Nasal Spray Accessory
The Nasal Spray Accessory provides users with the ability to reproducibly measure the droplet or particle size distributions produced by nasal drug delivery devices, as part of bioequivalence studies or production quality control. Studies can also be carried out to determine how changes to the nasal spray device, formulation or device actuation profile can affect the delivered spray particle size.
The Nasal Spray Accessory will:
- Remove user bias during nasal pump testing, through the use of most commonly available automated nasal spray actuation systems.
- Accurately position nasal pump devices relative to the Spraytec system, reducing measurement uncertainty.
- Validate that the nasal pump spray position and angle is correctly set prior to measurement, improving measurement reproducibility.
- Allow users to specify methods which follow the US FDA’s guidance for Bioavailability (BA) and Bioequivalence (BE) Studies for Nasal Aerosols and Nasal Sprays for Local Action.
- Enable the reproducible testing of nasal sprays following the Chemical Manufacturing and Controls guidance from the FDA.
The Nasal Spray Accessory provides users with the ability to position a nasal pump spray at a specific distance from the measurement zone of the Spraytec laser diffraction system. In addition, the angle of the nasal spray can be adjusted.
The nasal spray pump is held in an automated nasal spray actuator, which can be used to control either the force or the velocity of device actuation. Most commonly available automated actuators can be used with the Nasal Spray Accessory, including those produced by Proveris Scientific and InnovaSystems.
The nasal spray actuator is held in a support bracket within the Nasal Spray Accessory. This is mounted on a linear slide, enabling the distance between the Spraytec laser diffraction measurement zone and the nasal pump spray to be adjusted. In addition, the accessory can be tilted in order to change the angle of the actuator. These adjustments enable users to follow the US FDA’s guidance relating to the testing of nasal sprays as part of bioavailability and bioequivalence studies.
A set of encoders are used to accurately measure the distance between the nasal spray pump and the Spraytec measurement zone, and the angle of actuation. These are recorded using the Spraytec software.
- Measurement Distance Range:
- 0 – 100mm to an precision of +/- 1mm.*
- Measurement angle:
- 0 – 45 degrees in 5 degree increments.
- Software Feedback:
- Full software feedback of the vertical position and angle of the nasal spray support system.
- Position Validation:
- Standard Operating Procedures (SOPs) can be configured to request a specific vertical distance and angle for the nasal spray support. Setting of the reference position can also be requested each time measurements are made.
- Dimensions (W, D, H):
- 170mm x 390mm x 260mm.
- The range of measurement positions possible using the Spraytec NSS will be dependent on the size of the nasal spray device.