In vitro and in vivo erosion of two different hydrophilic gel matrix tablets.
The aim of the present work was to establish in vivo predictive in vitro tests for the tablet erosion of two different compositions (A and B) of hydrophilic matrix tablets based on hydroxypropyl methylcellulose. The tablet erosion was studied in a modified USP II apparatus at different agitation intensities and ionic strengths according to 2(2) factorial design. The in vivo tablet erosion was studied in 8 healthy human volunteers by gamma scintigraphy after administration of the tablets together with breakfast. In vitro agitation intensity increased the erosion rate for both tablets whereas increased ionic strength caused a slower rate for tablet A and a faster rate for tablet B. The choice of in vitro testing conditions proved to be critical for the attainment of in vivo predictive results. The best in vitro/in vivo correlation for the two formulations was obtained at a paddle stirring rate of 140 rpm and a ionic strength of 0.14 obtained by addition of sodium chloride.
Department of Radiation Physics, Sahlgren's University Hospital, Gothenburg, Sweden.
B
B
Abrahamsson
M
M
Alpsten
B
B
Bake
A
A
Larsson
J
J
Sjögren
D000328:Adult; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004064:Digestive System / Q000378:metabolism*; D006801:Humans; D020100:Hydrogels / Q000737:chemistry / Q000378:metabolism*; D065347:Hypromellose Derivatives; D008297:Male; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry / Q000378:metabolism; D011877:Radionuclide Imaging; D013607:Tablets
D020100:Hydrogels; D013607:Tablets; D065347:Hypromellose Derivatives; D008747:Methylcellulose