The influence of carrier roughness on adhesion, content uniformity and the in vitro deposition of terbutaline sulphate from dry powder inhalers.
The aim of this study was to establish a correlation between carrier characteristics and the dispersibility of drug from the blend. The influence of the roughness of a commonly used carrier material, lactose monohydrate, on the adhesion, dose uniformity, and aerodynamic properties of a model drug, terbutaline sulphate was investigated. Evaluation of adhesion was carried out with a mechanical sieve and an Alpine air-jet sieve. For the characterisation of lactose roughness, we used image analysis software. Aerodynamic evaluation of fine particle dose and emitted dose was obtained using a twin stage impinger. The study with the mechanical sieve demonstrated that at least 60% of drug adheres to lactose. The Alpine air-jet sieve assays showed there was a correlation between drug separation from a carrier by sieving and that obtained from longer in vitro deposition studies. Adhesion, blend homogeneity and stability are related to the surface roughness of the lactose used as carrier. There is a linear relationship between the parameters "fine particle fraction" and "roughness". A compromise between homogeneity and drug liberation must be found: a certain roughness is necessary to allow for drug adhesion and blend homogeneity, but if too high it will prevent drug liberation after inhalation.
Flament
Marie-Pierre
MP
Laboratoire de Pharmacotechnie Industrielle, Faculté des Sciences Pharmaceutiques et Biologiques, 3 rue du Professeur Laguesse, Lille 59006, France. mpflamen@phare.univ-lille2.fr
Leterme
Pierre
P
Gayot
Anne
A
D000268:Adhesiveness; D000280:Administration, Inhalation; D004337:Drug Carriers; D004339:Drug Compounding; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry; D007785:Lactose / Q000737:chemistry; D009330:Nebulizers and Vaporizers; D010316:Particle Size; D011208:Powders; D013726:Terbutaline / Q000008:administration & dosage / Q000737:chemistry*
D004337:Drug Carriers; D005079:Excipients; D011208:Powders; D007785:Lactose; D013726:Terbutaline