23-07-2015 дата публикации
Номер: US20150202301A1
Esterified cellulose ethers which have i) a combination of aliphatic monovalent acyl groups and groups of the formula —C(O)—R—COOA wherein R is a divalent aliphatic or aromatic hydrocarbon group and A is hydrogen or a cation, ii) a weight average molecular weight Mw of from 80,000 Dalton to 350,000 Dalton, iii) a Polydispersity Mw/Mn of from 1.3 to 4.1, and iv) a viscosity of up to 4.0 mPa s, measured as a 2.0 wt % solution of the esterified cellulose ether in 0.43 wt % aqueous NaOH at 20° C., are useful as enteric polymers for pharmaceutical dosage forms. 1. An esterified cellulose ether havingi) as ester groups aliphatic monovalent acyl groups or a combination of aliphatic monovalent acyl groups and groups of the formula—C(O)—R—COOA wherein R is a divalent aliphatic or aromatic hydrocarbon group and A is hydrogen or a cation,{'sub': 'w', 'ii) a weight average molecular weight Mof from 80,000 Dalton to 350,000 Dalton,'}{'sub': w', 'n, 'iii) a Polydispersity M/Mof from 1.3 to 4.1, and'}iv) a viscosity of up to 4.0 mPa·s, measured as a 2.0 wt % solution of the esterified cellulose ether in 0.43 wt % aqueous NaOH at 20° C. according to an Ubbelohde measurement according to DIN 51562-1:1999-01,{'sub': w', 'n', '2', '4', '3, 'wherein Mand Mare measured by SEC-MALLS using as mobile phase a mixture of 40 parts by volume of acetonitrile and 60 parts by volume of aqueous buffer containing 50 mM NaHPOand 0.1 M NaNO.'}2. The esterified cellulose ether of wherein the aliphatic monovalent acyl groups are acetyl claim 1 , propionyl or butyryl groups and the groups of the formula{'sub': 2', '2', '6', '4, '—C(O)—R—COOA are —C(O)—CH—CH—COOA, —C(O)—CH═CH—COOA, or —C(O)—CH—COOA.'}3. The esterified cellulose ether of being an esterified hydroxyalkyl methyl cellulose.4. The esterified cellulose ether of being hydroxypropyl methyl cellulose acetate succinate.5. The esterified cellulose ether of having a weight average molecular weight Mof from 110 claim 1 ,000 Dalton to 200 claim 1 ,000 ...
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