Comparison between gamma and beta irradiation effects on hydroxypropylmethylcellulose and gelatin hard capsules.
The effects of electron beam or gamma-irradiation on technological performances (capsule hardness, expressed as deforming work and dissolution time) of empty 2-shell capsules made of gelatin or hydroxypropylmethylcellulose (HPMC) were studied. Capsule structural changes induced by radiation treatment were investigated by capillary viscometry and atomic force microscopy (AFM). The capsules were irradiated in the air at 5, 15, and 25 kGy. The deforming work of nonirradiated HPMC capsules (0.06 +/- 0.01 J) was lower than that of gelatin capsules (0.10 +/- 0.01 J). The dissolution time of the HPMC capsules (414 +/- 33 seconds) was slightly higher than that determined for gelatin hard capsules (288 +/- 19 seconds). The hardness and dissolution time of gelatin and HPMC capsules were not significantly influenced by the irradiation type and the applied irradiation dose. As the viscometry analyses are concerned, irradiation caused a reduction of the intrinsic viscosity and water and dimethyl sulfoxide solvent power in both the cases. AFM analysis showed that the radiation treatment did not appreciably affect the surface roughness of the samples nor induce structural changes on capsule surface. However, measurements of force-distance curves pointed out a qualitative parameter for the identification of the irradiated capsules. On the bases of these preliminary results, empty gelatin or HPMC hard capsules can be sanitized/sterilized by ionizing radiation.
Cilurzo
Francesco
F
Istituto di Chimica Farmaceutica e Tossicologica, Università degli Studi di Milano, viale Abruzzi 42, 20131 Milano, Italy. francesco.cilurzo@unimi.it
Selmin
Francesca
F
Minghetti
Paola
P
Montanari
Luisa
L
Lenardi
Cristina
C
Orsini
Francesco
F
Poletti
Giulio
G
D001610:Beta Particles; D002214:Capsules; D005720:Gamma Rays; D005780:Gelatin / Q000737:chemistry / Q000528:radiation effects*; D065347:Hypromellose Derivatives; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry / Q000528:radiation effects
D002214:Capsules; D065347:Hypromellose Derivatives; D005780:Gelatin; D008747:Methylcellulose