Anatomical Throat Models from the Consortium Project
Emmace Consulting have the pleasure to offer an anatomical throat concept that enhance the prediction of the in-vivo properties and behaviour of inhalation products.
Three anatomical throat models (small, medium, and large) were developed by a consortium (OPC) consisting of AstraZeneca, GlaxoSmithKline and sanofiaventis1. The geometry of the models originate from MRI studies of adults oropharynx part at inhalation maneuver and the three models were selected based on their dose filtering properties performed on different products (pMDI, DPI and Nebulizer). In vitro in vivo correlation (IVIVC) studies2 showed later on that the dose that passes these throat models correlated with the lung dose that was found in in vivo lung deposition studies. Moreover, by analyzing and comparing the aerosol doses that survive the small and the large throat models, the “lung dose” variability in an adult population can be estimated. The throat models can be used with cascade impactors, laser diffraction instruments, particle counters or combined with an integral filter downstream the model, which offers a case by case flexibility. These throat models are commercially available to the inhalation community by Emmace Consulting.
The anatomical throats are available in three different fashions, one durable design for repetitive, standard use in lab testing (white model, middle), in a transparent design (left) for a visual assessment of aerosol motion and deposition, and a metal version (right). All designs have the same interior geometry.
By analyzing the aerosol dose that passes through the anatomical models during inhalation experiment, the following investigations can be performed,
- Combination of the three throat models with a set of clinically relevant flow profiles gives a good prediction of how your inhalation product will behave clinically.
- Inhaler handling robustness testing – predicts the effect on lung dose of inhaler vs. e.g., mouth position angle, distance from tongue position, or dose loading procedure.
- Predict the effect on lung dose from add-on devices to inhalers, such as spacers.
- Data from anatomical throat models are useful input when designing clinical studies, including selection of dose strength and number of doses.
- Excellent screening tool in your daily development work; rank different device prototypes or formulation concepts by simply measure the dose that survives the models using a single filter downstream the throat model.
- Compare your product/prototype versus competitors or reference products on the market.
- Scientific marketing of your inhaler and formulation concept.
The anatomical throat models are manufactured according to the data from the OPC work1 and are made as single solid bodies, which reduces the risk for leakages of both air and solubilized drug. Customized adapters for inhaler adaptation, are manufactured upon request.
Emmace Consulting also offers analytical testing using these throats as a service on a CRO basis.
Please contact us for more information!