Nanopharm-logo-with-signature-Pantone (1)
Search
Close this search box.

08 Oct 2024

Exploring PBPK Modeling in Nasal Drug Delivery: Expert Insights from Will Ganley

Share

Download the Article

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.

Download the Article

Related Posts

Innovation & Insights

Interview with Jane Provis Evans, Head cGMP services at Nanopharm

In the ever-evolving world of pharmaceuticals, the importance of stringent quality control cannot be overstated. This interview with Jane Provis-Evans, Head of cGMP Analysis at Nanopharm, sheds light on the critical role of cGMP testing in the development and optimization of drug-device combinations, particularly for orally inhaled and nasal drug products (OINDPs). With the launch of Nanopharm’s new GMP services, the company is well-positioned to help clients bring innovative treatments to patients.

Read More »
Innovation & Insights

Driving Innovation in Inhaled and Nasal Drug Product Development

Explore how Nanopharm, a globally recognized Contract Research Organization (CRO), is becoming the inevitable choice for inhalation and nasal drug product development. Under the leadership of Gemma Budd, the new General Manager, Nanopharm has established itself as a Centre of Excellence in Orally Inhaled and Nasal Drug Products (OINDP). With its state-of-the-art, purpose-built facility, Nanopharm offers comprehensive inhalation services, characterized by an in-depth understanding of OINDP science, products, and test methods.

Read More »