Engineering the Mechanical Properties of Amorphous Spray-Dried Dispersions

Описание: Drug candidates with low oral absorption potential in the crystalline state are frequently converted to the amorphous form to increase solubility, prevent precipitation, and increase dissolution rate, thereby improving the extent of absorption and bioavailability. Spray drying drug from a solution containing an amphiphilic polymer is one of the most common and scalable methods used to achieve these enabling properties. The resulting powder contains the amorphous drug molecularly suspended or solubilized within the polymer matrix. Typical crystalline drug properties, often unfavorable for downstream processing, are masked by the amorphous state of the drug and matrix polymer. In addition, unlike many crystalline drug substances, spray-dried dispersion (SDD) particles are tunable, even within the spray drying process. Given this tunability, SDD composition and physical properties can be co-optimized for absorption potential, physical and chemical-state stability, mechanical and powder flow properties, and spray drying throughput. This is a departure from traditional development, where drug substance and drug product are progressed somewhat independently, with drug substance form and morphology often changing during the development and scaling processes. This often results in constraining the oral dosage formulation and process to overcome undesirable crystalline drug properties.

In this webinar, experts will discuss:
• How particle engineering by spray drying can be used to co-optimize several facets of SDD development with a specific focus on optimization of SDD mechanical properties
• Reduction of SDD tableting scale up risks and pill burden through identification of the primary mechanismof compaction and rational formulation design
• Development case studies highlighting SDDs whose primary mechanism of compaction is plastic flow versus brittle fracture.

Key Learning Objectives
• The mechanical properties of SDDs can be tuned by changing the degree of atomization and drying rate in the spray dryer.
• A review of typical SDD mechanical properties, including stress stain behaviors, and how these can be exploited to optimize tableting.
• Engineering SDD particles provides opportunities to reduce pill burden by maximizing SDD loading in the dosage form through rational excipient selection and SDD physical property design.

Who Should Attend
• Large pharma, mid-size pharma, biotech companies
• Product development group leaders and formulators, technical, and engineering positions involved in scale-up and manufacturing of oral solid dosage forms