Developing Controlled-Release Multi-Particulate Formulations: Considerations in Manufacturing the Core and the Coating - Junshu Zhao, Ph.D. (BMS)

Developing Controlled-Release Multi-Particulate Formulations: Considerations in Manufacturing the Core and the Coating

Junshu Zhao, Ph.D.,
Bristol-Myers Squibb

With the enhanced regulations from the FDA and EMEA in the past decades, there has been an increased emphasis on the development of quality drugs for the pediatric patients in recent years. A mutli-particulate formulation defined as particle size ≤ 2.5 mm has a desirable combination of advantages compared to traditional oral solid dosage forms and liquid dosage forms for pediatric use. This includes better swallowability, accurate and flexible dosing, capability of non-sugar based taste masking and good stability. However, it also has unique challenges especially when it comes to the development of a controlled-release formulation. To achieve robust release profiles, specific requirements apply to both the formulation and process for manufacturing the core particulates as well as controlled-release coating, such as swellability of the core that can disrupt the integrity the film coating during release, consistency in core size to ensure consistent coating thickness, specific interactions between the coating material and core components; as well as interactions with the dissolution media for developing a biorelevant dissolution method.
This talk will discuss the different core manufacturing techniques (extrusion spheronization, drug layering and mini-tablet compression) with a focus on understanding the process parameters in making a robust dry granulation process for mini-tablet compression. The two common extended release coating systems: Surelease® and Eudragit® RS/RL will also be discussed, including the effect of sub-coat, their swelling properties, effect of curing and interactions with the core composition and the dissolution media.

Date and Location

About the speaker

Junshu Zhao is currently a Senior Research Investigator in Pharmaceutical Development at Bristol-Myers Squibb (BMS) in New Jersey. She is the 2017 chair-elect of the AAPS Excipient focus group and a steering committee member of the Modified Release focus group. Junshu received her B.S. in Chemical Physics (2004) from University of Science and Technology of China and her Ph.D. in Physical Chemistry (2010) from University of Wisconsin-Madison. Junshu’s current area of expertise at BMS is in the formulation development of oral solid dosage forms with experience in developing combination products, controlled-release formulations, pediatric formulations and amorphous dispersions. For the past 3 years, Junshu has been leading an internal scientific community in better understanding the properties and functionalities of polymer excipients.

Junshu is a member of various professional organizations including the American Association of Pharmaceutical Scientists (AAPS) and the American Institute of Chemical Engineers (AIChE). She has been serving as a Scientific Advisor to the Editors of the Journal of Pharmaceutical Sciences since 2013. Junshu was the chair of the session “Product Performance Models (In Vivo) and Applications from Pre-POC to Phase 3 and Beyond” in the 2015 AIChE Annual Meeting, and the moderator of the short course “Fundamentals of Polymer Science and Application In Drug Delivery & Product Development” in the 2016 AAPS Annual Meeting and Exposition.