An innovative floating gastro retentive dosage system: Formulation and in vitro evaluation

Christophe Sauzet (1, 2) , M Claeys-Bruno (1) , Maxime Nicolas (3) , J Kister (1) , P Piccerelle (2) , P Prinderre (2)

1 ISM2-AD2M - CNRS UMR 6263 - Institut des Sciences Moléculaires de Marseille
2 Laboratoire Thérapie des maladies génétiques
3 IUSTI - Institut universitaire des systèmes thermiques industriels

Over the years, different formulation technologies intended for gastro retentive dosage delivery were investigated and patented. The aim of this study was to develop an innovative floating gastro retentive dosage form (GRDF). The developed technology induces a low-density dosage form containing high active pharmaceutical ingredient (API) concentration by using a hydrophobic dusty powder excipient under specific conditions. The new dosage form was obtained by state of the art wet granulation manufacturing process. An experimental design using a discrete variable and four mixture variables was conducted in order to optimize API concentration and buoyancy of the new dosage form. An apparatus was developed to measure the apparent density of floating tablet. The GRDF was characterized for apparent density, buoyancy, porosity and dissolution using in vitro experimentations.

Keywords: Wet granulation; Hydrophobic dusty powder; Floating tablet; Gastro retentive dosage form; Experimental design

Domains: Life Sciences [q-bio]; Pharmaceutical sciences; Galenic pharmacology

Christophe Sauzet, M Claeys-Bruno, Maxime Nicolas, J Kister, P Piccerelle, et al.. An innovative floating gastro retentive dosage system: Formulation and in vitro evaluation. International Journal of Pharmaceutics, 2009, 378, pp.23 - 29. ⟨10.1016/j.ijpharm.2009.05.027⟩. ⟨hal-01432996⟩