Making Medicines Baby Size: The Challenges in Bridging the Formulation Gap in Neonatal Medicine

International Journal of Molecular Sciences

David Clapham¹  Grazia Caivano²  Marisa Pertile²  Hannah Batchelor³  Anthony Nunn⁴  Fiona O’Brien⁵  Kamelia Krysiak⁵  Peter Field⁶  Catherine Tuleu⁶ 

[1] 14 Tailors, Bishops Stortford CM23 4FQ, UK;Chiesi Farmaceutici S.p.A. Largo Francesco Belloli 11/A—43122 Parma, Italy;College of Medical and Dental Sciences, Institute of Clinical Sciences, University of Birmingham, Birmingham B15 2TT, UK;Department of Women’s and Children’s Health, University of Liverpool, Liverpool Women’s Hospital, Liverpool L8 7SS, UK;School of Pharmacy, Royal College of Surgeons in Ireland, 111 St Stephens Green Dublin 2, Ireland;University College London School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK;

关键词: neonates;    formulation;    product development;    formulation development;    oral;    parenteral;    topical;    inhaled;    intra nasal;    biopharmaceutics;    administration;    excipient;    NICU;    device;    medication error;    dosage form;   

DOI  :  10.3390/ijms20112688

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown