Choosing the right device: the case for DPIs (DDL22)
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Choosing the right device: the case for DPIs (DDL22)

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David Harris, principal consultant at Team Consulting, was invited by the DDL organising comittee to present the case for DPIs at the Drug Delivery to the Lung (DDL) conference in December 2011

David Harris, principal consultant at Team Consulting, was invited by the DDL organising comittee to present the case for DPIs at the Drug Delivery to the Lung (DDL) conference in December 2011

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    Choosing the right device: the case for DPIs (DDL22) Choosing the right device: the case for DPIs (DDL22) Presentation Transcript

    • Choosing the right deviceThe case for DPIsDavid HarrisDrug Delivery to the Lungs 22, 8th December 2011Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 1 www.team-consulting.com
    • Choosing the right device – the case for DPIsWhere did it all begin? Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 2 www.team-consulting.com
    • Choosing the right device – the case for DPIs First capsule DPI – First multi-unit dose DPI - Spinhaler (Fisons) Serevent Accuhaler (GSK) First DPI –Aerohalor (Abbott)The first DPI patent -“Inhaling Apparatus” High performance multi-unit First DPI with a „breath-triggered‟ dose DPI – Starhaler (Sun first Reservoir DPI – actuation mechanism – Novolizer Turbuhaler (Astra) (Sofotec Almirall) Pharma) 1864 1948 1967 1987 1995 2001 2011 Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 3 www.team-consulting.com
    • Choosing the right device – the case for DPIsThe story behind the Spinhaler is inspiring…• Invented by Roger Altounyan, a long-suffering asthmatic and medical doctor  former RAF Spitfire pilot and instructor, who saw the potential to use a propeller in an inhaler to deliver dry powder effectively• He spent half a year experimenting with prototypes in his living room ‘laboratory’• It still didn’t work. The powder impacted on the inside of the tube, rather than forming an acceptable aerosol However… Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 4 www.team-consulting.com
    • Choosing the right device – the case for DPIs“One day he noticed that when he sucked one of the models it vibrated and buzzed like a dentist’s drill, presumably because the bearing was poor and rattled. Then he wondered if this shaking might prevent the powder from impacting. He tried it with some powder, and at last it produced a steady and efficient inhalation. Ironically, it was the very fault in the eccentric action of the slightly imperfect bearing that made the little machine work.” Rodney Dingle, Biography of Roger Altounyan Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 5 www.team-consulting.com
    • Choosing the right device – the case for DPIs“The most exciting phrase to hear in science, the one that heralds new discoveries, is not Eureka! (I found it!) but ‘Thats funny ...’” Isaac Asimov Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 6 www.team-consulting.com
    • Choosing the right device – the case for DPIsWhy are DPIs difficult to get right? Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 7 www.team-consulting.com
    • Choosing the right device – the case for DPIsRespirable particles are very small• The diameter of an average human hair is ~50 times that of a respirable drug particle• It’s extremely difficult to transfer energy to disperse such fine particles efficiently• They can easily become trapped in fluidic boundary layers – shielded from aerodynamic drag forces• Large surface area to volume ratio means that they are susceptible to acquiring high specific charge (electrostatic charge to mass ratio) Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 8 www.team-consulting.com
    • Choosing the right device – the case for DPIsI asked a fluid dynamics expert, James Tibbatts (Concept Flow Ltd) how well he could simulatean aeroplane in order to optimise efficiency and he replied with -“You’d be able to get lift and drag coefficients to within a few percent – but you’d need a lot of computing power.”In contrast, I posed the same question about optimising the airway of a dry powder inhalerand his reply was -“Quantitatively, you can’t get any discernible accuracy at all. Because the physics isn’t well understood you can throw all the computing power in the world at it and not get a meaningful solution.” Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 9 www.team-consulting.com
    • Choosing the right device – the case for DPIsIt can be done… Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 10 www.team-consulting.com
    • Choosing the right device – the case for DPIs• Sun Pharma (with Cambridge Consultants & Design Directions)  8 dimensional reduced order numerical model of DPI airway  based upon CFD, empirical and theoretical inputs  successfully mapped out design space  enabled performance optimisation + high independence of flowrate  future proof – easy to fine tune Conix 1 Disposable single-dose• 3M’s Conix DPI family are all based upon one single aerosolisation engine Conix 2 Reloadable single-dose  three different inhaler products  all have the same performance Conix 3 Pre-metered multi-dose Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 11 www.team-consulting.com
    • Choosing the right device – the case for DPIs“Remember that all models are wrong; the practical question is how wrong do they have to be to not be useful” George E. P. Box, 1987 Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 12 www.team-consulting.com
    • Choosing the right device – the case for DPIsAn exciting future! ? Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 13 www.team-consulting.com
    • Choosing the right device – the case for DPIsSemiotics – ‘the study of signs and symbols’ 1 2 3 4 5 6 How is this relevant to DPIs… ? Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 14 www.team-consulting.com
    • Choosing the right device – the case for DPIs• Huge diversity of scientific / technological approach to inhaler design…  but does this have to be presented as diversity of user interactions?• There may be an opportunity to agree a common symbol for a key inhaler use step  e.g. “load dose”• There is certainly an opportunity to agree a common approach to instructions for use“The nice thing about standards is that you have so many to choose from.” Andrew S. Tanenbaum Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 15 www.team-consulting.com
    • Choosing the right device – the case for DPIs• The MannKind Corporation  pursuing the delivery of inhaled insulin - DPI product Afrezza  which is undergoing late stage clinical studies• Successful treatment of diabetes CricketsTM - disposable through the systemic delivery of inhaled insulin would be a major breakthrough  potentially opening the route for many forms of the therapeutic delivery of new molecules • pain management • vaccinationWhat therapies will DPIs of DreamBoatsTM – reusablethe future deliver? Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 16 www.team-consulting.com
    • AcknowledgementsMany thanks to:-• Mark Sanders, Inhalatorium for kindly providing the images of Aerohalor and Spinhaler• John Bell, Stewart Erl Associates, for sharing his extensive insights about the early development of the Spinhaler• Robert N Slinn, who worked on the synthesis of analogues of cromoglycate at Fisons, for sending me a copy of Roger Altounyan’s biography• Hans Lundback, Astra Zeneca, for the kind provision of images of early Turbuhaler images• David Blakey & The Device Technology Group, GSK, for kindly providing images of the original Serevent Accuhaler• Prashant Kane, Sun Pharma, for permission to use images of the Starhaler (developed in collaboration with Cambridge Consultants and Design Directions)• Jag Shur, University of Bath, for providing excellent SEMs of Salbutamol on a human hair• James Tibbatts, Concept Flow, for the quotations and informative discussion around CFD and reduced order numerical modelling• Georgina Fradley, 3M, for kindly providing images of the three Conix DPI platforms• Chad Smutney, MannKind Corporation, for the great images of their Cricket and Dreamboat ranges of DPIs• Julian Dixon, Team Consulting, for his input on the usability of DPIs Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 17 www.team-consulting.com
    • Confidential © Team Consulting 2011: Presentation_DDL22_v1-0 slide 18 www.team-consulting.com