Acta Pharm. 59 (2009) 199-210

full paper

Original research paper

Production variables affecting characteristics of pellets in melt pelletization with wax combination in a laboratory scale spheronizer

SUDARSAN BISWAL, JAGANNATH SAHOO, PADALA NARASIMHAM MURTHY, RAJESH PANDURANG GIRADKAR, SUBASH DAS and JASMINE GEV AVARI

sudarsan_mpharm@yahoo.co.in

¹Royal College of Pharmacy and Health Sciences, Andhapasarsa Road, Berhampur-760002 Orissa, India

²Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University Campus, Nagpur-440033, (M.S.), India

Accepted March 17, 2009

The purpose of the study was to evaluate the suitability of laboratory scale spheronizer for the production of spherical pellets loaded with diltiazem hydrochloride by wax combination. The 1:1 combination of cetyl alcohol and hydrogenated castor oil, as low and high melting point waxes, were used. The various production variables affecting the different characteristics of pellets and the process efficiency were evaluated. Drug loaded pellets were evaluated for drug release in distilled water. Bowl temperature primarily affects the sphericity and adhesion of pellets to the bowl. Mass temperature has a pronounced effect on size, size distribution and sphericity of pellets. Wax concentration affects all characteristics of pellets but adhesion was least affected. The effect of these three variables can be compensated by optimizing the friction plate speed. It has been found that the highest yield of pellets (850-1400 mm) with maximum sphericity can be produced by using 45 °C bowl temperature, 52 °C mass temperature and 1400 rpm friction plate speed.

Keywords: diltiazem hydrochloride, pellets, spheronizer, bowl temperature, cetyl alcohol, hydrogenated castor oil