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Granule and method for making thereof. RU patent 2456980.

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutics. A pharmaceutical granule is spherical or spheroidal and has volume density 0.6-1.3 g/ml and disintegration 0.5-5 minutes. Active pharmaceutical ingredients are preparations of Traditional Chinese Medicine, herbal preparations or their extracts with a nucleus made of an extract of Traditional Chinese Medicine or herbal preparations, and a pharmaceutically acceptable carrier. The content of the pharmaceutically acceptable carrier with respect to total granule weight makes 10-60 wt %. The granule diameter can be equal to 700-1500 mcm. The granule nucleus diameter can be equal to 200-750 mcm. The granule can be also coated with a layer of 2-5 wt % with respect of total granule weight. A method for making the granules consists in introducing initial granules into a layer of a fluidised material as an excipient; the active pharmaceutical ingredients are prepared in the form of a suspension or a solution of the viscosity controlled within 6.0-9.8 MPa·s with using a viscosity-control agent; then they are sprayed over a surface of the initial granule for making a finished granule.

EFFECT: granules possess fast disintegration, contain a small amount of the carrier and contain a low single dose.

12 cl, 5 ex

 


 

IPC classes for russian patent Granule and method for making thereof. RU patent 2456980. (RU 2456980):

A61P9/10 - for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
A61P3/10 - for hyperglycaemia, e.g. antidiabetics
A61P31 - Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
A61P25 - Drugs for disorders of the nervous system
A61P1/16 - for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
A61K9/16 - Agglomerates; Granulates; Microbeadlets
A61K47/38 - Cellulose; Derivatives thereof
A61K47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
A61K47/04 - Non-metals; Compounds thereof
A61K36 - PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J0003000000; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L)
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