In contrast to classic single-unit dosage forms such as tablets, the dosage of the drug substance in multi-particulate systems is divided on a plurality of subunits – typically consisting of
thousands of spherical pellet particles with a diameter of between 100 and 2,000 μm. This means that non-disintegrating, monolithic single-unit forms retain their structure in the digestive tract,
whereas the multi-particular preparations consist of numerous sub-units which disperse after administration. Each single sub-unit then acts as an individual modified release entity. As a consequence
of this property, the multiple-unit approach offers certain advantages as a modified release dosage form over preparations such as tablets, including:
Several creative options can be explored that result in intelligent, sophisticated and reliably acting pharmaceutical dosage forms.The question is: do we have feasible technologies that can establish reproducible product and process quality?
- Reduced variability of gastric emptying
- Reduced dependency on the nutrition state
- Minimised risk of high local drug concentrations within the gastrointestinal (GI) tract
- Reduced risk of sudden dose-dumping
- Lower intra- and inter-individual variability
- Controlled onset time of drug release
- Delivery of the active ingredient to distal sites within the GI tract
Several creative options can be explored that result in intelligent, sophisticated and reliably acting pharmaceutical dosage forms.The question is: do we have feasible technologies that can establish reproducible product and process quality?