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The Use Of Chemometric Component Analysis for Standardless Quantitative Analysis Of Drug Products Using X-ray Diffraction

Wednesday, September 28th

7:30 am PDT / 10:30 am EDT

Speaker – Dr. Simon Bates

 

 

 

 

 

Abstract: X-ray powder diffraction has a unique advantage over many analytical technics for organic solids, in that it is possible to perform standardless quantitative analysis. Fortunately, for X-ray powder diffraction it is possible to assemble standardless methods. In this webinar, Dr. Bates will discuss the use of chemometric component analysis combined with Vainshtein’s equal area rule to assemble truly standardless quantitative methods.

Dr. Simon Bates is the V.P. of Science and Technology at Rigaku Americas Corp. Before joining Rigaku, Dr. Bates worked in pharmaceutical contract research for 17 years, during which he expanded his toolkit for materials analysis to embrace thermal methods and IR/Raman spectroscopy. He also experimented in organic chemistry and molecular modeling.

He received his Ph.D. from the University of Hull for his neutron diffraction studies on the magnetic properties of rare earth materials. Dr. Bates completed his postdoctoral work at the University of Edinburgh where he first started to design and build specialized high resolution X-ray diffraction system for materials characterization.

 

 


Natoli Scientific Wednesday Academy

Wednesday, October 5th

7:30 am PDT / 10:30 am EDT

Speaker – Dr. Kenneth Morris

 

 

 

 

Abstract: In this webinar, the sticking propensity is investigated using ibuprofen, flurbiprofen, and ketoprofen as model substances with the ultimate goal of estimating the rank order of sticking of drug substances from molecular simulations. It is hypothesized that intermolecular interactions between a drug molecule and a punch face are the first step in the adhesion process and the rank order of adhesion during tablet compression should correspond to the rank order of the energies of these interactions. The molecular basis of adhesion leading to sticking is investigated by exploring the correlation between thermal analysis and AFM with molecular simulations.

Dr. Ken Morris is a special government employee of the U.S. FDA-CDER-OPQ. He has worked in the field of pharmaceutical materials science for over 30 years, studying the impact of the physico-chemical properties of formulation components on the performance of the final pharmaceutical dosage form, with a focus on the use of advanced analytical techniques. Dr. Morris has worked in research and chemist roles at various Federal agencies and private firms. Academic roles include professorship at the University of Hawaii at Hilo and Purdue university, where he also served as the associate department head in the IPPH department. Dr. Morris has also been the Director of the Lachman Institute for Pharmaceutical Analysis at Long Island University.

 

 


Natoli Scientific Wednesday Academy

Wednesday, October 12th

7:30 am PDT / 10:30 am EDT

Speaker – Dr. Antonios Zavaliangos

 

 

Webinars on Demand

Speaker – Robert Sedlock, Natoli Scientific

 

 

 

 

 

 

 

Mr. Robert Sedlock is the Director of Natoli Scientific. He is a leading expert in the tablet compression industry with over 25 years of experience and has authored numerous technical articles and journal publications. Mr. Sedlock is responsible for global solid dosage customer support, training seminars, contract compression services, and continuous research

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Speaker – Dr. Greg Mehos

 

 

 

 

 

 

 

 

Abstract: Many formulators use metrics such as Hausner ratio, Carr Index, and FFC as a measurement of powder flowability.  Unfortunately, many formulations that are deemed “easy flowing” by these powder testing results find that the material will not flow reliably in powder handling equipment.  By using a shear cell tester to measure cohesive strength, internal friction, compressibility, and wall friction over a range of consolidation pressures, an investigator can determine if (1) the outlet of a bin or hopper is large enough to prevent arching or the formation of a stable rathole and (2) the walls are steep enough to allow flow along them.  This webinar will discuss how to use a shear cell tester and how Andrew Jenike’s analysis can be used to predict flow behavior in a bin or hopper.

