Copley Scientific introduces new, upgraded breath simulators for inhaled product testing

14 Nov 2017

The upgraded BRS simulators make it even easier to apply specified inhalation profiles during OIP testing.

Copley Scientific has launched new, advanced breath simulators - the BRS 2100 and BRS 3100, for orally inhaled product (OIP) development and testing. In recent years, in response to regulatory and pharmacopoeial changes, and the drive to ensure closer correlation between in vivo and in vitro performance, scientists have increasingly incorporated breath simulators into their testing methods. Now, the upgraded BRS simulators from Copley Scientific make it even easier to apply specified inhalation profiles during OIP testing.

Copley Scientific introduces new, upgraded breath simulators for inhaled product testing
a test set-up optimised for improved IVIVCs, incorporating the BRS3100 and the adult Alberta Idealised Throat.

The BRS 2100 is ideally configured for testing nebulisers and metered dose inhalers (MDIs) with spacers/valved holding chambers (VHC) in accordance with US Pharmacopeia Chapter <1601> and Chapter <1602> respectively; the latter having only recently been released. The BRS 2100 has a maximum volume of 900 mL making it ideally suited to the low-volume, tidal breathing applications required by these chapters. The BRS 3100 offers greater volumes (500 mL up to 5000 mL) and the increased power (maximum flow rate of 240 L/min) needed for generating profiles typical of patients using MDIs and dry powder inhalers (DPIs) under forced inhalation conditions, helping to improve in vitro-in vivo correlations (IVIVCs).

As well as generating the ‘standard’ breathing profiles needed to measure delivered dose uniformity (DDU) according to pharmacopoeial requirements, namely: neonate, infant, child, and adult, for nebulisers and MDIs with spacers/VHCs, both the BRS 2100 and 3100 are designed to generate user-defined, patient-derived breathing profiles that more closely mimic real-world clinical situations. Importantly, the standard profiles can be used as a base and edited for development studies, adjusting the selected square, sinusoidal or triangular pattern, the tidal volume and the number, duration and timing of each breathing cycle, for example. For even more control, users can build and then save their own unique breathing profiles to simulate any desired pattern or breathing technique, as may have been recorded in clinic. Both breath simulators can be used for DDU applications or combined with a cascade impactor, using a mixing inlet, for aerodynamic particle size distribution (APSD) studies under more patient realistic conditions.

Compared with prior BRS 2000 and 3000 models, the BRS 2100 and BRS 3100 both feature an upgraded Quad-Core processor, increased RAM, improved Windows 10 operating system, and redesigned software, as part of the embedded, on-board computer. Significant gains in data processing speed and usability are the result. The instruments are also more flexible; for example, flow rates can be displayed in mL/s or L/min, and it is now easier to simulate uncoordinated product use, in the case of VHCs, by synchronising sampling with the exhalation portion of a breathing profile. In addition, the mechanics have been advanced – with improved motor, piston and cylinder performance enabling the more rigorous testing of high-resistance inhalers, and the creation of more powerful inhalation profiles. Additional peripherals and external data transfer are improved by the increased number of USB ports.

Mark Copley, Sales Director at Copley Scientific, comments: “In recent years, breath simulators have become a core piece of OIP testing equipment. This is partly because of the need to achieve better in vitro-in vivo relationships to enhance product development, and also in response to changing regulatory guidance, which has been updated for greater clinical relevance. Significant progress was made when the previous generation of breath simulators was introduced and now, with our upgraded series of instruments, we are very pleased to be putting state-of-the-art tools once again into the hands of our users.”

Read More

Related tags

Market News

Related news

Aptar Pharma to showcase an industry first

Aptar Pharma to showcase an industry first

12 Sep 2018

PureHale is a new portable drug delivery device designed for upper respiratory care.

Read more 
Novartis to divest the Sandoz US dermatology business and generic US oral solids portfolio

Novartis to divest the Sandoz US dermatology business and generic US oral solids portfolio

11 Sep 2018

The Sandoz US portfolios to be sold to Aurobindo include approximately 300 products, as well as additional development projects.

Read more 
New SGS biopharmaceutical testing capabilities in Illinois

New SGS biopharmaceutical testing capabilities in Illinois

11 Sep 2018

The new services will focus on quality control analysis and stability testing of biopharmaceuticals.

Read more 
Exciting skincare to protect against blue light emitted by phones and devices

Exciting skincare to protect against blue light emitted by phones and devices

10 Sep 2018

Novel, dual-acting product revitalizes and protects skin against blue light and environmental aggressors around the clock.

Read more 
24/7 life science manufacturing IT service launches

24/7 life science manufacturing IT service launches

7 Sep 2018

Faster GMP incident response and resolution times when manufacturing IT applications fail or are not running to their optimum capacity.

Read more 
Catalent signs commercial supply agreement for Aucta Pharmaceuticals' vigabatrin

Catalent signs commercial supply agreement for Aucta Pharmaceuticals' vigabatrin

6 Sep 2018

Novel dosage form employs Catalent’s proprietary stick pack dosage form.

Read more 
Sartorius and Repligen partner to introduce next-generation perfusion-enabled bioreactors

Sartorius and Repligen partner to introduce next-generation perfusion-enabled bioreactors

5 Sep 2018

Customers to benefit from simplified, scalable solutions for intensified cell culture.

Read more 
Boehringer Ingelheim to build new tablet manufacturing facility

Boehringer Ingelheim to build new tablet manufacturing facility

4 Sep 2018

Facility to manufacture innovative drugs for worldwide market launches and technologically advanced production.

Read more 
Plasticell wins military contract to develop regenerative medicines for the battlefield

Plasticell wins military contract to develop regenerative medicines for the battlefield

4 Sep 2018

Company to use its combinatorial stem cell screening platform to develop technologies for the conversion of pluripotent stem cells into platelets.

Read more 
Bio processing and manufacturing league table ranks US top and China bottom

Bio processing and manufacturing league table ranks US top and China bottom

3 Sep 2018

US, Germany and Japan revealed as tier one nations in all categories with Sweden ranking the best of the rest.

Read more