0000000000175190
AUTHOR
Heribert Häusler
Conditioning following powder micronization: influence on particle growth of salbutamol sulfate.
Micronization is a high-energy process that induces changes in the crystallinity of materials. As a result, the crystalline structures on the particles' surface are being destroyed and amorphous areas are formed. After micronization of salbutamol sulfate to be used in dry powder inhalers, only small amounts of amorphous material are produced. Nevertheless, even these small amounts can have important effects on the physical stability of the powder. The amorphous state is thermodynamically unstable and tends to convert to the stable, crystalline state. The recrystallization process of disordered regions on the particles' surface leads to particle growth of milled particles. In this case, brid…
High-performance liquid chromatography of lactose with evaporative light scattering detection, applied to determine fine particle dose of carrier in dry powder inhalation products
A method for quantification of the fine particle dose of lactose is described, using a hydrophilic interaction chromatography (HILIC) method and evaporative light scattering detection. The HILIC method used an aminopropyl column and a mobile phase consisting of acetonitril/water (80/20, v/v) for isocratic elution. Sensitive chromatography was obtained using a low concentration of water in the extraction solvent. The detection limit (RSD10%) at an injection volume of 10 microL is 10 microg/mL. Linearity was obtained in the range of 10-80 microg/mL (R(2)0.99). A relative standard deviation (RSD) of 0.5% (N=6) demonstrated good precision of the optimized method.
Influence of mechanical activation on the physical stability of salbutamol sulphate.
Abstract In order to obtain the optimal particle size distribution for pharmaceutical powders in dry powder inhalers the particles have to be micronised. In most cases the process of micronisation is connected with a high input of energy which induces disorder and defects on the surface of the drug particles and as a result changes in the crystallinity. Consequently, changes in the physical stability of the powders may occur. To investigate changes on the physical stability of the powder, different analytical methods are used in the present investigation: laser diffraction, Differential Scanning Calorimetry (DSC), isothermal microcalorimetry and DVS-method. Air-jet-milling is one of the mos…
Influences of heat seal lacquer thickness on the quality of blister packages.
A sealability of aluminium lidding foils against formable polymer materials of blister packages is usually achieved by a coating of aluminium with certain grammages of heat seal lacquers. To investigate influences of their thickness on quality of blister packages, lidding foils with different grammages of two lacquer types were manufactured. Sealing experiments (variation of temperature, pressure and sealing time) were performed. Sealed seam strengths were determined with mechanical tensile tests, tightness of cold form blisters were analysed by means of helium leakage tests. Time-dependent moisture uptake of stored blisters was monitored with micro-gas chromatography. By means of a simple …
Comparison of quantitative analysis techniques for the determination of heat seal lacquer layers on aluminum blister foils
For decades a gravimetric method has been common standard for the determination of heat seal lacquers on aluminum blister foils. With the availability of appropriate techniques such as interferometric, infrared reflection absorption spectroscopic (IRRAS), beta backscatter, impedance spectroscopic and eddy current techniques respectively, more efficient determinations can be foreseen which are subject of the present communication. The different methods were compared to each other regarding parameters required for validation of analytical procedures according to the ICH guidelines Q2 (R1) such as linearity, precision, accuracy, robustness and quantitation limits. The interferometric, IRRAS an…