title: Investigation on the aerosol performance of dry powder inhalation hypromellose capsules with different lubricant levels.
abstract: HPMC capsules are made by a dipping process and a surface lubricant for the mould pins is an essential processing aid for removing dried capsules shells. For the purpose of this study, the level was determined by quantifying methyloleate (MO) a component found in the lubricant but not in the hypromellose capsules. Here we investigated the influence of the lubricant, low (10.81 μg/capsule=60 mg/kg MO), medium (15.97 μg/capsule=90 mg/kg MO) and high (23.23 μg/capsule=127 mg/kg MO) content on powder (binary mixture of salbutamol: lactose, 1:50 w/w) aerosolization properties was investigated. Results indicated significantly lower emitted dose from capsules with 60 mg/kg MO. Furthermore, the 90 and 127 mg/kg MO level of lubricant capsules produced almost double the Fine Particle Dose & Fine Particle Fraction compared with the low level of lubricant. The data indicates that lubricant level within capsules has an influence on deposition profiles and amount of drug remaining in capsule and inhaler device after actuation. It is suggested lubricant levels greater than 60 mg/kg MO per capsule are required to minimise powder retention within capsules and maximise deposition profiles. AFM (atomic force microscopy) data suggest that internal surface roughness may be related with this phenomena.
authors.affiliation: School of Pharmacy & Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, UK. Electronic address: i.saleem@ljmu.ac.uk.
authors.forename: I Y
authors.initials: IY
authors.lastname: Saleem
authors.affiliation: Qualicaps Europe, S.A.U., Calle de la Granja 49, 28 108, Alcobendas, Madrid, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Diez
authors.affiliation: Qualicaps Europe, S.A.U., Calle de la Granja 49, 28 108, Alcobendas, Madrid, Spain.
authors.forename: B E
authors.initials: BE
authors.lastname: Jones
authors.affiliation: Mass Spectrometry Centre, Faculty of Chemistry, Complutense University of Madrid, Madrid, Spain.
authors.forename: N
authors.initials: N
authors.lastname: Kayali
authors.affiliation: Mass Spectrometry Centre, Faculty of Chemistry, Complutense University of Madrid, Madrid, Spain.
authors.forename: L
authors.initials: L
authors.lastname: Polo
mesh_terms: D000336:Aerosols; D000420:Albuterol / Q000737:chemistry; D002214:Capsules; D058995:Dry Powder Inhalers; D065347:Hypromellose Derivatives / Q000737:chemistry*; D007785:Lactose / Q000737:chemistry; D054327:Lubricants / Q000032:analysis / Q000737:chemistry*; D009829:Oleic Acids / Q000032:analysis / Q000737:chemistry*
chemical_list: D000336:Aerosols; D002214:Capsules; D054327:Lubricants; D009829:Oleic Acids; C005576:methyl oleate; D065347:Hypromellose Derivatives; D007785:Lactose; D000420:Albuterol
keywords: Atomic force microscopy (AFM); Dry powder inhalation; Hypromellose (HPMC) capsules; Inhaler; Lubricant