Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug...

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Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Physicochemical Profiling in Drug Development Welcome to Pion Seminar Celebrating Pion’s 20 years in the industry

Transcript of Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug...

Page 1: Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Pion Celebrates 20 Years in 2016! Pion founded

Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.

Physicochemical Profiling in Drug Development

Welcome to Pion Seminar

Celebrating Pion’s 20 years in the industry

Page 2: Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Pion Celebrates 20 Years in 2016! Pion founded

Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.

Pion in WikipidiA

Pion consists of a quark and an antiquark and is therefore a meson.

It is unstable with mean lifetime of 26 nanoseconds

Pion extended its lifetime ~ 6*1017 times

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Here we go: Pion consists of quark and antiquark and is therefore a meson. This is kind of obvious. It is unstable with mean lifetime of 26 nanoseconds. Well, this mean has quite a big standard deviation because it’s been more that 6*1017 nanoseconds already and I hope it is still not a half life. I think this particular Pion longevity comes from what we do. Once I was travelling and as usual was working on one of presentation putting a picture of Rainbow on the slide and my neighbor asked if Pion makes Desktop computers.
Page 3: Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Pion Celebrates 20 Years in 2016! Pion founded

Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.

We are not making Desktop PC!

No worries about laptop batteries, their incompatibilities between the models and constant need to charge them!

No more carrying heavy laptop on your shoulder!

No more taking laptops out during security checks at the airports!

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We are not making or… selling Desktop PC. However, imagine the marketing campaign of Desktops versus Laptops.
Page 4: Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Pion Celebrates 20 Years in 2016! Pion founded

Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.

Pion Celebrates 20 Years in 2016!

Pion founded in 1996 Develops, manufactures, markets, and distributes worldwide analytical tools for measurements related to Absorption: permeability, solubility, dissolution and ionization of active (pharmaceutical, cosmetic, etc.) ingredients. Products include high-precision analytical instruments, robotic systems, software, and reagents for pharmaceutical, biotechnology and cosmetology research labs. Pion provides Analytical Services (CRO) in all areas of its expertise. Pion continues to be involved in fundamental independent and collaborative scientific research.

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Pion celebrates its 20th Birthday of not making Desktop PCs!
Page 5: Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Pion Celebrates 20 Years in 2016! Pion founded

Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.

Permeability, Solubility: PAMPA, µSOL

HITS LEADS PREFORMULATION DEVELOPMENT and QC

Pulse pKa, log P/D Solubility and more…

Rainbow Dynamic Dissolution Monitor

µDISS Profiler™ Powder Dissolution

Formulations Solubility Supersaturation

… Explorer

Evolution

Pion Products

Transdermal Penetration: Skin PAMPA

µFLUX™

Formulation effect on ABSORPTION

DissoPRO™ Software

Macro FLUX

µIDR Press

Page 6: Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Pion Celebrates 20 Years in 2016! Pion founded

Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.

System Validation Study (1999)

Bynum KC, Kraft E. A new technique in dissolution testing. Pharm. Technol. 1999, 23(10).

Page 7: Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Pion Celebrates 20 Years in 2016! Pion founded

Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.

Advances in FO Technology

• Miniaturized Disk and Powder IDR measurements* • Two step (SGF – SIF) dissolution testing • Supersaturation investigations • Formulation screening • Salt screening • Precipitation kinetic monitoring • Zero Intercept Method for Nanoparticles solubility and dissolution • Introducing an absorption chamber into miniaturized and USP

dissolution apparatus to study flux of API released from drug products

Multiple Publications in Peer-Review Journals

Page 8: Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Pion Celebrates 20 Years in 2016! Pion founded

Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.

Powder IDR Disk IDR

Anderson S., et.al. *Interlaboratory Validation of Small-Scale Solubility and Dissolution Measurements of Poorly Water-Soluble Drugs. J. Pharm. Sci., 2016 (on line).

Inter-laboratory Validation

Uppsala University, Sweden Janssen Pharmaceutica, Belgium Sanofi-Aventis, France Pfizer Ltd, UK AstraZeneca, UK Sanofi, MA USA Pharmaceutical Science and CMC Biologics, Denmark University of Copenhagen, Denmark AbbVie, Germany Bayer Pharma AG, Germany Orion Pharma, Finland Boehringer Ingelheim, Germany

Tsinman K. et.al. Powder dissolution method for estimating rotating disk intrinsic dissolution rates of low solubility drugs. Pharm Res. 2009;26(9):2093-2100.

13 Institutions!

Page 9: Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Pion Celebrates 20 Years in 2016! Pion founded

Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.

Today’s Seminar is Continuation of a Pion Tradition!

Page 10: Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016. Pion Celebrates 20 Years in 2016! Pion founded

Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.

2:15 – 3:15 The importance of knowing the pKa accurately in physicochemical profiling: dissolution, solubility, permeability, lipophilicity Presenter: Dr. Alex Avdeef, in‐ADME Research 3:15 – 4:15 Interpreting Cocrystal Solubility Data: When Failure is Really Success in Disguise Presenter: Dr. Scott L. Childs, Renovo Research 4:15 – 5:15 Physicochemical Sciences in Drug Compound and Formulation Design: Achievements and Future Challenges Presenter: Dr. Manuel Sanchez-Felix, Novartis

Monday Program