Pediatric Product Development

Want to talk with our experts about your pediatric or geriatric product development challenges?

We provide specialized drug product development for pediatric and geriatric populations. We offer a full range of multiparticulate technologies, as well as chewable and orally disintegrating tablet options, and expertise in taste and odor masking. Our integrated solutions provide for API, drug product intermediates and specialized drug products from feasibility to commercial manufacture.

Driven by regulatory requirements in North America and Europe, pediatric product development continues to increase rapidly. Development must take into account the patient sub-populations within the pediatric spectrum, from neo-natal to late teenage groups. Pediatric product development must also take into account the needs of the care giver, (e.g. ease of administration), as well as the patient.

Lipid multiparticulates (LMPs) are versatile drug delivery systems that offer flexibility in both drug release and final dosage form. The wide variety of available matrices and formulation approaches make LMPs amenable to a broad range of targeted release kinetics and delivery strategies.

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Applying Visual Techniques to the Product Design of Lipid Multiparticulates

Our approach for pediatric applications

Our product development teams appreciate the significant challenges in defining problem statements and developing formulation strategies for pediatric applications:

Physiology, pharmacology and toxicology can differ from adults
Disease patterns and trajectories can differ
Individualized dosing regimens, by age, body weight, etc., are required
Excipients restricted to those with proven safety in pediatric patients with limited / immature ADME
Immature swallowing function limits choice of dosage form
Taste, odor and palatability must be acceptable to facilitate administration

Some of these formulation challenges, such as ease of administration and swallowing issues, are equally applicable to the geriatric population. Additionally, stability and ease of transport can be critical to supplying patient populations in developing areas of the world.

We therefore take a rational design approach in developing viable formulations for these specialized populations:

We have found that multiparticulate (MP) technologies can typically meet the diverse requirements of specialized patient therapies. MP approaches are highly flexible in terms of meeting target product profiles and formulation requirements, and are frequently the most appropriate approach for designed drug products for specialized patient populations.

When oral solid dosing is preferred, the final choice between orally dissolving tablets, chewable tablets and MP technology is based on multiple factors, including dose loading required, spectrum of pediatric patients targeted, degree of taste/odor masking needed, and commercial objectives.