Our approach for pediatric and geriatric applications
Our product development teams understand the challenges in defining problem statements and developing formulation strategies for pediatric and geriatric applications:
- Physiology, pharmacology and toxicology can differ
- Swallowing function limits the choice of dosage form
- Disease patterns and trajectories can differ
- Individualized dosing regimens, by age, bodyweight, etc., are required
- Taste, odor and palatability must be acceptable to facilitate the administration
- Excipients restricted to those with proven safety in pediatric patients with limited/immature ADME
Our rational design approach
We take a rational design approach in developing viable formulations for 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 designing drug products for specialized patient populations.
When oral solid dosing is preferred, the final choice between orally dissolving tablets, tablets and MP technology is based on multiple factors. These iclude dose loading required, the spectrum of pediatric and geriatric patients targeted, the degree of taste or odor masking needed and commercial objectives.
Benefit from our extensive experience with a range of proven enabling technologies, many of which have been developed or advanced by our teams:
- solid dispersions
- multiparticulates
- particle size reduction
- fixed-dose combinations
- engineered particles for inhaled applications
- modified- and targeted-release formulations
- sterile fill and finish for parenteral applications
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