Production variables affecting characteristics of pellets in melt pelletization with wax combination in a laboratory scale spheronizer.
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 microm) with maximum sphericity can be produced by using 45 degrees C bowl temperature, 52 degrees C mass temperature and 1400 rpm friction plate speed.
Biswal
Sudarsan
S
Royal College of Pharmacy and Health Sciences, Berhampur-760002 Orissa, India. sudarsan_mpharm@yahoo.co.in
Sahoo
Jagannath
J
Murthy
Padala Narasimham
PN
Giradkar
Rajesh Pandurang
RP
Das
Subash
S
Avari
Jasmine Gev
JG
D000268:Adhesiveness; D002121:Calcium Channel Blockers / Q000737:chemistry*; D002368:Castor Oil / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D004110:Diltiazem / Q000737:chemistry*; D005233:Fatty Alcohols / Q000737:chemistry*; D005240:Feasibility Studies; D017276:Friction; D007700:Kinetics; D010316:Particle Size; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods; D013696:Temperature; D014885:Waxes / Q000737:chemistry*
D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D005233:Fatty Alcohols; D014885:Waxes; D002368:Castor Oil; C005031:cetyl alcohol; D004110:Diltiazem