Tablet containing hardly soluble active ingredient

A tablet and a whole technology, applied in the field of tablets containing insoluble active ingredients, can solve problems such as changes in drug efficacy, and achieve the effect of inhibiting changes in dissolution

Active Publication Date: 2012-10-10
TAKEDA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because these changes are related to changes in the absorption of the active ingredient, a certain level or more of the range of variation may also result in changes in the efficacy of the drug

Method used

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  • Tablet containing hardly soluble active ingredient
  • Tablet containing hardly soluble active ingredient
  • Tablet containing hardly soluble active ingredient

Examples

Experimental program
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Embodiment 1

[0183] According to the formula in Table 2, after compound A, lactose and cornstarch were uniformly mixed in a fluidized bed granulation dryer, the mixture was sprayed with an aqueous solution of dissolved hydroxypropyl cellulose to granulate in a dryer, and then Dry in this same dryer. The obtained granules were sieved and sized using an electric mill with 1.5 mmφ to obtain a powder with an adjusted particle size. Corn starch and magnesium stearate were added to the sized powder and mixed in a drum mixer to obtain granules for tableting. The granules were compressed into tablets with a weight of 130 mg on a tablet machine using a punch of 7.0 mmφ to obtain uncoated tablets. The obtained uncoated tablets were sprayed in film coating equipment with titanium oxide, hypromellose 2910 dispersed with iron oxide yellow or ferric oxide, and vinylpyrrolidone / vinyl acetate copolymer to obtain Tablets Film-coated tablets of Formulation A (Comparative Example) and Formulation B (Exampl...

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PUM

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Abstract

A tablet showing regulated variation in elution from lot to lot which contains from about 3 to about 50% by weight (w / w), based on the whole tablet, of (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide, magnesium stearate and hydroxypropylcellulose having a viscosity of about 1 to about 4 mPa<.>s.

Description

technical field [0001] The invention relates to a tablet, in particular to a tablet containing insoluble active ingredients. Background technique [0002] In a tablet containing a poorly soluble active ingredient, the dissolution behavior of the active ingredient changes in some cases. Because these changes are related to changes in the absorption of the active ingredient, a certain level or more of variation may also lead to changes in the efficacy of the drug. Also, even when these substantive issues are absent, it is more desirable, if possible, that there is no change in product quality. This is not limited to drugs, but to all products. Contents of the invention [0003] Problems solved by the present invention [0004] The present inventors studied intensively and found as a conclusion that the viscosity of a binder generally used in tablets is related to the dissolution behavior of active ingredients, and further studied to complete the present invention. [000...

Claims

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Application Information

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Patent Type & AuthorityPatents(China)
IPC IPC(8): A61K31/407A61K9/28A61K47/12A61K47/38A61P25/20
CPCA61K9/2866A61K9/284A61K31/407A61K9/2054A61P25/20A61P43/00A61K9/28A61K9/20A61K47/12
Inventor丸中成之福田诚人
OwnerTAKEDA PHARMA CO LTD