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RESEARCH PRODUCT

Statistical tools and control of internal lubricant content of inhalation grade HPMC capsules during manufacture

Rafael Martín-portuguésFernando DíezB.e. JonesJuan Ramiro-aparicioGuillermo AyalaMaría T. Gassó

subject

Dry powder inhaler (DPI)Materials scienceChemistry PharmaceuticalPharmaceutical ScienceNanotechnologyCapsulesOleic Acids02 engineering and technology030226 pharmacology & pharmacy03 medical and health sciences0302 clinical medicineHypromellose DerivativesAdministration InhalationAerodynamic diameterHPMC capsulesLubricantskin and connective tissue diseasesLubricantsFactorial modelModels StatisticalInhalationDry Powder Inhalers021001 nanoscience & nanotechnologyHypromellose DerivativesDry-powder inhalerbody regionsAerosolizationInternal lubricantLinear models0210 nano-technologyMATEMATICA APLICADABiomedical engineeringParticle fraction

description

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. (C) 2016 Elsevier B.V. All rights reserved.

yearjournalcountryeditionlanguage
2016-04-01
10.1016/j.ijpharm.2016.02.017