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Advising Services

Emmace has significant commercial experience in developing and characterizing inhaled medicinal products and medical devices 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.

Plan The Development of Inhaled Medication

Emmace 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.

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We Offer Support in Various Research Areas

Modeling of Lung Dose and Prediction of Systemic Exposure

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.

For more information, please contact Dr Per Bäckman, per@emmace.se or Dr Bo Olsson, bo@emmace.se

In support of product design, setting of clinically relevant specifications and batch selection for BE studies we offer:

  • Mathematical modeling 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.

Development and Understanding of Dry Powder Formulations for Inhalation

For more information, please contact Dr Kyrre Thalberg, kyrre@emmace.se

  • Development strategies for DPIs
  • Modeling and simulation of the performance of dry powder inhalers
  • Selection of raw materials, compositions, and manufacturing processes
  • Trouble-shooting related to issues in development of formulations and DPI products
  • Selection of material science methods
  • Advice on advanced characterisation and simulation studies
  • Guidance regarding in process control and quality by design strategies

Get in Touch With Emmace