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Last Updated: December 16, 2025

Claims for Patent: 12,350,377

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Summary for Patent: 12,350,377

Title:	Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivatives
Abstract:	The solid preparation which improved the dissolution profile and the stability of the 6,7-unsaturation-7-carbamoyl morphinan derivative is provided. When 6,7-unsaturation-7-carbamoyl morphinan derivative, croscarmellose sodium and ferric oxide were contained, not titanium oxide in the solid preparations and the coating solid preparations, a dissolution rate after 15 minutes of the dissolution test is more than 85%, and stability, particularly, light stability can be improve.
Inventor(s):	Akira Mashimo, Shunji Ichio, Yoshinori Tamura, Kouichi Noguchi
Assignee:	Shionogi and Co Ltd
Application Number:	US17/156,892
Patent Claims:	1. A coated solid preparation, which comprises a p-toluenesulfonic acid salt of a compound represented by formula (IA), as an active ingredient, croscarmellose sodium, and D-mannitol, wherein the coated solid preparation comprises a core and a coating layer comprising hydroxypropylmethylcellose, talc and ferric oxide, wherein the coating layer does not substantially contain titanium oxide, wherein the core does not substantially contain ferric oxide, wherein a dissolution rate after 15 minutes of a dissolution test according to a paddle method of the Japanese Pharmacopeia in a test liquid having a pH of 6.8 was more than 85%, and wherein a dissolution rate after 5 minutes of a dissolution test according to the paddle method of the Japanese Pharmacopeia in a test liquid having a pH of 6.8 was more than 60%.

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