Influence of formulation and process parameters on pellet production by powder layering technique.
The goal of the present study was to evaluate the influence of the formulation and operating conditions on pellet preparation by pan technique. To this end, a new pelletization process, typified by the application of powdered drug on sugar-based cores using the GS coating system was studied. Inert cores were intermittently treated with micronized drug powder and adhesive solution. This treatment led to the formation of multiple layers of drug particles around an inert core resulting in the production of pellets that can further be coated by different polymers to obtain modified release formulations. Different procedures have been used to evaluate a series of important parameters such as initial core weight; speed of powder application; speed, type, and position of the atomizers; atomization degree; temperature; and air cap. Good yield of drug layering was obtained by adjusting the quantity of both the drug powder to apply and the binder solution. Pellets obtained following the optimal operating conditions (defined in a pre-formulation study) were film coated with the acrylic polymer Eudragit L30D in order to produce a model formulation consisting of enteric polymer-coated pellets containing ibuprofen. During its preparation, the formulation showed no degradation of the drug; moreover, a low percentage of residual humidity was obtained, indicating that this system is very efficient for the production of highly stable formulations. This study showed the good performance of the GS automated pan-coating system in obtaining enteric coated pellets prepared by powder layering technique using aqueous solutions.
Nastruzzi
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C
Department of Pharmaceutical Sciences, University of Ferrara, 44100 Ferrara, Italy. nas@unipg.it
Cortesi
R
R
Esposito
E
E
Genovesi
A
A
Spadoni
A
A
Vecchio
C
C
Menegatti
E
E
D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations / Q000737:chemistry / Q000378:metabolism; D004339:Drug Compounding / Q000379:methods*; D004343:Drug Implants; D007052:Ibuprofen / Q000737:chemistry* / Q000378:metabolism*; D011208:Powders / Q000378:metabolism*; D013608:Tablets, Enteric-Coated / Q000737:chemistry / Q000378:metabolism; D013678:Technology, Pharmaceutical / Q000295:instrumentation
D003692:Delayed-Action Preparations; D004343:Drug Implants; D011208:Powders; D013608:Tablets, Enteric-Coated; D007052:Ibuprofen