title: Production and characterization of spray-dried theophylline powders prepared from fresh milk for potential use in paediatrics.
abstract: OBJECTIVE
  This work evaluates the potential of using fresh milk to deliver theophylline to children.
  
  
  METHODS
  Theophylline-fresh milk systems were prepared using different solids ratios (0 : 1-1 : 0) and three fat contents in commercial milks (low, medium and high), which were spray-dried at different inlet air temperatures (Tinlet- 105, 130 and 150 °C). The process was evaluated for yield and the resulting powders for moisture content (MC), particle size and shape, density and wettability. Theophylline-milk potential interactions (differential scanning calorimetry (DSC) and FT-IR) and chemical (theophylline content) and microbiological stability of powders (shelf and in-use) were also evaluated.
  
  
  RESULTS
  The production yield (13.6-76.0%), MC (0.0-10.3%) and contact angles in water (77.29-93.51°) were significantly (P < 0.05) affected by Tinlet, but no differences were found concerning the mean particle size (3.0-4.3 μm) of the different powders. The milk fat content significantly (P < 0.05) impacted on the density (1.244-1.552 g/cm3). Theophylline content remained stable after 6 months of storage, before extemporaneous reconstitution. After reconstitution in water, low-fat milk samples (stored at 4 °C) met the microbial pharmacopoeia criteria for up to 7 days. No theophylline-milk components interaction was observed.
  
  
  CONCLUSIONS
  Spray-dried milk-composed powders may be used as vehicles for theophylline delivery in paediatrics following further characterization and in-vivo evaluation.
authors.affiliation: CiiEM - Centro de Investigação Interdisciplinar Egas Moniz, Instituto Superior de Ciências da Saúde Egas Moniz, Caparica, Portugal.
authors.forename: João P
authors.initials: JP
authors.lastname: Aguiar
authors.affiliation: CiiEM - Centro de Investigação Interdisciplinar Egas Moniz, Instituto Superior de Ciências da Saúde Egas Moniz, Caparica, Portugal.
authors.forename: Tânia A P
authors.initials: TA
authors.lastname: Fernandes
authors.affiliation: iMed.ULisboa - Dep. Farmácia Galénica e Tecnologia Farmacêutica, Faculdade de Farmácia, Universidade de Lisboa, Lisboa, Portugal.
authors.forename: Carlotta
authors.initials: C
authors.lastname: Nese
authors.affiliation: CiiEM - Centro de Investigação Interdisciplinar Egas Moniz, Instituto Superior de Ciências da Saúde Egas Moniz, Caparica, Portugal.
authors.forename: Ana I
authors.initials: AI
authors.lastname: Fernandes
authors.affiliation: iMed.ULisboa - Dep. Farmácia Galénica e Tecnologia Farmacêutica, Faculdade de Farmácia, Universidade de Lisboa, Lisboa, Portugal.
authors.forename: João F
authors.initials: JF
authors.lastname: Pinto
mesh_terms: D000818:Animals; D002152:Calorimetry, Differential Scanning / Q000379:methods; D005079:Excipients / Q000737:chemistry; D008892:Milk / Q000737:chemistry*; D010316:Particle Size; D010372:Pediatrics; D011208:Powders / Q000737:chemistry*; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods; D013806:Theophylline / Q000737:chemistry*; D014867:Water / Q000737:chemistry; D017155:Wettability
chemical_list: D005079:Excipients; D011208:Powders; D014867:Water; D013806:Theophylline
keywords: extemporaneous preparation; milk; paediatrics; spray drying; theophylline