Pilot scale-up and shelf stability of hydrogel wound dressings obtained by gamma radiation

Radiation Physics and Chemistry

Volumn 81, Issue 8, 2012, Pages 1249-1253

  Soler, Dulce María ^a   Rodríguez, Yanet ^a   Correa, Hector ^a   Moreno, Ailed ^b   Carrizales, Lila ^b  

^a National Center for Animal and Plant Health CENSA   (Cuba)

^b INSTITUTO VENEZOLANO DE INVESTIGACIONES CIENTÍFICAS   (Venezuela)

Author keywords

Hydrogel; Poly(vinyl pyrrolidone); Scale up; Stability; Wound dressing

Indexed keywords

ACIDIC MEDIA; ALKALINE MEDIA; COMPRESSION RATES; GAMMA IRRADIATOR; GEL FRACTION; HYDROGEL FORMATION; HYDROGEL SURFACES; MOISTURE RETENTION; MORPHOLOGY ANALYSIS; PILOT BATCH; POLY VINYL PYRROLIDONE; POLYESTER FILMS; POLYETHYLENE BAGS; POROUS STRUCTURES; ROOM TEMPERATURE; SCALE-UP; SHELF STABILITY; SINGLE-STEP PROCESS; STABILITY STUDY; STERILITY TEST; STORAGE CONDITION; SWELLING CAPACITIES; WOUND DRESSINGS;

BIOMATERIALS; CONVERGENCE OF NUMERICAL METHODS; ESTERS; GAMMA RAYS; POLYETHYLENE GLYCOLS; POLYETHYLENES; STABILITY; THERMOPLASTICS;

HYDROGELS;

AGAR; MACROGOL; POLYMER; POVIDONE;

AQUEOUS SOLUTION; ARTICLE; BATCH PROCESS; GAMMA RADIATION; GEL; HYDROGEL; MOISTURE; MORPHOLOGY; PH; PHYSICAL CHEMISTRY; POROSITY; RADIATION DOSE; RADIATION STERILIZATION; SCALE UP; SCANNING ELECTRON MICROSCOPY; SHELF LIFE; WOUND DRESSING; WOUND HEALING;

EID: 84861943057     PISSN: 0969806X     EISSN: 18790895     Source Type: Journal    
DOI: 10.1016/j.radphyschem.2012.02.024     Document Type: Article

References (20)

1. Ajji Z., Othman I., Rosiak J.M. Production of hydrogel wound dressings using gamma radiation. Nucl. Instr. Meth. B 2005, 229:375-380.
2. Bryan J. Moist wound healing: a concept that changed our practice. J. Wound Care 2004, 13(6):227-228.
3. Chao G.T., Deng H.X., Huang Q., Jia W.J., Huang W.X., Gu Y.C., Tan H.P., Fan L.Y., Liu C.B., Huang A.L., Lei K., Gong C.Y., Tu M.J., Qian Z.Y. Preparation and characterization of pH sensitive semi-interpenetrating network hydrogel based on methacrylic acid, bovine serum albumin (BSA), and PEG. J. Polym. Res. 2006, 13(5):349-355.
4. FDA Draft Guidance for Industry, Stability Testing of Drug Substances and Drug Products. Fed. Regist. (Notices) 1998, 63(109):31224-31225. (combination of ICH Q1A-Q1C and Q5C, draft).
5. Levin M. Pharmaceutical Process Scale-Up. Series: Drugs and the Pharmaceutical Sciences 2005, 157:570-576. Marcel Dekker, New York. second ed.
6. Lugao A.B., Malmonge S.M. Use of radiation in the production of hydrogels. Nucl. Instr. Meth. B 2001, 185:37-42.
7. Razzak M.T., Darwis D., Zainuddin Sukirno Irradiation of polyvinyl alcohol and polyvinyl pyrrolidone blended hydrogel for wound dressing. Radiat. Phys. Chem. 2001, 62:107-113.
8. Rosiak J.M., Olejniczak J. Medical applications of radiation formed hydrogels. Radiat. Phys. Chem. 1993, 42(4-6):903-906.
9. Rosiak J.M., Ulański P., Pajewskji L.A., Yoshii F., Makuuchi K. Radiation formation of hydrogels for biomedical purposes. Some remarks and comments. Radiat. Phys. Chem. 1995, 46(2):161-168.
10. Hydrogels for biomedical purposes. Nucl. Instr. Meth. B 1995, 105:335-339.
11. Rosiak, J.M., 1991. Hydrogel dressings. In: Clough, R.L., Shalaby, S.W. (Eds.), Radiation Effects on Polymers, ACS Series 475. Washington, DC, pp. 271-297.
12. Rosiak, J.M., Rucinska-Rybus, A., Pekala, W., 1989. Method of Manufacturing of Hydrogel Dressings, Patent U.S.A. no. 4, 871, 490.
13. The World Health Organization (WHO), 2002. Annex 9: Guidelines on packaging for pharmaceutical products. WHO Technical Report Series, no. 902, 121-122. The World Health Organization.
14. United States Pharmacopeia (USP, 2009): <71> Sterility Tests as presented in Pharmacopeial Forum, 34(6), Interim Revision Announcement No. 6, December 1, 2008, official on May 1, 2009.
15. Wang M., Xu L., Hu H., Zhai M., Peng J., Nho Y., Li J., Wei J. Radiation synthesis of PVP/CMC hydrogels as wound dressing. Nucl. Instr. Meth. B 2007, 265:385-389.
16. Westkämper E. Live Cycle Management and Assessment. Approaches and Visions Towards Sustainable Manufacturing. CIRP Ann. 2000, 49(2):501-522.
17. Winter G.D. Formation of the scab and the rate of epithelialization of superficial wounds in the skin of the young domestic pig. Nature 1962, 193(4812):293-294.
18. Winter G.D., Scales J.T. Effect of air drying and dressings on the surface of a wound. Nature 1963, 197:91-92.
19. Wu M., Bao B., Yoshii Y., Makuuchi K. Irradiation of crosslinked, Poly(Vinyl Alcohol) blended hydrogel for wound dressing. J. Radioanal. Nucl. Chem. 2001, 250(2):391-395.
20. Yang X., Zhu Z., Liu Q., Chen X., Ma M. Effects of PVA, agar contents, and irradiation doses on properties of PVA/ws-chitosan/glycerol hydrogels made by γ-irradiation followed by freeze-thawing. Radiat. Phys. Chem. 2008, 77:954-960.