Specialty matrix drug delivery systems, like osmotic pump tablets, play an important role in patient-centric drug design. In this upcoming webinar, experts will delve into how one unique excipient, POLYOX™ polyethylene (PE) oxide, provides critical material properties that result in robust drug product performance.

https://www.pharmtech.com/pt_w/oxide-essentials

Advanced Drug Delivery: Harnessing the Unique Properties of POLYOX™ Polyethylene Oxide in Oral Solid Dosages


Specialty matrix systems, like osmotic pump tablets, offer an array of advantages in drug delivery, such as zero-order release profiles, no food effects, and targetable site of delivery. These benefits contribute to improved efficacy of the drug product in patient outcomes. One polymer stands out as being uniquely designed for use in osmotic pump tablets: POLYOX™ polyethylene oxide.

In this presentation, we explore the material properties of POLYOX™ that make the polymer well suited for specialty matrices. We will also cover the naturally degradative nature of polyethylene oxide, discussing how it impacts drug product performance and ways to overcome this challenge.

Understand key material attributes of POLYOX™ polyethylene oxide and how POLYOX™ is used in specialty matrix formulations

Identify properties that impact polyethylene oxide degradation both in powder and in formulations

Explore ways to overcome degradation challenges through storage conditions and packaging

Technical transfer and scale up scientists


Lead Applications Scientist
IFF
Elizabeth Tocce is a lead applications scientist for IFF Pharma Solutions, where she heads technical marketing projects promoting the expertise of the Pharma Solutions business unit.

Elizabeth joined the IFF Pharma Solutions team in 2018 as a pharma application development scientist. In this role, she provided technical support to pharmaceutical customers and project leadership on growth and innovation projects using IFF’s pharmaceutical excipients. Prior to her roles with IFF, Elizabeth was a research and development scientist for the Dow Chemical Company’s Pharma & Food Solutions excipient business where she led R&D projects in areas of specialty oral solid dosages and quality improvement.

Elizabeth received her Ph.D. in chemical and biological engineering from the University of Wisconsin in Madison.

Webcasts

Webinar Date/Time: Tue, Nov 19, 2024 11:00 AM EST


POLYOX™ Polyethylene Oxide Essentials: An Expert Guide to Polymer Properties and Drug Formulation

In this webinar, you will learn from industry experts about collaborative strategy that helps mitigate the nitrosamine risk in your drug formulations. Experts will address the industry’s core need for reliability, sustainability, quality, and predictable performance standards in drugs to develop and produce robust formulations.

https://www.pharmtech.com/pt_w/nitrosamine-risk-reduction

Nitrosamine risk assessment and control have become an integral part of pharmaceutical drug development and the quality evaluation process. Regulatory bodies mandate that manufacturers of active pharmaceutical ingredients and finished pharmaceutical products must evaluate the risk of nitrosamines and take appropriate risk-mitigating measures.

During this webinar, industry experts will share strategies to mitigate the nitrosamine risk. This webinar will capture the key risks and root causes of nitrosamine formation in drug products. Speakers will use model amine studies to confirm risk factors and predictive models in support of risk assessments. This webinar will also cover excipient supplier strategies for managing nitrite impurities and analytical methods to quantify nitrite content in a consistent and reliable manner.

Causes and risks of nitrosamine formation in pharmaceutical dosage drugs

Risk mitigation strategies considered by the pharmaceutical industry and the excipient manufacturer

Use of model amine studies to confirm risk factors and inform the magnitude and extent of nitrosamine formation

Development and use of predictive models for nitrosamine formation in support of risk assessments

Analytical method development and support to monitor nitrite in excipients

Case studies with respect to low nitrite excipient offering


Principal Scientist – Vaccine Drug Product Development
Merck & Co.

Justin Moser is a Principal Scientist at Merck & Co., Inc. within the research and development division. His role is in vaccine drug product development focusing on formulation and process design, clinical supply support and scale-up and technology transfer to the manufacturing division. Prior to this assignment and at the beginning of 2020, Justin led the drug product N-nitrosamine risk evaluation team chartered with building data and understanding that can be utilized to assess risk for Merck & Co., Inc. marketed products. He took over leadership of the overall cross-functional N-nitrosamines core risk team which authored and submitted the risk assessment outcomes to health authorities.

He has a B.S in Chemical Engineering from The Pennsylvania State University and has been working at Merck for over 21 years. Justin’s experience in drug product development spans candidate approval through commercial process validation and product registration. He has held roles of increasing responsibility from bench level scientist through team leader of cross-functional teams developing oral solid dosage drug products from drug candidate approval into phase 3 and registration stability lot execution. He has also led technology implementation of spray drying at Merck for over 13 years including managing outsourced development and manufacture, design and installation of a pilot scale spray drying plant and authoring several core sections of the dossier for Merck’s first spray dried amorphous dispersion product Zepatier. He is an author on over 17 publications, co-inventor on 8 patents and presented at numerous conferences. Most recently, he served as an author of the editorial for the J. Pharmaceutical Sciences special edition on N-nitrosamines and lead author on an included publication addressing N-nitrosamine formation risk in solid drug products.





IFF’s Pharma Solutions

Dr. Meinolf Brackhagen is a Principal Pharma Application Scientist at IFF's Pharma Solutions. His responsibilities include technical service and development for the Pharma application markets as well as in-depth analysis of structure/property relationships used to commercialize new products and assist customer´s developments.

Prior to his current role at IFF, Meinolf spent 20 years in different assignments with increasing leadership responsibility at Bayer, Dow and DuPont R&D, and more than 10 years in Pharma Solutions working with excipients and applications.

Dr. Meinolf Brackhagen holds a diploma in Organic Chemistry from the Technical University of Dortmund (Germany) and a PhD in Carbohydrate Chemistry from the University of Rostock (Germany). He is a certified Six Sigma Black Belt. Dr. Meinolf Brackhagen is the author or co-author of more than 40 published patent applications and eight articles in peer-reviewed journals.


Webinar Date/Time: Wed, Nov 1, 2023 11:00 AM EDT

IFF

Articles