Vehicles for delivery of biologically active substances

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form

Reexamination Certificate

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Details

C424S423000, C424S443000, C424S434000, C424S078040, C424S437000

Reexamination Certificate

active

06960346

ABSTRACT:
A formulation containing one or more biologically active substances dissolved, dispersed, emulsified, or suspended within a vehicle of one or more citric acid esters and/or citric acid ethers. Methods for making and using are disclosed, as are kits for administration of the pharmaceutical formulation.

REFERENCES:
patent: 4297353 (1981-10-01), Maulding
patent: 5047166 (1991-09-01), Weil
patent: 5204121 (1993-04-01), Bucheler
patent: 5352662 (1994-10-01), Brooks
patent: 5591727 (1997-01-01), Bencsits
patent: 5635190 (1997-06-01), Cheetham
patent: 5747058 (1998-05-01), Tipton
patent: 5958937 (1999-09-01), Hausheer
patent: 6001822 (1999-12-01), Wicks
patent: 6117857 (2000-09-01), Carlsson
MORFLEX, INC., Technical Bulletin 102, “Citrate Esters as Plasticizers for Aqueous Based Pharmaceutical Coatings” (1993).
MORFLEX, INC., Technical Bulletin 103, “Medical Grade Citroflex® Plasticizers” (1993).
MORFLEX, INC., “Permanence of Plasticizers in Polymeric Films” (1993).
MORFLEX, INC., Pharmaceutical Coatings Bulletin 102-1, “Influence of Citrate Ester Plasticizers on the Properties of Acrylic Resin Polymers” (1993).
MORFLEX, INC., Pharmaceutical Coatings Bulletin 102-2, “Physical and Mechanical Properties of Acrylic and Cellulosic Polymers Plasticized with Citrate Esters” (1994).
MORFLEX, INC., Pharmaceutical Coatings Bulletin 102-3, “Influence of Plasticizers on the Dissolution and Physical Properties of Ethyl Cellulose Films and Coated Beads” (1995).
Kennedy, SW, “Triethyl Citrate”, in Kibbe, AH (ed.), Handbook of Pharmaceutical Exciplents, 3rd ed., pp. 574-575, American Pharmaceutical Association (2000).
USP 23 NF 18 (United States Pharmacopoeia/National Formulary), “Pharmaceutical Dosage Forms”, pp. 1944-1949 (1995).

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