Moisture permeability mechanisms of some aqueous-based tablet film coatings containing soluble additives.

Moisture permeation parameters--diffusion, solubility and permeation coefficients--for hydroxypropyl methylcellulose (HPMC) and partially hydrolyzed polyvinyl alcohol (PVA) films containing either of two water-soluble additives (citric acid and urea) have been evaluated from transmission and time lag data. Contrary to expectations, the moisture diffusivities of the films were markedly lowered by the presence of these additives. However, the solubility coefficients increased while the permeability coefficients were largely unchanged up to 10 wt% of the additives. A complex phenomenon involving an extensive interlacing network of mainly hydrogen bond interactions between additive and films former was believed to influence the permeation properties of the films. The estimated limits of compatibility of the additives with the film-former were in the range of 5-10 wt%.