title: The hygroscopicity of moisture barrier film coatings.
abstract: 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. Sepifilm had the fastest sorption and took up the greatest mass of water. The rate of uptake for Opadry film was similar to Sepifilm. However, this film continued to sorb moisture for a longer period. When returned to 0% RH it retained moisture in the film showing that it had a high affinity for moisture within the film. The data for the different cores indicated that there was very little benefit in using a moisture barrier film on cores with low hygroscopicity, the mass gain being a sum of that which would be expected to sorb to the film and that which sorbs to the uncoated core. There was, however, some advantage for hygroscopic cores where, even though the barrier coatings allowed substantial water sorption into the core, the extent of this was less and the rate of uptake lower than for the uncoated sample.
authors.affiliation: Department of Pharmaceutics, The School of Pharmacy, University of London, 29-39 Brunswick Square, London, WC1N 1AX, UK.
authors.forename: Enosh
authors.initials: E
authors.lastname: Mwesigwa
authors.forename: Graham
authors.initials: G
authors.lastname: Buckton
authors.forename: Abdul W
authors.initials: AW
authors.lastname: Basit
mesh_terms: D000327:Adsorption; D000465:Algorithms; D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D004058:Diffusion; D004339:Drug Compounding; D005079:Excipients / Q000737:chemistry*; D007700:Kinetics; D008689:Methacrylates / Q000737:chemistry*; D011108:Polymers; D011145:Polyvinyls / Q000737:chemistry*; D013229:Stearic Acids / Q000737:chemistry*; D013607:Tablets / Q000737:chemistry*
chemical_list: C477852:Eudragit L 30 D-55; D005079:Excipients; D008689:Methacrylates; D011108:Polymers; D011145:Polyvinyls; D013229:Stearic Acids; D013607:Tablets; C508450:opadry AMB; C508451:sepifilm LP 014; D002482:Cellulose