title: Comparison of physical and inhalation properties of spray-dried and micronized terbutaline sulphate.
abstract: Terbutaline sulphate particles, for use in dry powder inhaler formulations, were prepared by spray-drying, using a Büchi 190 mini spray dryer. Spray-drying conditions were chosen to allow the production of spray-dried terbutaline sulphate with a size similar to micronized terbutaline sulphate, that is to say about 2.9 microm of volume mean diameter. The physical properties and in vitro inhalation behaviour of micronized and spray-dried terbutaline sulphate were compared. X-ray diffraction, DSC, SEM and laser size analysis were investigated. Spray-dying produced spherically shaped particles with amorphous structure. After blending with different lactoses, adhesion and aerodynamic properties were investigated. Evaluation of adhesion was carried out with a mechanical sieve and an Alpine air-jet sieve. The adhesion of terbutaline sulphate on the lactoses tested was lower in the case of the spray-dried drug. Aerodynamic evaluation of fine particle dose and emitted dose was conducted using a twin stage impactor. The emitted doses and the fine particle doses were higher with the spray-dried terbutaline sulphate. The Alpine air-jet sieve assays showed that there was a correlation between drug separation from a carrier by sieving and that obtained from longer in vitro deposition studies. There was a linear relationship between the adhesion characteristics and the fine particle dose.
authors.affiliation: Laboratoire de Pharmacotechnie Industrielle, Faculté des Sciences Pharmaceutiques et Biologiques, Université de Lille, Lille Cedex, France.
authors.forename: Thanh Huong Hoang
authors.initials: TH
authors.lastname: Thi
authors.forename: Florence
authors.initials: F
authors.lastname: Danède
authors.forename: Marc
authors.initials: M
authors.lastname: Descamps
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Flament
mesh_terms: D000280:Administration, Inhalation; D000336:Aerosols; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D003890:Desiccation; D004337:Drug Carriers; D007785:Lactose / Q000737:chemistry; D009330:Nebulizers and Vaporizers; D010316:Particle Size; D011208:Powders; D013499:Surface Properties; D013678:Technology, Pharmaceutical / Q000379:methods*; D013726:Terbutaline / Q000008:administration & dosage / Q000737:chemistry*; D000267:Tissue Adhesions
chemical_list: D000336:Aerosols; D001993:Bronchodilator Agents; D004337:Drug Carriers; D011208:Powders; D007785:Lactose; D013726:Terbutaline