Drug delivery device which can be retained in the stomach for a controlled period of time
AssigneeMerck & Co., Inc.
InventorsLarry J. Caldwell, Colin R. Gardner, Robyn C. Cargill
Life of this patent
Estimating the term…
Abstract
Drug delivery device retained in the stomach comprising at least one drug and a continuous solid-stick figure made from polymer(s) that releases said drug slowly over a controlled, predictable and extended period of time.
Claims12
A gastric retention device comprising a gelatin capsule having squeezed together and compressed therein a continuous stick figure prepared from at least one erodible polymer, selected from the group consisting of soluble cellulosic materials, ethylene vinyl alcohol, ethylene maleic anhydride copolymer, polyacrylates, polycaprolactones, inorganic glass based on polyphosphates and fused salts, polyanhydrides, poly(ortho)ester, biodegradable polyurethanes, polyvinyl pyrrolidone, polyactones, polyamides and polypeptides, gelatin and derivatives, polyacrylonitriles, polyesters, and combinations thereof;
- said device having a biological active drug dispersed as a solution or suspension incorpcrated therein or in a module attached to the retention device, consisting of a frame work having a maximum dimension of 2 cm before deployment and presenting a minimum diameter of 2 cm and a maximum diameter of 5 cm after deployment into the stomach of man and non-ruminant mammals, composed of more or less rigid rods or sticks having a Tensile Modulus of at least 1.times.10.sup.3 to 50.times.10.sup.6 psi, which are bent or fastened together in a manner such that the frame work will not pass the stomach having a pyloric valve with a 3-5 cm maximum inner circumference between the stomach and the intestines, said figure having the following properties:
- (a) compressible to a size suitable for swallowing;
- (b) expandable to size which will prevent passage through a pylorus for a predetermined time;
- (c) sufficiently resistant to a simultaneous force in two directions by a stomach to prevent passage through a pylorus for a predetermined time;
- and
- (d) erodible in the presence of gastric juices so that said device after a predetermined time is no longer able to retain or attain the expanded configuration defined in (b) above and/or resist a simultaneous force in two directions as defined in (c) above.
A method for the controlled release over a period of time of a drug in the stomach by administering a gastric retention device comprising a gelatin capsule having squeezed together and compressed therein a continuous stick figure prepared from at least one erodible polymer selected from the group consisting of soluble cellulosic materials, ethylene vinylalcohol, ethylene maleic anhydride copolymer, polyacrylates, polycaprolactones, inorganic glass based on polyphosphates and fused salts, polyanhydrides, poly(ortho)esters, biodegradeabe polyurethanes, polyvinyl pyrrolidone, polyactones, polyamides and polypeptides, gelatin and derivatives, polyacrylonitriles, polyesters and combinations thereof;
- said device having a biological active drug dispersed as a solution or suspension incorporated therein or in a module attached to the retention device, consisting of a frame work having a maximum dimension of 2 cm before deployment and presenting a minimum diameter of 2 cm and a maximum diameter of 5 cm after deployment into the stomach of man and non-ruminant mammals, composed of more or less rigid, rods or sticks, having a Tensile Modulus of at least 1.times.10.sup.3 to 50.times.10.sup.6 psi fastened together in a manner such that the frame work will not pass the stomach having a pyloric valve with a 3-5 cm maximum inner circumference between the stomach and the intestine, said stick figure having the following properties:
- (a) compressible to a size suitable for swallowing;
- (b) expandable to size which will prevent passage through a pylorus for a predetermined time;
- (c) sufficiently resistant to a simultaneous force in two directions by a stomach to prevent passage through a pylorus for a predetermined time;
- and
- (d) erodible in the presence of gastric juices so that said device after a predetermined time is no longer able to retain or attain the expanded configuration defined in (b) above and/or resist a simulaneous force in two directions as defined in (c) above.
Dependencies are inferred from the claim text.