Process for production of buprenorphine pharmaceutical preparation to be applied to mouth mucosa

A technology for oral mucosa and buprenorphine hydrochloride, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, pill delivery, etc., and can solve the problem of decomposition of preparations, poor stability of buprenorphine, etc. question

Inactive Publication Date: 2010-01-20
TOYOBO CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, in preparations manufactured using buprenorphine hydrochloride aqueous solution, the stability of buprenorphine is poor, and there is a problem that decomposition products are generated in the preparation

Method used

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  • Process for production of buprenorphine pharmaceutical preparation to be applied to mouth mucosa
  • Process for production of buprenorphine pharmaceutical preparation to be applied to mouth mucosa
  • Process for production of buprenorphine pharmaceutical preparation to be applied to mouth mucosa

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Buprenorphine hydrochloride crystals were pulverized four times with a hammer mill to obtain fine particles with a 50% cumulative diameter of 25 μm and a 90% cumulative diameter of 61 μm. Granules for a sustained-release layer were prepared in the same manner as in Comparative Example 2 (2) except that the buprenorphine hydrochloride crystals were used.

Embodiment 2

[0093] The buprenorphine hydrochloride crystals used in Comparative Example 2 above were sieved so that the 50% cumulative diameter was 23 μm and the 90% cumulative diameter was 48 μm. Using the buprenorphine hydrochloride crystals, except that the content of buprenorphine hydrochloride was halved, a bilayer tablet for buprenorphine hydrochloride for oral mucosal adhesion was prepared in the same manner as in Comparative Example 2.

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Abstract

The invention aims at providing a process for the production of a buprenorphine pharmaceutical preparation to be applied to mouth mucosa. The process is characterized by comprising the step of preparing granules for rapid release layer containing buprenorphine hydrochloride crystals whose 90% cumulative diameter is 200¢mu!m or below, the step of preparing granules for sustained release layer containing buprenorphine hydrochloride crystals whose 90% cumulative diameter is 250¢mu!m or below, and the step of compressing both the granules into double-layer tablets.

Description

technical field [0001] The present invention relates to a method for producing a buprenorphine formulation attached to the oral mucosa. Background technique [0002] Buprenorphine hydrochloride is a non-narcotic analgesic sold as injections and suppositories in Japan. In addition, outside Japan, it may also be sold as a sublingual agent. [0003] However, when the above preparations are administered, the blood concentration of buprenorphine increases rapidly and then decreases rapidly, so the effect is transient. Therefore, frequent administration is necessary for chronic pain, and there is also a problem of side effects. In addition, when sublingual preparations are used, there is a problem that the absorption efficiency of buprenorphine itself is poor. In addition, there is also an example of using buprenorphine as an external preparation, but buprenorphine is not practical because of its extremely poor percutaneous absorption. [0004] For this reason, the researchers...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/485A61K9/22A61K9/70A61K47/26A61K47/32A61P25/04
CPCA61K9/006A61K9/1635A61K31/485A61K9/0056A61K9/209A61P25/04A61K9/70
Inventor 椋木史典宫坂忠与
Owner TOYOBO CO LTD
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