Lipid Based Drug Delivery Systems Focus Group

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1 Lipid Based Drug Delivery Systems Focus Group Monday, November 11, :15 pm- 1:15 pm Room 006 CD Henry B. Gonzalez Convention Center Welcome to the Great State of Texas!

2 AAPS Lipid Based Drug Delivery Graduate Student Awards Sponsored by Gattefosse and presented Jasmine Musakhanian, M.Sc. Amit Kumar Jain National Institute of Pharmaceutical Education and Research (NIPER) Antioxidant containing solid self nano-emulsifying drug delivery system (s-snedds) of tamoxifen: Implication on oral bioavailabaility, antitumor efficacy and hepatotoxicity Mitan R. Gokulgandhi - University of Missouri, Kansas City Novel Conjugates of Cidofovir: Transporter Affinity, Bioreversion and Antiviral Activity

3 Agenda Introduce Focus of Group Steering Committee Members Activities Current & Next Year Results from Focus Group Members Survey Upcoming Election Incoming Chair Lipid Related Sessions in Current Meeting Graduate Student Research Presentations & Travel Awards New Business

4 Focus of Group It is the mission of the focus group to continue advancing the science and pharmaceutical applications of lipidbased systems in a multidisciplinary approach.

5 We are on LinkedIn Lipid-based Drug Delivery Systems Focus Group Find it - and SIGN UP! 705 members to date Ask questions Discuss Announce lipid related events Available positions

6 Focus Group Steering Committee Francis C. Szoka, Ph.D. Chair Anette Mullertz, Ph.D. Past Chair Shaukat Ali, Ph.D. Ben J. Boyd, Ph.D Paul M. Bummer, Ph.D. Panayiotis P. Constantinides, Ph.D. Heidi Ferguson, PhD Irena McGuffy, M.Sc. Jasmine Musakhanian, M.Sc. Christopher J.H. Porter, Ph.D. Kareen Riviere, Ph.D. Walter Shaw, Ph.D. Kishor M. Wasan, Ph.D. Hywel David Williams, PhD

7 Activities Past Year Membership survey Proposed various short course, workshop, symposium, minisymposium, roundtables Selection of graduate student awards Promoting online lipid-related resources

8

9 57 members responded Survey Highlights 90% in formulation process development Joined to keep up on developments in field Communicate via , website, newsletter Webinar > symposium=short course>workshop Topics = oral, formulation, other routes, emulsion

10 16 sessions proposed for 2014 Lipophilicity in Drug Development : Too much or not enough? Topical Delivery: Strategies for Permeation/Penetration Enhancement Advances in Lipid-Based Drug Delivery Systems for Transdermal & Parenteral Drug Administration Lipids in Oral Drug Delivery - the link between lipid-based formulation and oral drug bioavailability Exciting Advances in Lipid Based Drug Delivery Systems: Oral, Transdermal & Parenteral Formulation approaches for sparingly aqueous soluble drugs for use in preclinical and early stage clinical trials Reformulation of drugs for the young and the old; Tastemasking, swallowabilty and reduction of dosing frequency Using lipids to increase oral bioavailabiltiy of peptide and protein drugs In vitro digestion testing for lipid-based DDS: towards standard protocols

11 Upcoming election of new chair My advice: Preferably someone who is active with focus group Experience with process for getting sessions on Annual Meeting program Committed to actively lobby for sessions

12 Lipid related Posters Monday, 11 th November M Functional Solid Lipid Nanoparticles Using a Fluorescent Molecule for Targeted Delivery to HIV-1 Infected Cells M One-Step Particle Size Reduction and Softgel Fill Material Manufacturing Utilizing Lipid-Based Systems and Wet Milling Processes M High-Performing Cationic Liposomes for Cellular Delivery of Nucleic Acids and Protein Biologics M In Vitro Dispersion Tests are an Effective First Screen during Lipid-Based Formulation Development and Evaluation M Disruption of Endocytic Recycling Enhances Cellular Retention and Efficacy of Lipid Based Nanoparticles for sirna Delivery Courtesy Hywel Williams, PhD

