Inhalation Drug Product Development Services

Orally inhaled and nasal drug product (OINDP) development services including CMC support for registration (NDAs/ANDAs), formulation development, GMP analytical testing, product characterisation, stability testing and clinical manufacturing services for small molecule and biologic OINDPs

Inhaled drug product development demands a strategic approach to formulation, analytical testing and device selection to meet requirements for pharmaceutical CMC development and regulatory compliance and optimize product efficacy, quality, safety and performance. 

With 30 years of experience in supporting development of inhalation drug products for our global clients, our experts provide formulation development, repurposing or reformulation, product characterisation studies, method development and validation, inhalation product analysis, device verification testing, in vitro bioequivalence testing, CMC support for NDAs/ANDAs and clinical manufacturing services. With the largest GMP ICH stability storage facility in Europe, we manage all aspects of stability including storage, long-term and accelerated stability across product's development from early preclinical to commercial batch stability. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory expectations.

 
Our expert formulation development scientists have extensive experience in product development across all categories of inhaled products including dry powder formulations and devices, nebulised solutions/suspensions and metered dose inhalation (pMDI) product types, as well as a range of other novel respiratory delivery systems. Our unique project management approach enables you to interact directly with our expert scientists as the development process advances.

DDL take place Dec 7-9 in Edinburgh. We are delighted to be Platinum Sponsors once again. Our DDL2022 poster can be requested here.

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: bd.melbourn@intertek.com. Our team would be happy to send this after the conference. 
Biopharmaceuticals including proteins, peptides or monoclonal antibodies and also oligonucleotides or mRNA therapies present multiple challenges to development of an inhaled and nasal administration route for delivery. Our RDD 2022 workshop addressed the key concepts, technologies and considerations for involved in building effective OINDP products from a range of biologic APIs. Find out more about the workshop. 

 
 
 
 
 

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+44 1763 261648
UK:
+44 1763 261648