Equip Your APSD/DDU Drug Characterization Processes

MSP, a Division of TSI®, provides equipment to support every step of the drug chemical characterization cycle. As the creator of the Next Generation Impactor (NGI) (working with a consortium of pharmaceutical companies), MSP is dedicated to supporting the needs of the aerosolized drug development industry.

We are partners with Copley Scientific to provide a wide range of complete systems and products for aerodynamic particle size distribution (APSD) and delivered dose uniformity (DDU) as prescribed by USP guidelines for most respiratory drug delivery devices.

The Drug Chemical Characterization Cycle

Test Preparation

Prior to starting your pharmaceutical testing, you need to prepare your system. This includes holding as many variables as possible constant, or recording important variables (such as environmental variables like temperature or humidity, batch/lot number, time of day, analyst conducting the test, etc.). Test preparation also involves confirming critical flow, fire force, etc. to verify the testing will be performed correctly.

• Vertus® III and DecaVertus® III - automated solutions that will control test parameters to provide highly reproducible and reliable testing. The Vertus ® III and DecaVertus® III automatically measure and report on the variables listed above (from environmental factors to confirming fire force). This provides consistency in controllable factors.
• NGI Cup Coater - coats the collection surfaces within the NGI/NGI+ to mitigate particle bounce during testing. The NGI Cup Coater dispenses a uniform, precise layer into the bottoms of the NGI collection cups while in situ in the NGI collection cup tray - eliminating inter-analyst variability.
• EnviroMate™ Environmental Chamber - affordable, compact, benchtop solution that addresses the challenges faced by analysts seeking to maintain stable environmental conditions for their delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) testing.

Sample Collection

Once you begin the testing, the drug will be dispensed through the system and collected to be analyzed. A variety of products support that collection, such as:

• Next Generation Impactor (NGI) - seven-stage cascade impactor with a Micro-Orifice Collector (MOC) at the end. The NGI has been accepted into the Pharmacopoeias as the gold standard for aerosol characterization in the pharmaceutical industry. MSP is proud to have worked alongside the consortium of pharmaceutical companies to develop the Next Generation Impactor - a cascade impactor designed by and for the pharmaceutical testing industry.
• NGI+ - using the same design and functionality of the original industry-proven NGI, the NGI+ contains substituted base design materials to enable a wider range of applications (such as nebulizer testing) and increased longevity. (Learn more about what makes the NGI+ different)
• Andersen Cascade Impactor (ACI) - eight-stage cascade impactor with a small footprint.
• Multi Stage Liquid Impinger (MSLI) - four-stage cascade impactor with a final filter stage.
• DUSA Waste Shot Collector - compact vacuum filtration system which collects large quantities of a drug for safe disposal during DDU testing.
• Vertus® III+ and Vertus® III - automated solution that will control test parameters to provide highly reproducible and reliable testing. The Vertus® III+ and Vertus® III controls the shaking profile, angle of fire, pauses between shaking and firing, resting position of the inhaler, and airflow control.
• TPK - critical flow controller responsible for controlling the flow amount/duration of inspiration volume required for the test.
• Flow meter - used to monitor the flow rate at the inlet of the impactor, verifying that the flow rate lies within ±5% of the target flow (as specified in the Pharmacopoeias).
• Fast Screening Andersen (FSA) - Abbreviated Impactor Measurement (AIM)-modified ACI (reduced number of stages) used during quality control and product development.
• Fast Screening Impactor (FSI) - AIM-modified cascade impactor (reduced number of stages) designed using NGI principles.
• Reduced NGI (rNGI) - AIM-modified NGI (reduced number of stages, additional options to optimize/simplify) used in quality control and/or AIM-HRT applications. The rNGI is directly translatable back to an NGI.

Sample Preparation

After the samples are collected, they need to be prepared before they can be analyzed. While the preparation can be done manually by analysts, automating the process enhances your process control and method transfer by improving consistency and repeatability. Automation equipment boosts efficiency, increases throughput, and allows analysts to spend more time on higher-value work. A few automated solutions include:

• DUSA Shaker - automated solution to dissolve individual doses (collected in DUSA collection tubes during DDU testing). The DUSA shaker holds DUSA collection tubes, and is designed to ensure full, fast and repeatable drug recovery from all internal surfaces while freeing up analysts to work on higher-value tasks.
• NGI Gentle Rocker - automated solution to gently agitate NGI collection cups, dissolving the active drug in solvent before analysis. The constant gentle movement of the NGI Gentle Rocker produces more reliable, consistent, and repeatable results than manual agitation, and it frees up analysts time for other work.
• Sample Preparation Unit (SPU) - automated solution to alleviate the repetative manual task of recovering active drug from the induction ports used with the ACI and both the induction ports and preseparator fixtures used with the NGI. When combined with the NGI Gentle Rocker, the SPU provides a complete NGI sample preparation system.

Sample Analysis

After the samples have been collected and prepared, they can be analyzed. Sample analysis determines whether the drug delivery method produces the correct drug amounts in the correct sizes. A solution to help during sample analysis is:

• Inhalytix - fully validated software, providing analysts with a standardized approach to data entry, analysis, and reporting for metered dose inhalers (MDIs), dry powder inhalers (DPIs), and nebulizers in accordance with European and US Pharmacopoeial specifications.

Cleaning & Maintenance

Cascade impactors are precision instruments that need to be regularly cleaned to provide accurate and consistent test results and to extend their life expectancy. A cleaning system is often required to completely clean and dry a cascade impactor, such as:

• Impactor Cleaning System - containing a variety of individual parts, the Impactor Cleaning System is designed specifically to clean ACI and NGI/NGI+ components. Some of the cleaning system parts include an Impactor Ultrasonic Cleaning Bath, an Impactor Rinse Bath, an Impactor Suction Aspirator, and an Impactor Drying Oven.

Applications & Services

MSP has extensive background including technical equipment and applications, partnering with other industry leading companies, and staying ahead of governing regulations and industry expectations. We offer training and consulting, field service options, equipment optimization, and equipment recalibration. Our comprehensive mensuration and qualification services were developed per USP section <1058>, a guide to ensure that analytical instruments continue to operate and perform within a given specification.

MSP specializes in equipment, training, and consulting for:

• Pressurized meter dose inhalers (MDI)
• Dry powder inhalers (DPI)
• Nebulizers
• Nasal sprays
• New/novel technologies, such as soft mist inhalers