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Respiron Consulting specialises in development of inhaled products from pre-clinical to CMC with focus on:

– Device and Device/Formulaton interaction

– Product/Patient interaction

– System characterisation

– Inhalation Toxicology system design, optimization and evaluation

– Documentation and due dilligence

Respiron Consulting Offers the Following Services

  • Characterisation of liquid and powder aerosols generated from inhalation products using state of the art instrumentation.
  • Setting specification for testing of inhalers, testing according to specification,  follow up, and documentation according to GxP.
  • Advice in setting up aerosol test laboratories; specifications, equipment, documentation, guidelines/SOP’s and education of personnel (according to GxP).
  • Advice when developing liqud inhaler design to meet specification.
  • Understanding device/formulation interaction, optimisation of drug delivery from device and delivery to patient.
  • Identifying equipment and delivery systems, conducting trials, evaluation and reporting.
  • Identifying and connecting with CRO’s for evaluation of inhaler/formulation options.
  • Liaison in negotiations with pharma and device companies.
  • Advice when scouting and identifying new inhalation systems (e. g. inhalers).
  • Advice when technically designing, performing and evaluating inhalation toxicology studies.
  • Optimisation of inhaled drug delivery to animals.
  • Conduct inhalation technology due diligence, evaluate and report.

Laser Diffraction

Respiron Consulting has the capabilities to perform investigations of the particle size distribution of inhalation products using laser diffraction methodology. Typical applications are time separation of the evolving aerosol plume from a dry powder inhaler, or the liquid aerosol exiting a nebulizer. In the graphs below two typical example are seen.

Spiriva Respimat Placebo

Figure 1

In the above Figure a mean time average droplet size distribution of a liquid inhaler actuation is seen. Two distributions peaks is seen, one around 5 um and one (bimodal) above 200 um. In this case it is important to understand if the large peak(s) is an artefact or not. To investigate this further an incremental time resolution of the actuation was performed, see Figure 2 on the right hand side.

Spiriva Respimat Placebo

Figure 2

The same liquid inhaler droplet size distribution was assessed using 40 individual measurements of incremental 50 ms time steps giving a total time period of 2 seconds. From Figure 2 it was concluded that larger droplets are produced and are more pronounced at the end of the actuation. This results in an increased droplet size above 200 um, thereby causing the large droplet size distribution seen in the mean time average droplet size distribution Figure 1 on the left.

Spray Pattern/Plume Geometry

Respiron Consulting can, perform measurements of plume geometry and spray pattern of released aerosols from an inhaler. Typical attributes as spray angle, length, plume velocity and oblongation index. This is done according to the relevant FDA guidelines.

Below are typical examples of the evolving plume and spray pattern of an inhaler visualized.

Movie 1

Movie 2

Movie 3

Movie 4

Movie 3 and 4 are from investigations done in collaboration with Imaging Resource AB.

Collaborations

Respiron Consulting has joined partnership or has a collaboration with

MVIC AB

MVIC AB

Medicon Valley Inhalation Consortium, MVIC, is a full service CRO specialized in inhalation product development and is located in Skåne in the Medicon Valley area. MVIC offers world class expertise within the field of inhalation, covering the whole value chain of drug discovery and development.

Read more about MVIC.

Emmace Consulting AB

Emmace Consulting AB

Offers excellence in pharmaceutical inhalation technology and base the business on three main corner stones;

  • Inhaler testing on CRO/partner basis, using the NGI impactor, Laser Diffraction and anatomical throat models as main techniques.
  • Consultancy within inhalation science in general and inhalation testing in particular.
  • Provider of lab accessories, such as anatomical throat models for characterisation of inhalers and software for measure inhalation flow profiles.

Read more about Emmace Consulting.

Inhalation Sciences AB

Inhalation Sciences AB

Respiron Consulting and Inhalation Sciences have a collaboration regarding the PreciseInhale inhalation system: A novel tool for aerosol generation in precise, repeatable, controlled doses.

Read more about Inhalation Sciences AB.

