Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Patent
1993-09-30
1996-03-05
Azpuru, Garlos A.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
514773, 514774, 514801, 514953, A61F 1302, A61K 4742
Patent
active
054965594
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to a solid pharmaceutical formulation for buccal or oral administration which contains a proteinaceous physiologically active substance as an active ingredient, as well as collagen and a water-soluble additive, said formulation being characterized by being porous and having a good disintegration property, and to a preparation thereof.
THE PRIOR ART
Development of biotechnology, in particular, genetic recombination and cell culture technology has provided and will be providing substantial amount of proteinaceous physiologically active substances such as cytokines and proteinaceous hormones, for the purpose of the treatment and diagnosis in medical and animal industries.
Such proteinaceous physiologically active substances are usually administered via injection, because they have, in general, poor absorption in digestive tracts.
There is a report which demonstrates that buccal administration of a little amount (2 IU/kg/day) of interferon, proteinaceous physiologically active substance, to patients suffering from a disease caused by human immunodeficiency virus type 1 (HIV-1), which is called AIDS, resulted in an improvement in its symptom (Davy K. Koech et al., Mol. Blother. Vol.2, 91-95 (1990)). WO88/03411 describes a method of contacting an interferon to the buccal cavity and the pharyngeal mucosa.
Also, a sustained release formulation which contains interferon and collagen is described in the Japanese Patent Publication (kokai) No. 97918/1985.
However, any stable solid formulations have not yet been known, which can be administered in a form for a buccal or oral route, and which can release proteinaceous physiologically active substances in an amount and over a time necessary for treating the diseases.
DESCRIPTION OF THE PRESENT INVENTION
The inventors of the present invention have completed the invention by making efforts to find the above-noted ideal formulation.
Specifically, the present invention relates to a stable solid pharmaceutical formulation which can be administered in the form suitable for a buccal or oral route, and which can release the proteinaceous physiologically active substances in an amount and over a time necessary for treating the disease, as well as a preparation thereof. More specifically, the present invention relates to a solid pharmaceutical formulation for buccal and oral administrations, which contains a proteinaceous physiologically active substance as an active ingredient, as well as collagen and a water-soluble additive, said formulation being characterized by being porous and having a good disintegration property, and to a preparation thereof.
In one embodiment, the present invention relates to a pharmaceutical formulation for treating AIDS, or for preventing the progress of AIDS, when it contains interferon as a proteinaceous physiologically active substance.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows a time-course of a release of interferon from the spongy formulation of the present invention (Example 1).
FIG. 2 shows a release of interferon from the collagen needle pellet as a control.
DESCRIPTION OF THE PREFERRED EMBODIMENTS FOR CONDUCTING THE PRESENT
INVENTION
As shown above, the present invention relates to a solid pharmaceutical formulation for buccal and oral administrations, which contains a proteinaceous physiologically active substance as an active ingredient, as well as collagen and a water-soluble additive, said formulation being characterized by being porous and having a good disintegration property, and to a preparation thereof.
Collagen
"Collagen" which can be used in the invention includes, for example, atelocollagen which is derived from a natural resource, and which is free of a telopeptide which is an antigenic portion of collagen; chemically modified atelocollagen; naturally-occurring collagen, and so on. The collagen which has been chemically derived from the atelocollagen includes, for example, a succinylated collagen, a methylated collagen, and so on. The naturally-occurring c
REFERENCES:
patent: 4371516 (1983-02-01), Gregory et al.
patent: 4774091 (1988-09-01), Yamahira et al.
patent: 4950483 (1990-08-01), Ksander et al.
Koech, Davy et al., Mol. Biother., vol. 2, 91-95 (1990) The Lancet, 1530-1531 (1987).
Fujioka Keiji
Sato Shigeji
Takada Yoshihiro
Azpuru Garlos A.
Sumitomo Pharmaceuticals Company Limited
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