Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2000-10-17
2003-07-08
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S435000, C424S045000, C424S046000, C514S002600, C514S012200
Reexamination Certificate
active
06589559
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a nasally administrable composition and more particularly, a nasally administrable composition that provides excellent absorption of a physiologically active substance into human bodies through nasal administration.
BACKGROUND ART
Various physiologically active substances, including calcitonin, insulin, parathyroid hormone (PTH), human grows hormone (HGH), interferon, and the like and their derivatives, are macromolecular compound used for various medical purposes in clinical practice owing to their unique physiological activities.
These physiologically active substances, however, can little be absorbed intact from the mucous membrane of the intestine because they are likely to be decomposed with proteases existing in the digestive tract or are high in molecular weight and polarity. Hence, they are hard to administer orally and their administration route is limited to injection.
Recently, there has been proposed nasally administrable preparations of these physiologically active substances instead of injection route. By the nasally administration, the physiologically active substances are absorbed through the mucous membrane of the nasal cavity into the body, and the bioavailability thereof is enhanced to similar level as that obtained with conventional injectable preparations. Therefore, the nasally administrable preparations are expected to be useful preparations for administration of physiologically active substances.
The physiologically active substances to be absorbed into the human body through nasal administration are not limited to those mentioned above, and other physiologically active substances conventionally administered in oral or injectable preparations are also applicable for nasally administration. Accordingly, there has been demand for development of more effective nasally administrable preparations for these physiologically active substances.
Previously, the inventor developed a nasally administrable composition to nasally administer physiologically active substances unlikely to be orally administered or other physiologically active substances with higher absorbability and less irritation, and he found that a nasally administrable composition wherein physiologically active substance is dispersed homogeneously in and adsorbed onto several specific carriers.
The present inventor further performed investigations to develop the nasally administrable compositions, and he perceived a fine powdery form of cereal such as rice, wheat, soybean, corn, foxtail, millet, buckwheat and the like, which has not yet been studied as a carrier for use with nasally administrable composition. That is, when physiologically active substances were administered nasally with fine powdery form of cereal as a carrier, those active substances were extremely well absorbed, and their absorbability was equivalent to or even higher than that obtained by other nasally administrable preparations so far proposed, and the pharmaceutical stability of the compositions were excellent. Thus the present inventor completed the invention based on these findings.
DISCLOSURE OF THE INVENTION
Accordingly, the object of the present invention is to provide a new nasally administrable composition that can nasally administer physiologically active substances with higher bioavailability though the mucous membrane of nasal cavity, and with the excellent pharmaceutical stability of the compositions.
One aspect of the present invention is to provide the nasally administrable composition containing a physiologically active substance and fine powdery form of cereal, wherein a physiologically effective amount of said physiologically active substance is dispersed homogeneously in and adsorbed homogeneously onto said fine powdery form of cereal.
The other aspect of the present invention is to provide fine powdery form of cereal as a carrier to be used for nasally administrable composition.
In still another aspect of the present invention, use of fine powdery form of cereal as a carrier for nasally administrable composition, is provided.
The nasally administrable composition of the present invention constitutes a characteristic future of using fine powdery form of cereal as a carrier to be used for nasally administrable composition, which has not yet been. Therefore, according to the present invention, when the physiologically active substance was administered nasally with fine powdery form of cereal as the carrier, the active substance contained in the composition may be extremely well absorbed into the body through the mucous membrane of the nasal cavity.
REFERENCES:
patent: 5578567 (1996-11-01), Cardinaux et al.
patent: 0 490 806 (1992-06-01), None
patent: 2 248 550 (1992-04-01), None
patent: 2 268 185 (1994-01-01), None
patent: 60-224616 (1985-11-01), None
patent: 63-115821 (1988-05-01), None
Crowell & Moring LLP
Dees Jose′ G.
DOTT Research Laboratory
George Konata M.
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