Short CV Ola Nerbrink

Respiron Consulting AB was formed in 2009 and is owned by Ola Nerbrink who acts as a consultant within inhalation product development

Ola Nerbrink has a Ph D in Occupational Medicine and has been active in the pharmaceutical industry since 1985. During this time he has worked with development of inhalers and inhaled products for two major pharmaceutical companies, AstraZeneca in Lund, Sweden and NovoNordisk A/S in Hilleröd, Denmark. Between 2011 and 2013 he was employed by FOI in Umeå, Sweden where he was a deputy research director responsible for the aerosol activities for the armed forces. In 2014 he returned to Respiron Consulting to act as a consultant full time. He also acts as CEO of MVIC AB, in part time, as of May 2014 to May 2017. Today he works part time as VP Business Developemen for MVIC AB and as Senior Business Developer for Inhalation Sciences AB in Stockholm.

He has been a member of both the Swedish (SIS) and Danish (DS) standardisation organisations, acting as an expert when developing EC and ISO standards. Between 2002 and 2008 he was a member of IPAC-RS and EPAG. Over the years he has acquired a broad network of contacts in the inhaled field, both within the industry and academia. He has more than 20 papers published in the inhaled field in recognised journals and is a frequent lecturer at international conferences.

Bibliograhpy

In this section you can find the written publications and presentations given by Ola Nerbrink. The link below will give you directions and abstract information regarding a majority of the publications.

http://www.researchgate.net/profile/Ola_Nerbrink/publications

Presentations

Nerbrink O. Workshop organizer; Inhalation Drug Delivery Device Technology Masterclass: A comprehensive guide to successfully developing inhalation products, Informa conference, 27-29 September 2010, London, UK.

Nerbrink O. Plenar lecture; The future therapies – Future DPI technologies Management Forum DPI conference, 29-30 June, 2010, London, UK.

Nerbrink O, Novel devices and points to consider when optimising performance, Inhalation Drug Development, 22-23 September, 2009, London, UK.

Nerbrink O, Recent Trends in Nanodrug Delivery – Innovation Technologies and Commercial Vialibility, International Conference and Exhibition on Nanotechnology and Advanced Materials, 11-14 December 2007

Nerbrink O, Formulation and inhalers:their interaction and the consequence for aerosol performance, Particle Design for Oral Dosage forms, 15-18 October 2007, Amsterdam, Netherlands.

Nerbrink O, Application of nano technology in oral inhalation device technology, PharmaMedDevice Conference, 24-26 April, 2007,New York, USA.

Nerbrink O, Keynote address: Mapping Inhaled Drug Delivery, 5th Annual Intranasal, Inhaled and Pulmonary Drug Development and Delivery Symposium, 10-11 Oct 2006, Washington DC, USA

Nerbrink O, The pulmonary delivery of powder and liquid drugs, Drug Delivery Global Summit, 20-21 Sept, 2006 London, UK

Nerbrink O, Novel technology possibilities for protein /peptide delivery, Dry Powder Inhalers conference, 29-30 June, 2006, London, UK

Nerbrink O, Inhaled protein and peptide device overview, Drug Delivery 2006, 17-19 May, San Diego, USA

Nerbrink O, In vitro aerosol characterisation technologies, Medical Plastics Seminar, 14-15 Nov, 2005, Copenhagen, Denmark

Nerbrink O, 2nd Annual Drug Delivery Systems 2005 Conference, Inhaled Insulin: a potential starter for large molecular delivery through the lungs? 6-7 Sept, 2005, London, UK

Nerbrink O, An update on Insulin administration by ADI, Aqueous droplet inhaler conference, 11-12 Oct, 2004, London, UK

Nerbrink O, Inhalation Devices, DPI, pMDI and Nebulizers: a Short up to date Overview, Pharmaceutical and Medical Packaging conference, 13-14 May 2003, Copenhagen, Denmark.

Nikander K, Berg E and Nerbrink O. Impact Of Breathing Patterns On Output Rate And Particle Size Of Nebulized Budesonide And Terbutaline During Inhalation, Drug Delivery to the Lungs XIII, 2002 (Poster)

Nerbrink O. Presentation the nebuliser potential at internal workshop on protein and peptide drug delivery, 1 day, October 1999 Södertälje

Nerbrink O. A Future for Nebuliser Therapy. Management Forum. Sept 20-21, 1999, London, England.

