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Pediatric formulation development - Challenges of today and strategies for tomorrow: Summary report from M-CERSI

David Cheng Thiam Tan1, Yuet Mei Khong1, Steven Mount2

  • 1AbbVie Inc., North Chicago, IL, United States.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|April 20, 2021
PubMed

Insights

This workshop addressed pediatric formulation development challenges and strategies. Key discussions covered drug acceptability, excipients, analytical methods, clinical considerations, and regulatory differences for pediatric drug products.

Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Science
  • Pediatric Medicine

Background:

  • A workshop convened experts from academia, industry, and regulatory bodies (U.S. Food and Drug Administration [FDA], International Consortium for Innovation and Quality in Pharmaceutical Development [IQ]) to discuss pediatric formulation development.
  • The event focused on current challenges and future strategies in creating safe and effective medications for children.

Purpose of the Study:

  • To summarize key discussions and outcomes from a multi-disciplinary workshop on pediatric formulation development.
  • To identify and review critical aspects of pediatric drug formulation, including acceptability, excipients, analytical testing, clinical considerations, and regulatory landscapes.

Main Methods:

  • The workshop featured sequential sessions on formulation, analytical, clinical, and regulatory aspects of pediatric drug development.
  • Each session included framing presentations, facilitated breakout groups, and panel discussions to foster multi-stakeholder input.

Main Results:

  • Discussions highlighted the importance of drug product acceptability, pediatric-specific excipients, and oral device considerations in formulation.
  • Key analytical strategies for mini-tablets and dosing vehicle selection were explored, alongside the influence of pharmacokinetic predictions on formulation design.
  • Regulatory differences across regions and patient-centric factors for novel pediatric formulations were examined, alongside potential collaborations.

Conclusions:

  • The workshop provided a comprehensive overview of current pediatric formulation development challenges and proposed strategies for future advancements.
  • Collaboration and a focus on patient-centric factors are crucial for overcoming regulatory hurdles and improving pediatric drug accessibility.

Keywords:
AcceptabilityChildrenClinicalDeviceDosing vehiclesExcipientsMini-tabletsMultiparticulatesPediatric formulationsRegulatory

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