L'omeprazole, un benzimidazole substitue, est un inhibiteur specifique, non competitif, de la H + /K + - ATPase, connue comme pompe des protons gastriques. Il est instable en milieux de faibles pH et doit etre protege des effets de l'acide gastrique lorsqu'il est administre par voie orale. Il est par consequent administre sous forme enterique enrobee. Dans cette etude, differentes solutions d'enrobage ont ete preparees a differentes concentrations etappliquees surdes comprimes d'omeprazole prealablement proteges par un sous-enrobage afin de determiner si cet enrobage peut proteger l'omeprazole d'une degradation en milieu acide. Des essais de dissolution ont ete effectues en milieux acide et alcalin afin de determiner les taux d'enrobage appropries. Pour l'etude de stabilite, des essais de vieillissement accelere ont ete effectues sur les formules de comprimes etudiees et sur des capsules commerciales. Les echantillons ont ete examines en ce qui concerne l'aspect macroscopique, la teneur en omeprazole et les caracteristiques de dissolution sur un mois. Des resultats tres encourageants ont ete obtenus avec l'HPMCP 4 et le CAP 4 (4% d'enrobage enterique par une solution a base, respectivement, de phtalate d'hydroxypropylmethyl cellulose et d'acetate de cellulose) applique sur des comprimes comportant un sous-enrobage. Du point de vue de la stabilite, seules les capsules de Losec (produit commercial de Astra-Turquie) semblent donner de bons resultats.

/pdf/formulation-and-stability-evaluation-of-enteric-coated-1p4xqj2b54.pdf

Formulation and stability evaluation of enteric-coated omeprazole formulations

Omeprazole, a new antiulcer drug with a unique mechanism of action.

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Omeprazole, a new antiulcer drug with a unique mechanism of action.