Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1997-06-27
2000-12-05
Levy, Neil S.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424408, 424451, 424463, 424474, 424475, 424476, 424479, 424480, 424482, A61K 934
Patent
active
061563439
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to a novel controlled release preparation. More specifically it relates to a controlled release preparation consisting of a tablet containing (a) a mixture of a drug and a water-soluble polymer or a solid dispersion thereof, (b) polyvinylalcohol and (c) one or more salts selected from a group consisting of trisodium citrate, sodium sulfate and sodium chloride, and the tablet being coated by (d) a coating material consisting of a water-insoluble polymer and a water-soluble polymer and/or an enteric polymer.
BACKGROUND ART
To keep the plasma level of a drug constant for long hours has many merits not only to enhance preventing or curing diseases,but also to reduce administration times of the drug and to improve the compliance of the patient. Therefore, many kinds of controlled release preparations which control drug release rate from the preparation have been developed and used extensively.
For example, in Japanese Patent Publication No. 11699/1995 a tablet in which a core portion containing a drug (nifedipine) is rapidly released and is coated compressively with a coating material consisting of a hydrophilic gelforming polymer and the drug is described. On administration of this tablet once a day the suitable continuation is attained, but it is not satisfied enough and, in addition to that, there is such a problem that it needs two step-compressing procedures to prepare such a tablet. These are troublesome.
Besides, different from the above preparation, membrane-coated granules and membrane-coated tablets, which are prepared by coating the core portion or an uncoated core-tablet containing a drug with a water-insoluble polymer and a water-soluble polymer, and matrix tablets which are prepared by compressing a drug with a water-insoluble polymer or wax, etc. and so on are evaluated. In such preparations, because the drug release rate is reduced with the lapse of time on administration in vivo, the plasma level of the drug is reduced from time to time. There is such a problem that it is difficult to keep the plasma level of the drug for long hours.
Recently the relationship between circadianrhythm and disease has been given attention to and it becomes important to consider the circadianrhythm in the medical treatment.
From the facts mentioned above, the improvement of controlled release preparations has in various respects have been studied.
DISCLOSURE OF THE INVENTION
The object of the present invention is to provide the controlled release preparation in which a drug in the preparation is continuously released for long hours and the prophylaxis and treatment of diseases are expected on administration of the preparation once or twice a day.
As the result that the present inventors extensively engaged in the study to attain the above mentioned object, it is found that a controlled release preparation prepared by coating an uncoated core-tablet that contains (a) a mixture of a drug and a water-soluble polymer, or a solid dispersion thereof, (b) polyvinylalcohol, and (c) one or more salts selected from a group consisting of trisodium citrate, sodium sulfate and sodium chloride, with (d) a coating material which consists of a water-insoluble polymer and a water-soluble polymer and/or an enteric polymer, is suitable for the object of the present invention.
According to the present invention, on administration of the controlled release preparation of this invention to human body, a water-soluble polymer and/or an enteric polymer in a membrane consisting of a water-insoluble polymer and a water-soluble polymer(referred to as a water-soluble pore-forming membrane), a membrane consisting of a water-insoluble polymer and an enteric polymer (referred to as enteric pore-forming membrane) or a membrane consisting of a water-insoluble polymer, a water-soluble polymer and an enteric polymer (referred to as water-soluble enteric pore-forming membrane) are dissolved in gastro-intestinal fluid, pores are formed in the membrane and then via the pores the drug on the surface o
REFERENCES:
patent: 4892741 (1990-01-01), Ohm et al.
patent: 5320853 (1994-06-01), Noda et al.
patent: 5340590 (1994-08-01), Wong et al.
patent: 5698220 (1997-12-01), Cardinal
Arahira Mitsutoshi
Honda Ritsuko
Morita Ryoichi
Takahashi Yoshiteru
Akzo Nobel N.V.
Levy Neil S.
LandOfFree
Controlled release preparation does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Controlled release preparation, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Controlled release preparation will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-959117