Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Patent
1990-12-13
1993-07-13
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
424501, 424489, 424490, A61K 928, A61K 922
Patent
active
052271714
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to a process for producing a flavored pharmaceutical preparation for oral administration and more particularly to a process for producing a flavored pharmaceutical preparation for oral administration wherein the taste of a drug contained therein is well masked.
BACKGROUND ART
Various flavored pharmaceutical preparations and their production processes have hitherto been known; however, no satisfactory flavored pharmaceutical preparation and production process thereof have been developed.
In view of such a situation, the present inventors provided an invention described in Japanese Patent Application Kokai (Laid-Open) No. 188621/1988. The invention provided a flavored pharmaceutical preparation for oral administration wherein the taste of a drug contained therein is well masked, as well as a process for producing said pharmaceutical preparation. In this production process, however, droplets varying in diameters are allowed to fall onto a powder bed to produce a flavored pharmaceutical preparation for oral administration; therefore, the process has had problems in that the separation of the powder bed and the pharmaceutical preparation is difficult and the yield of the pharmaceutical preparation is low.
It is an object of the present invention to solve the above problems caused by the use of the powder bed and to provide a process for producing a flavored pharmaceutical preparation for oral preparation wherein the taste of a drug contained therein is well masked.
DISCLOSURE OF THE INVENTION
The present invention relates to a process for producing a flavored pharmaceutical preparation for oral administration, characterized by spraying, in a moistened and heated air, a suspension of a drug or drug-containing particles dispersed in a cold water solution of polyvinyl acetal diethylaminoacetate (hereinafter referred to as AEA), and drying the resulting fine particles.
The production process of the present invention is described in detail below.
First, there is sprayed, in a moistened and heated air, a suspension of a drug or drug-containing particles dispersed in a cold water solution of AEA.
Herein, the drug refers to a solid drug which has an undesirable taste and is difficultly soluble in water, such as macrolide antibiotic (e.g. Erythromycin, 6-0-methylerythromycin A), anti-inflamatory analgesic (e.g. Ketoprofen, Ketophenylbutazone, Ibuprofen, Acetaminophen), antihistamine (e.g. Promethazine HCl), antitussive (e.g. Clobutinol HCl, Oxeladin Tannate), antidiarrheal agent (e.g. Berberine HCl), spasmolytic (e.g. Propantheline Bromide, Papaverine HCl), antithrombotic agent (e.g. naclopidine HCl), antirheumatic agent (e.g. Mefenamic acid, Flufenamic Acid), tranquilizer (e.g. Chloropromazine HCl, Promethazine HCl), cardiotoxic (e.g. Digitoxin, Aminophylline), gallstone-solubilizing agent (e.g. chenodeoxycholic acid), travail-inducing agent (e.g. Dinoprostone) or the like.
Further, drug-containing particles refers to fine particles obtained by dissolving a wall-forming substance (e.g. AEA, gelatin, emulsion polymer of methacrylic acid and ethyl acrylate, cacao butter) in a solvent (e.g. purified water, ethanol) under heating or at the ordinary temperature, suspending the above-mentioned drug in the resulting solution, introducing the resulting suspension into an atomizer by the use of a metering pump to effect spraying, followed by drying.
The "cold water" refers to a "cold water" of 10.degree. C. or lower. AEA is dissolved therein at a concentration of 1-30% by weight. When the concentration of AEA is more than 30% by weight, AEA is insoluble in the cold water.
The moistened and heated air is an air of 20.degree.-95.degree. C., preferably 50.degree.-90.degree. C. having a relative humidity of 70% or more.
The spraying of the suspension is effected by introducing the suspension into an atomizer by the use of a metering pump while keeping the suspension at a temperature at which AEA causes no gelation. In this case, a jacket is fitted to the metering pump and the ato
REFERENCES:
patent: 4016254 (1977-04-01), Seager
patent: 4533562 (1985-08-01), Ikegami et al.
patent: 4892740 (1990-01-01), Takasima et al.
patent: 5002775 (1991-03-01), Toya et al.
Koyama Ikuo
Makabe Eri
Ozawa Yasuo
Shimano Kimihide
Kulkosky Peter F.
Page Thurman K.
Taisho Pharmaceutical Co. Ltd.
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