Characterisation and functionality of inhalation anhydrous lactose.

The relationships between the physicochemical properties and functionality in dry powder inhaler (DPI) performance was investigated for inhalation grade anhydrous lactose and compared to monohydrate grades. The excipients were characterised using a range of techniques including particle size analysis, moisture sorption and powder rheometry. The inhalation anhydrous lactose grades were readily characterisable. The aerosolisation performance of capsule based DPI formulations containing budesonide (200microg) and different grades of lactose evaluated using inertial impaction measurements produced fine particle doses of budesonide ranging from 24 to 49microg. There were no apparent relationships between aerosolisation performance and excipient characteristics, such as particle size and powder density. However, formulations containing lactose grades which exhibit higher powder fluidisation energy values resulted in higher fine particle doses of budesonide.

[1]  A. Hickey,et al.  Signal Processing and Analysis Applied to Powder Behavior in a Rotating Drum , 1999 .

[2]  H. Steckel,et al.  Alternative sugars as potential carriers for dry powder inhalations. , 2004, International journal of pharmaceutics.

[3]  D. Papadopoulos,et al.  Physical characterization of component particles included in dry powder inhalers. I. Strategy review and static characteristics. , 2007, Journal of pharmaceutical sciences.

[4]  Antonio Castellanos,et al.  The relationship between attractive interparticle forces and bulk behaviour in dry and uncharged fine powders , 2005 .

[5]  J. Valverde,et al.  Fine cohesive powders in rotating drums: Transition from rigid-plastic flow to gas-fluidized regime. , 2002, Physical review. E, Statistical, nonlinear, and soft matter physics.

[6]  A. Hickey,et al.  Dry powder inhaler formulation. , 2005, Respiratory care.

[7]  D. Papadopoulos,et al.  Physical characterization of component particles included in dry powder inhalers. II. Dynamic characteristics. , 2007, Journal of pharmaceutical sciences.

[8]  Matthew D. Jones,et al.  Predicting the behavior of novel sugar carriers for dry powder inhaler formulations via the use of a cohesive-adhesive force balance approach. , 2006, Journal of pharmaceutical sciences.

[9]  P. Young,et al.  The influence of relative humidity on particulate interactions in carrier-based dry powder inhaler formulations. , 2002, International journal of pharmaceutics.

[10]  R L Carr,et al.  EVALUATING FLOW PROPERTIES OF SOLIDS , 1965 .

[11]  S. K. Tee,et al.  The use of different sugars as fine and coarse carriers for aerosolised salbutamol sulphate. , 2000, International journal of pharmaceutics.

[12]  G. P. Martin,et al.  The use of different grades of lactose as a carrier for aerosolised salbutamol sulphate. , 1999, International journal of pharmaceutics.

[13]  C. Lerk,et al.  Alterations of α-Lactose During DifferentialScanning Calorimetry , 1984 .

[14]  Stephen Edge,et al.  Factors Affecting Defining the Quality and Functionality of Excipients Used in the Manufacture of Dry Powder Inhaler Products , 2008 .

[15]  Antonio Ramos,et al.  The tensile strength of cohesive powders and its relationship to consolidation, free volume and cohesivity , 1998 .

[16]  R. Jackson,et al.  The Dynamics of Fluidized Particles , 2000 .

[17]  Matthew D. Jones,et al.  The Influence of Fine Excipient Particles on the Performance of Carrier-Based Dry Powder Inhalation Formulations , 2006, Pharmaceutical Research.

[18]  John N. Staniforth,et al.  Enhancement of Small Particle Size Dry Powder Aerosol Formulations using an Ultra Low Density Additive , 1999, Pharmaceutical Research.

[19]  Matthew D. Jones,et al.  An investigation into the relationship between carrier-based dry powder inhalation performance and formulation cohesive-adhesive force balances. , 2008, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[20]  Reg Freeman,et al.  Measuring the flow properties of consolidated, conditioned and aerated powders — A comparative study using a powder rheometer and a rotational shear cell , 2007 .

[21]  M. Hussain,et al.  Form conversion of anhydrous lactose during wet granulation and its effect on compactibility. , 2008, International journal of pharmaceutics.

[22]  Matthew D. Jones,et al.  The Role of Fines in the Modification of the Fluidization and Dispersion Mechanism Within Dry Powder Inhaler Formulations , 2008, Pharmaceutical Research.