Rc. Moreton et Na. Armstrong, THE EFFECT OF FILM COMPOSITION ON THE DIFFUSION OF ETHANOL THROUGH SOFT GELATIN FILMS, International journal of pharmaceutics, 161(1), 1998, pp. 123-131
Changes were made in the composition of plasticized gelatin gels, anal
ogous to those used in the manufacture of soft shell capsules, and the
effect of these changes on the diffusion of ethanol through the films
was investigated. The substitution of glycerol by higher polyols such
as xylitol, sorbitol and lycasin (hydrogenated corn syrup) caused a s
ignificant reduction in the diffusion process, as indicated by a reduc
tion in the apparent diffusion co-efficient. When allowance was made f
or film moisture content, a 5-10-fold reduction in the apparent diffus
ion co-efficient was observed with the greatest reduction occurring in
films having lower moisture contents. This reduction in apparent diff
usion co-efficient is believed to be due to a 'phobic' interaction bet
ween ethanol and the higher polyols which increases the energy barrier
to the diffusion process. A general case is postulated whereby any di
ffusion process will be modified by the inclusion of 'diffusantophilic
' (increased rate of diffusion) or 'diffusantophobic' (reduced rate of
diffusion) components in the barrier. The implications of the changes
in the formulation of the films for the filling of soft shell capsule
s by the rotary-die method is discussed. Attempts to modify diffusion
by inclusion of solid particles or liquid crystals in the gel structur
e were unsuccessful, as was the replacement of part of the gelatin by
hydrolyzed gelatin. (C) 1998 Elsevier Science B.V.