Enabling Clinical Development of Poorly Soluble Molecules Through Formulation Solutions

The majority of new chemical entities (NCEs) are limited by poor solubility and bioavailability issues and are unable to proceed to the clinical development phase despite promising therapeutic activity. A lot of resources and effort would have been directed towards identifying and synthesizing potentially useful NCEs, hence it is of the utmost importance to intervene at the early stages to understand the physicochemical properties of the molecule and devise appropriate formulation approaches that can aid in improving its solubility-related absorption and bioavailability issues.

In the development of NCEs, the phase after the discovery of a potential NCE hit and before the start of human clinical studies, it is critical to involve a preclinical formulator to deliver formulations for various studies in preclinical (animal) species. The role of a preclinical formulator requires a thorough understanding of many aspects of the drug development process.

Apart from the knowledge of various formulation parameters, a preclinical formulator should have understanding of toxicology, pharmacokinetics, analytical techniques and chemical and physical characterization. A formulator must understand the needs of a toxicologist or a pharmacokineticist with respect to the dose, volume, species and safety of components used in formulation. A preclinical formulator can then devise appropriate formulation approaches to resolve formulation challenges of NCE.

Register for this webinar to hear about novel formulation approaches to overcome solubility issues and enable clinical development of NCEs. The speaker will discuss various formulation techniques like solutions, microemulsions, amorphous solid dispersions and nanosuspensions. They will share how Aragen has helped overcome some of these challenges by providing integrated formulation and PK solutions to accelerate the development of NCEs.

Speaker

Sreehari Babu Putchakayala, VP & Head, Formulation Development Solutions, Aragen Life Sciences

Sreehari Putchakayala has over 18 years of experience in pharmaceutical development, with 12 years in leadership roles covering early phase, drug discovery support, product development in drug discovery R&D, generics formulation development and clinical supplies management. Sreehari previously worked with Novartis Pharmaceuticals, Ranbaxy Research Laboratories, Gurgaon and Dr. Reddy’s Laboratories, Hyderabad.

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