Regulatory and CMC Considerations for Developing Modified Release Versions of Immediate Release Oral Solid Dosage Forms, Upcoming Webinar Hosted by Xtalks
In this free webinar, the featured speakers will identify key strategic decisions and essential information that a development team will need to be successful. Attendees will understand the benefits of appropriate API characterization and preformulation work in modified release oral solid dosage form development.
TORONTO (PRWEB) JUNE 10, 2020 – Developing a modified release formulation of an existing immediate release oral solid dosage form is a common request. Often, modified release formulations offer patient compliance, marketing, and exclusivity/patent benefits over their immediate release predecessor. What is not as obvious is that modified release dosage forms present their own unique set of complications, nuances, and regulatory expectations that are not always apparent.
There are specific strategic decisions to be made with respect to the desired in vivo behavior and final dosage form that critically impact formulation strategy and process selection. For example, do you want a tablet or capsule? Once-a-day or twice-daily dosing? Sustained release or pulsatile? These decisions have multiple nuanced implications that can have significant impact on the development and approval timeline.
In addition, there are also key data elements to acquire during Active Pharmaceutical Ingredient (API) characterization and preformulation that can make or break a development team’s efforts. Particle size and polymorphic form are also key for immediate release formulations, but once a modified release formulation is considered, pH solubility and stability profiles in different buffers and the impacts of different ions or surfactants in the medium (e.g., SGF, SIF, FaSSGF, FaSSIF, FeSSIF) become important information. Finally, modified release dosage forms are subject to specific health authority expectations for Chemistry, Manufacturing, and Controls (CMC) and clinical data that differ from those for immediate release dosage forms.
Join Richard Sidwell, PhD, Senior Vice President and Chief Scientific Officer, Recro and R. Wayne Wiley, RPh, Vice President, Regulatory Affairs and Pharmacovigilance, Recro in a live webinar on Thursday, June 25, 2020 at 1pm EDT.
For more information or to register for this event, visit Regulatory and CMC Considerations for Developing Modified Release Versions of Immediate Release Oral Solid Dosage Forms.
Recro provides oral solid dosage form development, regulatory support, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market. Specializing in modified release oral solid dose and DEA controlled substances, Recro has the experts to deliver our clients’ most complex pharmaceutical development and manufacturing projects in our best-in-class facilities, totaling 120,000 square feet. For more information about Recro’s flexible CDMO solutions, visit recrogainesville.com.
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