Webinar

 

Watch this e-symposium to gain insights into the latest research and innovative solutions in drug development and formulation. Learn how you can shorten your time-to-market, reduce development costs, increase yield, and assure quality and pharmacopoeia compliance throughout the drug development process.

You will learn useful strategies regarding oral solid dosage (OSD) formulation, drug delivery systems, and implant development, as well as process R&D and manufacturing. In addition, the series covers several key techniques:

  • Hot-melt extrusion for OSD and implants
  • Twin-screw granulation and continuous manufacturing
  • Utilizing PAT for process monitoring and quality assurance
  • Raman microscopy for diagnosis and final product verification
  • UV-Visible spectroscopy for quality control and adherence to pharmacopoeial standards

Key learning objectives:

  • Streamline manufacturing drug formulations and implants using hot-melt extrusion and twin-screw granulation
  • Ensure process quality through monitoring with PAT techniques
  • Verify final product quality using Raman microscopy and UV-Vis spectroscopy

Register below by clicking on the registration link(s) to access the sessions of interest to you.

Topics and speakers:
Hot melt extrusion, process monitoring, and final product verification

Hot melt extrusion (HME) is a powerful and versatile tool for modern pharmaceutical formulation development. HME can be used for many applications, from increasing bioavailability to devising novel drug delivery methods.

Presenters:

Margarethe Richter, Applications Scientist, Thermo Fisher Scientific

Margarethe Richter, Applications Scientist, Thermo Fisher Scientific

Dr. Margarethe Richter is a Pharma Application Specialist at Thermo Fisher Scientific, where she develops new applications for pharmaceutical twin-screw extruders. The publication of her findings as well as the worldwide support for Thermo Fisher’s customers are her main responsibilities. She has international experience on hot melt extrusion, twin-screw granulations for various pharmaceutical dosage forms, scale-up, and GMP. Margarethe was a researcher at the German Aerospace Center (DLR), Institute of Engineering Thermodynamics, in Stuttgart, Germany. There she focused on thermochemical energy storage, heat transformation, thermal analysis, thermodynamic and kinetic reaction models. In this position, she earned her PhD degree (Dr.-Ing.) from the University of Stuttgart. Margarethe is a chemical engineer by training and graduated from the Karlsruhe Institute of Technology (KIT).

Ramesh Muttavarapu, Manager, Research & Development, Pharma Services Group, Thermo Fisher Scientific

Ramesh Muttavarapu, Manager, Research & Development, Pharma Services Group, Thermo Fisher Scientific

Ramesh Muttavarapu is the Manager of R&D Formulations at Thermo Fisher Scientific. He holds a master’s in pharmacy and an MBA from University of Cincinnati. He has 20+ years of research experience including 14 years at Thermo Fisher Scientific. His research experience includes formulation, scale-up and commercialization of conventional and complex modified-release solid oral dosage forms. Pertaining to HME, he is experienced in solubility enhancement, abuse deterrent, and controlled release applications.

Downstream Processing of Itraconazole: HPMCAS Amorphous Solid Dispersion: from Hot-Melt Extrudate to Tablet Using a Quality by Design Approach

Hot melt extrusion (HME) -based amorphous solid dispersion (ASD) offers many advantages, but further processing of those ASD extrudates can be challenging. The presented work shows how a robust platform for downstream processing was established using a quality by design (QbD) approach. Different cutting techniques at the end of the extruder barrel and different milling conditions were tested for their influence on critical quality attributes (CQAs). For a successful scale-up, correlations from early-formulation hand-cut processing at the lab scale to industrial-applicable processes are established.

Presenter:

Saurabh Mishra, Formulation Scientist, Manager of Pharmaceutical Laboratory SE Tylose USA Inc.

Saurabh Mishra, Formulation Scientist, Manager of Pharmaceutical Laboratory SE Tylose USA Inc.

Dr. Saurabh M. Mishra is currently working as a formulation scientist and Manager of Pharmaceutical Application Laboratory of SE Tylose USA Inc (ShinEtsu Chemicals, LTD) based in Totowa, NJ. In his current role, he carried out application studies of cellulose ether-based pharmaceutical excipients of Shin-Etsu, and he supports pharma and Nutra customers in formulation development studies. Before joining Shin-Etsu, he earned his master's (MS) and PhD in Industrial Pharmacy from St. John's University, New York, USA.  He carries out research in powder compaction, continuous granulation, solid dispersions, and controlled release formulations. He has published more than 10 research articles in high-impact peer reviewed journals and presented more than 15 abstract posters/presentations in national and international conferences. During his graduate studies, he was awarded with the “Dr. Charles Jaworski Research Scholarship” for best research and “Certificate of Academic Excellence” for completing his PhD.

