Advancing the Science
of Nasal and Inhaled
Drug Delivery

Offering

Description

Objectives

Patient Usage Ergonometric Studies

Provide critical, quantitative information on how patients in the product’s target age and gender group operate the product

• Replicate human usage through automated actuation
• Assess the Product(s) pump/valve delivery and priming specifications
• For generics, ensure comparable usage to Reference Product
• Comply with FDA Draft Guidance recommendations
• Identify any patient usage issues

Reference Product Characterization

Determine the Product’s operating profile through a series of screening experiments to define the critical actuation parameters and develop methods for spray performance tests

• Evaluate brand performance and manufacturing variability
• Determine appropriate method(s) to achieve optimal in vitro bioequivalence (BE) correlation of spray performance

Device Component Optimization

Compare the Test Product’s formulation-device component combination(s) to the patient usage and spray performance of the Reference Product

• Recommend an optimal Test device component combination(s) to achieve in vitro bioequivalence (BE) correlation of spray performance
• Evaluate and assess variables in formulation-device component combinations

Method Development

Utilize a Patient Usage Study to screen the critical actuation parameters and develop spray pattern and plume geometry methods on the SprayVIEW® Measurement System

• Deliver robust, reliable methods for accelerated Product development and verification
• For generics, confirmation of device selection and overall performance

Method Transfer and Verification

Ensures rapid implementation and use of method(s) on new or existing systems

• Facilitate site to site transfers, new installations, new method deployment on existing systems, and outsourcing to contract service organizations