Claims for Patent: 5,124,318

Summary for Patent: 5,124,318

Title:	Injectable ready-to-use solutions containing an antitumor anthracycline glycoside
Abstract:	A sealed glass container containing therein a stable, injectable, sterile, pyrogen-free doxorubicin anti-tumor composition in a solution which consists essentially of a physiologically acceptable salt of doxorubicin dissolved in a physiologically acceptable solvent therefor, wherein said solution has not been reconstructed from a lyophilizate, and wherein said solution has a pH of from 2.5-3.5 and a concentration of said doxorubicin of from 0.1 to 100 mg/ml.
Inventor(s):	Gatti; Gaetano (Milan, IT), Oldani; Diego (Milan, IT), Bottoni; Giuseppe (Bergamo, IT), Confalonieri; Carlo (Milan, IT), Gambini; Luciano (Milan, IT), De Ponti; Roberto (Milan, IT)
Assignee:	Farmitalia Carlo Erba S.r.l. (Milan, IT)
Application Number:	07/471,005
Patent Claims:	1. A sealed container containing therein a stable, injectable, sterile, pyrogen-free doxorubicin anti-tumor composition in a solution which consists essentially of doxorubicin hydrochloride dissolved in a physiologically acceptable solvent therefor, wherein said solution has not been reconstituted from lyophilizate, and wherein said solution has a pH adjusted to from 2.5-3.5 with hydrochloric acid and a concentration of said doxorubicin is from 0.1 to 100 mg/ml. 2. A container according to claim 1, wherein said container is hermetically sealed. 3. A container according to claim 1, wherein the pH of said solution is from 2.7 to 3.5. 4. A container according to claim 1, wherein said physiologically acceptable solvent is a physiologically acceptable saline solution. 5. A container according to claim 1, wherein the pH of said solution is from 2.7 up to 3.0. 6. A container according to claim 1, wherein said physiologically acceptable solvent is a physiologically acceptable dextrose solution. 7. A container according to claim 4, wherein said physiologically acceptable solvent is sterile water. 8. A container according to claim 1, wherein the physiologically acceptable solvent is selected from the group consisting of water, ethanol, polyethylene glycol, dimethylacetamide and mixture thereof. 9. A container according to claim 1, which further contains a tonicity adjustment agent selected from the group consisting of sodium chloride, dextrose, lactose, mannitol, and sorbitol. 10. A container according to claim 9, containing about 0.9% w/v sodium chloride. 11. A container according to claim 9, containing about 5% w/v dextrose, lactose, mannitol or sorbitol. 12. A container according to claim 1, which further contains a preservative selected from the group consisting of esters of para-hydroxybenzoic acid and chlorocresol. 13. A container according to claim 1, wherein the concentration of doxorubicin is from 0.1 mg/ml to 50 mg/ml. 14. A container according to claim 1, wherein the concentration of doxorubicin is from 1 mg/ml to 20 mg/ml. 15. A container according to claim 1, wherein the rate constant of decomposition, measured under accelerated conditions at a temperature of around 55.degree. C. and a concentration of said doxorubicin as the hydrochloride of around 2 mg/ml, is less than about 0.150 day.sup.1.

Details for Patent 5,124,318

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2005-08-02