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Tablets & Capsules March 2019 13 formulations to support for development and commer- cialization, making product development quicker, cheaper, and more efficient while also increasing the probability of regulatory and technical success. Prioritizing the patient As with all patients, children need safe and effective medicines; but the challenges of developing appropriate pediatric SODFs are significant. Overcoming those chal- lenges remains an important goal for the industry and requires that companies carefully consider and investigate how drugs behave in children at different stages of physi- cal development and the manner in which the product delivers the drug to the patient. A pediatric dosage form must ensure maximum effi- cacy while offering the greatest level of acceptability to both children and their caregivers. Research pioneers and formulation experts should collaborate and use every available tool and technology to effectively and efficiently develop new drug products in this area, so children will have access to the next generation of potentially life-saving treatments. T&C Uwe Hanenberg is director of product development, science, and technology; Pascale Clement is director of project manage- ment; and William Wei Lim Chin is technical specialist at Catalent (877 587 1835, www.catalent.com). sweeteners and flavors to more advanced techniques such as complexation with ion-exchange resin and cyclodextrin, polymer-film coating, hot-melt coating, spray congealing, melt extrusion, or melt granulation. An outsourcing partner with a broad toolkit of formu- lation technologies can help the developer consider the many options and find a product's optimal dosage form. However, even after establishing the dosage form, there must be flexibility within that form to ensure that the patient receives the correct dose of medication. This is relatively straightforward for liquid formula- tions or soluble powders—simply adjust the dose by dis- pensing a different volume. The situation is less simple for an SODF. One approach is to create several conven- tional formulations in different dosage strengths, although this may bring about changes to the formula- tion. Another alternative would be to use a counting device filled with mini-tablets to dispense the appropriate number needed to meet the prescribed dose. Collaborative approaches to pediatric drug development Commercial outsourcing partners are taking the initia- tive to address the specific challenges of pediatric formu- lation and drug delivery, and a number of cross-industry consortiums have been created for this purpose. In 2017, for example, the Catalent Applied Drug Delivery Institute, which brings together medical physicians and experts from academia, pharmaceutical research, and technology innovation, entered into a collaboration with the department of pharmacy practice at Rutgers University to undertake further research into the devel- opment and administration of medicines to children. In the UK, the Smart Paediatric Drug Development consortium (SPaeDD-UK) includes a number of aca- demic and industry partners with the goal of establishing an industry standard framework and suite of tools to develop safe and efficacious pediatric dosage forms. The project will provide novel predictive analytical and in-sil- ico tools to help companies select the most appropriate Photo 2: No single solution exists for successful pediatric formulation, so having access to a broad range of expertise and drug development technologies can help companies overcome the numerous challenges and shorten the development process.