Exemple of gastroresistance

Evaluation of the gastro resistance of the micro-incorporated anti acid molecule, depending on the lipid composition.

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• Degradation of anti-acid in a middle HCI 0,1N
  
  
• Pre clinical study
  
  
• Clinical study
  
  
  
  
  
  
  
  

Dégradation of anti-acid ORA1 in a medium HCI 0,1 N

Size of the particles : 200 µm Incorporation rate : 20 % w/w Incorporation yield : 90 % Gastro resistance : Stability pH=1 > 60 min Drug : Anti acid referent TG2, TG3 = micro-incorporated Anti-acid with 2 lipid compositions.

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Pre clinical study

The product ORA 1 has completed a pre-clinical study successfully.
Drug is released and absorbed on the GIT.
Global bioavailability seems equal or superior to the reference formulation, depending on lipid composition.

Clinical study

ORALANCE PHARMA has launched Phase I clinical trials in early 2005.



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Mean plasma concentration of anti-acid ORA 1after a single administration of one 20 mg ORA1 formulation (Mean A) versus a single administration of one 20 g commercial formulation (Mean B).