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Pharmaceutical composition

A technology of composition and medicine, applied in the field of pharmaceutical composition of salt, to achieve the effect of improving stability

Pending Publication Date: 2021-07-23
KYOWA HAKKO KIRIN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Although studies for designing a pharmaceutical composition suitable for bardoxolone methyl have been conducted (see Patent Document 4), further stabilization of bardoxolone methyl is still being sought

Method used

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preparation example Construction

[0068] Regarding the preparation method of solid dispersion, according to "The Forefront of Oral Formulation Technology for Poorly Water-soluble Drugs" (CMC Publishing, 2016) (Reference 1), from the stability of amorphous drugs in solid dispersion From a point of view, the higher the glass transition point of the solid dispersion, the better. It is also described that, from the viewpoint of production, the exhaust gas temperature during spray drying is preferably equal to or lower than the glass transition point of the solid dispersion (see page 195 of Reference Document 1). In addition, water, methanol, ethanol, acetone, dichloromethane, etc. are mentioned as typical solvents usable in solid dispersions by the spray-drying method, and appropriate solvents are selected from these depending on the drug and the carrier. It is described that when the drug and carrier are dissolved at a high concentration, the production efficiency can be improved, so the drug concentration of the...

Embodiment

[0157] Hereinafter, the present invention will be more specifically described using examples, but the technical scope of the present invention is not limited to these examples.

manufacture example

[0159] Formulation example 1:

[0160] Using a mixer (TBM-25, manufactured by Tokushou Works Co., Ltd.), a solid dispersion (manufactured by a spray drying method, hereinafter referred to as "solid dispersion") containing 40% by weight of Compound A (bardoxolone methyl) Also produced in the same way) 480.8g, silicic acid-treated crystalline cellulose (Prosolv, JRS Pharma) 1976.9g, lactose hydrate (Japanese Pharmacopoeia) 1715.4g, hypromellose (TC-5E, manufactured by Shin-Etsu Chemical Co., Ltd.) 250.0 g, 500.0 g of low-substituted hydroxypropyl cellulose (L-HPC, manufactured by Shin-Etsu Chemical Co., Ltd.), and 38.5 g of light silicic anhydride (Adsolider 101, manufactured by Freund Corporation) were mixed. To this mixture, 19.2 g of magnesium stearate was added and further mixed. This mixture was subjected to dry granulation and sizing using a roll compactor (CCS-220, manufactured by Powrex Co., Ltd.). Magnesium stearate was added in an amount of 0.38% by weight based on...

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Abstract

Provided is a pharmaceutical composition that has an improved stability of bardoxolone methyl or a pharmaceutically acceptable salt thereof. Use is made of a pharmaceutical composition provided with a coating film, said pharmaceutical composition comprising bardoxolone methyl or a pharmaceutically acceptable salt thereof, a disintegrating agent and a binder.

Description

[0001] References for Associated Applications [0002] This patent application claims priority based on Japanese Application Japanese Application No. 2018-221650 filed on November 27, 2018, and the entire disclosure of the Japanese application is incorporated by reference as a part of the disclosure of the present invention. technical field [0003] The present invention relates to a pharmaceutical composition, more specifically, to a pharmaceutical composition containing bardoxolone methyl or a pharmaceutically acceptable salt thereof. Background technique [0004] As a synthetic terpenoid compound, bardoxolone methyl (2-cyano-3,12-dioxoolean-1,9(11)-diene-28-acid methyl ester (Methyl2 -cyano-3,12-dioxooleana-1,9(11)-dien-28-oate)) (hereinafter, sometimes referred to as "compound A") is known (see Patent Document 1), and also known This bardoxolone methyl has a polymorphic form (see Patent Document 2). [0005] [chemical formula 1] [0006] [0007] It has been clear ...

Claims

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Application Information

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IPC IPC(8): A61K31/277A61K9/32A61K9/36A61K9/30A61P3/10A61P9/00A61P13/12A61P29/00A61P35/00A61P39/06A61K47/02A61K47/26A61K47/32A61K47/34A61K47/36A61K47/38
CPCA61K31/277A61K9/28A61K9/2054A61K9/2866A61K9/2813A61K9/282A61K9/2027A61K9/2009A61K9/2018A61K9/2013A61P29/00A61P35/00A61P3/10
Inventor 岩田见二藏本诚小阪和德
Owner KYOWA HAKKO KIRIN CO LTD