Technology (UPN: 35)

Technology Advanced in-vitro model to evaluate the disposition and bio-performance of oral pharmaceuticals and nutritional products.
Organisation Type Company
Organisation Region European Union
Overview A dynamic in-vitro system that fully replicates the complex biochemical conditions and the array of gastric forces crucial for the prediction of the bio-performance of pharmaceuticals and nutritional based materials.
Description

The model is the first true laboratory simulation of the human stomach that can be fed real (human chewed) food. Development of the model included studies across a range of food intake values and structural forms using Echo Planar Magnetic Resonance Imaging (EPI), in vivo studies using ileostomy patients and gastric and duodenal aspirations. These studies provided novel insight and detailed understanding into gastric response to complex structured food and pharmaceutical systems.

For pharmaceuticals, the model is typically used to evaluate disintegration, dissolution and drug release processes. It can further be used to predict and/or compare the performance of different pharmaceutical systems under fasted state, fed state or a combination of both to mimic human clinical study conditions.

For nutritional applications, the model is typically used to evaluate the integrity and release of nutrients from food matrices to determine the delivery profile to the systemic circulation.

The model can process all dietary meals ranging from complex multiphase and highly structured foods through to a simple glass of water. It has been designed to simulate both the physical and biochemical conditions found within the human stomach, responding to changes in meal properties during processing by modifying digestion conditions in real time. Within the pharmaceutical context this innovative technology can assist drug developers in a broad range of studies including selection and rationalisation of formulation choices, IVIVC studies and bioequivalence studies.

Fundamentally, the model is considered to be more physiological than any other in vitro gastric systems currently available. Acid and enzymes are not bulk added but are continual and controlled secretions. Mixing of fed material with gastric secretions is not homogeneous - even with liquid meals in order to reflect the mixing modality of a real human stomach. Delivery of food content to the small intestine is calorie and viscosity dependent as would be found in vivo.

The key features of the model can be summarized as follows:

  • Processes real food input rather than unrepresentative homogenized material
  • Accurately simulates physical mixing, transit and breakdown forces (including flow, shear and hydration) within complete physiological range
  • Accurately simulates the correct biochemical environment for the gastric contents. Allowing for fed / fasted comparisons and studies of the behavior of dosage form with varying food-types
  • Carries out digestions in real time and uses realistic volumes of material (200-600ml)
  • Provides samples of digested materials at any sampling times within the total digestive period
  • Provides full data readout on the digestive process; residence time, emptying profiles, pH gradients; gastric additions/flow rates, etc.
  • Adapts for varying digestion patterns (for example pediatrics and geriatrics)

Possible Applications:

Food-drug effect evaluation, Dose-dumping assessment, Alcohol interaction quantification, Gastro-retentive dosage forms evaluation, Metabolism and stability assessment, Allergenic proteins testing, Probiotic survival, Digestion of foodstuffs and release of nutrients., Biorelevant testing of pharmaceuticals

Competitive Advantage

Compared to other competing models, the proposed model is designed to accurately mimic the non-homogeneous mixing in the fundus, the shear dependence on meal viscosity and solid content and the different gastric emptying rates that are dependent on the meal energy, composition and viscosity. In addition, the proposed model is not limited to test only homogeneously mixed meals and can process real “chewed food”. Moreover, it does account for the in vivo shear forces that are meal viscosity and solid content dependent or provide the different gastric emptying profiles that are also dependent on the meal composition.

Development Stage:

In user / Testing result available

Intellectual Property:

Europe, US and other major territories worldwide patent protection.

Innovator The company is interested in contract services and licensing opportunities. Custom models, and protocols can be developed to match customers' needs.
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