13 Lipid related Posters Tuesday, 12 th November (morning session) T In Vitro Investigations on the Protection of Desmopressin in the Gastrointestinal Tract Using Solid Lipid Particles T A Lipid Based System for Oral Delivery of Peptides and Proteins T A Combination of Cyclodextrin Complexes in Liposomes and Chemical Permeation Enhancers to Improve Tetracaine Topical Delivery T Precipitation of Drug during Digestion of Lipid-Based Formulations Often Unavoidable but Is the Solid State Form Predictable? T Mechanistic Modeling of Lipid Based Drug Delivery Systems for Oral Drug Delivery T Percolation Threshold of Compritol 888 in Matrix Tablet: Assessing the Minimum Concentration to Create an Infinite Lipid Network Courtesy Hywel Williams, PhD

14 Lipid related Posters Tuesday, 12 th November (afternoon session) T Effective Hepatic Delivery of Factor VII sirna Using Lipid Based System T Molecular Biophysics as a Tool to Develop Improved Lipid-Based Systems for Nystatin Delivery Wednesday, 13 th November (morning session) W Solid Lipid Nanoparticles (SLN) for Topical Pulmonary Codelivery of Prostaglandin E and sirna Courtesy Hywel Williams, PhD

15 Lipid related Posters Wednesday, 13 th November (afternoon session) W Lipid Nanoparticles with No Surfactant Improve Oral Absorption Rate of Poorly Water-Soluble Drug W Lipid-Based Formulation versus Solid Dosage Form:In Vivo Evaluation of Super-SNEDDS, Lipid Suspension, Solid Dispersion and Micronized Drug W Development of Lipid-Based Drug Delivery System (LBDDS) to Further Enhance Solubility and Stability of Pterostilbene Cocrystals Courtesy Hywel Williams, PhD

16 Lipid related Posters Thursday, 14 th November (morning session) R Prediction of Drug Solubility in Single Excipients and Lipid Based Formulations R Simulating Drug Absorption and Lipolysis-Triggered Drug Precipitation to Better Predict the Oral Bioavailability of Lipid- Based Formulations R Evaluation of Standardized In Vitro Dispersion and In Vitro Digestion Protocols for Semi-solid Lipid-Based Formulations Courtesy Hywel Williams, PhD

17 Lipid Related Mini-Symposium Monday, 11 th November, 2-4 PM Overcoming Physical Stability Challenges with Multiphasic Lipid Dispersed Systems and Impact on Product Quality and Performance Organized by Panayiotis P. Constantinides, Ph.D.

18 AAPS Lipid Based Drug Delivery Focus Group Travelship Recipients Sponsored by Gattefosse and presented Jasmine Musakhanian, M.Sc. Mohammed Alvi Beaverton, Oregon An Evaluation of Nonionic Formulation Excipients for Enhancing Absorption of Hydrophilic Drugs through Paracellular Pathway Pramod Jagtap South Dakota State University Localized Topical Delivery of 5-Fluorouracil via Mammary Papilla (Nipple)

19 AAPS Lipid Based Drug Delivery Graduate Student Awards Sponsored by Gattefosse and presented Jasmine Musakhanian, M.Sc. Amit Kumar Jain National Institute of Pharmaceutical Education and Research (NIPER) Antioxidant containing solid self nano-emulsifying drug delivery system (s-snedds) of tamoxifen: Implication on oral bioavailabaility, antitumor efficacy and hepatotoxicity Mitan R. Gokulgandhi - University of Missouri, Kansas City Novel Conjugates of Cidofovir: Transporter Affinity, Bioreversion and Antiviral Activity

20 Election New Chair Activities Next Year Lipid Formulation Workshop Webinar on lipid excipients for oral use Propose various sessions 2014 meeting Selection Graduate Student Awards Selection Outstanding Lipid Based Researcher-past winners listed on website

21 New Business

22 Thanks for participating in the LBDDS Focus Group ENJOY THE MEETING!

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