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US 10,646,447 B2Granted
Oral sustained-release triple layer tablet
AssigneeGl Pharmtech Corp.
InventorsJun Sang Park, U-Hun Song, Ji-Yeon Sim
Life of this patent
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Abstract
The present invention relates to an oral sustained-release triple layer tablet, more particularly, a triple layer tablet consisting of an inner immediate-release layer containing a pharmaceutically active ingredient and two outer layers containing swellable polymers. Upon exposure to aqueous media, the two outer layers swell to form gelled layers surrounding the lateral side of the inner layer rapidly, thereby control effectively the release of the pharmaceutically active ingredient from the inner immediate-release layer.
Claims16
An oral sustained-release triple-layer tablet comprising:
- an inner immediate-release layer comprising a pharmaceutically active ingredient and a binder, and
- two outer layers, each outer layer comprising a swellable polymer which is polyethylene oxide having a viscosity of 400 cps or greater in 2% aqueous solution, or hydroxypropyl methylcellulose having a viscosity of 4,000 cps or greater in 2% aqueous solution, or a mixture of the polyethylene oxide and the hydroxypropyl methylcellulose,
- wherein the inner immediate-release layer has an exposed lateral side which is not covered by the two outer layers,
- wherein only the two outer layers comprise the swellable polymer, and the two outer layers swell upon exposure to aqueous medium to form gelled layers that surround the exposed lateral side of the inner immediate-release layer, and
- wherein the two outer layers comprise 40 to 95% by weight of the swellable polymer, based on the total weight of the tablet.
2 more elements
An oral sustained-release triple-layer tablet comprising:
- an inner immediate-release layer comprising a pharmaceutically active ingredient and a binder, wherein the pharmaceutical active ingredient is selected from the group consisting of doxazosin, terazosin, tamsulosin, simvastatin, lovastatin, fluvastatin, acetaminophen, zaltoprofen and tramadol, and
- two outer layers comprising polyethylene oxide having a viscosity of 400 cps or greater in 2% aqueous solution,
- wherein the inner immediate-release layer is characterized during dissolution testing in an aqueous medium such that 80% or more of the pharmaceutically active ingredient is released from the inner immediate-release layer without the outer layers within one hour from exposure to the aqueous medium,
- wherein the inner immediate-release layer has an exposed lateral side which is not covered by the two outer layers, wherein only the two outer layers comprise the polyethylene oxide, and the two outer layers swell upon exposure to aqueous medium to form gelled layers that surround the exposed lateral side of the inner immediate-release layer, and
- wherein the oral sustained-release triple-layer tablet comprises 5 to 60% by weight of the inner immediate-release layer and 40 to 95% by weight of the polyethylene oxide, based on the total weight of the tablet.
2 more elements
An oral sustained-release triple-layer tablet comprising:
- an inner immediate-release layer comprising a pharmaceutically active ingredient and a binder, wherein the pharmaceutical active ingredient is selected from the group consisting of doxazosin, terazosin, tamsulosin, simvastatin, lovastatin, fluvastatin, acetaminophen, zaltoprofen and tramadol, and
- two outer layers comprising polyethylene oxide having a viscosity of 400 cps or greater in 2% aqueous solution,
- wherein the inner immediate-release layer is characterized during dissolution testing in an aqueous medium such that 80% or more of the pharmaceutically active ingredient is released from the inner immediate-release layer without the outer layers within one hour from exposure to the aqueous medium,
- wherein the inner immediate-release layer has an exposed lateral side which is not covered by the two outer layers,
- wherein the two outer layers swell upon exposure to aqueous medium to form gelled layers that surround the exposed lateral side of the inner immediate-release layer, and
- wherein the oral sustained-release triple-layer tablet comprises 5 to 60% by weight of the inner immediate-release layer and 40 to 95% by weight of the polyethylene oxide, based on the total weight of the tablet.
3 more elements
An oral sustained-release triple-layer tablet comprising:
- an inner immediate-release layer comprising a pharmaceutically active ingredient, a pharmaceutical acceptable diluent and a binder, and
- two outer layers, each outer layer comprising a swellable polymer which is polyethylene oxide having a viscosity of 400 cps or greater in 2% aqueous solution, or hydroxypropyl methylcellulose having a viscosity of 4,000 cps or greater in 2% aqueous solution, or a mixture of the polyethylene oxide and the hydroxypropyl methylcellulose,
- wherein the inner immediate-release layer is characterized during dissolution testing in an aqueous medium such that 80% or more of the pharmaceutically active ingredient is released from the inner immediate-release layer without the outer layers within one hour from exposure to the aqueous medium,
- wherein the inner immediate-release layer has an exposed lateral side which is not covered by the two outer layers,
- wherein the two outer layers swell upon exposure to aqueous medium to form gelled layers that surround the exposed lateral side of the inner immediate-release layer, and
- wherein the two outer layers comprise 40 to 95% by weight of the swellable polymer, based on the total weight of the tablet.
3 more elements
Dependencies are inferred from the claim text.