Granulation methods are used in the pharmaceutical sector to enlarge and densify small powder particles into larger ones, typically to improve powder flow so that the material can be processed effectively and efficiently into solid dosage forms. In addition, granulation methods are important for “locking in” the API within the formulation, thereby reducing the risk of segregation. Granulated material is attained by direct size enlargement of primary particles or size reduction from dry compacted material (1).
The emerging field of peptide and protein therapeutics is responsible for a new therapeutic era. Peptides are attractive therapeutic molecules due to their high specificity and potency. Peptides biodegrade into nontoxic or low toxicity metabolites, with minimal potential for drug–drug interactions and low immunogenicity compared to larger proteins. These advantages are reflected in a regulatory approval rate of more than 20% probability, which is double that of small molecules. The average number of new candidates entering clinical evaluation every year has steadily increased from 1.2 per year in the 1970s to 4.6 per year in the 1980s, 9.7 per year in the 1990s, and 16.8 per year in the 2000s.
The application of a coating layer on a tablet is a commonly used technique to selectively control tablet characteristics. [...]
This case study describes the implementation of process analytical technology on the cultivation process step of a whole-cell vaccine against whooping cough disease
