Understanding the Complexities of Paediatric Drug Development and Manufacturing
Bringing a paediatric drug product to the marketplace can be very complex and also incredibly important as it increases the limited treatment options available for children, especially for niche and novel medications. The formulation development and manufacturing of paediatric medications poses unique challenges compared to that of adult medications. Developing safe, effective, and age-appropriate drug formulations for children requires a careful consideration of factors such as taste, dosage form, dosing accuracy, and palatability. Adhering to strict guidelines and best practices in the manufacturing process enables pharmaceutical companies to ensure that their paediatric patient is receiving the medication exactly as intended. Exploring the key challenges encountered in the formulation development and manufacturing of paediatric medications enables us to address and continually improve the healthcare outcomes of children.
Paediatric medications prompt a very specific set of challenges. They are required to reach across a broad age and developmental range, must be easy to swallow correctly, while being palatable to the patient, as well as being administered with ease at the point of care. Hence, these medications have very stringent guidelines that regulate their development, manufacturing, and packaging. Having the knowledge and expertise to navigate the regulatory complexities is therefore essential to making sure that when the drug product reaches the marketplace it can be held to the highest quality, integrity, and safety standards.
One of the significant challenges in paediatric formulation development is ensuring palatability and taste masking. As children are often sensitive to taste, this can create difficulties in administering medications due to their aversion to bitter and unpleasant flavours. Ensuring that medications are palatable is also crucial in supporting adherence and compliance and foster treatment plan effectiveness. Making use of various techniques such as flavouring, sweeteners, or encapsulation to mask the bitterness and enhance palatability is therefore essential. However, the taste masking techniques can be complex and may affect the stability and bioavailability of the medication.
To establish the suitability and effectiveness of a medication such as mini tablets, formulation scientists must conduct food-drug interaction studies. Food exposure assessments covering the dose range are carried out for multiple exposure times, mimicking in-use practices performed by parents and guardians. Carrying out this research is vital in establishing the effect that the food has had on the physical structure, assay, impurity and dissolution profile of a medicine. These studies should be carried out on new and aged mini tablets, demonstrating consistent characteristics throughout the shelf life of the drug to ensure effectiveness. In addition, the formulations must consider factors such as age-appropriate flavours, allergies, and other potential interactions. Finding the right balance between effectiveness, safety, and palatability is essential in paediatric medication development.
The paediatric patients span a wide age range, from newborns to adolescents, each with unique anatomical and physiological characteristics. Ensuring the safety and effectiveness of medications across various age groups requires extensive testing to account for all the developmental differences and side effects that can occur. As children’s bodies metabolise drugs differently at various stages of their development, formulation scientists need to have a thorough understanding of age-specific pharmacokinetics and pharmacodynamics.
