title: Multivariate Analysis of Effects of Asthmatic Patient Respiratory Profiles on the In Vitro Performance of a Reservoir Multidose and a Capsule-Based Dry Powder Inhaler.
abstract: OBJECTIVE
  The aim of this work was to evaluate the effect of two different dry powder inhalers, of the NGI induction port and Alberta throat and of the actual inspiratory profiles of asthmatic patients on in-vitro drug inhalation performances.
  
  
  METHODS
  The two devices considered were a reservoir multidose and a capsule-based inhaler. The formulation used to test the inhalers was a combination of formoterol fumarate and beclomethasone dipropionate. A breath simulator was used to mimic inhalatory patterns previously determined in vivo. A multivariate approach was adopted to estimate the significance of the effect of the investigated variables in the explored domain.
  
  
  RESULTS
  Breath simulator was a useful tool to mimic in vitro the in vivo inspiratory profiles of asthmatic patients. The type of throat coupled with the impactor did not affect the aerodynamic distribution of the investigated formulation. However, the type of inhaler and inspiratory profiles affected the respirable dose of drugs.
  
  
  CONCLUSIONS
  The multivariate statistical approach demonstrated that the multidose inhaler, released efficiently a high fine particle mass independently from the inspiratory profiles adopted. Differently, the single dose capsule inhaler, showed a significant decrease of fine particle mass of both drugs when the device was activated using the minimum inspiratory volume (592 mL).
authors.affiliation: Department of Pharmacy, University of Parma, Viale delle Scienze 27/A, 43124, Parma, Italy. francesca.buttini@unipr.it.|Institute of Pharmaceutical Science, King's College London, 150 Stamford Street, SE19NH, London, UK. francesca.buttini@unipr.it.
authors.forename: Francesca
authors.initials: F
authors.lastname: Buttini
authors.affiliation: Chiesi Farmaceutici SpA, Via Palermo 26, 43122, Parma, Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Pasquali
authors.affiliation: Chiesi Farmaceutici SpA, Via Palermo 26, 43122, Parma, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Brambilla
authors.affiliation: Chiesi Farmaceutici SpA, Via Palermo 26, 43122, Parma, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Copelli
authors.affiliation: Chiesi Farmaceutici SpA, Via Palermo 26, 43122, Parma, Italy.
authors.forename: Massimiliano Dagli
authors.initials: MD
authors.lastname: Alberi
authors.affiliation: Interdepartmental Center, Biopharmanet-TEC, University of Parma, Viale delle Scienze 27/A, 43124, Parma, Italy.
authors.forename: Anna Giulia
authors.initials: AG
authors.lastname: Balducci
authors.affiliation: Department of Pharmacy, University of Parma, Viale delle Scienze 27/A, 43124, Parma, Italy.
authors.forename: Ruggero
authors.initials: R
authors.lastname: Bettini
authors.affiliation: Chiesi Farmaceutici SpA, Via Palermo 26, 43122, Parma, Italy.
authors.forename: Viviana
authors.initials: V
authors.lastname: Sisti
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage; D002214:Capsules / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical / Q000379:methods; D058995:Dry Powder Inhalers / Q000379:methods; D005260:Female; D000068759:Formoterol Fumarate / Q000008:administration & dosage; D006801:Humans; D007320:Inspiratory Capacity / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010316:Particle Size; D010614:Pharynx / Q000187:drug effects; D011208:Powders / Q000008:administration & dosage*; D012119:Respiration / Q000187:drug effects*; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D002214:Capsules; D011208:Powders; D001507:Beclomethasone; D000068759:Formoterol Fumarate
keywords: Alberta throat; Breath simulator; Multivariate analysis; NEXThaler®; RS01