Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug...
Transcript of Physicochemical Profiling in Drug Development · Pion is 20! Physicochemical Profiling in Drug...
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
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
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!
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.
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
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).
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
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!
Pion is 20! Physicochemical Profiling in Drug Development Seminar. Monday, May 23 2016.
Today’s Seminar is Continuation of a Pion Tradition!
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