title: The formulation, chemical and physical characterisation of clarithromycin-based macrolide solution pressurised metered dose inhaler.
abstract: OBJECTIVE
  The formulation of a clarithromycin (CLA) pressurised metered dose inhalers (pMDIs) solution formulation opens up exciting therapeutic opportunities for the treatment of inflammation in chronic obstructive lung diseases. In this study, we have formulated and tested a low dose macrolide formulation of CLA for treatment of inflammation and studied its physicochemical and aerosol properties.
  
  
  METHODS
  The system was characterised for in-vitro aerosol performance using an Andersen cascade impactor. Short-term chemical and physical stability was assessed by dose content uniformity over a range of temperatures. Standard physicochemical characteristics were also investigated using scanning electron microscopy, thermo analysis and laser diffraction techniques.
  
  
  RESULTS
  The formulation had a relatively high fine particle fraction (47%) and produced a particle size distribution suitable for inhalation drug delivery. Particles had an irregular morphology and were predominately amorphous. Furthermore, the short-term stability showed the formulation to be stable from 4 to 37°C.
  
  
  CONCLUSIONS
  This study demonstrated the feasibility of formulating a solution-based pMDI containing CLA for the treatment of lung inflammatory diseases.
authors: Department of Life Sciences and Biotechnology, University of Ferrara, Ferrara, Italy.
authors: Alessandro
authors: A
authors: Saadat
authors: Bing
authors: B
authors: Zhu
authors: Mehra
authors: M
authors: Haghi
authors: Gregory
authors: G
authors: King
authors: Gaia
authors: G
authors: Colombo
authors: Paul M
authors: PM
authors: Young
authors: Daniela
authors: D
authors: Traini
mesh_terms: D000280:Administration, Inhalation; D000335:Aerosol Propellants; D000336:Aerosols; D002626:Chemistry, Pharmaceutical; D017291:Clarithromycin / Q000008:administration & dosage* / Q000627:therapeutic use; D016503:Drug Delivery Systems; D004355:Drug Stability; D018942:Macrolides / Q000008:administration & dosage / Q000627:therapeutic use; D036501:Metered Dose Inhalers; D010316:Particle Size; D011014:Pneumonia / Q000188:drug therapy*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D012996:Solutions
chemical_list: D000335:Aerosol Propellants; D000336:Aerosols; D018942:Macrolides; D012996:Solutions; D017291:Clarithromycin
keywords: clarithromycin; cosolvent; lung infection; macrolides; pressurised metered dose inhaler