Monoolein-water liquid crystalline gels of gentamicin as bioresorbable implants for the local treatment of chronic osteomyelitis: in vitro characterization
Ouédraogo, M; Semdé, R; Somé, I.Tet al.
2008 • In Drug Development and Industrial Pharmacy, 34, p. 753-760
[en] To maximize the efficacy of chronic osteomyelitis antibiotherapy while reducing antibiotic systemic toxicity, as well as time and costs of hospitalizations, it has been thought that monoolein-water gels incorporating gentamicin sulfate could be used as local, bioresorbable,and sustained-release implants. For this purpose, four formulations were examined with regard to their physicochemical and in vitro drug release characteristics. Hot stage microscopy, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA),and X-ray diffraction showed cubic liquid crystalline and eutectic structures. The more suitable formulation consisting of 80-15-5%wt/wt monoolein-water-gentamicin sulfate progressively released the antibiotic for a period of 3 weeks without burst effect. Moreover, the content and the release profile of gentamicin sulfate were not significantly changed after storage at 2-6 degrees C for a period of 10 months.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Ouédraogo, M
Semdé, R
Somé, I.T
Traoré Ouédraogo, R
Guissou, I.P
Henschel, V
Dubois, J
Amighi, K
Evrard, Brigitte ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Language :
English
Title :
Monoolein-water liquid crystalline gels of gentamicin as bioresorbable implants for the local treatment of chronic osteomyelitis: in vitro characterization
Publication date :
2008
Journal title :
Drug Development and Industrial Pharmacy
ISSN :
0363-9045
eISSN :
1520-5762
Publisher :
Taylor & Francis, Philadelphia, United States - Pennsylvania
Budavari, S., O'Neil, M. J., Smith, A., Heckelman, P. E., & Kinneary, J. F. (1996). The Merck index (12th ed.). London, Great Britain: Merck Research Laboratories.
Burrows, R., Collett, J. H., & Attwood, D. (1994). The release of drugs from monoglyceride-water liquid crystalline phases. Int. J. Pharm., 111, 283-293.
Caboi, F., Amico, G. S., Pitzalis, P., Monduzzi, M., Nylander, T., & Larsson, K. (2001). Addition of hydrophilic and lipohilic compounds of biological relevance to the monoolein/water system. I. Phase behaviour. Chem. Phys. Lipids, 109, 47-62.+
Chang, C., & Bodmeier, R. (1997a). Swelling and a drug release from monoglyceride-based drug delivery systems. J. Pharm. Sci., 86, 747-752.
Chang, C., & Bodmeier R. (1997b). Effect of dissolution media and additives on the drug release from cubic phase delivery systems. J. Control. Release, 46, 215-222.
Changez, M., Burugapalli, K., Koul, V., & Choudhary, V. (2003). The effect of composition of poly (acrylic acid)-gelatin hydrogel on gentamicin sulfate release: in vitro. Biomaterials, 24, 527-536.
Désévaux, C., Dubreuil, P., & Lenaerts, V. (2002). Characterization of crosslinked high amylose starch matrix implants. 1. In vitro realease of ciprofloxacin. J. Control. Release, 23, 3-93.
Engström, S. (1990). Drug delivery from cubic and other lipid-water phases, Lipid Tech., 2, 42-45.
European Pharmacopoeia. (2002). (4th ed.). Strasbourg, France: European Department for the Quality of the Medicines.
Garvin, K. V., Miyano, J. A., Robinson, D., Giger, D., Novak, J., & Radio, S. (1994). Polylactide/polyglycolide antibiotic implants in the treatment of osteomyelitis. J. Bone Joint Surg., 76A, 1500-1507.
Geraghty, P. B., Attwood, D., Collett, J. H., & Dandiker, Y. (1996). The in vitro release of some antimuscarinic drugs from monolein/water lyotropic liquid crystalline gels. Pharm. Res., 13, 1265-1271.
Geraghty, P. B., Attwood, D., Collett, J. H., Sharma, H., & Dandiker, Y. (1997). An investigation of the parameters influencing the bioadhesive properties of Myverol 18-99/water gels. Biomaterials, 18, 63-67.
Kim, J. C., Lee, K. U., Shin, W. C., Lee, H. Y., Kim, J. D., Kim, Y. C., Tae, G., Lee, K. Y., Lee, S. J., & Kim, J. D. (2004). Monoolein cubic phases containing hydrogen peroxide. Colloids Surf., B, 36, 161-166.
Lew, D. P., & Waldvogel, F. A. (1997). Current concepts, Osteomyelitis. N. Engl. J. Med., 336, 999-1007.
Li, L. C., Deng, J., & Stephens, D. (2002). Polyanhydride implant for antibiotic delivery - from the bench to the clinic. Adv. Drug Deliv. Rev., 54, 963-986.
