A recent collaboration with our colleagues further advances the field of X-ray pair distribution function analysis applied to the analysis of amorphous solid dispersions. In this paper, we present the results of different polymer:flubendazole drug dispersions exposed to aging conditions. We discovered that if the polymer has ion-base interactions with the drug, the resulting 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 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
Improved Pharma COO Pamela Smith is co-author of a chapter in the latest edition of Specification of Drug Substances and Products: Development and Validation of Analytical Methods. The chapter, Solid-State Characterization – Method Development and Validation, focuses on the key issues that must be addressed when developing solid-state methods. Method development and validation for pharmaceuticals 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, controlling the disintegration rate to facilitate regional dissolution along the gastrointestinal tract (GIT), bulking up the dosage form to enable Read more
WEST LAFAYETTE, IND. (PRWEB) SEPTEMBER 15, 2020 Improved Pharma has expanded their offerings by acquiring S. I. Photonics’ top-of-the-line spectrophotometer, model 440. This model has a high sensitivity, low noise CCD detector that enables the collection of a full spectrum within a second. The power of this instrument is enhanced by the number of accessories and Read more
WEST LAFAYETTE, IND. (PRWEB) JULY 20, 2020 Improved Pharma is pleased to announce new collaborations with Westport Pharmaceutical Consulting, LLC (dba WPC, LLC) and Ravine Pharmaceuticals LLC enabling expansion of expertise and service offerings to the pharmaceutical industry in support of drug substance and drug product development. These additions bring a vast amount of relevant industrial Read more
Polymorph screens and salt screens are important components for drug development. The goal of polymorph screening is to try to find all possible crystal forms by small-scale crystallization and to select a stable form that can be manufactured and formulated into a dosage form. Salt screens are commonly used to alter the physicochemical properties of Read more
Accelerated development is a complex and difficult task. S-fIND (Synchrotron-based fast to IND) is a strategy to speed development of the most difficult cases using powerful X-ray methods only available at a Synchrotron X-ray source. S-fIND integrates powerful methods with practical pharmaceutical development approaches and excellent people in a package that accelerates development. Accelerated development services Read more
