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Will Ganley provides valuable insights into the role of physiologically based pharmacokinetic (PBPK) modeling in the development of Orally Inhaled and Nasal Drug Products (OINDPs). PBPK modeling uses computational simulations to predict how drugs behave in the body, particularly focusing on absorption, distribution, metabolism, and excretion. This in silico approach is especially crucial for optimizing nasal drug delivery systems.
PBPK models simulate the movement of drugs through the body, mapping their behavior after inhalation or nasal administration. For inhaled products, the models focus on how drugs interact with different regions of the lungs and how they are absorbed into the bloodstream. Nanopharm’s in-house model, Simhalation™, allows researchers to run simulations for various formulations and patient demographics, optimizing drug exposure and reducing the need for clinical trials.
By utilizing input data such as deposition rates from computational fluid dynamics (CFD) and dissolution data from in vitro studies, PBPK models can predict drug behavior in diverse scenarios. This capability is vital for addressing critical questions during drug development, whether refining formulations or supporting regulatory submissions.
PBPK modeling has practical applications in product development at Nanopharm. For example, it has been used to study the impact of dissolution rates on the absorption of fluticasone propionate and to evaluate the delivery of amikacin sulfate to cystic fibrosis patients. These models help understand the influence of disease states and physiological differences on drug distribution and efficacy. With increasing regulatory interest, PBPK models are gaining recognition as tools to streamline drug approval processes for OINDPs. The FDA has shown openness to using these models for alternative bioequivalence approaches, potentially reducing the need for extensive clinical testing. As the acceptance of PBPK models grows, they are set to become a cornerstone in the development and approval of safer, more effective nasal drug delivery systems.
