The dissolution behavior of drugs remains one of the most challenging aspects in formulation development for BCS II and IV APIs. With the advent of combinatorial chemistry and high throughput screening, the number of poorly water soluble drug candidates dramatically increased. Solubility enhancement is an important enabling strategy to enhance drugability of NCEs as well as life cycle management for marketed pharmaceutical products.
This course provides an overview of formulation strategies of poorly soluble drugs for drug dissolution enhancement. The presentations, delivered by key thought leaders, highlight fundamental principles, as well as enabling technologies, for solubility enhancement.
This course covers an introduction to the topic as well as takes a deeper dive into three key areas:
- Solid Formulations
- Liquid Formulations
- Regulatory Aspects
COURSE OBJECTIVESUpon completion of this course, participants will be able to:
- Review solubility, permeability, and dissolution and explore the details of BCS and its applications and discuss formulation strategies based on BCS.
- Analyze the need and drivers for particle size reduction, its role on dissolution and bioavailability, link to BCS classification of drugs, and its place among other BA improving technologies.
- Explore the physical principles of spray drying and discuss polymer selection, process development, and the controls of spray drying.
- Review Hot Melt Extrusion (HME) as a pharmaceutical technology and provide a brief historical overview of HME as a pharmaceutical technology and review recent applications.
- Discuss lipid chemistry, nomenclature, and physical behavior and explore how lipids improve solubility and bioavailability.
- Analyze the design, evaluation, and development of lipid formulations.
- Review scale up & QbD aspects in manufacturing of amorphous solid dispersions and describe how the QbD principles may be applied to the development of enabled formulations of poorly soluble drugs.
- Discuss the impact of BCS classification into II/IV categories on regulatory submission and/or review and which areas of the submission become more involved or focused.
- Discuss the regulatory aspects of setting dissolution specifications, IVIVC, post-approval changes, bioequivalence evaluation, and polymorphic stability.
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