Study On Powder Spray Of Transfer Factor

Transfer factor (TF) is a mixture of low molecular weight peptides and nucleotide acids with bidirectional adjusting functions on immune system. TF is widely used in the clinics. In this thesis, powder spray of TF for the buccal delivery was prepared by spray drying method.Carrier system was screened firstly. The main components included mannitol (Man, as diluent), sodium hyaluronate (HA, as bioahesive material), 0.5%(w/w) of sodium deoxycholate (SDOC, as absorption enhancer), and L-Leucine (L-Leu, as disperser). The rate of HA to Man was 1:20~1:5, and the rate of Man to L-Leu was 7:3 or 5:5. In vitro study showed that TF had permeability and the absorption enhancer was not essential.Then spray drying variables were optimized as follow: 130℃of inlet temperature 9%of pump rate, 90% of aspirator, 550L/h of flow control, and 7mg/ml of sample concentration. The suitable system was composed of HA/[Man/L-Leu (7:3)] at a rate of 1:20 among seven formulations, with 43%of the process yield rate. Dried powders were corrugation sphere with size of 2.61μm and angle of repose of 41.42°. The bulk density and knocked density were 0.209g/L and 0.342g/L, respectively. The nebulizing properties of dried powders were excellent with 100% of dumping rate. The podowers were dissolved for 388.6min. Moisture absorptions in RH 23% and in RH 75% were 1.81% and1.89%. After moisture absorption, surface morphology and nebulizing property were similar to before with 95% of dumping rate. The bioadhesive behavior was good with 72.54 % resort rate, which enhanced 3.35 times than mannitol used only.Four formulations with different amount of TF were evaluated. 5% of carried ammout of TF was suitable with the yield rate of 35%. Final TF particle size of corrugation sphere was 2.77μm with span of 1.641. The TF powders had good nebulizing property with 100% of dumping rate. TF powders were amorphorous by differential thermal analysis and X-ray powder diffraction, suggesting that moisture absorption should be prevented in the preparation and storage processes.