Compressed glyceryl monostearate based biodegradable implant of Gentamicin using melt granulation technique: In vitro evaluation & biocompatibility in animals

Abstract

Objective

Osteomyelitis is a multibacterial bone infection which is still remains challenging and difficult to treat, despite of advances in antibiotics and new operative techniques. Present study aims at formulating Gentamicin implants in treatment of Osteomyelitis & other bone infections using glyceryl monostearate (GMS) matrices as a carrier.

Methods

Gentamicin implants were prepared by using combination of glyceryl monostearate and poly ethylene glycol as hydrophobic biodegradable sustained release matrices along with different percentage of Sorbitol and Tween80 as erosion enhancers. Several formulations were prepared (K1–K7) by melt granulation followed by compression to form disc shaped implants. The prepared formulations were evaluated for different in vitro parameters & optimized formulation was subjected to in vivo study.

Results & discussion

Formulation K4 shows excellent cumulative drug release profile and it does not completely lose its physical shape even after 28 days thus this formulation conclude to be optimum formulation among the all GMS based implant formulations. Also optimized GMS based implant does not show any severe signs of inflammation and other foreign body reactions in laboratory animals, thus it was concluded that GMS based implant have acceptable biological compatibility even after 28 days.

Conclusion

Therefore from this study it is proved that, the glyceryl monostearate based implants have potential to retard the drug release for more than five weeks in the treatment of osteomyelitis & bone infections.