Process for manufacturing drug delivery formulations
A drug and drug technology, applied in the field of preparing drug delivery products, can solve unmet problems
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Embodiment 1
[0090] In vitro release of gentamicin
[0091] In vitro studies were performed to demonstrate the release of highly soluble gentamicin sulfate from the packaged silicone cups. solid drug granules ( figure 1 , 105) dip-coated with polylactic acid, and packaged in silicone cups ( figure 1 , 101). The drug can be released from only one end of the silicone, which is then coated with a controlled-release polymer formulation of parylene ( figure 1, 107) to control its release. Two grams of parylene were loaded into the vaporization chamber to create an extended release formulation. Release was tested using conventional dissolution systems. Briefly, dissolutions were performed in 2 ml of distilled water in 2 ml polypropylene microcentrifuge tubes at room temperature without agitation. During the course of 7 days, 40 [mu]l samples of gentamicin were taken at different time intervals and the concentration at each time point was measured by comparing the absorbance of the samples ...
Embodiment 2
[0102] In vivo release of gentamicin
[0103] Gentamicin sulfate-releasing implants prepared as described in Example 1 were implanted in the round window niche of juvenile albino guinea pigs. Pharmacokinetics: Perilymph samples were collected 1 day, 4 days, 7 days and 10 days after gentamicin implant placement and assayed for gentamicin sulfate (HPLC, reverse phase, with AB SCIEX API 3000MS Agilent 1100 Series HPLC / MS).
Embodiment 3
[0105] In vitro release of immunoglobulin G
[0106] In vitro studies were performed to demonstrate the release of highly soluble immunoglobulin G (IgG) from the packaged silicone cups. Solid drug particles were produced by mixing 75% IgG with 25% hydroxypropylmethylcellulose (HPMC) ( Figure 4 , 402). The solid particles are packaged in silicone cups ( figure 1 , 101). The drug can be released from only one end of the silicone, which is then coated with 5 μl of a controlled release polymer formulation of 10% polylactic acid ( figure 1 , 107) to control its release. Dissolution studies were performed using IgG packaged extended release formulations. For each sample, release into 600 μl of water was performed at room temperature (23° C.) with stirring. Aliquots were taken intermittently and analyzed by UV absorption spectroscopy at 280 nm using a Spectramax Plus 384 96-well microplate reader. Extended release formulations of packaged IgG demonstrated drug dissolution ove...
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