Addressing Challenges with Low-Solubility Compounds: The Importance of Functional Excipients in the Formulation of Amorphous Dispersions

October 12, 2012

 

Ray, R.J., “Addressing Challenges with Low-Solubility Compounds: The Importance of Functional Excipients in the Formulation of Amorphous Dispersions,” Drug Dev. Delivery, 12:8(2012)26-34.

 

Because more than half of the compounds in early development are considered poorly soluble, improving oral bioavailability represents a significant challenge to the pharmaceutical industry. Bend Research, a problemsolving, drug-development, and manufacturing company, is well-known for its spray-dried amorphous dispersion technology, which is recognized as a reliable solution to this challenge due to its proven performance, long-term stability, and excellent manufacturability.

Excipient selection is critical to optimizing the performance of these amorphous dispersions. Because excipients play a "functional" role, they must be chosen based on scientific rationale to ensure they meet formulation and process criteria to achieve the desired performance, stability, and manufacturability.

In a previous interview in this publication (May 2012), I described the company's background and problemsolving approach to drug delivery challenges faced by the pharmaceutical industry. This interview was followed by an article (July/August 2012) describing how science and technology are used to solve bioavailability challenges. In this article, the importance of functional excipients in the performance of amorphous dispersions will be discussed. A case study is presented on the history and solubilization performance of hypromellose acetate succinate (HPMCAS) - a particularly effective functional excipient in amorphous dispersions.

 

 

Topics: 
Bioavailability Enhancement