Formulation of controlled release venlafaxine tablets

Venlafaxine er serótónín-norepinefrín endurupptökuhemill sem er notaður sem þunglyndislyf. Markmið verkefnisins var að hanna lyfjaform með stýrðri losun sem myndi hafa ákveðið magn af venlafaxine uppleyst á þremur mismunandi tímapunktum. Markmiðið var einnig að læra að leysa þau vandamál sem gætu komið upp í ferlinu. Þar sem venlafaxine er fitusækið efni var salt form lyfsins, venlafaxine HCl, notað í formúleringarnar til þess að bæta vatnsleysni þess. Töflur með stýrða losun voru hannaðar með því að prófa mismunandi fjölliður og bindiefni ásamt því að breyta eðlisbundnum eiginleikum taflnanna. Stýrðri losun var náð með því að nota vatnssækið matrixu kerfi, þar sem vatnssækin fjölliða var notuð til að mynda gel matrixu. Tuttugu mismunandi formúleringar voru prófaðar í ferlinu, formúlering F13 sýndi bestu niðurstöðurnar í leysnihraðaprófunum og var því notuð til frekari þróunar. Prófanir samkvæmt European Pharmacopoeia voru framkvæmdar á lokaafurð til þess að tryggja gæði þess lyfsins.Venlafaxine is a serotonin-norepinephrine reuptake inhibitor that is used as an antidepressant. The goal of this project was to design a controlled release dosage form that would have a certain amount of venlafaxine dissolved at three different time points. The aim was also to learn to solve the problems that could take place in the process. Since venlafaxine is a lipophilic compound the salt form, venlafaxine HCl, was used in the formulations to improve its aqueous solubility. Tablets with controlled release were designed by testing different polymers and binders as well as different physical properties of the tablets. Controlled release was achieved by using a hydrophilic matrix system, where a hydrophilic polymer was used to form a gel matrix. Twenty different formulations were tested during the process, formulation F13 showed the best results in the dissolution tests and was therefore used for further development. Tests according to the European Pharmacopoeia were performed on the final product to ensure its quality