DDL 2022 - Discuss Development at Drug Delivery to the Lungs Conference

Connect with our team during DDL 2022 - The Drug Delivery to the Lungs Conference. Discuss your respiratory drug delivery challenges for all categories of inhaled products including dry powder formulations and devices, nebulized solutions/suspensions, metered dose inhalers products and a range of novel respiratory delivery systems.

We are excited to be DDL2022 platinum sponsors once again. Focusing on recent developments in the field of inhalation therapy, DDL2022 is the premier International Conference covering all aspects of respiratory drug delivery. Our team of experts will be available at our booth to discuss how we support development projects for both small and large molecules across all respiratory delivery technology platforms. Key themes for DDL2022 include:

 

• Formulation development - including particle engineering approaches
• Specialist support for biologics and DNA based medicines with a dedicated suite for testing and characterisation
• Clinical manufacturing
• Independent device screening and selection
• CMC package support
• ICH stability study testing and program management
• QC and GMP Batch Release testing
• In-vitro bioequivalence (IV-BE) studies including
  GMP IV-IVC tools; MDRS, Inhaled Dissolution, Idealised inlet models and realistic breathing profiles for impaction testing

DDL POSTER PRESENTATION:

Candidate Device Selection for pMDI In-Vitro only Bioequivalence focussing on Spray Pattern and Plume Geometry Analysis
Miles Jeanneret, Michael Kurowski, Joe Woodcock & Mervin Ramjeeawon
Intertek Melbourn, Saxon Way, Melbourn, Herts, SG8 6DN, UK

Summary

In-Vitro only bioequivalence (IVBE) submissions for orally inhaled and nasal drug products (OINDP) have become an increased focus for the generic pharmaceutical industry in recent years. Spray pattern (SP) and plume geometry (PG) testing can be included as in-vitro studies to facilitate a weight of evidencebased approach to submission for a pMDI product. SP and PG are well-established techniques for OINDP characterisation and are good indicators of spray performance and therefore the likely bioavailability of delivered drug product.

Two different commercially available pressurized metered dose inhalers (pMDIs) were selected to investigate comparative performance - these devices were a generic pMDI device and its’ reference listed drug (RLD). Three additional commercially available actuators were also investigated using the canister from the generic pMDI device to further examine the impact of actuator selection on product performance. SP and PG were analysed for a full range of actuator/canister combinations along with force to actuate, plume duration and spray intensity. The change in actuator with identical canisters was seen to alter the spray characteristics such as for the SP area.

Request a copy here. Our team would be happy to send this after the conference. 
Questions? Contact us: bd.melbourn@intertek.com. 

 

RESOURCES

Watch our DDL 2021 Presentation: Plume Front Velocity and Force to Actuation Characterisation of Pressurised Metered Dose Inhalers and Soft Mist Inhalers 

• BROCHURE: Our Orally Inhaled and Nasal Drug Product Development Expertise
• BROCHURE: Inhaled or Intranasal Biologic Drug Development
• WEBINAR ON-DEMAND: Development of Inhaled Oligo or mRNA Therapeutics
• ARTICLE: IVBE Particle Characterisation of Generic Mometasone Furoate using MDRS and Laser Diffraction 
• ARTICLE DOWNLOAD: In Vitro Bioequivalence for Pulmonary and Nasal Delivery
• WEBINAR RECORDING: Formulation and Manufacturing Approaches for Nasal Drug Products

Our OINDP Development Expertise 
With 30 years of experience in supporting our clients’ inhaled and nasal product developments, we deliver world-class support to help you meet the challenges of your demanding development programs. We provide integrated OINDP development and testing services for both small molecules and biologics through its centres of excellence across Europe. We conduct critical performance and quality testing such as laser particle sizing, aerodynamic particle size distribution (APSD) by impaction (ACI, NGI) and spray pattern/plume geometry. Intertek’s integrated formulation and analytical teams carry out early stage pre-formulation support, solubility screening, drug-excipient compatibility, stability testing and device selection support. For large molecule development, comprehensive protein characterisation services supported by forced degradation and stability monitoring for the protein’s structure and bioactivity throughout formulation and storage can also be provided. Interaction with the device and closure systems are evaluated through comprehensive extractable and leachable testing and toxicological assessments. The laboratory is inspected and approved by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for GMP compliance. The Laboratory has also been inspected by the US Food and Drug Administration (FDA) against GMP as part of clients’ pre-approval inspections.