Details for Patent: 5,741,523
✉ Email this page to a colleague
Summary for Patent: 5,741,523
Title: | Stabilized prostaglandin E1 |
Abstract: | A stable and lyophilized formulation of prostaglandin E-1 made by the process comprising a) dissolving PGE-1 in a solution of lactose and tertiary butyl alcohol wherein said tertiary butyl alcohol is present in an amount of from about 15% to about 33% volume/volume and the ratio of said lactose to PGE-1 is from about 40,000 to 1 to about 10,000 to 1 weight/weight whereby a formulation of PGE-1dispersed in lactose is formed; b) adjusting and maintaining the pH of said formulation from about 3.5 to about 6 with an organic acid buffer; c) freezing said formulation to about -50.degree. C.; and d) drying said formulation to obtain a moisture content of less than 1% by dry weight and a tertiary butyl alcohol content of less than 3% by dry weight. Preferably, step c) includes after freezing said formulation to about -50.degree. C., warming to about -25.degree. C. for about 2 hours then refreezing to about 50.degree. C. Preferably, the prostaglandin is in an amount of about 25 to 100 ppm in lactose and the pH is maintained at about 4 to 5. |
Inventor(s): | Teagarden; Dirk L. (Kalamazoo, MI), Petre; William J. (Kalamazoo, MI), Gold; Paul M. (Vicksburg, MI) |
Assignee: | Pharmacia & Upjohn Company (Kalamazoo, MI) |
Application Number: | 08/619,690 |
Patent Claim Types: see list of patent claims | Formulation; Process; |
Drugs Protected by US Patent 5,741,523
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
Foreign Priority and PCT Information for Patent: 5,741,523
PCT Information | |||
PCT Filed | September 06, 1994 | PCT Application Number: | PCT/US94/09648 |
PCT Publication Date: | May 04, 1995 | PCT Publication Number: | WO95/11683 |
International Family Members for US Patent 5,741,523
Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
---|---|---|---|---|---|
Austria | 187071 | ⤷ Try a Trial | |||
Australia | 688792 | ⤷ Try a Trial | |||
Australia | 7716794 | ⤷ Try a Trial | |||
China | 1060042 | ⤷ Try a Trial | |||
China | 1133561 | ⤷ Try a Trial | |||
>Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |