Film-coated tablet containing methotrexate
A technology of film coating and methotrexate, applied in the direction of medical preparations containing active ingredients, sugar-coated pills, organic active ingredients, etc., can solve the problem that there is no record of photostable tablets containing methotrexate, and achieve Produces less, prevents formulation or taking effects
Active Publication Date: 2022-01-07
NIPPON ZOKI PHARM CO LTD
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[0007] As another photostabilization method, Patent Document 4 discloses a photo-stability-improved composition in which one or more substances selected from yellow and red coloring agents are blended with a photo-labile fat-soluble drug, But there is no record about photostable tablets containing methotrexate
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[0092] The relationship between the type and content of iron oxides in the film coating layer and the generation of analogues when the obtained tablet was exposed to light was investigated. The results are shown in Tables 2-9. It will be explained below.
[0093] According to the formulations No.1 to No.3 shown in Table 2, for a 2 mg tablet, weigh 0.2 kg of methotrexate, 3.58 kg of crystalline cellulose, 2.00 kg of corn starch, 7.47 kg of lactose hydrate, and cross-linked carboxymethyl Sodium cellulose 0.87kg and ferric oxide 0.03kg. Put the weighed powder into a high-speed stirring granulator (FG-GS-50, Fukae Powtec Co., Ltd.) for pre-mixing. 2.00 kg of purified water was added to the mixed powder, stirred and granulated, and dried using a fluidized bed dryer (2011-141, Jeil Machine). The granules were sized using an oscillator type granulator to obtain 14.15 kg of granules. The obtained granules were put into a double cone mixer (SY-M, BOSEONG machine), 0.10 kg of light ...
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Abstract
An object of the present invention is to provide a tablet that prevents the content reduction of methotrexate as an active ingredient due to light and the generation of analogues, and can prevent misidentification by having different colors according to content specifications. The present invention provides a methotrexate tablet which suppresses the decrease in content of methotrexate as an active ingredient due to light and the like by containing iron oxide in a film-coated layer and an uncoated tablet. The generation of things. This methotrexate tablet can ensure photostability even if it is light-colored, so it can be used in different colors according to content specifications, so it is very useful in drug management at medical sites and drug storage at patients' homes.
Description
technical field [0001] The present invention relates to film-coated tablets containing methotrexate with improved photostability. Background technique [0002] Methotrexate, which is an antirheumatic agent, has a sufficient inhibitory effect on arthritis and joint destruction and rarely causes serious side effects, so it has become the drug of choice for rheumatism treatment. However, methotrexate sometimes decomposes when exposed to a large amount, thereby increasing harmful analogues and reducing the potency as an active substance. Due to such light instability of methotrexate, oral solid preparations containing methotrexate have conventionally required preparation techniques for ensuring stability to light or storage in a dark place. [0003] Conventionally, various methods for improving the stability of drugs are known for the formulation of drugs that are unstable to light. For example, Patent Document 1 discloses a capsule preparation obtained by stabilizing active v...
Claims
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IPC IPC(8): A61K31/519A61K47/02A61P29/00A61K9/28
CPCA61K47/02A61K9/28A61K31/519A61P29/00
Inventor 片冈宪志
Owner NIPPON ZOKI PHARM CO LTD