Cambrex
March 16, 2023
Pharmaceutical companies are looking to pediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. The desire to develop pediatric dosage forms (PDFs) of drugs with existing adult indications has two main drivers: (1) the US Food and Drug Administration’s (FDA’s) role in limiting off-label use in pediatric patients, which aligns with the FDA’s role in ensuring the safety and efficacy of approved products for all patients; and (2) sustaining revenue growth through ...
Pharmaceutical companies are looking to pediatric indications
of approved adult dosage forms (ADFs) to sustain and fuel
growth. The desire to develop pediatric dosage forms (PDFs)
of drugs with existing adult indications has two main drivers: (1)
the US Food and Drug Administration’s (FDA’s) role in limiting
off-label use in pediatric patients, which aligns with the FDA’s
role in ensuring the safety and efficacy of approved products for
all patients; and (2) sustaining revenue growth through pediatric
exclusivity that typically adds 180 days of intellectual property
protection and thus almost 6 additional months of branded drug
sales, which in some cases could translate to billions of dollars in
revenue.
#scale-up #manufacturing #pediatric drug development #dosage form
Adare Pharma Solutions
Oct. 20, 2022
Taste masking, combined with swallowability and palatability, are integral considerations for oral drug formulations; ensuring both as part of a drug product’s final formulation can serve to increase patient acceptability and adherence to the therapy, which in turn can bolster regulatory acceptance and commercial potential.
Adare Pharma Solutions
Oct. 6, 2022
To address the challenges of pediatric formulations, specialized technology platforms are often needed to provide ease of application and improve patient outcomes.