Pediatric Formulation and Product Development

The development of acceptable, palatable pediatric formulations is a key feature within industry today, driven by patient needs and regulatory requirements.

Quotient and our subsidiary businesses Co-Formulate and QS Pharma have extensive, complementary capabilities which enable us to provide a unique integrated development solution.

  • Formulation development

Our scientists have considerable experience of developing palatable formulations in the OTC/consumer healthcare industry which has been successfully applied to develop customized pediatric pharmaceutical formulations.

  • Taste masking

We have an extensive track record of developing age-appropriate dosage forms of aversive, bitter drug substances using a range of taste-modifying and taste-masking techniques without compromising on product stability and pharmacokinetic performance. 

  • Taste assessment and PK studies

Using our integrated GMP manufacturing and clinical testing platform we perform rapid, adaptive trials in humans to optimize taste attributes and/or PK performance to ensure clinical validation prior to proceeding to pivotal pediatric trials. 

  • Global patient clinical supplies 

We manufacture, package, release and supply GMP drug products ready for dosing on a worldwide basis, in line with study and recruitment needs.  Flexibility is key, ranging from a personalized, per-patient basis or via more traditional batch manufacturing.

  • Commercial manufacture 

Our production facilities in Philadelphia are fully inspected and approved by FDA, EMA, PDMA and DEA and specialize in low volume products.

  • PIP/PSP regulatory support 

We can support regulatory processes for Pediatric Investigation Plans and Pediatric Study Plans.

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pediatric formulation