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Article
Micronization and Nanoization of Active Pharmaceutical Ingredients
Author(s)
Stefan Mende
Full-Text PDF XML 1314 Views
DOI:10.17265/2159-5348/2018.03.001
Affiliation(s)
NETZSCH-Feinmahltechnik GmbH, Selb95100, Germany
ABSTRACT
More than 40% of newly discovered drugs have little or no water
solubility which presents a serious challenge to the successful development and commercialization of new drugs in the pharmaceutical industry. Additionally,
more than 90% of drugs approved since 1995 have poor solubility, poor
permeability, or both. Therefore, it may be necessary to increase the dose of a
poorly soluble drug to obtain the required efficacy which can lead to more side
effects and higher cost to the patient. Performance of drugs can be improved by
decreasing the particle size and, at the same time, increasing specific surface
area, dissolution rate and the bioavailability of the drug in the human
body.The routes of administration are different and listed as 60% for oral, 5%
for pulmonary, 5% for ocular, 5% for topical and 25% for injectable,
approximately.The injectable drugs are the most interesting ones for nanoization,
because smaller particles will increase performance, and will be useful when
using micro needles.In a typical manufacturing process of APIs (active pharmaceutical
ingredients) top down processes
like high pressure homogenization and wet bead milling are used as standard
methods to decrease the particle sizes down to a fineness range of 10 to 500
nanometers.
KEYWORDS
APIs, top down process, micronization, bioavailability, scale-up, GMP, reproducibility, IQ, OQ, FAT.
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