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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.

What You Will Learn

From this webinar, participants will learn about and be able to:

  • Identify key strategic decisions and essential information that a development team will need to be successful
  • Understand the benefits of appropriate API characterization and preformulation work in modified release oral solid dosage form development
  • Recognize the key CMC development data that health authorities will expect to see to be able to properly evaluate submissions