Research center pharmaceutical engineering - Styria, Austria
Title: Linking processing routes to molecular miscibility, in vitro performance and physical stability of amorphous drug-polymer solid dispersion
Symposium: Polymer Processing in Pharmacy
AMRIT PAUDEL, M.S. (Pharm.), Ph.D.
Dr. Amrit Paudel
Department Head Area II - Advanced Products and Delivery
Research Center Pharmaceutical Engineering GmbH (RCPE) (www.rcpe.at)
A-8010 Graz, Inffeldgasse 13/II
phone: +43 316 873 30912
mobile: +43 676 34 86 312
fax: +43 316 873 10 30912
e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Trained in pharmaceutics, I have a broad interest in physical chemistry of formulations. I have a long standing activities and interest in screening, engineering, stabilization and characterization of pharmaceutical solids intended for oral and inhalation routes. Recently, I am also keenly involved in predicting/ developing physical and chemical stability of pharmaceutical solids utilizing material science principles. Also, I work towards advancing the predictive knowledge of in vitro biopharmaceutics methodologies via elucidation of multi-factorial physical and chemical process governing drug dissolution and release from conventional to advanced solid dosage forms.
Research Experience
Department head (April 2014 onwards): Advanced Products and Delivery, RCPE, Graz, Austria
Cutting Edge R&D in pharmaceutical product development at industry-academia interface
Senior Scientist (September 2013 onwards): Advanced Products and Delivery, RCPE, Graz, Austria
Postdoctoral Research Associate (March 2013-September 2013): Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, University of Leuven, Belgium
Advanced characterization of pharmaceutical solids, nucleation/crystal growth
PhD Student (2009- 2013): Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, University of Leuven, Belgium
Formulation and process considerations in amorphous solid dispersions manufacturing
Scientist (2008-2009): Pharmaceutics and Analytical R&D, Bristol-Myers Squibb (BMS), India
Preformulation, solid-state screening, physicochemical profiling, preclinical formulation
Research Scholar (2006-2008): Department of Pharmaceutical Analysis, NIPER, S.A.S. Nagar, Punjab, India
Degradation chemistry and mass spectrometry of carbapenem antibiotics
Key Skills
Pharmaceutical particle engineering for oral and pulmonary delivery: Tailoring particle morphology, surface and micromeritics, composite micro- and nano-particles, carrier modification for inhalation delivery, fluid bed elutriation and spray-freeze drying
Formulation and processability of amorphous and nanocrystalline solid dispersion: Formulation and process parameters influence on microstructure, physical state, particulate and bulk properties, biorelevant in vitro dissolution behavior, oral dosage from spray dried products
Solid-state pharmaceutics: Thermodynamic/ kinetic parameters influencing the particulate, molecular properties of pharmaceutical solids, prediction of stability, process induced phase transformation, moisture-solid interactions Polymorph and hydrates/solvates screening/characterization, thermodynamics of polymorphic and hydrate/anhydrate relationship & phase transitions
Degradation chemistry of pharmaceuticals: Solid/solution state forced degradation, physical/ chemical interactions of drug and excipients, long term stability and mechanism/ kinetics of drug degradation
Preformulation and physicochemical profiling: Solubility, pKa, LogP, pH-solubility/stability, particle size, dissolution, solid-state stability, and drug-excipient compatibility
Academic Qualifications
| Postdoc Fellow (2013): | Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, University of Leuven, Belgium |
| Ph.D. (2009-2013): | Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, University of Leuven, Belgium |
| M.S. (Pharm.) (2006-2008): | Department of Pharmaceutical Analysis, NIPER, S.A.S. Nagar, Punjab, India |
| B. Pharm. (2000-2004): | Department of Pharmaceutical Sciences, L.M. college of Pharmacy, Ahmedabad, India |
Awards and Honours
| 2014 | Young Investigator Award, International Society of Drug Delivery Sciences and Technology (APGI) |
| 2009 | BMS R&D Star Award |
Professional Membership/Activities
| 2013 - present | Editorial Advisory Board, Journal of Pharmaceutical sciences |
| 2008-present | Reviewer of manuscripts published in J Pharm sci, Int J Pharm, J Controlled Release, Pharm Res, Drying Technol |
| 2006 - 2008 | Student Member, American Association of Pharmaceutical Scientists (AAPS), USA |
| 2006 - 2008 | Chair, NIPER-AAPS Student Chapter, NIPER, S.A.S. Nagar, India |
Supervising Experience
RCPE (2013-present):
Scientific lead to a group of PhD/postdocs dedicated towards the advancement of formulation and drug delivery research encompassing particle engineering, solid oral dosage, DPI, controlled release products, personalized medicine, material science, biopharmaceutics and pharmaceutical analysis
University of Leuven (2009-2013):
(Co)-supervised various masters and PhD students working in amorphous solid dispersion, nano-pharmaceutics, nucleation/crystallization, spray drying, hot melt extrusion
Research Collaboration (RCPE)
Multi-firm industrial collaborations in amorphous/ co-crystal product development, DPI particle engineering, personalized medicine, stability (Novartis, Pfizer, Astrazeneca Merck. GSK, UCB etc)
Academic collaborations in DPI particle engineering, oral/inhalation biopharmaceutics, material sciences and advanced manufacturing (Univ of Bath, Univ of Parma, Univ of Dusseldorf)
Lectures delivered as Invited Speaker
Influence of solvent composition on the miscibility and physical stability of naproxen/PVP K 25 solid dispersions prepared by cosolvent spray-drying (TA instrument, Annual Benelux Users Meeting 2011, Antwerp, Belgium)
