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|Abstract:||This invention is composition comprising a highly purified, substantially endotoxin-free polysaccharide preparation suitable for use as a parenterally administered pharmaceutical, and the method for producing the composition. The process produces a substantially endotoxin-free polysaccharide composition using a size separation technique in which the low molecular weight impurities are removed first, with a subsequent separation of the endotoxin from the polysaccharide, again, by size separation. Suitable size separation techniques include gel fitration, or more preferably, ultrafiltration. In the preferred embodiment of the invention, the polysaccharide arabinogalactan is first ultrafiltered using a 10,000 dalton membrane; the low molecular weight impurities (<10,000 da) are discarded. The retentate is ultrafiltered using a 100,000 dalton membrane; the high molecular weight retentate, which contains the endotoxin, is discarded, leaving a substantially purified endotoxin free arabinogalactan composition in the filtrate. Other polysaccharides such as dextran, mannan, and gum arabic are also well suited for this purification technique. The process and products produced thereby are well suited for use in parenteral pharmacuetical compositions.|
|Inventor(s):||Lewis; Jerome M. (Newton, MA)|
|Assignee:||Advanced Magnetics, Inc. (Cambridge, MA)|
|Filing Date:||Nov 29, 1994|
|Claims:||1. A method of making a highly purified, substantially endotoxin-free arabinogalactan composition which comprises the steps of: |
(i) removing from an arabinogalactan-containing preparation by ultrafiltration, materials of a molecular weight that are less than the molecular weight of the arabinogalactan composition, and collecting the arabinogalactan-containing fraction thereof;
(ii) thereafter removing from the arabinogalactan-containing fraction by ultrafiltration, endotoxin and materials of a molecular weight that are greater than the molecular weight of the arabinogalactan; and
(iii) collecting the resulting arabinogalactan-containing fraction, which has been rendered substantially endotoxin-free.
2. The method according to claim 1, wherein step (i) is preceded by the steps of:
(a) filtering the arabinogalactan through a membrane having a pore size no larger than 0.45 microns; and
(b) collecting the filtrate containing the arabinogalactan for use in step (i).
3. The method of claim 2, in which ultrafiltration according to step (i) utilizes a membrane having a pore size which retains materials greater than 10,000 daltons and ultrafiltration according to step (ii) utilizes a membrane having a pore size which retains materials greater than about 100,000 daltons.
4. A method of removing endotoxin from an arabinogalactan solution which comprises;
(i) passing the arabinogalactan preparation through a first membrane having a pore size smaller than the size of the arabinogalactan, and collecting the retentate;
(ii) passing the retentate of step (i) through a second membrane, the second membrane having a pore size permitting passage of substantially all of the arabinogalactan while retaining the endotoxin; and
(iii) collecting the filtrate produced in step (ii).
5. The method according to claim 4, in which step (i) is preceded by the steps of:
(a) filtering the arabinogalactan through a membrane having pores no larger than 0.45 microns; and
(b) retaining the filtrate containing the arabinogalactan for use in step (i).
6. The method according to claim 5, in which the first membrane has a pore size which retains materials greater than 10,000 daltons and the second membrane has a pore size which retains materials greater than about 100,000 daltons.
7. A method of making a highly purified, substantially endotoxin-free arabinogalactan composition, which comprises the steps of:
(i) refining an unpurified arabinogalactan composition by ultra filtering the composition through a membrane; which removes materials below 10,000 daltons, and collecting the retentate of the ultra filtration process; and
(ii) purifying the retentate of step (i) by ultrafiltration through a second membrane having a pore size greater than about 100,000 daltons; and
(iii) collecting the filtrate produced in step (ii).
8. The method according to claim 7 in which refining the arabinogalactan compostion in step (i) is preceded by the steps of:
(i) filtering the arabinogalactan composition through a membrane having pores no larger than 0.45 microns; and
(ii) collecting the filtrate containing the arabinogalactan composition.
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