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Paediatric Formulation: Design and Development
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The development of paediatric medicines can be challenging since this is a different patient population with specific needs. A medicine designed for use in paediatric patients must consider the following aspects: patient population variability; the need for dose flexibility; route of administration; patient compliance; excipient tolerability. For example, the toxicity of excipients may differ in children compared to adults and children have different taste preferences. Globally, about 75% of drugs do not carry regulatory approval for use in children; worldwide, many medications prescribed for the treatment of paediatric diseases are used off-label, and less than 20% of package inserts have sufficient information for treating children. This book provides an update on both state-of-the-art methodology and operational challenges in paediatric formulation design and development. It aims at re-evaluating what is needed for more progress in the design and development of age-appropriate treatments for paediatric diseases, focusing on: formulation development; drug delivery design; efficacy, safety, and tolerability of drugs and excipients.
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Keywords
- acceptable
- Administration
- age-related
- anakinra
- autoinflammatory disease
- bioavailability
- Biopharmaceutics
- canakinumab
- Child
- Children
- chronic myeloid leukemia
- confocal microscopy
- cyclodextrin inclusion complex
- dasatinib
- Design
- Design of experiments
- Development
- device
- dosage form
- Drug delivery
- Duchenne muscular dystrophy
- edible films
- excipient
- flavor profile
- formulation
- formulation development
- grinding
- imatinib
- inhaled
- innovative biotechnologies
- Interleukin-1
- intra nasal
- Kawasaki disease
- liquid formulation
- medication error
- medicine
- modified release
- neglected tropical diseases
- neonates
- NICU
- nilotinb
- Norvir®
- oral
- Orodispersible formulation
- paediatric
- paediatric age
- paediatric dosage forms
- paediatric formulation development
- palatability assessment
- palatable
- parenteral
- pediatric
- pediatric age
- pediatric drug delivery
- Pediatrics
- Penetration
- personalized medicine
- phase solubility studies
- polymorph
- ponatinib
- poorly soluble compound
- poorly water soluble drug
- product development
- pyrazinamide
- retinoblastoma
- ritonavir
- solubility enhancement
- spray congealing
- systemic juvenile idiopathic arthritis
- taste-masking
- topical
- topotecan
- Tuberculosis
- tumorspheres
- Tyrosine kinase inhibitors
Links
DOI: 10.3390/books978-3-0365-0741-5Editions