title: Selection of excipient, solvent and packaging to optimize the performance of spray-dried formulations: case example fenofibrate.
abstract: BACKGROUND
  Along with other options, solid dispersions prepared by spray drying offer the possibility of formulating poorly soluble drugs in a rapidly dissolving format. As a wide range of potential excipients and solvents is available for spray drying, it is usually necessary to carry out a comprehensive array of studies to arrive at an optimal formulation.
  
  
  OBJECTIVE
  To study the influence of formulation parameters such as co-sprayed excipients, solvents and packaging on the manufacture, in vitro performance and stability of spray-dried oral drug products using fenofibrate as a model drug.
  
  
  METHODS
  Solid dispersions of fenofibrate with different amorphous polymers were manufactured from two solvent systems by spray drying. These were characterized in terms of physicochemical properties, crystalline content and dissolution behavior in biorelevant media upon production and after storage in two packaging systems (Glass and Activ-Vials(™)).
  
  
  CONCLUSIONS
  Spray drying the same formulation from two different solvents led to different physicochemical properties, dissolution behavior and long-term stability. The dissolution behavior and long-term stability also varied significantly among excipients. The viscosity of the polymer and the packaging material proved to be important to the long-term stability.
  
  
  CONCLUSIONS
  For spray-dried products containing fenofibrate, the excipients were ranked according to dissolution and stability performance as follows: PVP derivatives >> HPMC 2910/15, HPMCAS-MF, HP-β-CD >> PVP:PVA 2:8. EtOH 96% proved superior to acetone/water for spray drying with polymers. The results were used to propose a general approach to developing spray-dried formulations of poorly soluble drugs.
authors.affiliation: Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany.
authors.forename: Marc
authors.initials: M
authors.lastname: Hugo
authors.forename: Klaus
authors.initials: K
authors.lastname: Kunath
authors.forename: Jennifer
authors.initials: J
authors.lastname: Dressman
mesh_terms: D004339:Drug Compounding; D004349:Drug Packaging / Q000379:methods*; D005079:Excipients / Q000737:chemistry; D011345:Fenofibrate / Q000737:chemistry*; D000960:Hypolipidemic Agents / Q000737:chemistry*; D010316:Particle Size; D012995:Solubility
chemical_list: D005079:Excipients; D000960:Hypolipidemic Agents; D011345:Fenofibrate