Intrabuccally disintegrating preparation and production thereof

Details Intrabuccally disintegrating preparation and production thereof Intrabuccally disintegrating preparation and production thereof

1994-06-22

1995-11-14

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Implant or insert

424439, 424474, 424479, 514960, 514961, 514440, A61K 4726

Patent

active

054664640

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD

This invention relates to a solid preparation which has a sufficient handling strength similar to the case of common tablets and also has a practically sufficient solubility or disintegration property in the buccal cavity, and to a process for producing the same.


BACKGROUND ART

Since dosage forms which take into consideration the ease of swallowing by patients are scarce in spite of the existence of various known dosage forms of pharmaceutical preparations for oral administration use, great concern has been directed toward the development of a dosage form which can be easily handled especially by the aged or children who have difficulty in swallowing a solid preparation.
For example, in the case of tablets and capsules frequently used as oral preparations, many aged patients or children having weak swallowing power are unwilling to take these solid preparations complaining that the drug is difficult to swallow or stops in the pharynx or gullet.
In the case of powders and granules, they are difficult to swallow because of their aptness to remain in the buccal cavity and therefore to cause an unpleasant feeling in the mouth. In some cases, the aged will be choked with powders or feel a pain or unpleasantness due to granules lodged between false teeth. In addition, powders and granules have to be used after tearing each package, but the aged or children often have difficulty in tearing the package or spill a portion of its contents.
To take these oral preparations, it is necessary to use water, and the aged or children especially require a large volume of water in many cases because of the swallowing difficulty. However, there is a situation that it is necessary to drink water moderately, especially before retire to bed because of the urination problem at night. In addition, in the case of patients who have to take oral preparations constantly while making daily life, water can hardly be obtained in certain cases depending on circumstances, thus sometimes entailing decline in the compliance.
Syrups and the like are regarded as desirable dosage forms for the aged or children, but the aged or children who have difficulty in measuring the necessary volume cannot be expected to use such preparations in correct dose. In addition, since there are many aged patients who can hardly take liquid preparations by mouth by themselves, such dosage forms cannot always be regarded as suitable dosage forms for the aged and children when trouble at the time of drug-taking is taken into consideration, except for a case in which a patient can ask a nurse for a helping hand.
On the basis of the above, when the forthcoming social condition of advanced age is taken into consideration, development of a dosage form which can be used easily especially by the aged seems to be an immediate need, because the morbidity rate of chronic diseases increases with advance in age and patients of advanced age have a tendency to take drugs for a long period of time. Also, in order to keep the quality of life, it is desirable to develop a dosage form which can be easily swallowed and handled according to the ability and life condition of each patient.
Several pharmaceutical preparations which dissolve or disintegrate in the buccal cavity are known as suitable dosage forms for the aged, children or patients who dislike taking drugs. For example, JP-B-62-50445 discloses a solid preparation having an open matrix network structure which is obtained by freezing an aqueous solution containing gelatin as the main component and a pharmaceutical substance and then sublimating the solvent. (The term "JP-B" as used herein means an "examined Japanese patent publication".) According to this patent publication, the open matrix network structure has a density of 10 to 200 mg/ml and disintegrates rapidly in water within 10 seconds by a tablet disintegration test. It also discloses that spitting of the preparation by patients who dislike drug-taking can be prevented, because the preparation disintegrates rapidly within 1 to 2 seconds in the bucc

REFERENCES:
patent: 3419657 (1978-12-01), Sanders et al.
patent: 5013557 (1991-05-01), Tai
patent: 5288497 (1994-02-01), Stanley et al.
Sterling Drug, Inc., Chemical Abstracts, vol. 14(16), Apr. 22, 1991, #150194c.
Pharm. Ind. vol. 34, No. 3, 1972 Nuernberg, E. p. 196 Table 6.

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