Pieron C A, Nerbrink O, Pagel J and Dennis J H. Development and application of a low flow casade impactor to size liquid aerosol. Environmental Science Departmental Research Conference. Jan 1999. Canada, (presented by Pieron)

Nerbrink O. Drug delivery to the Lung. The history of nebulisation; clinical perspective. Workshop: Recent advances in inhalation therapy, March 1997, Malaga, Spain.

Nerbrink O and Ekelius C. Investigation of the pulse form of two different commercial dosimeters. ISAM Sept 1997, Sendai, Japan.

Nerbrink O, Fagerström P-O, Wendel T, Eirefelt S, Källén ., Marchner H and Dahlbäck M. FIDO – a novel inhalation device for accurate dose delivery to large animals. AAAR Oct 1996, Orlando, FL, USA.

Nerbrink O and Svartengren M. TGLD2, a computer program for modelling of lung deposition. EAACI June 1994, Stockholm, Sweden. (Poster)

Nerbrink O and Svartengren M. TGLD2, a computer program for modelling of lung deposition. NOSA Nov 1994, Lund, Sweden.

Nerbrink O and Dahlbäck M. Basic nebuliser function. ISAM March 1993, Garmish-Partenkirchen, Germany.

Nerbrink O and Dahlbäck M. Basic nebuliser function. Allergy symposium, March 1993 Krakow, Poland.

Nerbrink O. Dahlbäck M and Hansson C-H. The Nebulizer function; Primary and secondary generation. European Aerosol Conference, Sept. 1992, Oxford, England.

Dahlbäck M, Eirefelt S, Nerbrink O, Prytz M and G-Wagner Z. A new aerosol delivery system to dogs. Third International Aerosol Conference, Sept, 1990, Kyoto, Japan. (presented by Wagner)

Dahlbäck, M, Eirefelt S, Karlberg I-B and Nerbrink O. Total deposition of Evans blue in aerosol exposed rats and guinea pigs. European Aerosol Conference Sept 1989, Vienna, Austria.

Berg E, Bäckström K, Dahlbäck M and Nerbrink O. Output and Particle size distribution of pulmicort suspension generated from MAD2 and PariBoy nebulizers. European Aerosol Conference, Sept 1988, Lund Sweden.

Nebrink O. Inhalation pharmacology; a new dicipline at AB Draco. NOSA Aerosolsymposium, Nov 1987, Lilleström, Norway.

Nerbrink O. Comparing measurments of non-spherical particles. NOSA Aerosolsymposium, Nov 1986, Stockholm, Sweden.

Nerbrink O. Output characteristics from three medical nebulizers. NOSA aerosol symposium, Nov 1985, Tammerfors, Finland. (Abstract)

Publications

Ola Nerbrink. Nebulizers: Past to Present Platforms and Future Possibilities. Inhalation, September, 2016. Read here.

Ola Nerbrink, and Mårten Svensson. Droplet and Particle Siz distribution. Characterization of personal care aerosol can aid product development and reduce negative health effects. Spray September 2016, #40. Read here

Ola Nerbrink, and Jolyon P. Mitchell. Comparison of ISO Standards for Device Performance; 20072 and 27427: A Critical Appraisal. Journal of Aerosol Medicine and Pulmonary Drug DeliveryVol. 25, No. 4. Published Online:https://doi.org/10.1089/jamp.2011.0927

Comparison of methods for generating bioaerosols. / Löndahl, J.; Nerbrink, O.; Massling, Andreas; Temkiv, Tina Santl.
2012. Poster session presented at European Aerosol Conference 2012, Malaga, Spain.

Anderson M, Svartengren M, Dahlback M, Nerbrink O, Philipson K and Camner P. Human tracheobronchial deposition and effect of two cholinergic aerosols. Experimental Lung Research. 19(6):653-69, 1993.

Berg E, Bäckström K, Dahlbäck M and Nerbrink O. Output and Particle size distribution of pulmicort suspension generated from MAD2 and PariBoy nebulizers. J. Aerosol Sci. Vol 19 (7) 1988. (Abstract)

Dennis JH, Pieron CA, Pagels J, Smurthwaite M, Nerbrink O. Development and application of a low flow cascade impactor to size nebulized aerosols. J. Aerosols Med, 12 (2), 134, 1999.

Dennis JH, Pieron CA and Nerbrink O.Standards in assessing in vitro nebulizer performance. Eur Repir Rev, 10, 72, pp178-192, 2000.

