Highlighting Inhalation Development at Drug Delivery to the Lungs (DDL) Conference
We will attend the Drug Delivery to the Lungs (DDL) Conference, 11 - 13th December 2019, Edinburgh, UK. Meet with us to discuss your development challenges for pulmonary and nasal drug delivery.
The Drug Delivery to the Lungs Conference (DDL) is Europe’s premier conference and industry exhibition dedicated to pulmonary and nasal drug delivery. The conference will cover some of the major issues for these product types, including; new formulations to treat unmet respiratory needs, including cystic fibrosis, connected & smart devices and advanced analytical techniques supporting inhaler development.
We are delighted to announce that we are platinum DDL sponsors this year and during the conference, our team of experts will be available to discuss your inhalation product development, inhalation product testing, formulation development or stability testing challenges. Contact our team now to arrange a meeting at our stand.
The Impact of Dry Powder Inhaler Performance of Testing Using Pharmacopeial Methodology Compared to More Realistic Testing Conditions
Monbi Chakma1, Mark Parry2 & Professor Ben Forbes1
1 Department of Pharmacy, King’s College London, 150 Stamford Street, London SE1 9NH, United Kingdom.
2 Intertek-Melbourn Scientific Limited, Saxon Way, Melbourn, SG8 6DN, United Kingdom.
This study looks at the effect of real-world breathing profiles on inhaler performance. Inhalers are normally tested under artificially sharp and steady inhalation flow rates, while in the case of patients - especially those with compromised respiratory function - the observed performance can differ with poorer performance potentially seen. Incorporating patient relevant profiles into inhaler testing provide for a stronger platform for developing robust devices, as well as an enhanced approach to IVIVC when considering the development of generic devices.
Investigation of DPI Particle Microstructure by MDRS to Explain Differences Observed in NGI Results Between Equivalent Products
Daniella Davies1, Mark Copley2, Deborah Huck-Jones3, Mervin Ramjeeawon1, Chris Vernall1, Anna Sipitanou2, Robert Taylor3, Teresa Iley1
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
This study looks at morphologically directed ramen spectroscopy (MDRS) provides evidence for a useful orthogonal technique to complement impaction. This technique combines optical microscopy, computerised particle measurement and per-particle ramen spectroscopy to deliver information on the size, shape and identity of individual particles. Using modified NGI stages we can examine individual size fractions and information regarding particle morphology to be generated and compared. Further development of the technique also allows for assessment of the product’s deposition behavior, allowing information regarding the deposition and distribution of API only, API/carrier,API1/API2 and API1/API2/carrier particles to be directly measured – which was not previously practical.
Modifications to an inhaler device to aid the interpretation of clinical trial data
George Bostock1, Tom Lawrie-Fussey1, Alison Hart1, Neil McCarragher1, David Harris1, James Baker1, Mark Parry2 & Ben Crundwell1
1 Cambridge Design Partnership, Church Road, Toft, Cambridge, CB23 2RF, UK
2 Intertek Melbourn, Saxon Way, Melbourn, Royston, SG8 6DN, UK
This poster discusses compact technology that can be integrated into existing inhaler designs to provide data on several critical patient behaviors, including failure to pierce the capsule, inhalation flowrate profile, orientation of inhaler throughout and confirmation of successful capsule emptying. This is targeted at this stage at a common inhaler device used in clinical studies which would allow for greater understanding of clinical data, especially when these are long term in-home studies.
Our OINDP Development Expertise
Our experts provide integrated OINDP development and testing services for both small molecules and biologics through its centres of excellence across Europe. We provide 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.
WEBINAR RECORDING: New Strategies for Optimizing Biologic Formulations
WEBINAR RECORDING: A Review of In-vitro Testing for Bioequivalence of Nasal Drug Products
WEBINAR RECORDING: Formulation and Manufacturing Approaches for Nasal Drug Products
WEBINAR RECORDING: Stability Programs for Orally Inhaled or Nasal Drug Products
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