Greg Mehos, Ph.D., P.E. is the director of Greg Mehos & Associates LLC and is a chemical engineering consultant who specializes in bulk solids handling, storage and processing and an adjunct professor at the University of Rhode Island.  Greg enjoys teaching professionals and students bulk solids engineering fundamentals so that they can solve powder handling problems and design equipment for reliable handling of solids.  He has authored dozens of technical papers on the subject and contributed to the Solids Processing and Particle Technology section of the ninth edition of Perry’s Chemical Engineers’ Handbook.  He received his B.S. and Ph.D. in chemical engineering from the University of Colorado and his masters from the University of Delaware.  Greg is a Fellow of the American Institute of Chemical Engineers and a past chair of the Boston local section.  He is a licensed professional engineer in Massachusetts.

 

Speaker – Dr. Martin Thomas (Anton-Paar)

 

 

 

 

 

 

 

 

Abstract: The materials that go into solid dosage formulations undergo various physical transformations from powder to tablet. This webinar will describe the characterization of these various solid forms with reference to appropriate USP chapters: <846> Specific Surface Area, <616> Bulk Density and Tapped Density of Powders, <699> (Gas Pycnometric) Density of Solids, <1174> Powder Flow, and <267> Porosimetry by Mercury Intrusion. The underlying technologies will be introduced to provide an understanding of the true nature of the various measurements, and how they relate to the various processes and final product behavior.

Dr. Martin Thomas is a Lead Scientist and Product Manager with Anton Paar. He has more than 38 years of experience in the characterization of powders and porous materials, with ten patents in the field and is co-author of “Characterization of Porous Solids and Powders: Surface Area, Pore Size, and Density” published by Springer. He gained his PhD from the University of Birmingham (UK) and spent eight years in the chemical industry before joining Quantachrome Instruments (which was incorporated into Anton Paar in 2018) in 1991.

Speaker – Salvatore Pilliteri (Granutools)

 

 

 

 

 

 

 

 

Abstract: The processability of pharmaceutical powders plays a key role in the design and improvement of tableting processes. It is therefore important to characterize the material properties and the behaviour of bulk powder to optimize processing methods. Good flowing and densification properties are required for filling of the dies of the tableting system and compaction of the powder. The rheological properties of pharmaceutical powders have been investigated with the rotating drum method (GranuDrum) and tapped density method (GranuPack) and correlated with the performance achieved in a tableting system. The ability of powders to build up charge during flow is also investigated with the GranuCharge and correlated with the flowability and the processability of the powders.

Salvatore Pillitteri studied Physics at the University of Liège. He did a PhD thesis on granular compaction under the supervision of Pr. Nicolas Vandewalle and developed expertise in the field of granular materials. His work is part of the European project Powderreg. The aim of this project was to boost the competitiveness and attractiveness of the Grande Région (Großregion) and is part of a plan to optimize processes applicable to industrially relevant powders within the highly developed sectors such as agrifood, chemicals, pharmaceuticals, and construction. After his thesis defense, he started a career at Granutools as a Particle Scientist to apply his knowledge in granular science to industrial problems.

 

Speaker – Dr. Rahul Haware, Natoli Scientific

 

 

 

 

 

 

 

Abstract: Metformin HCl is highly prescribed anti-diabetic drug. This drug poses various challenges in the tablet manufacturing in addition to a high dose. In this webinar, Dr. Haware will discuss molecular and macroscopic reasons for manufacturing challenges of Metformin HCl and how to solve these challenges with drug: drug cocrystal engineering approach.

Dr. Rahul Haware is a Pharmaceutical Scientist currently serving as the Director of Scientific Support and New Business Development at Natoli Scientific. His professional and academic expertise is in leveraging Process Analytical Technology (PAT), and Quality-by-Design (QbD) paradigms to develop the DM(3) approach. He was a professor for eight years and has authored several book chapters (3) and peer-reviewed international review and research papers (46). Dr. Haware holds Master’s degrees in Pharmacy and Molecular Biology. He completed his PhD in Powder Compaction Physics at UiT The Arctic University of Norway.

 

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