US2005047958A1PendingUtilityA1
Methods for sterilizing preparations of digestive enzymes
Est. expiryAug 31, 2021(expired)· nominal 20-yr term from priority
A61P 7/00A61P 9/00A61P 3/08A61P 43/00A61P 7/06A61P 25/28A61P 27/02A61P 3/00A61P 25/04A61P 27/16A61P 17/16A61P 13/12A61P 11/00A61P 1/12A61P 19/02A61P 1/18A61P 21/00C12N 13/00A61P 19/00A61P 1/16A61P 17/00A61P 1/06A61P 1/14A61L 2/08A61L 2/084A61L 2/082A61L 2/081A61L 2/16A61L 2/10A61L 2/02A61L 2/087A61L 2103/05
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Claims
Abstract
Methods are disclosed for sterilizing preparations of digestive enzymes to reduce the level of one or more active biological contaminants or pathogens therein, such as viruses, bacteria (including inter- and intracellular bacteria, such as mycoplasmas, ureaplasmas, nanobacteria, chlamydia, rickettsias), yeasts, molds, fungi, prions or similar agents responsible, alone or in combination, for TSEs and/or single or multicellular parasites. These methods involve sterilizing preparations of digestive enzymes, such as trypsin, α-galactosidase and iduronate-2-sulfatase, with irradiation.
Claims
exact text as granted — not AI-modified1 . (cancelled)
2 . A method for sterilizing a preparation of one or more digestive enzymes that is sensitive to radiation, said method comprising:
(i) adding to said preparation of one more or digestive enzymes at least one stabilizer in an amount effective to protect said preparation of one or more digestive enzymes from said radiation; and (ii) irradiating said preparation of one or more digestive enzymes with a suitable radiation at an effective rate for a time effective to sterilize said preparation of one or more digestive enzymes.
3 . A method for sterilizing a preparation of one or more digestive enzymes that is sensitive to radiation, said method comprising:
(i) reducing the residual solvent content of said preparation of one or more digestive enzymes to a level effective to protect said preparation of one or more digestive enzymes from said radiation; and (ii) irradiating said preparation of one or more digestive enzymes with a suitable radiation at an effective rate for a time effective to sterilize said preparation of one or more digestive enzymes.
4 . A method for sterilizing a preparation of one or more digestive enzymes that is sensitive to radiation, said method comprising:
(i) reducing the temperature of said preparation of one or more digestive enzymes to a level effective to protect said preparation of one or more digestive enzymes from said radiation; and (ii) irradiating said preparation of one or more digestive enzymes with a suitable radiation at an effective rate for a time effective to sterilize said preparation of one or more digestive enzymes.
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