Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2001-07-06
2004-05-25
Azpuru, Carlos A. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424SDIG005, C514S965000, C514S966000
Reexamination Certificate
active
06740333
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a composition comprising a biocompatible polymer and specially adapted for forming at least part of a suppository. The composition preferably comprises a medicament.
BACKGROUND OF THE INVENTION
CN 1109347 concerns a suppository made from a polyurethane sponge. The sponge in the shape of a suppository is dipped into a solution of the medicament to absorb it and is subsequently dried.
U.S. Pat. No. 4,292,300 relates to a non-dissolving, non-disintegrating slow-release suppository base consisting essentially of a linear polymer, such as methyl cellulose, and water in an amount of more than 35 parts by weight and less than 65 parts by weight of linear polymer. The linear polymers according to U.S. Pat. No. 4,292,300 can be distinguished from cross-linked polymers which swell, but do not dissolve in the presence of water and certain organic solvents. The linear polymers according to U.S. Pat. No. 4,292,300 have a high molecular weight, an affinity for water, and will dissolve in excess water, but in the relatively small amounts of water used in the formulation according to U.S. Pat. No. 4,292,300, a “gel”-like mass is formed. The linear polymers preferably resist biodegradation, or they are only slowly biodegradable. The polymers are capable of being extruded at ambient or near ambient temperatures, e.g. from 15° C. to 40° C., to give products with good strength and elasticity. They also have the ability to become instantaneously slippery when only slightly moistened and are therefore easily inserted into the anorectal or vaginal passage, this property is enhanced by the presence of the relatively large amounts of water in the formulations according to U.S. Pat. No. 4,292,300. Examples of linear polymers are methylcellulose, hydroxyproplymethylcellulose, hydroxymethylcellulose, polyvinyl alcohols, polyvinyl pyrrolidones, polyacrylamides, polyethylene oxides and certain modified starches. Typical average molecular weights vary between 100,000 and 300,000.
U.S. Pat. No. 4,405,883 relates to a non-dissolving, non-disintegrating, slow-release, shaped suppository consisting essentially of polyvinyl pyrrolidone, water, and a therapeutically effective amount of a water-soluble therapeutically active ingredient, wherein the water is present in an amount of more than 35 parts by weight wherein the suppository has flexibility and becomes slippery when moistened,
U.S. Pat. No. 5,330,427 relates to an improved suppository applicator which is a one-piece injection molded suppository applicator for ejecting medicament into a body cavity comprising a cylindrical main body portion having a distal end and a proximal end. The main body portion further comprises: an integral flexible chamber means at the distal end; a flexible junction means adjacent, integral to and at least partially the flexible chamber means; a plunger means adjacent and integral to the flexible chamber means; and a barrel stem; wherein the flexible junction means integrally joins the plunger means and flexible chamber means within the barrel stem.
U.S. Pat. No. 4,292,299 relates to a medical preparation composed of an adhesive layer comprising polymers which have adhesiveness to a wet mucous surface and swellability upon moistening and a nonadhesive layer which has no adhesiveness to a wet mucous surface and is water soluble or water disintegrable, with at least one of the layers made to contain a medicament. The medical preparation is administered by adhering to a wet mucous surface of the mucousal membrane and skin of men or animals, wherein exhibiting a property to release the medicament slowly extending over a long period of time to cure or prevent general or local diseases.
U.S. Pat. No. 4,404,296 relates to a polyol gel comprising i) 15-62 weight % (based on i)+ii)) of a high molecular weight covalently cross-linked polyurethane matrix; ii) 85-38 weight % (based on i)+ii)) of a liquid dispersing agent which is firmly bonded in the matrix by secondary valence forces; and optionally iii) fibers and/or additives and/or catalysts suitable for an isocyanate polyaddition reaction and/or active ingredients.
U.S. Pat. No. 5,411,737 relates to a slow release drug delivery device for the prolonged administration of topically active medicines which consists of a vehicle in which water is soluble. In the vehicle is dissolved a topically active drug formed into a stable organogel with a polymer matrix with a very low water absorbing capability. The organogel, in the presence of water or atmospheric water vapor, slowly imbibes such water into the vehicle and by doing so the vehicle becomes incompatible with the matrix and is slowly expelled therefrom. The vehicle dissolves the drug and the vehicle/drug combination is slowly pumped out of the polymeric matrix with substantially linear drug delivery occurring for periods in excess of 6 months. The drug delivery device may be used to administer drugs topically, such as a suppository or a subcutaneous implant.
U.S. Pat. No. 5,085,650 relates to a urethral suppository comprising i) a relatively long, relatively small diameter shaft, ii) a bulbous head extending from a rounded nose through a relatively gradually outwardly curving insertion surface having an axial length equaling about two thirds of the overall length of the head and a relatively sharply curving retention surface extending from the intersection with the insertion surface which is the maximum diameter of the head to an intersection with the shaft, the intersection between the retention surface and the insertion surface not comprising a sharp edge or corner, and iii) a conical tail including an outwardly tapered retaining surface extending from the shaft to a base having a diameter substantially greater than the maximum diameter of the bulbous head, wherein said shaft, head, and tail comprises predetermined dimensions and a unitary structure and are formed entirely from a medicament
U.S. Pat. No. 4,999,342 relates to a long lasting, viscous, adhesive contraceptive made from a quick melting suppository composition and comprising a mixture of a contraceptive effective amount of a spermicidal agent; a polymeric gum, such as a polysaccharide gum; a dispersing agent comprising silica; and a water miscible polymer suppository base, such as polyethylene glycol.
U.S. Pat. No. 4,765,978 relates to an antifungal vaginal suppository which contain cis-2-(1H-imidazolylmethyl)-3-(2′,6′-difluorobenzyloxy)-2,3-dihydro-5-fluo robenzo[b]thiophene as the antifungal agent, in a suppository base containing biocompatible polymers, a surfactant and an absorbent in a vegetable oil phase. The suppositories are substantive and provide a prolonged duration of effectiveness. The biocompatible polymer component of the suppository formulation comprises a combination of polyethylene and polyvinylpyrrolidione.
U.S. Pat. No. 5,750,100 relates to a sustained releasable parenteral pharmaceutical preparation in which a great release of a physiologically active peptide or protein in an early stage of the administration is suppressed and the peptide or protein can be released for a longer period. The sustained releasable parenteral pharmaceutical preparation of the present invention comprises a matrix comprising a physiologically active peptide or protein and a polyglycerol diester of a saturated fatty acid. The matrix may be in a pillar, granular or other form.
U.S. Pat. No. 4,259,314 relates to a controlled release, dry pharmaceutical composition containing a dry carrier comprised of 80 to 95% of hydroxypropyl methylcellulose and 20 to 5% of hydroxypropyl cellulose. The carrier is dried to a moisture content of not more than 1%. If the pharmaceutical composition is compressed under low pressure, a troche capable of being sucked or used in the mouth can be prepared, and a controlled release of the active therapeutic agent, which is mucousally absorbed into the blood stream is achieved. If higher pressures are used to compress the pharmaceutical material a harder and longer-lasting pha
Beckett Christian Westy
Eliasen Per Robert Topp
Anestic ApS
Azpuru Carlos A.
Cooper Iver P.
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