ALFADEX

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

Structure Search

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

HIDE SMILES / InChI

Description
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020649s023lbl.pdf | https://www.ono.co.jp/eng/cn/contents/sm_cn_051501.htm

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
Intermittent claudication 12 Sources: https://www.ono.co.jp/eng/cn/contents/sm_cn_051501.htm	Inactive ingredient		Approved 8429	Limaprost Approved Use Unknown Launch Date 2001
Erectile dysfunction 35 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020649s023lbl.pdf	Inactive ingredient		Approved 8429	EDEX Approved Use edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology. Launch Date 1997

PubMed

Title	Date	PubMed
Pharmacokinetics of intravenous ataprost alfadex, a new prostaglandin I2 analog in healthy volunteers.	1993 Aug	8225681
Intracavernous Alprostadil Alfadex--an effective and well tolerated treatment for erectile dysfunction. Results of a long-term European study.	1998 Dec	9884918
Intracavernous alprostadil alfadex (EDEX/VIRIDAL) is effective and safe in patients with erectile dysfunction after failing sildenafil (Viagra).	2000 Apr	10736486

Sample Use Guides

In Vivo Use Guide

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: Other

In Vitro Use Guide

Unknown

Name

Type

Language

ALFADEX

Official Name

English

ALPHA-DEXTRIN

Common Name

English

CAVAMAX W6

Brand Name

English

CAVAMAX W 6 FOOD

Common Name

English

ALPHA-CYCLODEXTRIN

Common Name

English

INS-457

Common Name

English

ORISTAR ACD

Brand Name

English

NSC-269470

Code

English

CYCLOHEXAAMYLOSE

Common Name

English

DEXY PEARL .ALPHA.-100

Common Name

English

E-457

Common Name

English

ALPHA-CYCLODEXTRIN [FCC]

Common Name

English

INS NO.457

Common Name

English

ALFADEX [II]

Common Name

English

CYCLOMALTOHEXAOSE

Common Name

English

Alfadex [WHO-DD]

Common Name

English

ALFADEX [MART.]

Common Name

English

RINGDEX-A

Brand Name

English

CELDEX A 100

Common Name

English

ALPHA CYCLODEXTRIN

Common Name

English

ALPHA CYCLODEXTRIN [USP-RS]

Common Name

English

ALFADEX [EP MONOGRAPH]

Common Name

English

.ALPHA.-CYCLODEXTRIN [MI]

Common Name

English

ALPHA-SCHARDINGER DEXTRIN

Common Name

English

.ALPHA.-CYCLODEXTRIN

Common Name

English

alfadex [INN]

Common Name

English

Classification Tree Code System Code

CODEX ALIMENTARIUS (GSFA)

INS-457