Abstract
The development of age-appropriate formulations should focus on dosage forms that can deliver variable yet accurate doses that are safe and acceptable to the child, are matched to his/her development and ability, and avoid medication errors. However, in the past decade, the medication needs of neonates have largely been neglected. The aim of this review is to expand on what differentiates the needs of preterm and term neonates from those of the older paediatric subsets, in terms of environment of care, ability to measure and administer the dose (from the perspective of the patient and carer, the routes of administration, the device and the product), neonatal biopharmaceutics and regulatory challenges. This review offers insight into those challenges posed by the formulation of medicinal products for neonatal patients in order to support the development of clinically relevant products.
Highlights
Neonates are not small adults, and neither can they be classified as small children when it comes to medicinal products and their formulation development.Neonates include term, post-term and preterm babies
The aim of this review is, to provide insights and factors to consider in order to assist those developing products for neonates, but with little or no neonatal medicine knowledge or paediatric formulation development background, to overcome the range of challenges posed by this patient group and so enhance the provision of clinically relevant products
Development of medicines is challenging per se, and this is even more relevant in the development of medicines for children, let alone preterm babies and neonates. When those children have such rapidly changing physiology and biopharmaceutical characteristics accompanied by critical clinical conditions and requirements, such as is the case for neonates, product development is very challenging
Summary
The neonatal period for term and post-term newborn infants is defined as the day of birth plus 27 days. The neonatal period for preterm newborn infants is defined as the day of birth through to the expected date of delivery plus 27 days [1]. Even if born at term and ready to grow outside of the mother’s womb, most organs and their functions are still immature. This immaturity of organ and function is more profound and impactful in preterm infants. Neonates have reduced gastric emptying, intestinal transit time and surface area, and transporter immaturity, which have relevance for oral drug delivery. A host of other physiological factors such as gastro intestinal (GI) pH, body surface to volume ratio, body fat to lean tissue ratio are different and are known to change rapidly with time [3]
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