Effect of sodium bicarbonate and sodium starch glycolate on the in vivo disintegration of hard gelatin capsules--a radiological study in the dog.
The release of drugs from hard gelatin capsules is often limited by the disintegration rate of the capsule. We set out to determine whether it is possible to hasten the in vivo disintegration of hard gelatin capsules by adding disintegrants (sodium bicarbonate or sodium starch glycolate) to the formulation. This radiological study was carried out in six beagle dogs. We conclude that if rapid disintegration is desired for a hard gelatin capsule formulation, water-soluble diluents should primarily be selected. Sparingly water-soluble, gelforming diluents cause slow in vivo disintegration. Using swellable disintegrants such as sodium starch glycolate does not accelerate disintegration and may even retard it. With sodium bicarbonate it is possible to shorten the disintegration time of capsules containing water-insoluble ingredients, but not to the extent possible with water-soluble diluents.
Marvola
M
M
Hannula
A M
AM
Ojantakanen
S
S
Westermarck
E
E
Rajamäki
M
M
D000818:Animals; D001639:Bicarbonates / Q000032:analysis*; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D004285:Dogs; D005079:Excipients; D005780:Gelatin; D011859:Radiography; D012964:Sodium / Q000032:analysis*; D017693:Sodium Bicarbonate; D012995:Solubility; D013213:Starch / Q000031:analogs & derivatives* / Q000032:analysis; D013270:Stomach / Q000000981:diagnostic imaging
D001639:Bicarbonates; D002214:Capsules; D005079:Excipients; D017693:Sodium Bicarbonate; D005780:Gelatin; D013213:Starch; C048390:sodium starch glycolate; D012964:Sodium