An investigation into moisture barrier film coating efficacy and its relevance to drug stability in solid dosage forms.

Barrier coatings are frequently employed on solid oral dosage forms under the assumption that they prevent moisture sorption into tablet cores thereby averting premature degradation of moisture-sensitive active ingredients. However, the efficacy of moisture barrier coatings remains unproven and they may actually accelerate degradation. This study aimed to investigate the barrier performance of four coating systems following application onto a low hygroscopic tablet formulation containing aspirin as a model moisture sensitive drug.

A facile approach to manufacturing non-ionic surfactant nanodipsersions using proniosome technology and high-pressure homogenization.

In this study, a niosome nanodispersion was manufactured using high-pressure homogenization following the hydration of proniosomes. Using beclometasone dipropionate (BDP) as a model drug, the characteristics of the homogenized niosomes were compared with vesicles prepared via the conventional approach of probe-sonication. Particle size, zeta potential, and the drug entrapment efficiency were similar for both size reduction mechanisms.

Air-jet and vibrating-mesh nebulization of niosomes generated using a particulate-based proniosome technology.

The aerosol properties of niosomes were studied using Aeroneb Pro and Omron MicroAir vibrating-mesh nebulizers and Pari LC Sprint air-jet nebulizer. Proniosomes were prepared by coating sucrose particles with Span 60 (sorbitan monostearate), cholesterol and beclometasone dipropionate (BDP) (1:1:0.1).

Moisture sorption and permeability characteristics of polymer films: implications for their use as barrier coatings for solid dosage forms containing hydrolyzable drug substances.

Moisture sorption and permeability characteristics of polymer films were studied and their effectiveness to protect a hydrolyzable drug assessed. Cast films were prepared from Eudragit L30 D-55, Eudragit EPO, Opadry AMB and Sepifilm LP dispersions, which were also applied onto tablet cores formulated with aspirin as a model moisture sensitive active ingredient. Sorption studies were undertaken using dynamic vapour sorption, ranging between 0% and 90% RH at 25 degrees C.

The hygroscopicity of moisture barrier film coatings.

The hygroscopicity of three commercial moisture-barrier film coatings, namely, Eudragit L30 D-55 (methacrylic acid-ethyl acrylate copolymer), Opadry AMB (polyvinyl alcohol based system), and Sepifilm LP 014 (hypromellose, microcrystalline cellulose, and stearic acid based formulation), was investigated using a dynamic vapor sorption apparatus. Moisture uptake by cast films and uncoated and coated tablet cores, which were designed to be hygroscopic, low hygroscopic, and waxy, was measured following exposure to repeat relative humidity (RH) cycles of 0-50-0-50-0%, 0-75-0-75-0%, and 0-90-0-90-0% RH at 25 degrees C. Eudragit cast film exhibited the fastest equilibration but was also the least hygroscopic.