Contemporary Perspectives on Developing Amorphous Pharmaceuticals, by Amitava Mitra, AAPS Blog
Despite significant advances in the understanding of amorphous molecular solids and successful introduction of several commercial products, there remain significant challenges in predicting with confidence the preferred composition, manufacturing process, stability, and bioperformance of solid dispersions. Additionally, challenges exist in translational science, translational engineering, and translational biopharmaceutics that provide multiscale linkages between in vitro, in silico, and in vivo quality and performance of stabilized amorphous pharmaceuticals. The Arden House conference will focus on sharing all aspects of current state-of-the-art to enable wider utilization of solid dispersions to enhance oral bioavailability of insoluble drugs with increased confidence.
Goals and Objectives
The pharmaceutical industry continues to face formulation development challenges due to increasing number of complex organic molecules with intractable biopharmaceutical properties due to inadequate aqueous solubility. It has been recognized that several formulation approaches can be undertaken to overcome limitations of aqueous solubility. In recent years the use of amorphous form of active pharmaceutical ingredients (API), adequately stabilized in a solid oral formulation, has attracted significant attention as an approach to enhancing dissolution and apparent solubility. However, there are several challenges associated with advancing amorphous drugs as they are inherently, thermodynamically unstable. Consequently, polymeric excipients have been utilized to kinetically stabilize amorphous pharmaceuticals in solid state as well as supersaturated solutions.
This conference will provide an up-to-date and in-depth understanding of the basics physics of the amorphous state; approaches for kinetic stabilization of amorphous pharmaceuticals with polymeric excipients to formulate solid dispersions; behavior of supersaturated solutions of solid dispersions; options for manufacturing of solid dispersions using different technologies and process modeling; and the characterization of in vitro and in vivo performance of solid dispersions. The conference will also provide a forum for pharmaceutical industries, excipient vendors, contract manufacturing organizations, academia, and regulatory agencies to discuss the state of the art in development and characterization of solid dispersions to support drug product development from toxicology studies to commercial solid dosage forms. Specific goals and objectives include but are not limited to the following:
- Bring physicists to share the advances in understanding of the amorphous state of materials with emphasis of molecular, organic glasses.
- Provide experimental approaches for the design and composition of solid dispersions based on molecular structure of drugs and excipients.
- Present case studies to demonstrate “state-of-the-market” application of science, engineering, and biopharmaceutical aspects of solid dispersions.
- Provide fundamental engineering aspects associated with different types of technologies for manufacture of solid dispersions such as spray drying, hot melt extrusion and precipitation.
- Provide understanding of the mechanisms for enhancement of oral bioavailability of insoluble drugs with solid dispersions.
- Share contemporary formulation and process design space practices, especially as they are evolving to support robust manufacturing processes.
Who Should Attend
Pharmaceutical scientists in academia, industry, and government interested in the successful progression of insoluble drugs through all stages of development.
- Preformulation scientists and leaders
- Formulation scientists and leaders
- Biopharmaceutics scientists and leaders
- Process engineers, process control engineers, and leaders
- Computational modelers and leaders
- Analytical and process analytical scientists
- Materials/powder science scientists
- Automation/advanced process control engineers
- Regulatory CMC personnel
- Pharmaceutical sciences project leaders and senior management
- Contract manufacturing organization scientists and management
- Excipient providers