The path from drug discovery to clinical development is a exciting yet complex journey. In the changing landscape of pharmaceutical development, it’s crucial to identify drug candidates with the best chances of success. Particularly during early stages, when resources are limited, it’s important to effectively prioritize these candidates. This is where the refined Developability Classification System (rDCS) plays an important role. By assessing the properties and key attributes of drug candidates, the rDCS helps identify those most likely to succeed.
Challenges and Strategies in Early Formulation Development
During the early formulation of a new product there are many challenges to overcome, including lack of material, physiological variability of early candidates, and tight deadlines. It’s important to address these issues through a variety of strategies that involve understanding material properties, conducting formulation tests, and using appropriate in-vitro models.
A crucial part of developing pharmaceuticals is gaining a thorough understanding of the physical, chemical and biological properties of the drug candidates. These evaluations provide information on key factors like how well the drug dissolves, how it travels through the body, its metabolism and how feasible it is to manufacture. By examining these characteristics, scientists can identify candidates that exhibit desirable attributes for further development such.
Strategic Formulation Development
Creating a formulation for preclinical studies goes beyond just improving solubility; it involves a thoughtful strategy based on how the substance will be administered and the animal species selected for testing. This strategic approach sets solubility goals, identifies additives and establishes appropriate study protocols.
Understanding how the substance will be administered helps customize formulation efforts to meet specific needs like GI tract stability, gut absorption, or compatibility with parenteral excipients. Choosing the right animal species ensures that the solubility goal aligns with physiological conditions, translating preclinical findings into human clinical trials more effectively.
The Role of rDCS in Drug Development
The refined Developability Classification System (rDCS) has proven to be a great tool to choose new drug candidates with the highest likelihood of a successful pharmaceutical advancement. Through evaluation and ranking of drug attributes, smart resource distribution, enhancing formulation strategies, and mitigating risks, the rDCS enables pharmaceutical companies to make informed choices and improve the drug development process. Embracing the rDCS ultimately leads to the development of safe, effective, and commercially viable drugs that meet patient needs worldwide.
Solitek: Expanding Capabilities in Preclinical Development
Three years ago Solitek was born. Initially, we focused on offering solid state services to pharmaceutical companies, capitalizing on the founders’ extensive professional background in this field. However, our goal has always been to grow into a preclinical development services Company. In 2023 we made investments in talent and we formed key partnerships that have significantly strengthened our capabilities in early formulation development. Whether its re-designing vehicles for toxicology formulations, or developing methods for quantification of amorphous material in drug products, for instance, we are now well prepared to support you in achieving success during the early preclinical development phases.
[1] J. Pharm. Sci., 2018, 107, 2020-2032s.
