title: Evaluation of extrusion/spheronisation, layering and compaction for the preparation of an oral, multi-particulate formulation of viable, hIL-10 producing Lactococcus lactis.
abstract: Three formulation techniques were compared in order to develop a multi-particulate formulation of viable, interleukin-10 producing Lactococcus lactis Thy12. First, freeze-dried L. lactis was compacted into mini-tablets. Next, liquid L. lactis culture was used as the granulation fluid for the production of pellets by extrusion/spheronisation. Finally, liquid L. lactis culture was layered on inert pellets as an alternative technique for the production of pellets. L. lactis viability and interleukin-10 production was evaluated. Viability dropped to 15.7% after compaction of freeze-dried L. lactis and to 1.0% after pelletisation of liquid L. lactis by extrusion/spheronisation. The viability in the mini-tablets and pellets, stored for 1 week at RT and 10% RH was reduced to 23 and 0.5% of initial viability, respectively. Storage for 1 week at RT and 60% RH resulted in complete loss of viability. Layering of L. lactis on inert pellets resulted in low viability (4.86%), but 1 week after storage at RT and 10% RH, 68% of initial viability was maintained. Increasing product temperature and cell density of L. lactis in the layering suspension did not significantly change viability after layering and storage. Interleukin-10 production capacity of L. lactis Thy12 was maintained after layering.
authors.affiliation: Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Huyghebaert
authors.forename: An
authors.initials: A
authors.lastname: Vermeire
authors.forename: Sabine
authors.initials: S
authors.lastname: Neirynck
authors.forename: Lothar
authors.initials: L
authors.lastname: Steidler
authors.forename: Eric
authors.initials: E
authors.lastname: Remaut
authors.forename: Jean Paul
authors.initials: JP
authors.lastname: Remon
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D006801:Humans; D016753:Interleukin-10 / Q000008:administration & dosage / Q000096:biosynthesis / Q000138:chemical synthesis*; D013294:Lactococcus lactis / Q000737:chemistry* / Q000378:metabolism; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D016753:Interleukin-10