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Details for Patent: 4,719,108

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Details for Patent: 4,719,108

Title: Chymopapain composition and method for its use
Abstract:An improved method for treating an intervertebral spinal disc in a mammalian subject which disc exhibits an abnormal condition, characterized by a reduced risk of toxic effect to the subject is provided which comprises, injecting in said disc an amount of a pharmaceutically acceptable solution of a purified chymopapain essentially free of proteolytically inactive and/or toxic protein components, said purified chymopapain being used in an amount sufficient to selectively dissolve the nucleus pulposus of said disc. Pharmaceutical compositions are also provided for said method which include a purified proteolytically active lyophilized chymopapain, essentially free of proteolytically inactive and toxic components, and an activating amount of a pharmaceutically acceptable reducing agent.
Inventor(s): Smith; William S. (Libertyville, IL)
Assignee: Smith Laboratories, Inc. (Rosemont, IL)
Filing Date:Mar 26, 1984
Application Number:06/593,158
Claims:1. A method of treating an intervertebral spinal disc to dissolve the nucleus pulposus in a mammalian subject which disc exhibits an abnormal condition, characterized by a reduced risk of toxic effect to the mammalian subject, which method comprises the step of injecting into said disc an amount of pharmaceutically acceptable solution of a purified chymopapian essentially free of proteolytically inactive and toxic protein components, said purified chymopapain also characterized by the absence of precipitate formation when a 10% weight/volume solution is acidified with hydrochloric acid followed by treatment with barium chloride, said purified chymopapain being used in amounts sufficient to selectively dissolve the nucleus pulposus of said disc.

2. A method according to claim 1 wherein the abnormal disc is a herniated intervertebral disc.

3. A method of treating a herniated intervertebral spinal disc in an mammalian subject which comprises the steps of:

(a) inserting the needle into said disc;

(b) confirming the placement of said needle by means of x-ray and

(c) injecting into said disc an amount of a pharmaceutically acceptable aqueous solution of a relatively non-toxic, purified chymopapain characterized as essentially free of proteolytically inactive compounds and bisulfite and by its failure to form a precipitate when an acidified solution thereof is treated with barium chloride reagent to selectively dissolve the said disc.

4. A pharmaceutical composition consisting essentially of a purified proteolytically active chymopapain admixture of chymopapain fractions I and II and characterized by the absence of precipitate formation when a 10% weight/volume solution is acidified with hydrochloric acid followed by treatment with barium chloride.

5. A pharmaceutical composition according to claim 4 wherein the purified chymopapain is an admixture of chymopapain fractions I and II and is essentially free of proteolytically inactive components.

6. A pharmaceutical composition according to claim 4 in dosage unit form wherein the purified chymopapain is an admixture of proteolytically active chymopapain fractions I and II.
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