Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2001-04-06
2003-11-04
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S423000, C424S424000, C424S425000, C424S484000, C424S486000, C424S487000, C424S488000, C514S772100
Reexamination Certificate
active
06641831
ABSTRACT:
The present invention relates to medical products with sustained pharmacological activity and a process for producing them.
DE-A-36 13 213 discloses an absorbable porous tricalcium phosphate with a mixture of an antibiotic and another filler, especially a hydrophilic amino acid, as being particularly advantageous for the preparation of bone cements. A low-molecular weight additive is incorporated in the tricalcium phosphate: glycine, which is water-soluble and accelerates the release of the active ingredient from the porous tricalcium phosphate.
WO 84/03623 discloses magnesium oxide, hydroxide or other magnesium salts which have effects on the release from tablets with calcium antagonists.
WO 89/09626 discloses a hydrogel coated flexible tube which is loaded with polymyxin and which is to prevent that polymyxin-sensitive microorganisms form thrombi or induce an infection.
U.S. Pat. No. 4,612,337 describes a method in which plastic materials are soaked in solutions containing various active substances, for example, ethanol, chloroform, and the thus surface-coated materials are later dried and induce a short-term release of active substances.
EP-A-0 520 160 describes the swelling of polyurethane catheters with fluorinated hydrocarbons in which quarternary ammonium salts are incorporated by such process. After drying, the catheters are to become antimicrobially active through release.
DE-A-37 25 728 describes a method in which silver metal ions are added to polyurethane silicone mixtures. Through the mixing of polyurethanes with silicone, body fluid is supposed to penetrate in the mixture of plastics and thus wash out the silver ions, which is to have an improved germicidal effect.
WO 89/04628 discloses the treatment of silicone implants with antibiotics and chloroform such that the active substances can diffuse into the outer layers of the implant material and thus a short-time release of active substances is provided after the implantation of the finished device.
WO 87/03495 describes exactly the same method as WO 89/04628, with a drawing illustrating how catheters can be impregnated.
EP 0 484 057 A2 describes an aqueous coating for rendering medical products antithrombogenic by mixing organic polymers, binders, spacers and heparin as the antithrombogenic agent with methylene/acrylic acid copolymer and colloidal silicates. This resin may also be preliminarily sulfonated before this resin coating is applied to the medical products.
U.S. Pat. No. 4,642,104 discloses a urethral catheter made of an olefinic polymer or a silicone material in which antimicrobial substances are bound on the outside and inside.
U.S. Pat. No. 4,677,143 describes antimicrobial mixtures for coating medical products. These mixtures consist of acrylonitrile block polymers, polyvinyl chloride, mixtures of polyesters and polyurethanes, styrene block copolymers and natural rubbers and polycarbonates, nylon and silicone materials which are mixed with oligody-namic substances, i.e., antibacterial metals, preferably silver oxide compounds. These catheters were examined in a clinical test with 1,300 patients. No difference as compared to uncoated catheters was found (Riley et al., 1995, Am. J. Med.).
WO 87/01595 discloses how antimicrobially active substances, antibiotics, are added to plastic materials prior to the chemical polymerization process. The active substance is uniformly distributed in the plastic material prior to polymerization. Application example: Fixateur externe.
WO 95/04568 describes injection ports which include antimicrobial substances, for example, chlorhexidine, silver sulfadiazine and others.
U.S. Pat No. 5,525,348 discloses coatings with polyvinylpyrrolidone in different solvents, followed by the addition of various other oligomers with heparin benzalkonium chloride which yield ionic surfactant coatings.
EP 0 640 661 A2 describes mixtures of silicone with silver-containing zeolites, the silver ions diffusing out of these zeolites.
EP 0 301 717 B1 also describes zeolites which are incorporated in medical plastics. These zeolites comprise silver, copper or zinc which are incorporated by kneading and are to achieve the antimicrobial effect.
EP 0 470 443 B1 discloses how thin coatings are applied, for example, to catheter materials at low extrusion temperatures together with temperature-sensitive pharmaceutical ingredients.
U.S. Pat. No. 5,451,424 describes lamination processes via the extrusion of plastics by which medical products are coated with medicaments on the outside and inside thereof.
WO 92/01542 describes how coatings for nasootopharyngial tubes are prepared by “solvent casting”, i.e., immersing the medical products in a solution of plastics in which medicaments are dissolved, for example, in order to prevent chronic infections and inflammations of the surrounding tissue.
WO 96/39200 describes that a metal salt can be incorporated in a plastic matrix by “solvent casting”.
U.S. Pat. No. 4,999,210 describes how a homogeneous melt of plastics and chlorhexidine is prepared, and the mixture is coextruded onto medical articles through a twin-screw compounder. These articles are later again placed in a dipping solution (solvent casting) with a hydrophilic polymer.
EP 0 350 161 A2 discloses how a substrate is coated with an ammonium salt and then heparinized at an alkaline pH value.
WO 91/01767 describes how ammonium heparin complexes are applied to medical plastics by “solvent casting” using dichloromethane, isopropanol and other solvents.
EP 0 231 573 B1 describes that pharmaceutical substances are incorporated in solid plastics by either solvent casting or adsorption by swelling.
U.S. Pat. No. 5,514,673 describes a pharmaceutical composition in which clinical effects are achieved by transmucosal administration of progesterone or 17-&bgr;-estradiol. Thus, 3 &mgr;g to 0.5 mg of 17-&bgr;-estradiol or progesterone is mixed with natural oils, and egg lecithin is added. These mixtures are to be administered via the nose and produce effecs there. This method is to reduce skin irritations, with lecithin acting as a solubilizing agent.
WO 96/32907 describes a metallic stent with a hydrophobic elastomeric plastic layer in which a biologically active substance is incorporated. The method involves “solvent casting”. Heparin is preferably used at a weight proportion of from 10 to 45%, with a layer thickness of between 30 and 150 &mgr;m, and dexamethason with a proportion of between 0.5 and 10%.
WO 96/39215 describes how a silicone flexible tube is produced which has a layer with pharmacologically active substances inside the material which slowly diffuse outwards through the uncoated outside layer. A sandwich catheter is produced using a silicone extrusion machine. Rifampicin and minocyclin are introduced in the intermediate layer as powders.
WO 96/33670 discloses how antimicrobial mixtures, preferably rifampicin/minocyclin mixtures, are incorporated in medical plastics by swelling and increasing the temperature followed by alkalizing the solution.
WO 94/10838 describes solutions with minocyclin-EDTA with which medical products are rinsed in order to prevent infections.
U.S. Pat. No. 5,688,516 describes mixtures of pharmaceutical substances which contain the three above mentioned groups of active substances, i.e., anticoagulants, antithrombotics and complexing agents, such as EDTA or DMSA. These active substances are to be applied to medical products precoated with TDMAC.
WO-A-96/33670 relates to catheters and medical implants impregnated with antimicrobial substances, and a method for impregnating these medical products. First, an antimicrobial composition is prepared with an effective concentration of the active ingredient to prevent the growth of organisms, followed by applying this composition to at least part of the medical product and permeating of the composition into the material of the medical product. The composition is prepared by dissolving the antimicrobial agent in an organic solvent with the addition of a penetration agent and an alkalinizing substance.
WO-A-97/25085 relates to medical
Di Nola-Baron Liliana
Jacobson Holman PLC
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