Claims for Patent: 10,588,947

Summary for Patent: 10,588,947

Title:	Ultrapure hypoallergenic solutions of sacrosidase
Abstract:	The invention provides a method for treating a subject who lacks endogenous sucrase activity by orally administering a solution of sacrosidase in about 1:1 glycerol/water having an enzymatic activity of at least about 7500 IU/mL and a residual papain concentration of less than about 10 ng/ml.
Inventor(s):	Reardan; Dayton T. (Shorewood, MN), Seekamp; Christopher (Brookfield, WI)
Assignee:	QOL Medical LLC (Vero Beach, FL)
Application Number:	15/844,184
Patent Claims:	1. A method for treating a subject who lacks endogenous sucrase activity, comprising orally administering an effective amount of a protein composition consisting essentially sacrosidase having a band volume ratio of sacrosidase to other proteins comprising papain of at least about 35:1 by SDS-PAGE of about 20 .mu.g of said composition, wherein the primary structure of the sacrosidase is a 513 amino acid polypeptide that is gycosylated. 2. The method of claim 1 wherein the band volume ratio is about 35-55:1. 3. A method of treating a subject who lacks endogenous sucrase activity comprising orally administering an effective amount of a protein composition consisting essentially of sacrosidase derived from Saccharomyces having residual papain in a concentration of less than about 10 ng/mL, papain, and having a band volume ratio of sacrosidase to other proteins comprising papain of at least about 35:1 by SDS-PAGE of about 20 .mu.g of said composition, wherein the primary structure of the sacrosidase is a 513 amino acid polypeptide that is glycosylated. 4. The method of claim 3 wherein the protein composition is administered in a solution. 5. The method of claim 4 wherein the sacrosidase has an enzyme activity of at least about 7500 IU/ml. 6. The method of claim 4 wherein a daily dose of the solution of about 2-10 mL per day does not induce an allergic reaction in a human patient afflicted with congenital sucrase-isomaltase deficiency. 7. The method of claim 3 wherein the sacrosidase contains less than about 3.0 ng/mL papain. 8. The method of claim 3 wherein the sacrosidase contains no detectable papain by an enzyme-linked immunosorbant assay having a lower limit of quantification of 3 ng/mL. 9. The method of claim 4 wherein the solution of sacrosidase contains no detectable papain by SDS-PAGE of up to about 15 .mu.g of said solution. 10. The method of claim 5 wherein the solution of sacrosidase has enzymatic activity of about 7500-10,000 IU/ml.

Details for Patent 10,588,947

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Qol Medical, Llc	SUCRAID	sacrosidase	Solution For Oral	020772	04/09/1998		2034-02-07