Dennis JH, Knoch M, Nerbrink O, Denyer J, Boe J. Summary of the ERS Nebulizer Guidelines Technical Workshop and Introduction to the CEN in vitro methods of assessing nebulizer performance. Eur Respir Rev 2000;10:497-502.

Dahlbäck, M, Nerbrink, O, Arborelius, M, Hansson, H C. Output characteristics from three medical nebulizers. J. Aer. Sci. 17 (1986) 563-564.

Dahlbäck, M, Eirefelt, S, Karlberg, I.-B Nerbrink, O. Total deposition of Evans blue in aerosol exposed rats and guinea pigs. J. Aerosol Sci. 20: 1325-1327, 1989.

Dahlbäck M, Eirefelt S, Nerbrink O, Prytz M, G-Wagner Z. A new aerosol delivery system to dogs. J Aerosol Sci., Vol 21, Suppl. 1 pp 467-470, 1990.

Eirefelt S, Nerbrink O, Dahlbäck M. Selective aerosol delivery to intubated rats; a comparison with nose only exposure. J Aerosol Sci. Vol23, Suppl 1, 491-494, 1992. (Abstract)

J.H. Dennis and O. Nerbrink. Atomization and nebulizers. Lung Biol- ogy in Health and Disease: Inhalation Aerosols (Edited by Hickey, A.), 94:273-312, 1996.

J.H. Dennis and O. Nerbrink. New nebulizer technology. Lung Biology in Health and Disease: Drug Delivery to the Lung (Edited by Bisgaard, H.), 162:303{336, 2002.

Mitchell J P, Nagel M W, Nichols S, Nerbrink, O ; Laser Diffractometry as a Technique for the Rapid Assessment of Aerosol Particle Size from Inhalers; J Aeroisol Med 19:4, 2006

Nerbrink O. Dahlbäck M. and Hansson C-H. The Nebulizer function; Primary and secondary generation. J Aerosol Sci. Vol 23. Suppl 1. 217-220, 1992. (Abstract)

Nerbrink O, Dahlback M, Hansson HC. Why do medical nebulizers differ in their output and particle characteristics? J Aerosol Med 1994:7:259-276.

Nerbrink O and Dahlback M. Basic nebulizer function. Journal of Aerosol Medicine. 7(Suppl 1):S7-11, 1994.

Nerbrink O and Ekelius C. Investigation of the pulse from two different commercial dosimeters. J Aerosol Med 1997;10: 272 [abstract].

Nerbrink O L, Lindstrom M, Meurling L and Svartengren M. Inhalation and deposition of nebulized sodium cromoglycate in two different particle size distributions in children with asthma. Pediatr Pulmonol. 34: 351-360,2002.

Nerbrink O L, Pagels J, Pieron C A, and Dennis J H. Effect of Humidity on Constant Output and Breath Enhanced Nebulizer Designs When Tested in the EN 13544-1 EC Standard. Aerosol Sci Technol. 37 (3): 282-292, 2003.

Nerbrink O, Fagerström P-O, Wendel T, Eirefelt S, Källén A, Marchner H and Dahlbäck M. A Novel Dry Powder Aerosol Delivery System for Real Time Measurement of the Inhaled Dose to Large Animals (Dogs). Aerosol Sci and Technol. Vol 27 (2) pp 147-161, 1997.

Nerbrink O, Dennis J H, Pagels J and Pieron C A. Technical aspects of nebulizers used in dosimetry Europ Respir Rev. (10)72. pp 232-237, 2000.

Svartengren K, Philipson K, Svartengren M, Nerbrink O and Camner P. Clearance in smaller airways of inhaled 6-XXm particles in subjects with Immotile-cilia syndrome. Exp Lung Res 21:667-682, 1995.

Svartengren M, Skogward P, Nerbrink O and Dahlbäck M. Regional deposition of inhaled evans blue dye in mechanically ventilated rabbits with air or helium oxygen mixture. Exp Lung Res 24:159-172, 1998.

Contact

Respiron Consulting AB
Medicon Village, Building 403
S-223 81 Lund
Sweden

Org # 556815-5500
VAT registered

info@respironconsulting.com
+46 760 16 02 70