The formulation development of melatonin (MLT) for infants and children with neurodevelopmental difficulties was fully investigated. This population have a higher prevalence of sleep disorders and present special challenges for drug administration and swallowing. To solve these issues, solid lipid microparticles (SLMs) were designed to obtain an oral flexible dosage form constituted by GRAS excipients and a free flow pulsatile delivery system for MLT, able to maintain its release through 8 hours. Three groups of SLMs were produced by spray congealing and characterized as regards particle size, morphology, flowability, solid state, drug content and release behavior. The SLMs manipulation with milk and yogurt and the MLT stability in these foods was also investigated. Microparticles with different excipient composition were selected to obtain a pulsatile release pattern over 8 hours. The final delivery platform displayed a prompt release from group I SLMs together with a lag phase of groups II and III SLMs, followed by a repeated MLT release from group II and a prolonged MLT release related to the last group. Finally, MLT was compatible and stable in milk and yogurt suggesting that microparticles sprinkled into food is acceptable for MLT administration to children unable to swallow capsules or tablets.

Formulating SLMs as oral pulsatile system for potential delivery of melatonin to pediatric population / Beatrice Albertini;Marcello Di Sabatino;Cecilia Melegari;Nadia Passerini. - In: INTERNATIONAL JOURNAL OF PHARMACEUTICS. - ISSN 0378-5173. - STAMPA. - 469:(2014), pp. 67-79. [10.1016/j.ijpharm.2014.04.055]

Formulating SLMs as oral pulsatile system for potential delivery of melatonin to pediatric population

ALBERTINI, BEATRICE;MELEGARI, CECILIA;PASSERINI, NADIA
2014

Abstract

The formulation development of melatonin (MLT) for infants and children with neurodevelopmental difficulties was fully investigated. This population have a higher prevalence of sleep disorders and present special challenges for drug administration and swallowing. To solve these issues, solid lipid microparticles (SLMs) were designed to obtain an oral flexible dosage form constituted by GRAS excipients and a free flow pulsatile delivery system for MLT, able to maintain its release through 8 hours. Three groups of SLMs were produced by spray congealing and characterized as regards particle size, morphology, flowability, solid state, drug content and release behavior. The SLMs manipulation with milk and yogurt and the MLT stability in these foods was also investigated. Microparticles with different excipient composition were selected to obtain a pulsatile release pattern over 8 hours. The final delivery platform displayed a prompt release from group I SLMs together with a lag phase of groups II and III SLMs, followed by a repeated MLT release from group II and a prolonged MLT release related to the last group. Finally, MLT was compatible and stable in milk and yogurt suggesting that microparticles sprinkled into food is acceptable for MLT administration to children unable to swallow capsules or tablets.
2014
Formulating SLMs as oral pulsatile system for potential delivery of melatonin to pediatric population / Beatrice Albertini;Marcello Di Sabatino;Cecilia Melegari;Nadia Passerini. - In: INTERNATIONAL JOURNAL OF PHARMACEUTICS. - ISSN 0378-5173. - STAMPA. - 469:(2014), pp. 67-79. [10.1016/j.ijpharm.2014.04.055]
Beatrice Albertini;Marcello Di Sabatino;Cecilia Melegari;Nadia Passerini
File in questo prodotto:
Eventuali allegati, non sono esposti

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/279514
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? 9
  • Scopus 25
  • ???jsp.display-item.citation.isi??? 25
social impact