EP0469520A2
Expired / Lapsed
EP
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Polyactide preparation and purification
Assignee: Novartis AG
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Filing: 1991-07-29
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Granted: —
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Expires: 2011-07-29
Abstract
Abstract A polylactide in a purified state, which meets the requirements of the colour strengths of reference solutions B2 - B9 of the brown colour test of the European Pharmacopoeia, 2nd Edition (1980) part I, Section V, 6.2 and containing one or more metals in cationic form, the metal ion(s) having a concentration of at most 10 ppm. The polylactide is especially suitable for use as microparticles or implants, and contains preferably a hydrophilic drug, like octreotide or a lipophilic drug like bromocriptine.
Inventors
- 👤 Walter Prikoszovich
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-24 17:07
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/14; A61K9/16; A61K9/1605; A61K9/1629; A61K9/1641; A61K9/1647; C; C08; C08G; C08G63/00; C08G63/02; C08G63/06; C08G63/08; C08G63/88; C08G63/90
Claims Analysis
Total Claims: 32
Claim 1
Independent Claim
60 words
A polylactide in a purified state, which meets the requirements of - the colour strengths of reference solutions B 2 - B9 of the brown colour test of the European Pharmacopoeia, 2nd Edition (1980) part I, Section V, 6.2 and - containing one or more metals in cationic form, the metal ion(s) having a concentration of at most 10 ppm.
Claim 2
Dependent Claim
60 words
A polylactide in a purified state, which meets the requirements of - the colour strengths of reference solutions B 2 - B9 of the brown colour test of the European Pharmacopoeia, 2nd Edition (1980) part I, Section V, 6.2 and - containing one or more metals in cationic form, the metal ion(s) having a concentration of at most 10 ppm.
Claim 3
Dependent Claim
17 words
A polylactide according to claim 1, having the colour strength of reference solutions B 4 - B9.
Claim 4
Dependent Claim
14 words
A polylactide according to claim 2, having the colour strength of reference solution B9.
Claim 5
Dependent Claim
17 words
A polylactide according to any one of claims 1-3, in which the metal ion is Sn .
Claim 6
Dependent Claim
15 words
A polylactide according to claim 4, having a Sn concentration of at most 1.5 ppm.
Claim 7
Dependent Claim
17 words
A polylactide according to any one of claims 1-5, in which the salt anion is ethyl hexanoate.
Claim 8
Dependent Claim
20 words
A polylactide according to claim 6, having an ethyl hexanoate concentration of at most 0.5% by weight of the polylactide.
Claim 9
Dependent Claim
11 words
A polylactide according to any one of claims 1-7, having a
Claim 10
Dependent Claim
13 words
A polylactide according to any one of claims 1-8, containing additionally glycolide units.
Claim 11
Dependent Claim
12 words
A polylactide according to claim 9, having lactide/glycolide molar ratio's of 100-25/0-75.
Claim 12
Dependent Claim
11 words
A polylactide according to claim 10, having molar ratio's of 75-25/25-75.
Claim 13
Dependent Claim
11 words
A polylactide according to claim 11, having molar ratio's of 60-40/40-60.
Claim 14
Dependent Claim
21 words
A polylactide according to any one of claims 1-12, being an ester of a polyol containing at least 3 hydroxyl groups.
Claim 15
Dependent Claim
17 words
A polylactide according to claim 13, being an ester of a sugar or of a sugar alcohol.
Claim 16
Dependent Claim
13 words
A polylactide according to any one of claims 13-14, being a glucose ester.
Claim 17
Dependent Claim
13 words
A polylactide according to any one of claims 1-12, being a linear polylactid-glycolide.
Claim 18
Dependent Claim
21 words
A polylactide according to any one of claims 13-15 having a mean molecular weight M w of from 10000 to 200000.
Claim 19
Dependent Claim
18 words
A polylactide according to any one of claims 13-15, having a polydispersity MW/Mn of from 1.7 to 3.0.
Claim 20
Dependent Claim
18 words
A polylactide according to claim 16, having a mean molecular weight M w of from 25,000 to 100,000.
Claim 21
Dependent Claim
15 words
A polylactide according to claim 16, having a polydispersity MW/Mn of from 1.2 to 2.0
Claim 22
Dependent Claim
27 words
A polylactide according to any one of claims 1-20, obtained by contacting a solution of the impure polylactide with a matrix having on its surface acidic groups.
Claim 23
Independent Claim
38 words
A method for obtaining the polylactide according to any one of claims 1-20, by contacting a solution of the impure polylactide with a matrix having on its surface carboxylic groups and isolating the purified polylactide from the eluate.
Claim 24
Independent Claim
32 words
A method for obtaining the polylactide according to any one of claims 1-20, by contacting a solution of the impure polylactide with active charcoal and isolating the purified polylactide from the eluate.
Claim 25
Dependent Claim
20 words
A method according to claim 22 or 23, in which the isolation includes a further purification step, which is ultrafiltration.
Claim 26
Independent Claim
18 words
A method according to any one of claims 22-24 in which the impure polylactide is dissolved in acetone.
Claim 27
Dependent Claim
20 words
A pharmaceutical composition containing a polylactide according to any one of claims 1-21 as a matrix for a drug compound.
Claim 28
Dependent Claim
13 words
A pharmaceutical composition according to claim 26, comprising bromocriptine as the drug compound.
Claim 29
Dependent Claim
14 words
A pharmaceutical composition according to claim 26, comprising a peptide as the drug compound.
Claim 30
Dependent Claim
14 words
A pharmaceutical composition according to claim 28, comprising a somatostatin as the drug compound.
Claim 31
Dependent Claim
18 words
A pharmaceutical composition according to claim 29, comprising octreotide or an acid addition salt or a derivative therof.
Claim 32
Dependent Claim
34 words
Process for the preparation of the pharmaceutical composition of any one of claims 26-30, which comprises working up the polylactide of claims 1-21 with the drug compound to form an implantate or a microparticle.
References Cited (Backward Citations)
No citation records indexed.
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