Capsule filled carrier-based DPI: Interplay of material attributes, particle engineering and processing (Innovation Days: Capsule-Based DPI Technology 2015, Harro Höfliger-Capsugel, Stuttgart, Germany)
List of Publications and Presentations
a. Publications
Faulhammer, E., Llusa, M., Wahl, P.R., Paudel, A., Lawrence, S., Biserni, S., Calzolari, V., Khinast, J.G. Development of a design space and predictive statistical model for capsule filling of low-fill-weight inhalation products. Drug Dev Ind Pharm. 2015
Paudel, A., Raijada, D., Rantanen, J. Raman spectroscopy in pharmaceutical product design Adv Drug Deliv Rev. 2015
Leane, M., Pitt, K., Reynolds, G., Paudel, A. et al. A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms Pharm Dev Technol 2014
Paudel, A., Geppi M., Van den Mooter, G. Structural and dynamic properties of amorphous solid dispersions: the role of solid-state nuclear magnetic resonance spectroscopy and relaxometry, J Pharm Sci 2014
Paudel, A., Loyson, Y., Van den Mooter, G. An investigation into the effect of spray drying temperature and atomizing conditions on miscibility, physical stability and performance of naproxen/PVP K 25 solid dispersions, J Pharm Sci 2013
Paudel, A., Nies, E., Van den Mooter, G. Relating hydrogen-bonding interactions with the phase behavior of naproxen/PVP K 25 solid dispersions: Evaluation of solution-casted and quench-cooled films Mol. Pharmaceutics 2012
Paudel, A., Worku, Z.A., Meeus, J., Guns, S., Van den Mooter, G. Manufacturing of solid dispersions of poorly water soluble drugs by spray drying: Formulation and process considerations Int. J. Pharm. 2012
Ayenew, Z., Paudel, A., Rombaut, P., Van den Mooter, G. Effect of compression on non-isothermal crystallization behavior of amorphous indomethacin. Pharm. Res. 2012
Ayenew, Z., Paudel, A., Van den Mooter, G. Can compression induce demixing in amorphous solid dispersions? A case study of naproxen–PVP K 25. Eur. J. Pharm.Biopharm. 2012
Paudel, A., Van den Mooter, G. Influence of solvent composition on the miscibility and physical stability of naproxen/PVP K 25 solid dispersions prepared by cosolvent spray-drying. Pharm. Res. 2012
Paudel, A., Van Humbeeck, J., Van den Mooter, G. Theoretical and experimental investigation on the solid solubility and miscibility of naproxen in poly (N vinyl pyrrolidone). Mol. Pharmaceutics 2010
Janssens, S., De Zeure, A., Paudel, A., Van Humbeeck, J., Rombaut, P., Van den Mooter, G. Influence of preparation methods on solid state supersaturation of amorphous solid dispersions: a case study with itraconazole and eudragit E100. Pharm. Res. 2010
Raijada, D.K., Prasad, B., Paudel, A., Shah, R.P., Singh, S. Characterization of degradation products of amorphous and polymorphic forms of clopidogrel bisulphate under solid state stress conditions. J. Pharm. Biomed. Anal. 2010
b. Book chapter
Singh, S., Paudel, A., Bedse, G., Thakare, R., Kumar, V. The Challenge of Diverse Climates: Adequate stability testing conditions for India. Chapter 6, Pharmaceutical Stability Testing to Support Global Markets 2010 (Springer New York)
Paudel, A., Meeus, J., Van den Mooter, G. Structural Characterization of Amorphous solid disperison. Springer New York (Book chapter for an AAPS book series 2014).
c. Conference abstracts/presentations
Improving dissolution rate of itraconazole by spray drying and electrospinning different eudragit-itraconazole solutions into solid dispersions [AAPS annual meeting, St. Antonio, USA, 2013]
Relating hydrogen-bonding interactions with the phase behavior of naproxen/PVP K 25 solid dispersions: Evaluation of solution-casted and quench-cooled films [Annual Pharmaceutical solid-state research cluster (PSSRC) Symposium, Portugal, 2012]
Towards understanding the processing parameters-physical structure relationship for spray dried naproxen/PVP K 25 solid dispersions: exploring the missing link [Forum of Belgian Society of Pharmaceutical Sciences, Blankenberge, Belgium, 2012]
Influence of solvent composition on the miscibility and physical stability of naproxen/PVP K 25 solid dispersions prepared by cosolvent spray-drying [AAPS annual meeting, Washington DC, USA]
The influence of formulation and process parameters on the physical structure of solid dispersions prepared by spray drying: A case study of naproxen-polyvinylpyrrolidone [Annual Pharmaceutical solid-state research cluster (PSSRC) Symposium, Helsinki, Finland, 2012]
Theoretical and experimental investigation on the solid solubility and miscibility of naproxen in poly (N vinyl pyrrolidone) [AAPS annual meeting, New Orleans, USA, 2010]
Solid state characterization of a new polymorphic modification of naproxen [European Symposium on Thermal Analysis and Calorimetry, Rotterdam, The Netherlands, 2010]
Application of LC-NMR and LC-MS for the structural characterization of epimeric degradation products of faropenem generated under alkaline media [International NMR Symposium, Bangalore, India, 2008]
Identification of degradation and interaction products formed during compatibility studies between atenolol and aspirin [Indian Pharmaceutical Congress, India, 2007]
References
Prof. Johannes Khinast
Head of the Institute of Process and Particle Engineering
Scientific Director Research Center Pharmaceutical Engineering (RCPE)
Graz University of Technology,
Inffeldgasse 13
A-8010 Graz, AUSTRIA
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Prof. Guy Van den Mooter
Professor, Dept. of Pharmaceutics
Drug Delivery and Disposition
Department of Pharmaceutical and Pharmacological Sciences
University of Leuven; Campus Gasthuisberg O+N2;
Herestraat 49
3000 Leuven, BELGIUM
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.