Purified guar galactomannan as an improved pharmaceutical excipient.
The purpose of this study was to assess certain pharmaceutical attributes of guar galactomannan, a hydrocolloid polysaccharide obtained from the endosperm of the leguminous plant Cyamopsis tetragonolobus (L.), following purification using both literature procedures and new processes. Experiments were performed to measure viscosity, hydration rate, tablet hardness, and dissolution profiles of guar galactomannan both before and after purification. The viscosity of an aqueous 1% purified galactomannan solution is typically 40-50% higher than its unpurified guar galactomannan precursor. The hydration rate of an aqueous 1% purified galactomannan solution increases by 100% after purification. These physicochemical changes resulted in improvements in pharmaceutical properties such as better stir speed independence in both tablet and capsule dissolution profiles and improved tablet hardness. For instance, time to 50% dissolution of ranitidine HCl from capsules containing unpurified guar gum was 0.4 and 1.8 hr at 20 and 40 rpm, respectively, using USP Apparatus II. Using the same amount of purified guar gum and the same conditions (20 and 40 rpm), these values were increased to 2.9 and 3.8 hr, respectively. These data demonstrate a reduced effect of changing agitation conditions and the need for less guar gum to sustain the release of a water-soluble drug. Tablet hardness of purified guar gum (particle size < 75 microns) was about 7 kP and the same unpurified guar gum of equal particle size and hydration gave a hardness of less than 1 kP.
Gebert
M S
MS
CIBUS Pharmaceutical, Inc., Burlingame, California 94010, USA.
Friend
D R
DR
D005079:Excipients / Q000737:chemistry*; D005685:Galactans / Q000737:chemistry*; D005690:Galactose / Q000031:analogs & derivatives; D008351:Mannans / Q000737:chemistry*; D008970:Molecular Weight; D010316:Particle Size; D053149:Plant Gums; D012995:Solubility; D013607:Tablets; D014783:Viscosity
D005079:Excipients; D005685:Galactans; D008351:Mannans; D053149:Plant Gums; D013607:Tablets; C012990:galactomannan; C007894:guar gum; D005690:Galactose