Aqueous film coating to reduce recrystallization of guaifenesin from hot-melt extruded acrylic matrices Film coating improves physical stability of melt extruded tablets

Drug Development and Industrial Pharmacy

Volumn 36, Issue 2, 2010, Pages 218-226

  Bruce, Caroline D ^a   Fegely, Kurt A ^b   Rajabi Siahboomi, Ali R ^b   McGinity, James W ^c  

^a PharmaForm LLC   (United States)

^b Colorcon ^*  (United States)

^c UNIVERSITY OF TEXAS AT AUSTIN   (United States)

Author keywords

Acryl EZE ; Curing; Diffusion; Eudragit ; Film coating; Guaifenesin; Hot melt extrusion; L100 55; Matrix tablets; Physical stability; Recrystallization

Indexed keywords

ACRYLIC ACID; ETHYL CELLULOSE; GUAIFENESIN; HYDROXYPROPYLMETHYLCELLULOSE; PLACEBO; POLYMER;

AQUEOUS SOLUTION; ARTICLE; CONTROLLED STUDY; CRYSTALLIZATION; DRUG COATING; DRUG SOLUBILITY; DRUG STORAGE; FILM COATING; HIGH TEMPERATURE; HOT MELT; HYDROPHILICITY; HYDROPHOBICITY; MATRIX TABLET; MELTING POINT; MOLECULAR WEIGHT; SURFACE PROPERTY; TABLET FORMULATION;

ACRYLIC RESINS; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; DRUG CARRIERS; DRUG COMPOUNDING; DRUG STABILITY; DRUG STORAGE; EXCIPIENTS; GUAIFENESIN; POLYMERS; SOLUBILITY; TABLETS, ENTERIC-COATED; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE; WATER;

EID: 75149179161     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639040903271277     Document Type: Article

References (26)

1. Yu L. (2001). Amorphous pharmaceutical solids: Preparation, characterization and stabilization. Adv Drug Deliv Rev, 48:27-42.
2. Bruce C, Fegely KA, Rajabi-Siahboomi AR, Mcginity JW. (2007). Crystal growth formation in melt extrudates. Int J Pharm, 341:162-172
3. Karbowiak T, Gougeon RD, Rigolet S, Delmotte L, Debeaufort F, Voilley A. (2008). Diffusion of small molecules in edible films: Effect of water and interactions between diffusant and biopolymer. Food Chem, 106:1340-1349
4. Lange J, Wyser Y. (2003). Recent innovations in barrier technologies for plastic packaging-A review. Packaging Technol Sci, 16:149-158
5. Moore TT, Damle S, Williams PJ, Koros WJ. (2004). Characterization of low permeability gas separation membranes and barrier materials; design and operation considerations. J Memb Sci, 245:227-231
6. Ulbricht M. (2006). Advanced functional polymer membranes. Polymer, 47:2217-2262
7. Garzon F, Raistrick I, Brosha E, Houlton R, Chung BW. (1998). Dense diffusion barrier limiting current oxygen sensors. Sens Actuators B Chem, 50:125-130
8. Mwesigwa E, Buckton G, Basit AW. (2005). The hygroscopicity of moisture barrier film coatings. Drug Dev Ind Pharm, 31:959-968
9. Lehermeier HJ, Dorgan JR, Way JD. (2001). Gas permeation properties of poly(lactic acid). J Memb Sci, 190:243-251
10. Hirata Y, Marais S, Nguyen QT, Cabot C, Sauvage J-P. (2005). Relationship between the gas and liquid water permeabilities and membrane structure in homogeneous and pseudo-bilayer membranes based on partially hydrolyzed poly(ethyleneco- vinyl acetate). J Memb Sci, 256:7-17.
11. Jonquières A, Clement R, Lochon P. (2002). Permeability of block copolymers to vapors and liquids. Prog Polym Sci, 27:1803-1877
12. Kamaev PP, Iordanskii AL, Aliev II, Wasserman AM, Hanggi U. (1999). Transport water and molecular mobility in novel barrier membranes with different morphology features. Desalination, 126:153-157
13. Dietzsch C, Fegely KA, Rajabi-Siahboomi AR, Mcginity JW. (2005). Influence of Polymeric Additives on the Physical Stability of Hot-Melt Extrudates containing Acryl-EZE® or Eudragit® L100-55 and Guaifenesin. AAPS 19th Annual Meeting, Nashville, TN.
14. Raghavan SL, Trividic A, Davis AF, Hadgraft J. (2001). Crystallization of hydrocortisone acetate: Influence of polymers. Int J Pharm, 212:213-221
15. Shen Q, Wei H, Zhao Y, Wang D-J, Zheng L-Q, Xu D-F. (2004). Morphological control of calcium carbonate crystals by polyvinylpyrrolidone and sodium dodecyl benzene sulfonate. Colloids Surf A Physicochem Eng Asp, 251:87-91.
16. Katzhendler I, Azoury R, Friedman M. (1998). Crystalline properties of carbamazepine in sustained release hydrophilic matrix tablets based on hydroxypropyl methylcellulose. J Control Release, 54:69-85.
17. Nafee NA, Ismail FA, Boraie NA, Mortada LM. (2003). Mucoadhesive buccal patches of miconazole nitrate: In vitro/in vivo performance and effect of ageing. Int J Pharm, 264:1-14.
18. Zhao ZJ, Wang Q, Zhang L, Liu YC. (2007). A different diffusion mechanism for drug molecules in amorphous polymers. J Phys Chem B, 111:11864.
19. Wang XY, In't Veld PJ, Lu Y, Freeman BD, Sanchez IC. (2005). A molecular simulation study of cavity size distributions and diffusion in para and meta isomers. Polymer, 46:9155-9161
20. Shanks R, Pavel D. (2002). Simulation of diffusion of O2 and CO2 in amorphous poly(ethylene terephthalate) and related alkylene and isomeric polyesters. Mol Simul, 28:939-969
21. Pavel D, Shanks R. (2005). Molecular dynamics simulation of diffusion of O2 and CO2 in blends of amorphous poly (ethylene terephthalate) and related polyesters. Polymer, 46:6135-6147
22. Aso Y, Yoshioka S, Kojima S. (2000). Relationship between the crystallization rates of amorphous nifedipine, phenobarbital, and flopropione, and their molecular mobility as measured by their enthalpy relaxation and 1 H NMR relaxation times. J Pharm Sci, 89:408-416
23. Clennell MB. (1997). Tortuosity: A guide through the maze. Geol Soc London Spec Publ, 122:299.
24. Guo JH, Robertson RE, Amidon GL. (1991). Influence of physical aging on mechanical properties of polymer free films: The prediction of long-term aging effects on the water permeability and dissolution rate of polymer film-coated tablets. Pharm Res, 8:1500-1504
25. Kucera SA, Felton LA, Mcginity JW. (2008). Physical aging of polymers and its effect on the stability of solid oral dosage forms. Aqueous polymeric coatings for pharmaceutical dosage forms, 3rd ed. New York: Informa Healthcare, 445.
26. Peppas NA, Wright SL. (1998). Drug diffusion and binding in ionizable interpenetrating networks from poly(vinyl alcohol) and poly(acrylic acid). Eur J Pharm Biopharm, 46:15-29.