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 because nitrosamines are genotoxic and are classified as possible or probable carcinogens. The guidance also described conditions under which nitrosamines can Read more
Improved Pharma is pleased to announce the open-source publication of research into finding new salts of bedaquiline, an important drug for the treatment of tuberculosis. The drug is currently marketed in the US as the fumarate salt. Our team discovered several new salts, and the crystal structures of two benzoate salts are described in this Read more
WEST LAFAYETTE, IND. (PRWEB) OCTOBER 26, 2020 Interact with us via poster number 924440 and the Advances and Innovation in Formulation Development Rapid Fire session. On Wednesday October 28th, Dr. Pamela Smith, COO of Improved Pharma, will present “Synchrotron-Based Formulation Development” in the Rapid Fire: Formulation and Quality – Chemical session. Those registered for the meeting 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, controlling the disintegration rate to facilitate regional dissolution along the gastrointestinal tract (GIT), bulking up the dosage form to enable 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 techniques could help guide the discovery of methods to prepare and analyze pure polymorphs. Their observations and suggestions are consistent 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 problem-solving capabilities. One such advanced strategy is the utilization of calcium carbonate as an excipient to enhance dissolution. The excipient 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 Improved Pharma scientists utilized a number of novel approaches to prepare amorphous dispersions while at SSCI, these new excipients provide Read more
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
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
