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

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Feature article

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 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

Introduction


Many of today’s largest pharma companies have selected Cambrex to reformulate their products and develop them in a variety of dosage forms appropriate for use in pediatric patients. Companies have come to rely on Cambrex as a trusted partner to provide specialized contract development and manufacturing services that meet the regulatory requirements of the US, Canada, and Europe, where Cambrex already manufactures PDFs for commercial sale through its customers. As a result of a growing industry trend, Cambrex has a Pediatric Center of Excellence to meet the growing demand for PDFs and to develop and manufacture dosage forms for pediatric indications. In support of its Pediatric Center of Excellence, Cambrex has developed the infrastructure, process trains, and equipment needed for efficient, cost-effective, and rapid production of small- to medium-scale cGMP clinical drug products that are used in pediatric clinical studies.


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