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Showing posts tagged as : #pediatric drug development

Feature article

Cambrex

March 16, 2023

Pediatric dosage forms: Rising demand for pediatric dosage forms requires reformulation and development expertise but also to-scale manufacturing capabilities

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

Feature article

Adare Pharma Solutions

Oct. 20, 2022

Taste Masking 101: Optimize Taste and Improve Patient Outcomes

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.

#drug formulation #pediatric drug development #dosage form

Feature article

Adare Pharma Solutions

Oct. 6, 2022

Formulation Considerations for Pediatric Populations: Finding the Right Dosage Form for Better Adherence

To address the challenges of pediatric formulations, specialized technology platforms are often needed to provide ease of application and improve patient outcomes.

#drug formulation #pediatric drug development #dosage form

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