Dual drug dosage forms with improved separation of drugs
a drug and dosage form technology, applied in the field of drug dosage forms, can solve the problems of swelling of the outer surface of the prolonged-release portion, difficulty in complying with such a schedule without the assistance of patients, and difficulty in maintaining dosage therapies such as these, so as to reduce or prevent any drug migration, reduce or eliminate any penetration
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example 1
[0042] This example illustrates the preparation of tablets in accordance with this invention that contain 500 mg metformin hydrochloride as the prolonged-release component and 1 mg glimepiride as the immediate-release component.
[0043] Pre-formed tablets containing 500 mg of metformin hydrochloride in a matrix of hydroxypropyl methyl cellulose, poly(ethylene oxide), microcrystalline cellulose, and magnesium stearate were used as a starting material. A barrier layer solution was prepared by dissolving OPADRY® YS-1-19025-A Clear (“OPADRY Clear,” hydroxypropyl methyl cellulose, available from Colorcon, West Point, Pa., USA) in purified water to a concentration of 8 weight percent. This solution was sprayed onto the metformin hydrochloride tablets until the tablet weight increased by approximately 1%.
[0044] A suspension for applying the immediate-release layer was prepared by dissolving polyethylene sorbitan monooleate in purified water, dispersing glimepiride (micronized, 2-4 micron a...
example 2
[0045] This example likewise illustrates the preparation of tablets in accordance with this invention that contain metformin hydrochloride as the prolonged-release component and glimepiride as the immediate-release component, but with a higher amount of glimepiride (2 mg) than Example 1.
[0046] Pre-formed metformin hydrochloride tablets identical to those used as a starting material in Example 1 were used. Likewise, an identical Opadry solution was used as the barrier layer solution. This solution was sprayed onto the tablets to achieve a weight increase of 1%.
[0047] To prepare the immediate-release layer, a suspension similar to that of Example 1 was prepared except that it contained 0.40% glimepiride rather than 0.20%. The suspension was sprayed onto the barrier layer until the tablet weight increased by approximately 4%.
example 3
[0048] This example illustrates the preparation of tablets in accordance with this invention that contain 500 mg metformin hydrochloride as the prolonged-release component and 2 mg glimepiride as the immediate-release component, but using a poly(vinyl alcohol)-poly(ethylene oxide) poly(ethylene oxide) both as the barrier layer and as a component in the immediate-release layer. The poly(vinyl alcohol)-poly(ethylene oxide) used in the barrier layer is KOLLICOAT® IR, a product available from BASF Corporation, Chemicals Division, Wyandotte, Mich., USA.
[0049] Pre-formed metformin hydrochloride tablets identical to those used as a starting material in the preceding examples are used. The barrier layer solution is then prepared by dissolving the KOLLICOAT IR in purified water to a concentration of 8% by weight. This solution is then sprayed onto the pre-formed tablets to achieve a weight increase of 1%.
[0050] The immediate-release drug-containing coating suspension is prepared by dissolv...
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