A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms
Journal Title: The AAPS Journal - Year 2013, Vol 15, Issue 4
Abstract
Despite the fact that a significant percentage of the population is unable to swallow tablets and capsules, these dosage forms continue to be the default standard. These oral formulations fail many patients, especially children, because of large tablet or capsule size, poor palatability, and lack of correct dosage strength. The clinical result is often lack of adherence and therapeutic failure. The American Association of Pharmaceutical Scientists formed a Pediatric Formulations Task Force, consisting of members with various areas of expertise including pediatrics, formulation development, clinical pharmacology, and regulatory science, in order to identify pediatric, manufacturing, and regulatory issues and areas of needed research and regulatory guidance. Dosage form and palatability standards for all pediatric ages, relative bioavailability requirements, and small batch manufacturing capabilities and creation of a viable economic model were identified as particular needs. This assessment is considered an important first step for a task force seeking creative approaches to providing more appropriate oral formulations for children.
Authors and Affiliations
Anne Zajicek, Michael J. Fossler, Jeffrey S. Barrett, Jeffrey H. Worthington, Robert Ternik, Georgia Charkoftaki, Susan Lum, Jörg Breitkreutz, Mike Baltezor, Panos Macheras, Mansoor Khan, Shreeram Agharkar, David Douglas MacLaren
Keywords
Related Articles
- EP ID EP681149
- DOI 10.1208/s12248-013-9511-5
- Views 86
- Downloads 0
Critical ligand binding reagent preparation/selection: When specificity depends on reagents
Throughout the life cycle of biopharmaceutical products, bioanalytical support is provided using ligand binding assays to measure the drug product for pharmacokinetic, pharmacodynamic, and immunogenicity studies. The spe...
Pilot Investigation on Long-Term Subcutaneous Microdialysis: Proof of Principle in Humans
Reliable drug concentration measurements at the target site are increasingly demanded and can be achieved by microdialysis. The aim of this pilot study was to demonstrate the proof of principle of long-term subcutaneous...
In Vitro Lipolysis Data Does Not Adequately Predict the In Vivo Performance of Lipid-Based Drug Delivery Systems Containing Fenofibrate
The present study investigated the utility of in vitro lipolysis performance indicators drug solubilization and maximum supersaturation ratio (SRM) for their predictive use for the in vivo performance in a minipig model....
Optimizing targeted gene delivery: Chemical modification of viral vectors and synthesis of artificial virus vector systems
In comparison to classical medicines, gene therapy has the potential to mediate the highest possible level of therapeutic specificity. Every normal or diseased cell can switch on or off a gene expression cassette in a ti...
Synergistic Antibiotic Combination Powders of Colistin and Rifampicin Provide High Aerosolization Efficiency and Moisture Protection
The online version of this article (doi:10.1208/s12248-013-9537-8) contains supplementary material, which is available to authorized users.