Preliminary Clinical Assessment of a Gentamicin-Loaded Monoolein Gel Intended to Treat Chronic Osteomyelitis

in Trends in Medical Research (2008), 3(2), 82-89

The aim of this current study was to perform a preliminary clinical assessment of efficacy and safety of a biodegradable gentamicin-loaded monoolein gel. An open single dose, one treatment study including ... [more ▼]

The aim of this current study was to perform a preliminary clinical assessment of efficacy and safety of a biodegradable gentamicin-loaded monoolein gel. An open single dose, one treatment study including 19 patients with chronic osteomyelitis caused by a microorganism sensitive to gentamicin was conducted. After surgical curettage of the infected bone, the dead space was filled in with the gentamicin-loaded monoolein gel. To prevent post-operative septicaemia, a systemic antibiotherapy was prescribed for 3 days following the operation. Clinical, biological and radiological follow-up was performed to assess the efficacy and the safety of the treatment. After a follow-up period ranging from 2 to 12 months, all 19 patients included in the study felt well. Eighteen patients recovered from chronic osteomyelitis without adverse events. The wound of one patient whose bone was exposed did not scar over after 10 months. However, it was no longer infected. In conclusion, gentamicin-loaded monoolein gel was efficacious in treating chronic osteomyelitis without side-effects. [less ▲]

In vivo Biocompatibility and Toxicity Assessment of a Gentamicin-Loaded Monoolein Gel Intended to Treat Chronic Osteomyelitis

in Journal of Pharmacology & Toxicology (2008), 3(5), 386-393

Biocompatibility and preliminary toxicity of a novel gentamicin-loaded monoolein gel (implant) intended for the local treatment of chronic osteomyelitis were investigated in mice. The mice, randomly ... [more ▼]

Biocompatibility and preliminary toxicity of a novel gentamicin-loaded monoolein gel (implant) intended for the local treatment of chronic osteomyelitis were investigated in mice. The mice, randomly allotted in 3 groups of 10, received respectively a single dose (0.05 mL) of normal saline, monoolein and the gel by subplantar injection. Clinical monitoring and assessment of induced oedema were carried out during 52 days after implantation. A histologic examination of the implantation site was performed at the end of the experiment. Renal and hepatic functions of the implant were also assessed on 52 days post-implantation by using biochemical and histological methods. In mice, no adverse reaction occurred after implantation. Only, a transitional foreign body reaction was observed in mice implanted by the monoolein and the implant. The paw volume of the mice increased within 3 h post-implantation and returned to baseline by 52 days. The liver and kidneys histology at light microscopy and biochemical parameters were similar for all mice. Further investigation is undertaken to detect eventual early damages which could have been resolved with time. Nevertheless, the novel gel is biocompatible and doesn`t show sub-chronic toxicity. [less ▲]

Storage Of Yarrowia Lipolytica Lipase After Spray-Drying In The Presence Of Additives

in Process Biochemistry (2007), 42(9),

Lipase from Yarrowia lipolytica is an enzyme that presents numerous potentialities for biotechnological applications. This work describes the development of powders obtained by atomization of supernatants ... [more ▼]

Lipase from Yarrowia lipolytica is an enzyme that presents numerous potentialities for biotechnological applications. This work describes the development of powders obtained by atomization of supernatants lipase from Y. lipolytica LGx6481. Two formulations were studied: one formulation with skim milk powder and gum arabic, and the other with maltodextrin, calcium chloride and gum arabic. After drying, powders were stored at 4 and 20 8C in aluminium hermetic bags to evaluate their stability over a period of one year. The influence of water activity and glass transition temperature (Tg) on the powder’s storage were also studied. [less ▲]