Granulation and PAT for monitoring granulation

Continuous granulation offers opportunities to overcome several challenges of traditional batch production of tablets and capsules. It is efficient and inherently scalable, and the technique has advanced to a point of true reliability and flexibility. It can also be implemented all at once, or a little at a time.

Presenters:

Dirk Leister, Technical Marketing Manager, Thermo Fisher Scientific

Dirk Leister, Technical Marketing Manager, Thermo Fisher Scientific

Dirk Leister is a Marketing Manager for extruders and compounders at Thermo Fisher Scientific in Karlsruhe, Germany. Together with the product line team he focuses on applications for extrusion-based processes used in the pharmaceutical, food, and polymer industries. Dirk holds an engineering degree in biotechnology and started his professional career in pharmaceutical research and development. After moving to the instrument manufacturing side of the industry, he had several positions in technical sales and product management. His expertise is developing applications for process equipment used to conduct formulation research, process development, and manufacturing scale-up for pharmaceutical and bulk material handling. Dirk is adept at helping companies minimize optimization time, costs, and efforts of their continuous process scale-up.

 

Shailesh Karavadra, Manager, Applications Scientist, Thermo Fisher Scientific

Shailesh Karavadra, Manager, Applications Scientist, Thermo Fisher Scientific

Shailesh Karavadra has over 15 years of experience in vibrational spectroscopy. He has served as Application specialist and Sales Manager in various regions of Europe and has helped to implement Raman, IR and NIR spectroscopy in Pharma/Biopharma, Chemical and Food and Agri sectors. He is currently working as Applications manager (Vibrational Spectroscopy) for the EMEA region.

Implants and applications of vibrational spectroscopy

Implantable drug delivery systems offer several advantages over conventional oral dosage formulations. Implants allow site-specific drug administration that delivers the drug where it is needed most. Raman microscopy can help to verify the effectiveness of the process.

Presenters:

Dirk Leister, Technical Marketing Manager, Thermo Fisher Scientific

Dirk Leister, Technical Marketing Manager, Thermo Fisher Scientific

Dirk Leister is a Marketing Manager for extruders and compounders at Thermo Fisher Scientific in Karlsruhe, Germany. Together with the product line team he focuses on applications for extrusion-based processes used in the pharmaceutical, food, and polymer industries. Dirk holds an engineering degree in biotechnology and started his professional career in pharmaceutical research and development. After moving to the instrument manufacturing side of the industry, he had several positions in technical sales and product management. His expertise is developing applications for process equipment used to conduct formulation research, process development, and manufacturing scale-up for pharmaceutical and bulk material handling. Dirk is adept at helping companies minimize optimization time, costs, and efforts of their continuous process scale-up.

 

Shailesh Karavadra, Manager, Applications Scientist, Thermo Fisher Scientific

Shailesh Karavadra, Manager, Applications Scientist, Thermo Fisher Scientific

Shailesh Karavadra has over 15 years of experience in vibrational spectroscopy. He has served as Application specialist and Sales Manager in various regions of Europe and has helped to implement Raman, IR and NIR spectroscopy in Pharma/Biopharma, Chemical and Food and Agri sectors. He is currently working as Applications manager (Vibrational Spectroscopy) for the EMEA region.

Identification of color in pharmaceutical products according to pharmacopeia procedures

The color of a pharmaceutical product has implications towards a variety of different aspects in the drug product development process. Both USP and EP describe analysis methods needed to quantitatively determine the color of a drug product, including acquiring CIE Lab color values. To perform this analysis, the UV-Visible absorption spectra of either liquids or powders are collected and used to determine the color values of the products.

Presenter: 

Jennifer Empey, Applications Specialist, Thermo Fisher Scientific

Jennifer Empey, Applications Specialist, Thermo Fisher Scientific

Dr. Jennifer Empey has been with Thermo Fisher Scientific as an Applications Scientist since October 2021 where she supports the Core UV-Visible instruments. Prior to this position, she received her PhD in Analytical Chemistry from The Ohio State University where she used various spectroscopic techniques to study colloidal nanoparticles.

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