Grants and Contracts Details
Description
During the manufacturing of an oral pharmaceutical solid dosage form (e.g. tablets or
capsules), the active pharmaceutical ingredient (API) is combined with one or more excipients
and transformed into a process intermediate. These intermediates improve the manufacturability
of the final solid dosage product or enhance the bioavailability of the API. For example, spray
dried intermediates (SDI) are often produced for delivering the small molecule API in the
amorphous form, with the intent of increasing the apparent solubility. Understanding the relation
between the process intermediates and the process parameters is essential for identifying the
risks, establishing a working operating space and scaling up. However, these processing
techniques are based on rich and complex multi-scale, multi-phase physics. Currently, analytical
techniques are used to better define the properties of the generated process intermediates,
including chemical (e.g. composition), physical (e.g. amorphous phase or certain crystalline
phase/polymorph), or structural/textural information (e.g. porosity or pore size distribution). These
properties may impact downstream processability, storage conditions, and most importantly
performance. Over the past 10 years, the industry has seen a huge increase in the use of spray
drying technology. However, the relationships between the critical processing parameters on the
critical quality attributes remains ill defined. This work will aim to fill this unmet need.
Status | Finished |
---|---|
Effective start/end date | 3/1/16 → 2/28/18 |
Fingerprint
Explore the research topics touched on by this project. These labels are generated based on the underlying awards/grants. Together they form a unique fingerprint.