Chymopapain and method for its use
AssigneeSmith Laboratories, Inc.
InventorWilliam S. Smith
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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.
Claims17
A pharmaceutical composition consisting of an effective amount of a purified chymopapain product essentially free of proteolytically inactive component materials and characterized by the absence of precipitate formation when a 10% weight/volume solution of said purified chymopapain is acidified with hydrochloric acid followed by treatment with barium chloride;
- and a minor amount of a pharmaceutically acceptable, non-toxic, reducing agent said composition being further characterized as being free of bisulfite additives.
A stable pharmaceutical composition comprising an effective amount of a lyophilized purified chymopapain characterized by being essentially free of proteolytically inactive component materials and bisulfite and relatively non-toxic, and further characterized by the absence of precipitate formation when a 10% weight/volume solution is acidified with hydrochloric acid followed by treatment with barium chloride;
- and a minor activating amount of a pharmacologically acceptable reducing agent;
- said reducing agent being present in said composition in an amount of from about 10 to about 20 percent by weight of the purified chymopapain.
A stable pharmaceutical composition in dosage unit form for use in dissolving the nucleus pulposus of an intervertebral disc by injection which comprises about 10,000 to about 11,500 proteolytic units of a purified essentially colorless chymopapain, said purified chymopapain being characterized by its being essentially free of protein components which are proteolytically inactive and being free of bisulfite and further characterized by the absence of precipitate when an acidified aqueous solution of said chymopapain is treated with barium chloride reagent and a sodium cysteinate hydrochloride activating agent, said composition being packaged in a vacuum container.
A method of 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 which method comprises the step of injecting into said disc an effective amount of a pharmaceutically acceptable aqueous solution of a purified chymopapain which is essentially free of proteolytically inactive and toxic protein components and bisulfite and is characterized by its failure to form a precipitate in an acidified aqueous solution when treated with a solution of barium chloride, and which solution contains a minor amount of sodium cysteinate hydrochloride solution sufficient to activate the chymopapain, said purified chymopapain being used in amounts sufficient to selectively dissolve the nucleus pulposus of said disc.
A method of treating a herniated intervertebral spinal disc in an mammlian 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 effective amount of a pharmaceutically acceptable aqueous solution of a relatively non-toxic, purified chymopapain characterized as essentially free of proteolytically inactive components and bisulfite, and by its failure to form a precipitate when an acidified solution thereof is treated with barium chloride reagent, and a pharmaceutically acceptable non-toxic reducing and activating agent for said purified chymopapain;
- to selectively dissolve said disc.
Dependencies are inferred from the claim text.