Emmace Consulting AB has significant commercial experience in developing and characterizing inhaled medicinal products and is therefore a suitable company to engage for any customer planning for the development of an inhaled medication, either as a new product or a generic product.
We can offer support in various research areas:
Modelling of Lung Dose and Prediction of Systemic Exposure
In support of product design, setting of clinically relevant specifications and batch selection for BE studies we offer:
- Mathematical modelling of lung dose and regional deposition along the airways base on cascade impactor data and inhalation flow profiles for medicinal aerosol products (nebulizers, pMDIs and DPIs).
- Sensitivity analysis to explore impact of (i) product performance and (ii) age, disease and airway remodeling on lung deposition pattern
- Sensitivity analysis to explore the impact of variations in dissolution of poorly soluble drugs on rate and extent of pulmonary uptake
- Predictions of absolute and relative (e.g. Test/Reference) systemic exposure (AUCt, Cmax) in support of batch selection and design of clinical bioequivalence studies.
- Evaluation of clinical pharmacokinetic studies to establish in vitro – in vivo correlations based on key product attributes.
As an integral part of these services we will provide the customer with purpose-built model(s) based on available physicochemical and pharmacokinetic data for each active pharmaceutical ingredient. We will also support the customer in identifying key product or batch specific attributes and associated experimental assays and test programs available via the analytical services provided by Emmace Consulting AB.
Advanced CMC Support
- Product development in early and late stage, including characterization of formulations and inhaler devices
- Support to development of high throughput analytical methodologies; for example, HPLC based on internal standard concept
- Specification strategies for formulation, inhaler device and product during development and for finished product considering current guidance in all major pharmaceutical compendia, including USP, EP, ICH, and ISO
- In vitro therapeutic equivalence strategy for generic inhaled medication
- CMC regulatory strategies and review from development to product registration
For more information, please contact Hans Lundbäck, firstname.lastname@example.org
Clinical Expert Support
- The design of phase 1-2 trials with inhaled medication
- Scientific interpretation and development implication of clinical trials outcome
- Assisting clients in their interaction with regulatory agencies on NDA/generic submissions
- Business and scientific evaluation of the in- and out-sourcing of drug and/or inhalation device opportunities
- Publication of scientific results, expert reports, and drug applications