Real-time particle size and particle quantitative determination of spray bursts for MDIs (Metered Dose Inhaler), nebulizers and DPIs
Benefits
Description
Application
Benefits
Measuring range 0.2 – 40 μm (3 measuring ranges selectable in one device)
Very high temporally resolved particle size and particle quantity determination down to 10 ms
Concentration range up to 107 particles/cm3
Characterization of a single spray burst in a few seconds
Rapid determination of size distributions and concentrations
Calibration, cleaning and lamp replacement can all be performed independently by the customer
Extensive, practically-oriented and user-friendly software
Low maintenance
Simple operation
Reliable function
Reduces your operating expenses
Description
Inas® is the only measurement system in the world that also reliably and reproducibly determines the particle size and particle quantity of individual spray bursts from inhalers with a temporal resolution of 10 ms and in concentrations up to 107 particles/cm3 .
It is based on the counting measurement method, the welas®
digital white light aerosol spectrometer and therefore guarantees very good particle size resolution and very good particle size classification accuracy (ISO 21501-1).
The Inas® 100 is equipped with the welas® 2070 sensor and a dilution unit and can be operated with variable suction volume flows of up to 100 l/min. The volume flow is set using a mass flow (measurement of MDIs and nebulizers).
With dynamic suction controlled by the differential pressure (measurement of DPIs), the suction is controlled using a critical nozzle. The established Copley breathing simulator (TPK 2000 with Copley Suction Pump HCP 5) is used for this purpose. This is a long established method in pharmaceutical research used in combination with cascade impactors (e.g. NGIs).
The so-called "Throat" is used as the aerosol inlet in accordance with the Pharmacopoeia. This simulates the separation of particles in the throat. The inhaler (DPI) is inserted in the Throat and the measurement is performed automatically. The Copley Preseperator is used between the throat and the aerosol spectrometer. This separates out the large particles (> 50 μm) that serve as the carrier for the active substance. The Copley TDK 2000 is connected before the HCP5 Copley Suction Pump to simulate different breaths.
In addition, the Inas® 100 system has a powerful processor that allows the course of a measurement to be determined with regard to concentration and other distribution parameters, such as the Sauter diameter, in the particle size range 0.2 - 40 µm.
The evaluation of the measured data for the determination of particle size distributions is exclusively based on unambiguous, mathematically reproducible algorithms. Several spray bursts can be displayed and compared in a graph.
The schematic structure of Inas® 100 is presented in Figure 1:
Figure 1: The schematic structure of Inas® 100
Graph 1*: The time course measured with Inas® of the number concentration and the mass-related X50 and X 90 value Inas of a single MDI spray burst (Respimat® Soft Inhaler, Boehringer Ingelheim) in 100 ms resolution
In contrast with a cascade impactor, with Inas® 100 a measurement can be performed in seconds and this can be immediately evaluated with a resolution down to 10 ms (see Graph 1). Compared with the laser diffractor, the Inas® 100 also measures the concentration of the aerosol and smallest particles with the highest accuracy.
The good agreement of the particle size determination with other measurement methods has been determined by the Pharmaceutical Institute of the Christian Albrecht University in Kiel (Germany). Graph 2 shows the size distributions measured with the Inas® 100 as compared with measurement using a cascade impactor (NGI) and laser diffractor.
Graph 2*: Comparison of mass-related sum distributions measured with the NGI impactor (MSP Corp., USA), the Helos laser diffractor (Sympatec GmbH, Germany) and the Inas® light-scattering spectrometer (Palas® GmbH, Germany) of a nano suspension nebulized with the Pari LC Plus (Pari GmbH, Germany).
On the basis of these special properties of the Inas® 100, the quality assurance of inhalers or the development of nozzle systems for various active substances can be carried out economically, reproducibly and convincingly.
The particle sizes and quantities of MDIs, DPIs and nebulizers can be determined in minutes at different temperatures, e.g. when stored in the car in summer or winter as compared with room temperature or with different breaths.
[*Source: "Entwicklung von Aufgabesystemen zur Charakterisierung pharmazeutischer Aerosole mit einem optischen Partikelzähler" (translation: "Development of sampling systems for characterization of pharmaceutical aerosols with an optical particle counter", Maren
Kuhli, doctoral theses at the Faculty of Mathematics and Natural Sciences Christian Albrecht University, Kiel (Germany)]
Application
Characterization of spray and nebulizer nozzles
Characterization of inhalation aerosols in accordance with the European Pharmacopoeia with 15 l/min, 30 l/min or variable flow rates
Characterization of inhalation aerosols in accordance with the European Pharmacopoeia with variable flow rates up to 100 l/min controlled by the differential pressure
Measurement of MDIs, nebulizers and PDIs
To enquire about the Inas® 100 Inas® system and the options available contact us now.
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