Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2001-08-03
2003-11-04
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S464000, C424S465000, C424S474000, C514S866000
Reexamination Certificate
active
06641841
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a tablet composition used for controlling the blood sugar levels of diabetics.
BACKGROUND OF THE INVENTION
It is known that N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine of the following formula:
(hereinafter referred to as “compound [1]) exhibits an excellent effect of lowering the blood sugar level when it is taken orally, and is thus usable as a medicine for diabetes [Japanese Patent Publication for Opposition Purpose (hereinafter referred to as “J. P. KOKOKU”) No. Hei 4-15221].
However, it was found that when compound [1] is orally taken before or after a meal for the purpose of preventing the blood sugar level after the meal from rising, the bioavailability of the compound is lowered.
DISCLOSURE OF THE INVENTION
The object of the present invention is to provide a tablet composition which is rapidly absorbed without being influenced by the meals and without impairing the essential properties of compound [1] contained therein, which has an effect of lowering the blood sugar level and only a short effect-lasting time.
The present invention relates to a tablet composition containing compound [1] as the active ingredient and a low substituted hydroxypropylcellulose as a disintegrator.
The present invention also relates to a tablet composition containing a filler, preferably a filler containing lactose, in addition to said compound [1] and the low substituted hydroxypropylcellulose.
The present invention further relates to the above-described tablet composition which further contains a hydroxypropyl cellulose as a binder.
After the administration, the above-described tablet compositions are rapidly disintegrated in the stomach after the administration and absorbed without being influenced by the meals to prevent the blood sugar level of diabetics after meals from rising.
REFERENCES:
patent: 4816484 (1989-03-01), Toyoshima et al.
patent: 6143323 (2000-11-01), Yabuki et al.
patent: 6296872 (2001-10-01), Yabuki et al.
Pharmaceutical Macromolecular Material Science, pp 77-79, Chinese Medicament Science & Technology Press, Apr. 30, 1993.*
Y. Kawashima, et al., “Preparation of a Sustained-Release Matrix Tablet of Acetaminophen with Pulverized Low-Substituted Hydroxypropylcellulose Via Dry Granulation”, Chemical & Pharmaceutical Bulletin, vol. 41, No. 10, pp. 1827-1831 (Oct., 1993).
Statement of Clinical Testing Mar. 1995.
Ando Takahiko
Kaida Masato
Ninomiya Nobutaka
Ozaki Masanao
Yabuki Akira
Ajinomoto Co. Inc.
Spear James M.
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