title: Statistical tools and control of internal lubricant content of inhalation grade HPMC capsules during manufacture.
abstract: The internal lubricant content (ILC) of inhalation grade HPMC capsules is a key factor to ensure good powder release when the patient inhales a medicine from a dry powder inhaler (DPI). Powder release from capsules has been shown to be influenced by the ILC. The characteristics used to measure this are the emitted dose, fine particle fraction and mass median aerodynamic diameter. In addition the ILC level is critical for capsule shell manufacture because it is an essential part of the process that cannot work without it. An experiment has been applied to the manufacture of inhalation capsules with the required ILC. A full factorial model was used to identify the controlling factors and from this a linear model has been proposed to improve control of the process.
authors.affiliation: Department of Statistics and O.R. University of Valencia, Avda. Vicent Andrés Estellés, 1, 46100 Burjasot, Spain. Electronic address: Guillermo.Ayala@uv.es.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Ayala
authors.affiliation: Qualicaps Europe, S.A.U., Avda. de Valdelatas 4, 28108 Alcobendas, Madrid, Spain. Electronic address: Fdiez@qualicaps.es.
authors.forename: Fernando
authors.initials: F
authors.lastname: Díez
authors.affiliation: Institute of Multidisciplinar Mathematics and Department of Mathematics Polytechnical University of Valencia, Camino de Vera s/n, 46022 Valencia, Spain. Electronic address: mgasso@mat.upv.es.
authors.forename: María T
authors.initials: MT
authors.lastname: Gassó
authors.affiliation: School of Pharmacy & Pharmaceutical Sciences, Cardiff University, Cardiff, UK. Electronic address: JBE2@cardiff.ac.uk.
authors.forename: Brian E
authors.initials: BE
authors.lastname: Jones
authors.affiliation: Qualicaps Europe, S.A.U., Avda. de Valdelatas 4, 28108 Alcobendas, Madrid, Spain. Electronic address: Rmartin-portugues@qualicaps.es.
authors.forename: Rafael
authors.initials: R
authors.lastname: Martín-Portugués
authors.affiliation: Qualicaps Europe, S.A.U., Avda. de Valdelatas 4, 28108 Alcobendas, Madrid, Spain. Electronic address: jraparicio@qualicaps.es.
authors.forename: Juan
authors.initials: J
authors.lastname: Ramiro-Aparicio
mesh_terms: D000280:Administration, Inhalation; D002214:Capsules / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D058995:Dry Powder Inhalers; D065347:Hypromellose Derivatives / Q000737:chemistry; D054327:Lubricants / Q000737:chemistry*; D015233:Models, Statistical; D009829:Oleic Acids / Q000737:chemistry
chemical_list: D002214:Capsules; D054327:Lubricants; D009829:Oleic Acids; C005576:methyl oleate; D065347:Hypromellose Derivatives
keywords: Aerosolization; Dry powder inhaler (DPI); HPMC capsules; Internal lubricant; Linear models