Cetirizine Hydrochloride → Cetirizine

HRID 1852351

Reaktionsgleichung

Reaktionsgleichung von HRID 1852351
[CH:1]1[CH:2]=[CH:3][C:4]([CH:7]([N:15]2[CH2:20][CH2:19][N:18]([CH2:21][CH2:22][O:23][CH2:24][C:25]([OH:27])=[O:26])[CH2:17][CH2:16]2)[C:8]2[CH:9]=[CH:10][C:11]([Cl:14])=[CH:12][CH:13]=2)=[CH:5][CH:6]=1.Cl.Cl.C(O)[C@@H]1O[C@H](O[C@]2(CCl)O[C@H](CCl)[C@@H](O)[C@@H]2O)[C@@H](O)[C@@H](O)[C@H]1Cl>Cl>[CH:1]1[CH:2]=[CH:3][C:4]([CH:7]([N:15]2[CH2:20][CH2:19][N:18]([CH2:21][CH2:22][O:23][CH2:24][C:25]([OH:27])=[O:26])[CH2:17][CH2:16]2)[C:8]2[CH:9]=[CH:10][C:11]([Cl:14])=[CH:12][CH:13]=2)=[CH:5][CH:6]=1

Komponenten

4

Edukt 2

HCID 55182Cetirizine HydrochlorideHCID 70683051(2R,3S,4R,5R,6S)-2-[(2R,3S,4S,5S)-2,5-bis(chloromethyl)-3,4-dihydroxyoxolan-2-yl]oxy-5-chloro-6-(hydroxymethyl)oxane-3,4-diol

Produkt 1

HCID 2678Cetirizine

Reagenzien, Katalysatoren, Lösungsmittel 1

HCID 313Hydrochloric AcidLösungsmittel

Versuchsvorschrift

Cetirizine Dihydrochloride ODT, 10 mg dose: 1560 g of taste-masked microparticles and 1762 g of rapidly dispersing microgranules, prepared as in Example 1, were blended with 400 g of microcrystalline cellulose (Avicel PH101), 200 g of crospovidone, 64 g of strawberry flavor, and 14 g of Sucralose (a sweetener) in a V-blender and compressed into tablets (13 mm in diameter) with an average weight of 450 mg and average hardness of about 37 N and friability of 0.24% to demonstrate robustness of the manufacturing (taste-masking and tabletting) process and meeting target dissolution specifications (not more than about 10% in 5 minutes in the simulated saliva fluid at pH 6.8 and not less than about 75% released in 15 minutes in 0.1N HCl).

Aufarbeitung

  1. dissolutionrobustness of the manufacturing (taste-masking and tabletting) process and meeting target dissolution specifications (not more than about 10% in 5 minutes in the simulated saliva fluid at pH 6.8 and not less than about 75%

Quellen und Nachweise

ORD-Eintrag
ord-75ab4800f69a4b6e8dffa28b56b43fca
Quelldatensatz
uspto-grants-2015_02
Patentnummer
US08962022B2

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