Acta Pharm. 61 (2011) 25-36

full paper

Original research paper

Development of hydroxyapatite-ciprofloxacin bone-implants using “Quality by design”

AMIT KUMAR NAYAK, BIBEK LAHA and KALYAN KUMAR SEN

amitkrnayak@yahoo.co.in

Department of Pharmaceutics, Gupta College of Technological Sciences, Asansol-713301, India

Accepted Dcember 15, 2010

The present study deals with the development of hydroxyapatite (HAp)-ciprofloxacin bone-implants using the “Quality by design” approach. The effect of various synthetic parameters like drug amount added in the process, stirring speed and addition rate of orthophosphoric acid on drug concentration in the HAp-ciprofloxacin system synthesized by the precipitation technique using 2³ factorial design was analyzed. Optimization methodology utilizing the first-order polynomial equation was used to search for optimal drug concentration in the HAp-ciprofloxacin implant system. The observed responses coincided well with the predicted values from the optimization technique. New implants were manufactured using various HAp-ciprofloxacin composites and 1.5 % (m/V) guar gum as a binder. Characterization of the delivery system was done by XRPD, FTIR spectroscopy and SEM. Even at highest drug concentration (76.6 ± 0.5 %, m/m), ciprofloxacin was present in noncrystalline state. The in vitro ciprofloxacin release from various bone-implants was sustained for several weeks and the drug release pattern correlated well with the Korsmeyer-Peppas model.

Keywords: hydroxyapatite, ciprofloxacin, bone-implant, “Quality by design”, osteomyelitis