Details
Stereochemistry | ABSOLUTE |
Molecular Formula | C36H60O30 |
Molecular Weight | 972.8436 |
Optical Activity | UNSPECIFIED |
Defined Stereocenters | 30 / 30 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
[H][C@@]12O[C@H](CO)[C@@]([H])(O[C@@]3([H])O[C@H](CO)[C@@]([H])(O[C@@]4([H])O[C@H](CO)[C@@]([H])(O[C@@]5([H])O[C@H](CO)[C@@]([H])(O[C@@]6([H])O[C@H](CO)[C@@]([H])(O[C@@]7([H])O[C@H](CO)[C@@]([H])(O1)[C@H](O)[C@H]7O)[C@H](O)[C@H]6O)[C@H](O)[C@H]5O)[C@H](O)[C@H]4O)[C@H](O)[C@H]3O)[C@H](O)[C@H]2O
InChI
InChIKey=HFHDHCJBZVLPGP-RWMJIURBSA-N
InChI=1S/C36H60O30/c37-1-7-25-13(43)19(49)31(55-7)62-26-8(2-38)57-33(21(51)15(26)45)64-28-10(4-40)59-35(23(53)17(28)47)66-30-12(6-42)60-36(24(54)18(30)48)65-29-11(5-41)58-34(22(52)16(29)46)63-27-9(3-39)56-32(61-25)20(50)14(27)44/h7-54H,1-6H2/t7-,8-,9-,10-,11-,12-,13-,14-,15-,16-,17-,18-,19-,20-,21-,22-,23-,24-,25-,26-,27-,28-,29-,30-,31-,32-,33-,34-,35-,36-/m1/s1
Alfadex also known as α-cyclodextrin, is used as an inactive ingredient in order to improve the water solubility of the different drugs, e.g. edex: is a sterile, pyrogen-free powder containing alprostadil in an alfadex inclusion complex. After intravenous infusion of radiolabeled α-cyclodextrin to healthy volunteers, the radiolabeled components were rapidly eliminated within 24-hours, urine accounting for 81-83% of radioactivity and feces for 0.1%. There was no evidence of significant accumulation of radiolabeled α-cyclodextrin in the body even after 7 days of repeated intravenous injection. After intracavernous administration in monkeys, radiolabeled α¬ cyclodextrin was rapidly distributed from the injection site with less than 0.1% of the dose remaining in the penis 1 hour after administration. There was no evidence of tissue retention of radiolabeled α-cyclodextrin in monkeys.
Approval Year
Conditions
Condition | Modality | Targets | Highest Phase | Product |
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Inactive ingredient | Limaprost Approved UseUnknown Launch Date2001 |
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Inactive ingredient | EDEX Approved Useedex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology. Launch Date1997 |
Sample Use Guides
The dosage range of edex (is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex) for the treatment of erectile dysfunction is 1 to 40 mcg. The intracavernous injection should be given over a 5 to 10 second interval. In a study with a dose range of 1 to 20 mcg of edex, the mean dose was 10.7 mcg at the end of the dose titration period. In two studies with a dose range of 1 to 40 mcg of edex, the mean dose was 21.9 mcg at the end of the dose titration period. Doses greater than 40 mcg have not been studied. A ½ inch, 27 to 30 gauge needle is generally recommended for the intracavernous injection. The patient is advised not to exceed the optimum edex dose which was determined in the doctor’s office. The lowest possible effective dose should always be used.
Route of Administration:
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CODEX ALIMENTARIUS (GSFA) |
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DSLD |
1288 (Number of products:25)
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NCI_THESAURUS |
C82130
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JECFA EVALUATION |
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C032613
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Alpha-Cyclodextrin
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100000087874
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ACTIVE MOIETY