Medical product with active ingredient coating and method for producing the same
A technology of active material coating and active material, which is applied in the field of medical products for the treatment of vascular diseases, and can solve the problems of low adhesion on the surface of stents or balloons
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[0065] Example 1
[0066] 10 mg of paclitaxel in solid form is provided by drying a ready-to-use solution of paclitaxel in ethyl acetate with a defined concentration. Paclitaxel was absorbed into a mixture of ethyl acetate and different contents of dimethyl sulfoxide (DMSO) and checked whether a transparent solution formed after 72 hours at room temperature.
[0067] In another group (Ansatz), it was determined that the maximum solubility of paclitaxel in DMSO was 400 mg / ml.
[0068] Solution experiments show that the composition of the coating solution formed by 10 mg paclitaxel in 200 μl ethyl acetate and 12 μl DMSO has obtained the desired transparent solution. The active substance content in this solution is about 833mg / ml DMSO, so it is about 2.1 times the maximum solubility of paclitaxel in DMSO.
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[0069] Example 2
[0070] A coating solution of 10 mg paclitaxel in 200 μl ethyl acetate and 22 μl DMSO was prepared. In this coating solution, the active substance content is 454 mg paclitaxel / ml DMSO, which is about 13.5% higher than the maximum solubility of paclitaxel in DMSO. Therefore, the content of DMSO contained in the solution is not enough to completely dissolve paclitaxel (10 mg) contained in a solvent mixture of 200 μl ethyl acetate and 22 μl DMSO.
[0071] The coating solution is applied on a stainless steel plate and kept at room temperature under normal air pressure until the solvent is completely evaporated. A paclitaxel coating with a crystal structure is obtained.
[0072] The coating experiment was repeated using the solution from Example 1 (10 mg of active substance in 200 μl ethyl acetate and 12 μl DMSO), and a crystal coating of paclitaxel was also obtained.
[0073] in figure 1 , Shows an electron micrograph of the coating obtained from the coating solution o...
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[0075] Example 3
[0076] 10 mg paclitaxel was dissolved in 2000 μl ethyl acetate and 22 μl DMSO. Unlike Example 2, the amount of the volatile first solvent is increased tenfold.
[0077] The coating solution thus obtained was applied on a stainless steel plate and kept at room temperature under normal air pressure until the solvent was completely evaporated. The crystal structure of paclitaxel coating was also obtained. It can be shown that the second solvent remains in the coating even when it is strongly diluted with the volatile first solvent, and the active material recrystallizes into a crystal form after the first solvent is removed.
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