multi-particular delivery systems even for handling of large drug substance loads and potent active ingredients. |
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