Detecting Differences In Formulations

As changes are made to the manufacturing process during drug development, it is often necessary to ensure that a drug or drug product made in a new way is the same as the material produced using the original methods. These equivalence studies often focus on chemical or physical properties and are relatively straight-forward for well-defined, Read more

Detecting Differences In Formulations2019-04-05T19:24:30+00:00

Structure of Amorphous Materials – Structure Determination Service

One of the most critical parts of drug discovery and development is identifying the structure of the drug substance and drug product. For crystalline materials and biologicals it is routine to determine the arrangement of covalent bonds in the drug substance and drug product and the structure of the solid forms of the drug substance. Read more

Structure of Amorphous Materials – Structure Determination Service2019-03-06T15:19:53+00:00

AAPS Poster – Presented at AAPS

Non-crystalline phases such as amorphous states can lead to increased solubility for drugs.  However, amorphous materials are notoriously unstable and tend to crystallize over time.  As such, many amorphous materials are created in a dispersion with a polymer to increase their physical stability.  X-ray powder diffraction patterns of amorphous materials are broad and not useful Read more

AAPS Poster – Presented at AAPS2019-04-17T17:43:25+00:00

Drug Delivery Device Summit Presentation

Current approaches to accelerated drug development typically involve parallel track activities utilizing sophisticated project management capabilities.  Improved Pharma has developed a strategy that continues to utilize these project management tools but in addition utilizes predictive tools based on structure analysis of formulations and anticipation of major instabilities of formulations by assessing formulation risk.  Orphan drugs Read more

Drug Delivery Device Summit Presentation2019-03-06T15:39:33+00:00