The disintegration behaviour of capsules in fed subjects: a comparison of hypromellose (carrageenan) capsules and standard gelatin capsules.
Two-piece hard shell capsules made from hypromellose (or hydroxypropyl methylcellulose, HPMC) containing carrageenan as a gelling agent have been proposed as an alternative to conventional gelatin capsules for oral drug delivery. We have previously compared the disintegration of hypromellose(carrageenan) (Quali-V(®)) and gelatin capsules (Qualicaps) in fasted human subjects using the technique of gamma scintigraphy. This second study used the same technique with both fasted and fed human subjects. Size 0 capsules were filled with powder plugs made from lactose and did not contain croscarmellose as in the original study. The capsules were separately radiolabelled with indium-111 and technetium-99m. Both capsules were administered simultaneously with 180ml water to eight healthy male subjects following an overnight fast. Each volunteer was positioned in front of the gamma camera and sequential 60s images were acquired in a continuous manner for 30min. The mean (±S.D.) disintegration time in the fasted state for the hypromellose(carrageenan) capsules was 8±2min and for gelatin 7±3min. These results were not statistically different from the data in the original study and show that the removal of the croscarmellose had no effect on the results. The mean (±S.D.) disintegration time in the fed state for the hypromellose(carrageenan) capsules was 16±5min and for the gelatin capsules was 12±4min. There was no statistical difference between the hypromellose(carrageenan) and gelatin capsules in either the fed or fasted state.
Qualicaps Europe, S.A.U., 28108 Alcobendas, Madrid, Spain.
B E
BE
Jones
A W
AW
Basit
C
C
Tuleu
D000284:Administration, Oral; D000328:Adult; D002214:Capsules; D002351:Carrageenan / Q000493:pharmacokinetics*; D004337:Drug Carriers / Q000493:pharmacokinetics*; D005215:Fasting / Q000378:metabolism; D005753:Gastric Mucosa / Q000378:metabolism; D005780:Gelatin / Q000493:pharmacokinetics*; D006801:Humans; D065347:Hypromellose Derivatives; D007205:Indium Radioisotopes; D008297:Male; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D011877:Radionuclide Imaging; D016037:Single-Blind Method; D013270:Stomach / Q000000981:diagnostic imaging; D016284:Technetium Tc 99m Pentetate; D055815:Young Adult
D002214:Capsules; D004337:Drug Carriers; D007205:Indium Radioisotopes; D065347:Hypromellose Derivatives; D002351:Carrageenan; D005780:Gelatin; D008747:Methylcellulose; D016284:Technetium Tc 99m Pentetate