Claims for Patent: 5,185,157

Summary for Patent: 5,185,157

Title:	Treatment of refractory Eosinophilia-Myalgia Syndrome with L-tryptophan composition
Abstract:	A method of treating a human patient with refractory Eosinophilia Myalgia Syndrome via oral administration of an effective dosage range of from 1000 mg. to 3000 mg. of a pharmaceutical composition, in unit dosage form, comprising a minor amount of a solid or liquid carrier and a major amount of the amino acid, pharmaceutical grade L-tryptophan, or its acid addition salt, with both of the carriers and the amino acid to be selected to exclude the zinc, magnesium, and calcium containing salts as adjuvants.
Inventor(s):	Caston; John C. (Spartanburg, SC)
Assignee:
Application Number:	07/518,499
Patent Claims:	1. A pharmaceutical composition in unit dosage form, which consists essentially of: (a) one or more pharmaceutically acceptable formulations, comprising a minor amount of solid or liquid carrier selected from one or more of lactose, terra alba, sucrose, gelatin talc, gelatin, agar, pectin, acacia, magnesium stearate, stearic acid, ascorbyl palmitate, sugar syrup, peanut oil, olive oil, and water; and (b) a major amount of the amino acid, pharmaceutical grade L-Tryptophan, or a pharmaceutically acceptable organic or inorganic, acid addition salt thereof, which is effective to treat refractory Eosinophilia-Myalgia Syndrome in a patient to whom one or more unit dosages of the formulated amino acid is to be administered; and (c) as to said solid carriers said liquid carriers and said pharmaceutically acceptable salts, such adjuvants are selected to exclude the zinc, magnesium, and calcium containing salts. 2. In a method of using a pharmaceutical composition containing one or more pharmaceutically acceptable formulations of an active ingredient and a solid or liquid carrier therefore novel for treating a human being with refractory Eosinophilia-Myalgia Syndrome, the improvement characterized by compounding as an active ingredient, a major amount of the amino acid, pharmaceutical grade L-Tryptophan, or a pharmaceutically-acceptable, organic or inorganic, acid addition salt thereof and a minor amount of a solid or liquid carrier, selected from one or more of lactose, terra alba, sucrose, gelatin talc, gelatin, agar, pectin, acacia, magnesium stearate, stearic acid, ascorbyl palmitate, sugar syrup, peanut oil, olive oil, and water in a unit dosage form, effective to treat said syndrome, such adjuvants are selected to exclude the zinc, magnesium, and calcium containing salts, as determined by reducing over time the elevated serum count of eosinophil cells to the normal range substantially above 350 eosinophil cells per cubic millimeter of blood, further comprising orally administering a therapeutically effective amount to an afflicted patient a daily dosage regimen of about 1000 mg. to about 3000 mg. of the active ingredient until the serum count of such cells is measured as having returned to the normal range. 3. The method of reducing elevated levels of eosinophil cells in a human patient which comprises: (a) orally administering to a human patient needing suppression of said abnormal cell levels a daily dosage regimen from about 1000 mg. to about 3000 mg. of the amino acid, L-tryptophan, selected from one of its free base and its non-toxic, pharmaceutically acceptable acid addition salts. 4. The composition of claim 1 wherein the unit dosage form is a tablet containing from 400 to 600 milligrams of L-Tryptophan and from 25 to 50 milligrams of a solid carrier. 5. The method of claim 2 wherein the treatment effective amount is a daily dosage regimen from about 1000 gm to about 3000 gm of a free base and its non-toxic, pharmaceutically acceptable acid addition salts. 6. The method of claim 2 wherein the unit dosage form is a tablet containing from 400 to 500 milligrams of the L-tryptophan. 7. The method of claim 6 wherein the unit dosage form is administered one to six times daily. 8. The composition of claim 1 wherein the unit dosage form is a syrupy diluent volume containing 400 to 600 milligrams of the amino acid. 9. A method of treating a human patient diagnosed with refractory Eosinophilia-Myalgia Syndrome, as can be characterized by abnormally elevated serum levels of eosinophil cells, which is substantially above 350 cells per cubic millimeter of blood comprising orally administering a therapeutically effective amount to such a patient of a daily dosage regimen of from about 1000 mg. to about 3000 mg. of the pharmaceutical composition of claim 1 over a period of 30 to 80 days sufficient to produce clinically observable symptomatic relief, for those in need thereof. 10. The composition of claim 1 wherein the minor amount of solid carrier comprises ascorbyl palmitate encapsulated with said amino acid in a gelatin capsule.

Details for Patent 5,185,157

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Aimmune Therapeutics, Inc.	PALFORZIA	peanut (arachis hypogaea) allergen powder-dnfp	Powder	125696	January 31, 2020		2010-05-02