Mauduit, J., Brukh, N., & Vert, M. (1993). Gentamycin/poly(lactic acid) blends aimed at sustained release local antibiotic therapy administered peroperatively. I. The case of gentamycin base and gentamycin sulfate in poly(D,L-lactic acid) olygomers. J. Control. Release, 23, 209-220.
Meyer, J. D., Falk, R. F., Kelly, R. M., Shively, J. E., Withrow, S. J., Dernell, W. S, Kroll, D. J., Randolph, T. W., & Manning, M. C. (1998). Preparation and in vitro characterization of gentamicin-impregnated biodegradable beads suitable for treatment of osteomyelitis. J. Pharm. Sci., 87, 1149-1154.
Nelson, C. L., Hickmon, S. G., & Skinner, R. A. (1997). Treatment of experimental osteomyelitis by surgical debridement and the implantation of bioerodable, polyanhydride-gentamicin beads. J. Orthop. Res., 15, 249-255.
Nielsen, L. S., Schubert, L., & Hansen, J. (1998). Bioadhesive drug delivery systems. I. Characterisation of mucoadhesive properties of systems based on glyceryl mono-oleate and glyceryl monolinoleate. Eur. J. Pharm. Sci., 6, 231-239.
Passerini, N., Albertini, B., Gonzalez-Rodriguez, M. L., Cavallari, C., & Rodriguez, L. (2002). Preparation and characterisation of ibuprofen-poloxamer 188 granules obtained by melt granulation. Eur. J. Pharm. Sci., 15, 71-78.
Powles, J. W., Spencer, R. F., & Lovering, A. M. (1998). Gentamicin release from old cement during revision hip arthroplasty. J. Bone Joint Surg., 80, 607-610.
Rowe, R. C., Sheskey, P. J., & Weller, P. J. (2003). Handbook of pharmaceutical excipients (4th ed., pp. 262-263). London, Great Britain: Pharmaceutical Press.
Sadhale, Y., & Shah, J. C. (1998). Glyceryl monooleate cubic phase gel as chemical stability enhancer of cefazolin and cefuroxime. Pharm. Dev. Technol., 3, 549-556.
Sallam, A., Khalil, E., Ibrahim, H., & Freij, I. (2002). Formulation of an oral dosage form utilizing the properties of cubic liquid crystalline phases of glyceryl monooleate. Eur. J. Pharm. Biopharm., 53, 343-352.
Schmidt, C., Wenz, R., Nies, B., & Moll, F. (1995). Antibiotic in vivo/in vitro release, histocompaibility and biodegradation of gentamicin implants based on lactic acid polymers and copolymers. J. Control. Release, 37, 83-94.
Scott, D. M., Rotschafer, J. C., & Behrens, F. (1988). Use of vancomycin and tobramycin polymethylmethacrylate impregnated beads in the management of chronic osteomyelitis. Drug Int. Clin. Pharm., 22, 480-483.
Shah, J. C., Sadhale, Y., & Chilukuri, D. M. (2001). Cubic phase gels as drugs systems. Adv. Drug Deliv. Rev., 47, 229-250.
Stephens, D., Li, L., Robinson, D., Chen, S., Chang, H-C., Liu, R. M., Tian, Y., Ginsburg, E. J., Gao, X., & Stultz, T. (2000). Investigation of the in vitro release of gentamicin from a polyanhydride matrix. J. Control. Release, 63, 305-317.
Trippel, S. (1986). Current concepts antibiotic-impregnated cement in total joint arthroplasty. J. Bone Joint Surg., 68A, 1297-1302.
United States Pharmacopeia (24th ed.) (USP24). (2000). Rockville, MD: United States Pharmacopeial Convention, Inc.
Vyas, S., Pradhan, S. D., Pavaskar, N. R., & Lachke, A. (2004). Differential thermal and thermogravimetric analyses of bound water content in cellulosic substrates and its significance during cellulose hydrolysis by alkaline active fungal cellulases. Appl. Biochem. Biotechnol., 118, 177-188.
Wyatt, M. D., & Dorschel D. (1992). A cubic-phase delivery system composed of glyceryl monooleate and water for sustained release of water-soluble drugs. Pharm. Technol., 8, 116-123.
Yang, X. F, Zeng, F. D., Zhou, Z. B., Huang, K. X., & Xu, H. B. (2003). In vitro release and antibacterial activity of poly(oleic/linoleic acid dimer: sebacic acid)-gentamicin. Acta Pharmacol. Sin., 24, 306-310.
Yaylaoglu, M. B., Korkusuz, P., Ors, U., Korkusuz, F., & Hasirci, V. (1999). Development of a calcium phosphate-gelatin composite as a bone substitute and its use in drug release. Biomaterials, 20, 711-719.
Zhang, X., Wyss, U. P., Pichora, D., & Goosen, M. F. A. (1994). Biodegradable controlled antibiotic release devices for osteomyelitis: Optimization of release properties. J. Pharm. Pharmacol., 46, 718-724.
