Selected formulations of the dTAT complexes were dosed intravenously up to 1000 mg/kg with minimal toxicity.
Forty milligram of the selected formulation (formulation 1), was sufficient to provide in vitro "therapeutic" concentrations of ibuprofen (8 μg/ml) up to 8 days.
Whereas the data suggested going to stage 2 was appropriate, the overall POS of meeting the equivalence requirements upon completion of the study were very low, leading to termination of the selected formulation concepts.
The selected formulation was tested in the femur of rabbits and showed a faster release rate in vivo than in vitro.
The selected formulation was further analyzed in terms of size, pH, osmolarity, and corneal epithelial cytotoxicity.
According to this goal, the selected formulation was F-D which was composed of 80% phosphates (25% hydroxyapatite, HAP and 75% tricalcium phosphate, TCP), 20% PLA (Mw, 30 kDa) and 3.5% gentamicin sulfate (GS) and was coated with PLA (Mw, 200 kDa).
The selected formulation was also subjected to comparative ex-vivo permeation studies through tympanic membrane (TM) of rabbits.
Lilly is studying a one-a-week formulation of Prozac for chronically depressed patients.
In this report we present our formulation experiences since the establishment of the JFWP with a selected number of agents: aphidicolin glycinate, bryostatin 1, carmethizole, carzelesin, combretastatin A4, dabis maleate, disulphonated aluminium phthalocyanine, E.O.9, 4-hydroxyanisole, pancratistatin, rhizoxin, Springer pro-drug, SRI 62-834, trimelamolde, trimelandl and V489.
Selected formulations (1 1 and 3 1 with 50 150 μm DBM) were evaluated in vivo compared to an empty control to investigate the effect of DBM dose and construct properties on bone augmentation.
