Regulatory and CMC Considerations for Developing Modified Release Versions of Immediate Release Oral Solid Dosage Forms

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.

Do you have the data to support product quality if clinical pharmacokinetic results are unexpected? Does your dissolution data set provide adequate support for reproducibility of the drug release profile across multiple batches and on stability?

In this webinar, presenters will discuss these issues as well as provide examples and information from the perspectives of real-world experience and expertise gained from numerous modified release development and commercial manufacturing projects over the past 20+ years.

Speakers

Richard Sidwell, PhD, Senior Vice President and Chief Scientific Officer, Recro Gainesville

Richard Sidwell is responsible for Recro’s overall scientific strategy for the CDMO business. He has worked at the Gainesville site since 2003, experiencing its evolution from Elan Drug Technologies to Alkermes in 2011 and finally to Recro in 2015. While at Recro, Sidwell has been instrumental in leading and building the CDMO’s product development team, which focuses on bringing innovative solutions to its clients.

With 25 years of pharmaceutical development experience, Sidwell is recognized as a thought leader in pharmaceutical formulation and process development for oral solid dosage forms, multi-particulate controlled release formulations and abuse-deterrent formulations for controlled substances. Sidwell holds multiple patents and publications in these areas.

Sidwell earned his PhD in pharmaceutics from the University of Georgia; Master of Science degree in health physics from the Georgia Institute of Technology; and Bachelor of Science degree in physics from Oglethorpe University. He is an active member of the American Association of Pharmaceutical Scientists (AAPS).

Message Presenter

R. Wayne Wiley, RPh, Vice President, Regulatory Affairs and Pharmacovigilance, Recro Gainesville

R. Wayne Wiley brings more than 30 years of experience in pharmaceutical regulatory affairs to Recro Gainesville, serving as the site’s vice president of regulatory affairs and pharmacovigilance. Wiley is an experienced manager with broad experience and success providing support for regulatory agency meetings in addition to IND, NDA, ANDA, DMF and ROW filings and approvals. Wiley has a strong understanding of regulatory, clinical, development and life cycle management filing requirements, including post-approval support for phase IV, pharmacovigilance and supplemental approvals.

Prior to joining Recro, Wiley held various positions of increasing responsibility at Alkermes, Elan Drug Technologies and Solvay Pharmaceuticals.

Wiley is a registered pharmacist and a graduate of the Mercer University School of Pharmacy. He has delivered lectures in regulatory affairs and pharmacovigilance for the University of Georgia School of Pharmacy: Master of Science in Regulatory Affairs program and serves on the curriculum and admissions committees. He has also provided support for the Mercer School of Pharmacy: Doctor of Pharmacy Preceptor training program. He is a member of RAPS, DIA and AAPS.

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