Connect with Intertek during Digital RDD 2020
Intertek's experts will present a poster focused on inhaled dissolution and the use of MDRS to drive insight into NGI results from equivalent DPI products during Digital RDD 2020, April 26-30. Connect with our team to discuss your OINDP development challenges.
During Digital RDD 2020, Intertek's inhalation experts will be present a technical poster on inhaled dissolution and will be available online to discuss all aspects of OINDP development such as in vitro testing approaches, optimising formulation development for systemic delivery, nasal drug development and more. Our team will also provide updates on our inhaled and nasal product development capabilities which includes the acquisition of a new 20,000 sq.ft facility for the development of biologics for respiratory delivery.
Investigation of DPI Particle Microstructure by MDRS to Explain the Difference Observed in NGI Results Between Equivalent Products
Daniella Davies1, Mark Copley2, Deborah Huck-Jones3, Mervin Ramjeeawon1, Chris Vernall1, Anna Sipitanou2, Robert Taylor3, Teresa Iley1, Kate Jolly1
1. Intertek Melbourn, Saxon Way, Melbourn, Royston, SG8 6DN, UK
2. Copley Scientific Ltd., Colwick Quays Business Park, Private Road No. 2, Nottingham, NG4 2JY, UK
3. Malvern Panalytical Ltd, Grovewood Rd, Malvern Worcestershire WR14 1XZ, UK
The Next Generation Impactor (NGI) is an in-vitro test that measures the aerodynamic particle size of an inhaled product based on particle inertia. Particle separation and sizing is achieved by drawing a fixed volumetric flow rate of particle entrained air through a series of nozzles containing progressively reducing jet diameters and impacting the particles on a collection surface (cup). Smaller particle size fractions are collected at each successive stage.
To give an insight into NGI profiles from two equivalent commercially available DPI devices, the deposition of FP through an NGI was measured and quantified. The Morphologi 4-ID was used to perform Morphology-Directed Raman Spectroscopy (MDRS) on stages 2 and 4 of the NGI. This not only gives particle size and shape information, but also shows any drug/excipient bound particles which may be present by chemically identifying the species by Raman Spectroscopy, therefore confirming the presence of multicomponent aggregates. This gives valuable information on equivalence before heading into costly clinical trials where the industry has seen failures for generic products which look to have a good in-vitro match.
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Learn more about our capabilities
Our integrated formulation and analytical teams carry out early stage pre-formulation support, solubility screening, drug-excipient compatibility, stability testing, device screening and clinical manufacturing services for all types of respiratory product. Comprehensive protein characterisation services services, aligned to monitoring a protein’s structure and potency throughout formulation and storage, can also be provided.
ARTICLE DOWNLOAD: Nebulised Drug Development Considerations
ARTICLE DOWNLOAD: In Vitro Bio-equivalence For OINDP - Where are we now?
ARTICLE DOWNLOAD: Overcoming the Challenges of Inhaled Biologic Drug Development
WEBINAR ON DEMAND: Formulation and Manufacturing Approaches for Nasal Drug Products
WEBINAR ON DEMAND: Review of In-vitro Testing for Bioequivalence of Nasal Drug Products
BROCHURE: Intertek Inhaled Product Development Services
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