What is the Additional Dosage Routes Module?

The Additional Dosage Routes Module in GastroPlus extends the program beyond the traditional oral and intravenous administration routes. With this module, you can simulate drug disposition through new dosing sites – ocular and pulmonary (intranasal and respiratory). These models were developed in collaboration with 2 top 5 pharmaceutical companies. The ability to predict concentration profiles in different regions of the eye, lungs, and nose can help you:  

• Explore various formulation/drug delivery options to achieve desired therapeutic effects
• Identify species-specific changes to estimate how a drug is handled in animals vs. humans
  

With the Additional Dosage Routes Module, simulating concentrations through these sites is managed through our easy-to-use interface. Mechanistic, physiologically-based models are provided for each tissue for different species. You can also customize your own physiology by entering available information into the program. These models are linked with either compartmental or physiologically-based pharmacokinetics (PBPK) in GastroPlus, so you may predict your drug’s distribution and elimination once it enters into the systemic circulation. As with other GastroPlus modules, there is no equation or code writing required.

Ocular Model

The Ocular model of the Additional Dosage Routes Module is shown below. This model provides dosing as an:

•  Eye drop (topical solution or suspension)
•  IVT (intravitreal injection)
•  Intravitreal or subconjunctival implants

 


Measured in vivo data for any ocular tissue can be used to compare with simulation results. All standard GastroPlus features, including Virtual Trials and Parameter Sensitivity Analysis, can be used with the Ocular model.

Pulmonary (Intranasal/Respiratory) Model

The Pulmonary model of the Additional Dosage Routes Module is shown below. This model provides dosing via the intranasal or respiratory route as an:

•  Immediate release solution
•  Immediate release powder

Both human and rat physiology models are provided. The Pulmonary model includes the advanced ICRP 66 deposition model (Smith et al., 1999, LUDEP) for calculating deposition fractions in each compartment of both
API and carrier particles. Additionally, you may account for the following processes in your simulations:

•  Mucociliary transit
•  Linear mucus and tissue binding
•  Lymphatic transport
•  Systemic absorption

As with the Ocular model, all standard GastroPlus features, including Virtual Trials and Parameter Sensitivity Analysis, can be used with the Pulmonary model.

For further information about licensing the Additional Dosage Routes Module, please contact:

Mr. John DiBella
Director, Marketing & Sales
661-723-7723 ext. 244
john.dibella@simulations-plus.com