Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Patent
1993-10-07
1996-03-12
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
424452, 424455, 424457, 424458, 5147726, 514781, 514964, 514783, A61K 952
Patent
active
054984220
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to a capsule. More particularly, the invention relates to a sustained release capsule having good mucosa adhering property and stability.
BACKGROUND ART
Pharmaceutical preparations with which the drug concentration in blood can be maintained at a desired level for a prolonged period of time are very useful since the frequency of administration thereof can be reduced and the compliance can be improved. Such control of blood concentration can serve to avoid unnecessary increases in blood concentration and thereby reduce or alleviate adverse effects of the drug. Therefore, such pharmaceutical preparations are useful as compared with ordinary preparations.
Various dosage forms have been proposed as means of controlling the drug concentration in blood. For instance, there may be mentioned 1 a preparation which comprises a core consisting of drug-containing granules and a semipermeable coat film covering said core, so that the drug can be released therefrom gradually in a body fluid for prolongation of the drug action, 2 gel matrix tablets that are made by admixing a water-soluble polymer having good gel forming ability with a drug and other appropriate ingredients and tableting the mixture for attaining sustained release by making use of the phenomenon of dissolution and peeling of the gel and 3 wax matrix tablets made by admixing a basically water-incompatible animal or vegetable oil or wax with a drug and tableting the mixture for attaining sustained release, among others.
However, the dosage forms mentioned above are invariably wanting in the function to control the transfer from the stomach to the small intestine after taking thereof and, as a result, cannot display satisfactory sustained release characteristics in many instances.
One of the means for solving this problem is to cause the pharmaceutical preparation to adhere to the gastrointestinal tract wall.
For instance, mention may be made of the method comprising coating pellets with an adhesive material (Japanese Kokai Tokkyo Koho JP 63-101332).
This technology comprises coating relatively large granular cores with an adhesive material to attain a sustained action. In this method, it is important that the adhesive material be used in large amounts to secure sustained release for a prolonged period of time.
However, to cover cores with a large amount of a highly sticky material is accompanied by problems very difficult to solve from the technology and cost viewpoints, for example measures for coping with secondary particles during handling and processing, and lowering the viscosity of the coating solution, which causes increases in process hours, for instance. In addition, since the adhesion time depends on the mutual relation between the adhesive power and detaching force (peeling force), such large grain size pellets show an adhesion time shortened due to the own weight of each grain as compared with fine particles.
Therefore, this technique is not always appropriate as a means of attaining sustained release by ensuring a long period of adhesion.
With another dosage form having adhesiveness, the transfer of a pharmaceutical preparation in the gastrointestinal tract is forcedly controlled by utilizing a carrier comprising a combination of an oil and a water-soluble polymer (Japanese Kokai Tokkyo Koho JP 61-233632).
Supposedly, this technique can prolong the adhesion time as compared with the method mentioned above because fine particles of a water-soluble polymer can be mixed in an oil.
However, it is evident that mere mixing of an oil with a water-soluble polymer does not necessarily give an excellent sustained release preparation. The reasons are as follows. is strong, the water-soluble polymer may be dissolved in the oil as the case may be. In that case, no adhesiveness is exhibited any longer. from the overall viewpoint, including administrability and economic aspects, will be a capsule form.
However, all oils are not utilizable in such a dosage form. For instance, propyleneglycol, glycerol, polyeth
REFERENCES:
patent: 4002731 (1977-01-01), Skulan
patent: 4250163 (1981-02-01), Nagai et al.
patent: 4680323 (1987-07-01), Lowey
patent: 4690822 (1987-09-01), Uemura et al.
patent: 5064650 (1991-11-01), Lew
Fukui Hiroshi
Izumi Shogo
Nakamichi Kouichi
Nippon Shinyaku Company Limited
Page Thurman K.
Spear James M.
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