Quality improvement of melt extruded laminar systems using mixture design

Simple item page
dc.cclicenceN/Aen
dc.contributor.authorHasa, Dritanen
dc.contributor.authorPerissutti, B.en
dc.contributor.authorCampisi, B.en
dc.contributor.authorGrassi, M.en
dc.contributor.authorGrabnar, I.en
dc.contributor.authorGolob, S.en
dc.contributor.authorMian, M.en
dc.contributor.authorVoinovich, D.en
dc.date.acceptance2015-04-17en
dc.date.accessioned2017-04-25T10:10:32Z
dc.date.available2017-04-25T10:10:32Z
dc.date.issued2015-04-23
dc.description.abstractThis study investigates the application of melt extrusion for the development of an oral retard formulation with a precise drug release over time. Since adjusting the formulation appears to be of the utmost importance in achieving the desired drug release patterns, different formulations of laminar extrudates were prepared according to the principles of Experimental Design, using a design for mixtures to assess the influence of formulation composition on the in vitro drug release from the extrudates after 1 h and after 8 h. The effect of each component on the two response variables was also studied. Ternary mixtures of theophylline (model drug), monohydrate lactose and microcrystalline wax (as thermoplastic binder) were extruded in a lab scale vertical ram extruder in absence of solvents at a temperature below the melting point of the binder (so that the crystalline state of the drug could be maintained), through a rectangular die to obtain suitable laminar systems. Thanks to the desirability approach and a reliability study for ensuring the quality of the formulation, a very restricted optimal zone was defined within the experimental domain. Among the mixture components, the variation of microcrystalline wax content played the most significant role in overall influence on the in vitro drug release. The formulation theophylline:lactose:wax, 57:14:29 (by weight), selected based on the desirability zone, was subsequently used for in vivo studies. The plasma profile, obtained after oral administration of the laminar extruded system in hard gelatine capsules, revealed the typical trend of an oral retard formulation. The application of the mixture experimental design associated to a desirability function permitted to optimize the extruded system and to determine the composition space that ensures final product quality.en
dc.funderN/Aen
dc.identifier.citationHasa, D. et al. (2015) Quality improvement of melt extruded laminar systems using mixture design. European Journal of Pharmaceutical Sciences, 75, pp. 169-176en
dc.identifier.doihttps://doi.org/10.1016/j.ejps.2015.04.013
dc.identifier.urihttp://hdl.handle.net/2086/14096
dc.language.isoenen
dc.peerreviewedYesen
dc.projectidN/Aen
dc.publisherElsevieren
dc.researchinstituteLeicester Institute for Pharmaceutical Innovation - From Molecules to Practice (LIPI)en
dc.subjectLaminar extrudatesen
dc.subjectSustained releaseen
dc.subjectMixture experimental designen
dc.subjectDesirability functionen
dc.subjectIn vivo studiesen
dc.titleQuality improvement of melt extruded laminar systems using mixture designen
dc.typeArticleen

Files

License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
4.2 KB
Format:
Item-specific license agreed upon to submission
Description:
Download

Collections

Leicester School of Pharmacy