SOURCE: Xtalks

Xtalks Webinars

February 22, 2016 07:00 ET

Product Development Strategies for Poorly Soluble Compounds: Adding Value With Spray Dried Dispersion

First of a Two Part Series on Spray Dried Dispersion Hosted by Xtalks

TORONTO, ON--(Marketwired - February 22, 2016) - On Thursday, March 3, 2016, experts from Pharmatek will outline the process of data driven formulation development and discuss spray dried dispersion formulation development for early phase clinical studies.

Data Driven Formulation Development

As NCEs coming out of discovery present solubility challenges, often companies do not have the expertise to identify the most appropriate formulations to support toxicology and clinical studies. Regrettably, very rarely does the first solubility-enabling formulation solve dosing requirements. Fortunately, there are several key compound characteristics that can help direct formulation develop and formulation selection. Pharmatek recommends taking an agnostic approach therefore relying on relevant data and formulation expertise to make these key unbiased decisions. A compound's physiochemical characteristics as well as dosing requirements should be carefully assessed while multiple formulation types are considered, including API-in-a-capsule, simple blends, liquids, spray-dried dispersions and melt granulations, to determine the best path forward. This presentation will cover multiple dosing strategies and methods to determine which technology is best suited for your needs.

Topics include:

  • What data is necessary to make confident development decisions
  • How to design a data-driven formulation development program
  • Options for difficult to formulate molecules

Spray Dried Dispersion Formulation Development for Early Phase Clinical Studies

Current estimates indicate that more than 70% of new chemical entities require solubility enhancement to achieve plasma exposure. Amorphous dispersion technology is a growing approach to improve solubility and in vitro dissolution rate of these insoluble compounds by providing a supersaturated concentration of drug, which often translates to rapid in vivo solubility and improved bioavailability. A common technology for preparing these amorphous dispersions is spray drying. This presentation will focus on the fundamentals of developing and handling spray-dried dispersions, including stability assessment, in-vitro performance, and downstream manufacturability.

Topics will include:

  • Parameters that indicate amorphous dispersions and spray dried dispersions are an optimal formulation approach
  • Best practices for formulation screening and evaluation of stability, performance, and manufacturability of spray dried dispersions
    • Pre-Formulation solvent solubility screening and stability assessment
    • Rapid polymer screening for solubility enhancement
    • Screening of selected polymers and drug loads for physical and chemical stability
    • Excipient compatibility testing
    • In-vitro and in-vivo formulation screening

Join Bryan Knox, Senior Director of Pharmaceutics and Nathan Barksdale, Scientist, at Pharmatek for an informative session. To learn more about this complimentary event visit: Product Development Strategies for Poorly Soluble Compounds: Adding Value with Spray Dried Dispersion

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