title: Influence of the components of Kollicoat SR film on mechanical properties of floating pellets from the point of view of tableting.
abstract: The influence of pellet core ingredients on pellet behaviour, e.g. during compression, is well known. In this study the influence of components of a Kollicoat SR polymer film on mechanical properties was investigated. The aim of this study was to evaluate the influence of polymer film components on the mechanical properties of the pellet as a whole, from the point of view of tableting. Tablets should disintegrate into undeformed pellets floating in this environment for 5-6 h, releasing the model drug--verapamil hydrochloride--if possible in a controlled way. The usefulness of texture analysis and work of compression measurement was also evaluated. Kollicoat SR in the form of a 30D aqueous dispersion was chosen as the main component of the polymer film. Polyvinyl pyrrolidone K-30 as a pore former, and propylene glycol, triethyl citrate and dibutyl sebacate plasticisers were selected as typical additives. The influence of different thickness of polymer film on behaviour during stress was also evaluated. After coating the cores with a 20 microm Kollicoat SR dispersion film, an increase in mechanical strength, in comparison to the pellet core, was observed (2.74 to 3.34 mJ). Addition of porophor increased the work of compression by 50% to 5.1 mJ. The investigation of the influence of plasticiser on film properties proved that the kind of plasticiser used in the polymer film had no effect on the mechanical properties of the film or pellets. Only in the case of the film with triethyl citrate was no distinct of the pellet core found. Pellets coated both with films with triethyl citrate and with dibutyl sebacate, in contrast to pellets with a film coating with propylene glycol, showed a significant decrease of the dissolution rate of verapamil hydrochloride (20, 10 and 40% at 6 hours, respectively). It is possible to compress pellets with a 50 microm polymer film without affecting the dissolution rate, as was confirmed during release studies. When using Kollicoat SR the most appropriate plasticizer seems to be triethyl citrate, and in this case a change of behavior during compression analysis by texture analyzer was observed. But so relationship was found between the type of plasticizer and the work needed to obtain a given deformation.
authors.affiliation: Department of Pharmaceutical Technology, Medical University of Gdansk, Poland.
authors.forename: R
authors.initials: R
authors.lastname: Lunio
authors.forename: W
authors.initials: W
authors.lastname: Sawicki
mesh_terms: D001682:Biological Availability; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D004339:Drug Compounding; D006244:Hardness; D008855:Microscopy, Electron, Scanning; D010316:Particle Size; D010968:Plasticizers; D011145:Polyvinyls / Q000737:chemistry*; D013607:Tablets; D014700:Verapamil / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics
chemical_list: D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D010968:Plasticizers; D011145:Polyvinyls; D013607:Tablets; C013215:polyvinyl acetate; D014700:Verapamil