Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
2000-01-20
2001-05-22
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
C514S573000, C514S912000
Reexamination Certificate
active
06235781
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to aqueous pharmaceutical compositions containing prostaglandins. In particular, the present invention relates to aqueous prostaglandin compositions packaged in polypropylene containers.
BACKGROUND OF THE INVENTION
As used herein, “LDPE” means low density polyethylene.
Prostaglandins have notoriously low water solubility, and are generally unstable. Attempts have been made to solubilize and stabilize various prostaglandins by complexing them with different cyclodextrins. See, for example: EP 330 511 A2 (Ueno et al.) and EP 435 682 A2 (Wheeler). These attempts have met with varying success.
Surfactants and/or solubilizers have been used with other types of drugs having low water solubility. However, the addition of surfactants and/or solubilizers may enhance or adversely affect the chemical stability of drug compounds. See
Surfactant Systems, Their Chemistry, Pharmacy, and Biology
, (eds. Attwood et al.), Chapman and Hall, New York, 1983, Ch. 11, particularly pp. 698-714.
The use of non-ionic surfactants, such as polyethoxylated castor oils, as solubilizing agents is known. See, for example, U.S. Pat. No. 4,960,799 (Nagy).
The use of non-ionic surfactants such as polyethoxylated castor oils in stable emulsions is also known. U.S. Pat. No. 4,075,333 (Josse) discloses stable, intravenous emulsion formulations of vitamins. El-Sayed et al., Int.
J. Pharm
., 13:303-12 (1983) discloses stable oil-in-water emulsions of an antineoplastic drug. U.S. Pat. No. 5,185,372 (Ushio et al.) discloses topically administrable ophthalmic formulations of vitamin A which are stable preparations in which a non-ionic surfactant is used to form an emulsion of vitamin A in an aqueous medium.
U.S. Pat. No. 5,631,287 (Schneider) discloses storage-stable prostaglandin compositions containing a chemically stabilizing amount of a polyethoxylated castor oil.
Presently, there are only two commercially available ophthalmic multidose prostaglandin products, Xalatan™ (latanoprost solution; Upjohn) and Rescula™ (isopropyl unoprostone; Fujisawa). Xalatan™ is packed in a polyethylene (LDPE) container. According to the package insert, this product must be stored under refrigeration at 2-80° C. until opened. Once opened, the container may be stored at room temperature up to 25° C. for six weeks.
Rescula™ is also packaged in a polyethylene (LDPE) container.
SUMMARY OF THE INVENTION
The present invention is directed to pharmaceutical products containing an aqueous prostaglandin composition packaged in polypropylene containers. Aqueous prostaglandin compositions packaged polypropylene containers are more stable than those packaged in polyethylene containers.
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Fina® Polypropylene 3721WZ Product Information Sheet.
Rescula® Eye Drops (Package Insert and Carton).
Xalatan™ (Package Insert and Carton).
Product Labelling for Rescula® (unoprostone isopropyl ophthalmic solution, 0.15%) approved Aug. 28, 2000. Available from the FDA's Website (http://fda.gov/cder/approval/main4.htm) date = Aug. 28, 2000.
Airy Subhash C.
Clifford Julia A.
McCune William E.
Weiner Alan L.
Yarborough Cody
Alcon Laboratories Inc.
Fay Zohreh
Ryan Patrick M.
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