関与物質
| 役割 | 名称 | HCID | 仕込み量 |
|---|
| 反応物 | Glycolide | HCID 65432 | — |
| 反応物 | HCID 178435178 | HCID 178435178 | — |
| 反応物 | HCID 178476396 | HCID 178476396 | — |
| 溶媒 | Water | HCID 962 | — |
| 溶媒 | N-methyl-2-pyrrolidone | HCID 13387 | — |
| 生成物 | HCID 178465153 | HCID 178465153 | — |
反応手順
Poly(DL-lactide-co-glycolide) with a molar ratio of lactide to glycolide of 75/25 (Birmingham Polymer, Inc.) was dissolved in NMP to give a solution with 45% by weight polymer. This solution was filled into 3.0 cc polyproylene syringes with a male luer lock fitting and terminally sterilized by exposure to gamma irradiation at 23.2-24.6 kilograys. The polymer molecular weight after irradiation was 15,094 daltons. Leuprolide acetate was dissolved in water, sterile filtered through 0.2 mm filter and filled into a polypropylene syringe with a male luer lock fitting. The aqueous solution was frozen and the water removed by vacuum to yield a lyophilized cake of leuprolide. The two syringes were connected together with a coupler immediately prior to use and the contents of the two syringes mixed by moving the material back and forth between the two syringes for 40 cycles to provide a formulation with 6% by weight of leuprolide acetate. The product was then pulled into the syringe with the male luer lock fitting one a one-half inch 20 gauge needle attached.
情報源と証拠
| DOI | 10.6084/m9.figshare.5104873.v1 |
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| 特許番号 | US06565874B1 |
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| 出典データセット | uspto-grants-2003_05 |
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| ORD ID | ord-99951c4a067a46c7b16d996c7f586156 |
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| 出典メモ | uspto-grants-2003_05 |
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