title: Improving tablet coating robustness by selecting critical process parameters from retrospective data.
abstract: BACKGROUND
  Although tablet coating processes are widely used in the pharmaceutical industry, they often lack adequate robustness. Up-scaling can be challenging as minor changes in parameters can lead to varying quality results.
  
  
  OBJECTIVE
  To select critical process parameters (CPP) using retrospective data of a commercial product and to establish a design of experiments (DoE) that would improve the robustness of the coating process.
  
  
  METHODS
  A retrospective analysis of data from 36 commercial batches. Batches were selected based on the quality results generated during batch release, some of which revealed quality deviations concerning the appearance of the coated tablets. The product is already marketed and belongs to the portfolio of a multinational pharmaceutical company.
  
  
  RESULTS
  The Statgraphics 5.1 software was used for data processing to determine critical process parameters in order to propose new working ranges.
  
  
  CONCLUSIONS
  This study confirms that it is possible to determine the critical process parameters and create design spaces based on retrospective data of commercial batches. This type of analysis is thus converted into a tool to optimize the robustness of existing processes. Our results show that a design space can be established with minimum investment in experiments, since current commercial batch data are processed statistically.
authors.affiliation: a Department of Pharmacy and Pharmaceutical Technology , University of Barcelona , Barcelona , Spain and.|b Department of Pharmaceutical Technology, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain.
authors.forename: A
authors.initials: A
authors.lastname: Galí
authors.affiliation: b Department of Pharmaceutical Technology, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain.
authors.forename: E
authors.initials: E
authors.lastname: García-Montoya
authors.affiliation: a Department of Pharmacy and Pharmaceutical Technology , University of Barcelona , Barcelona , Spain and.
authors.forename: M
authors.initials: M
authors.lastname: Ascaso
authors.affiliation: b Department of Pharmaceutical Technology, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain.
authors.forename: P
authors.initials: P
authors.lastname: Pérez-Lozano
authors.affiliation: b Department of Pharmaceutical Technology, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain.
authors.forename: J R
authors.initials: JR
authors.lastname: Ticó
authors.affiliation: b Department of Pharmaceutical Technology, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain.
authors.forename: M
authors.initials: M
authors.lastname: Miñarro
authors.affiliation: b Department of Pharmaceutical Technology, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Suñé-Negre
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods* / Q000592:standards; D012189:Retrospective Studies; D013608:Tablets, Enteric-Coated / Q000138:chemical synthesis* / Q000592:standards
chemical_list: D013608:Tablets, Enteric-Coated
keywords: Coating defects; coating optimization; critical process parameters; design of experiments; design space; retrospective data