Thermodynamic stability and form selection. Form selection of active pharmaceutical ingredients is regarded as an essential part of drug development. The goal of form selection is to identify the most suitable solid form for Read more
Select the polymorph with attributes fit for development. It is well established that polymorphism is common in pharmaceutical active ingredients.1 Bernstein and others present statistics that, when they are appropriately screened up to three Read more
How to quantitate a solid form in your drug product. A very important aspect of pharmaceutical mixture analysis is detecting and possibly quantitating a specific solid form in a drug product, especially tablets. Chapter Read more
Utilizing Synchrotron-based analytical and Pair Distribution Function Data, Improved Pharma provides an expert assessment of the current status of your polymorph screening activities. These Synchrotron-based studies provide structural knowledge and also analytical information at/near the lowest possible detection Read more
In February 2021, the FDA issued a guidance aimed at preventing unacceptable levels of nitrosamine impurities in pharmaceutical products. This guidance required a risk assessment to be completed by March 31, 2021. This is Read more
Traditionally, excipients utilized for the development of pharmaceutically-marketed drug products have been considered largely inert. Excipients are added to formulations for a variety of reasons that may include assisting processability of the drug product formulation, Read more
Not according to the United States Court of Appeals, citing Improved Pharma’s CSO Steve Byrn’s early paper on polymorph screening. The United States Court of Appeals for the Federal Circuit is known as the Read more
A recent paper by Testa et al., Int. J. Pharm., 556 (2019) 125, investigated the mixture analysis of Olanzapine, which crystallizes in more than 60 solid forms, using synchrotron X-ray diffraction. They suggested that synchrotron Read more
At AAPS PharmSci 360, Improved Pharma found another exciting excipient for use in formulation. Like when SSCI was started, Improved Pharma was able to make several contacts at the AAPS meeting that will advance its Read more
At AAPS PharmSci 360 it was clear that new excipients could be utilized to innovatively solve a range of amorphous dispersion/formulation problems. These new excipients provide significant strategy advances over conventional approaches and although our Read more
