A topical nanoparticulate spironolactone formulation
A technology of nano-particles and spironolactone, which is applied in the direction of aerosol delivery, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the adverse effects of product stability, tiny particles and nanoparticles Aggregation and flocculation, narrow particle size range, etc.
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Embodiment 1
[0060] Example 1: Preparation of Nanoparticulate Spironolactone as Topical Formulation
[0061] Preparation of Nanoparticle Spironolactone
[0062] Table 1 shows a typical preparation method of nanoparticulate spironolactone incorporated into the crystal structure according to the present invention. Nanoparticle spironolactone can be prepared as follows:
[0063] Combine the aqueous formulation of the stabilizer with water or injection buffer under magnetic stirring until a clear solution is obtained; wet the spironolactone with the appropriate amount of aqueous surfactant to form a slurry; disperse the resulting suspension with high shear Disperse the suspension with magnetic force to eliminate foam; the obtained suspension passes through a high-pressure piston gap homogenizer to obtain a nano-suspension. Use Avestin C5 TM Formulations 1-7 were prepared using Avestin C50 TM Formulations 8-9 were prepared. During homogenization, drug particles are broken up by cavitation ...
Embodiment 2
[0122] Example 2: Size of spironolactone particles before and after storage
[0123] Figures 1, 2 and 3 are micrographs of spironolactone of the present invention when it is just prepared, after being stored for 7 months, and compared with commercially available spironolactone. The distance between each vertical grid in the figure is 0.01 mm or 10 microns.
[0124] The particles shown in Figures 1 and 2 are so small that they are barely visible under an optical microscope. The particles did not grow any longer after storage for 7 months. In contrast, the commercially available spirosterolactone "Spiroderm" (Figure 3) presents spironolactone crystals as large as 20 microns.
Embodiment 3
[0125] Example 3: Flux Study
[0126] raw material
provider
Crystalip TM Spironolactone nanosuspension 2% by weight
Lot number is 4014-000 / 06atc
Spironolactone
The batch number is 510 / 0
Skye Pharma, Switzerland
Aqueous Cream B.P.
The batch number is 28076
Hillcross, UK
ethanol
R grade analytically pure
VWR International Ltd., UK
Sodium dihydrogen phosphate dihydrate
The batch number is L298
Merckeurolab
Deionized water
Elga Ltd., UK
Acetonitrile HPLC grade
Rathburns Chemicals Ltd., UK
regenerated cellulose film
NBS-Biological, UK
[0127] Methods of Flow Research
[0128] Crystalip TMThe formulation was provided by SkyePharma AG, and the commercially available spironolactone control was no longer used in the experiment, so a standard cream base control was prepared as follows. Briefly, 100 mg of spironolactone powder was accurately weighed an...
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