CASE STUDY

1. Novel Delivery of Antipsychotic Product 
   

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The team was given the task of producing an ultra-controlled release version of a very widely used antipsychotice agent for patients struggling with daily dosing.

The Rune team assessed a variety of methods of controlling release of the active pharmaceutical ingredient, after reviewing the physical and chemical properties of the molecule and its absorption characteristics via the gastrointestinal tract.  Utilising in silico analysis methods, the team steadily discarded release retardation techniques.  Ease of access to tablet constituents was also taken into account, helping to drive the decision on how to progress to the final product design. 

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Micro-batches of tablets were manufactured, and tested in vitro to assess their dissolution profiles. These were also put into accelerated and standard stability testing environments.

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The in vitro work guided the team to selection of a final formulation to take forward into human in vivo work. Bioavailability studies were performed as a single dose, escalating dose designed study.  The pharmaco-kinetic result of this study gave the team the confidence to move forward with the client into a multiple dose study covering the target dose range.  The client has decided to supply this product as a Special (unlicensed) formulation for the time being to amass confidence before moving forward with dossier submission and subsequent marketing authorisation.

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Rune remains in close communication with the client and is actively initiating dossier preparations at the present time.

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"The Rune team provided excellent service to us throughout the research and development process and have now found a suitable manufacturing company to provide us with small batch production of our new product.  We cannot praise them enough - excellent service provided with a smile."

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Client wishes to remain anonymous