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

Journal of Pharmaceutical Sciences

Volumn 97, Issue 10, 2008, Pages 4433-4445

  Mwesigwa, Enosh ^a   Basit, Abdul W ^a   Buckton, Graham ^a  

^a UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

Degradation; Film coating; Formulation; Hydrolysis; Hygroscopicity; Moisture barrier; Polymer; Stability; Water uptake

Indexed keywords

ACETYLSALICYLIC ACID; EUDRAGIT; HYDROXYPROPYLMETHYLCELLULOSE; POLYMER; POLYVINYL ALCOHOL; POLY[BUTYLMETHACRYLATE (2 DIMETHYLAMINOETHYL)METHACRYLATE METHYLMETHACRYLATE COPOLYMER; PROTECTIVE AGENT; UNCLASSIFIED DRUG; XANTHAN;

ABSORPTION; ARTICLE; DRUG DEGRADATION; DRUG DOSAGE FORM; DRUG HYDROLYSIS; DYNAMIC VAPOR SORPTION; FILM COATING; ISOTHERM; KINETICS; MEASUREMENT; MOISTURE; MOISTURE SORPTION; PERMEABILITY; SOLUBILITY; WATER TRANSPORT; WETTABILITY;

EID: 55749103074     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21304     Document Type: Article

References (24)

1. Stern SA, Trohalaki S. 1990. Fundamentals of gas diffusion in rubbery and glassy polymers. In: Koros WJ, editor. Barrier polymers and structures, ACS Symposium series, 43: 22-59.
2. Guilbert S, Biquet B. 2000. Edible films and coatings. In: Bureau G, Moulton JL, editors. Food packaging technology, Vol. 1. Weinheim: Wiley-VCH Verlag GmbH. pp. 315-353.
3. Aulton ME, Abdul-Razzak MH, Hogan JE. 1984. Mechanical properties of hydroxypropylmethycellulose films derived from aqueous systems: Part 1. The influence of plasticizers. Drug Dev Ind Pharm 7:649-668.
4. Stanley P, Rowe RC, Newton JM. 1981. Theoretical considerations of the influence of polymer film coatings on the mechanical strength of tablets. J Pharm Pharmacol 33:557-560.
5. Okhamafe AO, York P. 1985. The adhesion characteristics of some pigmented and unpigmented aqueous-based film coatings applied to aspirin tablets. J Pharm Pharmacol 37:849-853.
6. Felton LA, McGinity JW. 1997. Influence of plasticizers on the adhesive properties of an acrylic resin copolymer to hydrophilic and hydrophobic tablet compacts. Int J Pharm 154:167-178.
7. Sargent JP, Ashbee KHG. 1984. Very slow crack growth during osmosis in epoxy and in polyester resins. J Appl Polym Sci 9:809-822.
8. Marais S, Metayer M, Nguyen TQ, Labbé M, Perrin L, Saiter JM. 2000. Permeametric and microgravimetric studies of sorption and diffusion of water vapour in an unsaturated polyester. Polymer 41:2667-2676.
9. Ismaeli AF, Lorna W. 2002. Penetrant-induced plasticization phenomenon in glassy polymers for gas separation membrane. Sep Purif Technol 27:173-194.
10. Mwesigwa E, Buckton G, Basit AW. 2005. The hygroscopicity of moisture barrier film coatings. Drug Dev Ind Pharm 31:959-968.
11. Lane RA, Buckton G. 2000. The novel combination of dynamic vapour sorption gravimetric analysis and near infra red spectroscopy as a hyphenated technique. Int J Pharm 207:49-56.
12. Ulutan S, Balkose D. 1996. Diffusivity, solubility and permeability of water vapor in flexible PVC/ silica composite membranes. J Membr Sci 115:217-224.
13. Crank J. 1975. The mathematics of diffusion, 2nd edition. Oxford: Clarendon Press.
14. Debeaufort F, Voilley A, Meares P. 1994. Water vapour permeability and diffusivity throughmethylcellulose edible films. J Membr Sci 91:125-133.
15. Nyqvist H. 1983. Saturated salt solutions for maintaining specified relative humidities. Int J Pharm Technol Prod Manuf 4:47-48.
16. Fogel J, Epstein P, Chen P. 1984. Simultaneous high-performance liquid chromatography assay of acetylsalicylic acid and salicylic acid in film-coated aspirin tablets. J Chromatogr A 317:507-511.
17. Stroeks A, Dijkstra K. 2001. Modelling the moisture vapour transmission rate through segmented block co-poly(ether-ester) based breathable films. Polymer 42:117-127.
18. Hancock BC, Zografi G. 1993. The use of solution theories for predicting water vapour absorption by amorphous pharmaceutical solids. A test of the Flory-Huggins and Vrentas models. Pharm Res 10:1262-1267.
19. Alfrey T, Gurnee EF, Lloyd WG. 1966. Diffusion in glassy polymers. J Polymer Sci Part C 12:249-261.
20. Fava RA. 1980. Polymers: Physical properties. In: Felder RM, Huward GS, editors. Methods of experimental physics, Vol. 16, Part C (Chap. 17). New York: Academic Press.
21. Debeaufort F, Martín-Polo M, Voilley A. 1993. Polarity homogeneity and structure affect water vapor permeability of model edible films. J Food Sci 58:426-434.
22. Fung RM, Parrot EL. 1980. Measurement of film-coating adhesiveness. J Pharm Sci 69:439-441.
23. Klages CP, Dietz A, Höing T, Thyen R, Weber A, Willich P. 1996. Deposition and properties of carbon-based amorphous protective coatings. Surf Coat Technol 80:121-128.
24. Barranco V, Carpentier J, Grundmeier G. 2004. Correlation of morphology and barrier properties of thin microwave plasma polymer films on metal substrates. Electrochim Acta 49:1999-2013.