Compressibility of floating pellets with verapamil hydrochloride coated with dispersion Kollicoat SR 30 D.
The purpose of this study was to work out a method of compression of floating pellets with verapamil hydrochloride (VH) in a dose of 40 mg. It was assumed that this form should reside in the stomach floating for several hours and gradually release the drug in a controlled way. Compression of pellets into tablets, being a modern technological process, is much more perfect than enclosing them in a hard gelatin capsule. Kollicoat SR 30 D was selected for coating. In experiments three plasticizers were examined-propylene glycol, triethyl citrate and dibuthyl sebecate (all at concentration of 10%). It was found that VH release from pellets coated by the films of the same thickness (70 microm), however, containing plasticizers is considerably different. Pellets were prepared by wet granulation of powder mixture, spheronization of the granulated mass and coating of the cores with a sustained release film. Two kinds of cellulose, microcrystalline and powdered, and sodium hydrocarbonate were the main components of pellet core. Proper pellet coating film thickness, ensuring obtaining desirable VH release profile and flotation effect, was defined. X compositions of tablets with pellets were examined in order to obtain formulation, from which VH release would mostly approximate pellets before compressing. The best formulation was evaluated taking into account the effect of compression force an tablet hardness and friability, and pellet agglomeration and flotation. Tablet cross-section photographs were taken confirming necessary coating film thickness preventing their deformation caused by compressing into tablets.
Sawicki
Wiesław
W
Department of Pharmaceutical Technology, Medical University of Gdańsk, Gdańsk, Poland. wsawicki@farmacja.amg.gda.pl
Lunio
Rafał
R
D000465:Algorithms; D002121:Calcium Channel Blockers / Q000008:administration & dosage* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D005079:Excipients; D006245:Hardness Tests; D007700:Kinetics; D010968:Plasticizers; D011145:Polyvinyls; D011208:Powders; D011786:Quality Control; D014700:Verapamil / Q000008:administration & dosage* / Q000737:chemistry
D002121:Calcium Channel Blockers; D005079:Excipients; D010968:Plasticizers; D011145:Polyvinyls; D011208:Powders; C013215:polyvinyl acetate; D014700:Verapamil