MilliporeSigma

Little Patients, Big Challenges: Developing Pediatric Formulations

From safety considerations to kid-friendly dosing, we can help you get your pediatric formulation right.


Pediatric Formulations

Developing formulations specifically for infants and children is increasingly important. Over time, it has become clear that it’s not enough to simply reduce the dosage to age and weight – in the development of age-appropriate medicines, different physiological characteristics and needs must be considered. In addition, there are high demands on patient compliance: for example, palatability has to be addressed during the development process and optimized child-friendly dosage forms are required. From syrups to orally dispersible mini-tablets to films, our products help you to develop high-quality formulations.

Pediatric pharmaceuticals: Safety first

New regulatory requirements aiming to improve little patients’ safety must also be taken into account and implemented throughout the manufacturing process, particularly with regard to impurities such as diethylene glycol in common formulation components.

OFFERING HIGH-QUALITY EXCIPIENTS AND APIS IN LINE WITH CURRENT REGULATORY REQUIREMENTS

To help you master these challenges effectively, we offer an extensive portfolio of well-established high-quality excipients and active pharmaceutical ingredients (APIs) for pediatric pharmaceutical formulations that are proven in practice. Mask bitter tasting APIs with neotame and sucralose from our sweetener toolbox. Meet new regulatory requirements to mitigate risks of diethylene glycol and ethylene glycol contamination with our glycerol, propylene glycol and sorbitol products used in liquid formulations. And make use of our Parteck® range of functional excipients to develop robust solid formulations. For our APIs, we offer a comprehensive regulatory documentation and support you throughout your registration process.

BENEFITS OF OUR EXCIPIENTS AND APIs FOR PEDIATRIC FORMULATIONS

  • Multi-compendial products to meet international quality standards
  • Life impacting APIs including folates for a wide range of pediatric applications
  • Well established excipients manufactured under IPEC-PQG GMP and APIs manufactured under ICH Q7 guidelines
  • Global regulatory support throughout your journey:
    • Regulatory e-submissions offered for APIs to efficiently support your drug product marketing authorization
    • Diethylene glycol and ethylene glycol declaration in accordance with US FDA industry guideline
  • Our Emprove® Program facilitates qualification, risk assessment, and process optimization to speed to market

APIs, Vitamins and Folates

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Related Resources

  • Liquid Formulation Strategies

    Explore a variety of excipient solutions that address small molecule liquid formulation challenges and requirements.

  • Solid Formulation Strategies

    Challenges such as API stability, release kinetics, and bioavailability have made the manufacturing of solid formulation pharmaceuticals more difficult, particularly given pressures to reduce costs and optimize process efficiency. Learn how new solutions and expert partnership can overcome these challenges.

  • Download: Formulation Handbook

    Formulating pharmaceutical dosage forms: In this formulation handbook, we have compiled information and formulation examples that can help you when developing your formulation.

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