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Medicinal composition having excellent absorption of drug into living body and excellent chemical stability

A technology for pharmaceutical compositions and hydrates, applied in the directions of pharmaceutical combinations, active ingredients of heterocyclic compounds, pharmaceutical formulations, etc., can solve the method of chemical stability without any enlightenment, deterioration of chemical stability, and no description of deterioration of chemical stability. And other issues

Active Publication Date: 2021-11-19
NOBELPHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, no method is described to solve the deterioration of chemical stability caused by factors other than acid
[0006] Patent Document 2 discloses a method of improving bioabsorbability of scopolamine without deteriorating the chemical and physical stability of scopolamine by using a composition that does not contain vinyl acetate and polar components. There is no description of a solution to the deterioration of chemical stability in compositions containing polar ingredients
In the case of using a salt of scopolamine from the viewpoint of handling and chemical stability, in order to obtain a pharmaceutical composition excellent in the absorbability of scopolamine to a living body, it is necessary to convert the salt of scopolamine into scopolamine during production or in the pharmaceutical composition The method of this patent cannot be applied because the free base contains a base as a polar component for the purpose
[0007] In Patent Document 3, Patent Document 4, and Patent Document 5, methods for improving the physical stability of scopolamine to maintain or improve bioabsorbability are shown, but there is no suggestion for a method for improving chemical stability.

Method used

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  • Medicinal composition having excellent absorption of drug into living body and excellent chemical stability
  • Medicinal composition having excellent absorption of drug into living body and excellent chemical stability
  • Medicinal composition having excellent absorption of drug into living body and excellent chemical stability

Examples

Experimental program
Comparison scheme
Effect test

manufacture example 1

[0053] According to the formulation ratio recorded in Table 1, scopolamine hydrobromide hydrate, isopropyl myristate, and dodecylamine were dissolved in ethyl acetate / methanol mixture, and an acrylic adhesive component (trade name: DURO - TAK87-4287, produced by Henkel) and mixed and stirred to obtain a homogeneous dissolved product. Next, the dissolved product was stretched into a release film using a knife coater so that the thickness after drying became 100 μm, dried to form a drug-containing adhesive layer, and then bonded to a support. Thereafter, it is cut to a desired size to obtain a patch.

manufacture example 2

[0055] A patch was obtained in the same manner as in Production Example 1, except that diethylamine was prepared in place of dodecylamine so that the amount of scopolamine free base was equal to that in Production Example 1 according to the compounding ratio described in Table 1.

manufacture example 3

[0057] According to the formulation ratio recorded in Table 1, except that the amount of scopolamine free base is equal to that of Production Example 1, methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer (commercial product Name: Eudragit EPO (manufactured by Evonik)) instead of laurylamine, a patch was obtained in the same manner as in Production Example 1.

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PUM

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Abstract

A medicinal composition containing a scopolamine salt and / or a hydrate thereof, polyvinylpyrrolidone, and a base. The medicinal composition is excellent in terms of absorption of the drug into the living body and chemical stability thereof.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing a salt of scopolamine and / or a hydrate thereof as an active ingredient. Background technique [0002] Scopolamine is widely known as an anticholinergic drug, and is a drug that has effects such as suppressing endocrine in the oral cavity and respiratory tract, preventing harmful parasympathetic reflexes, and the like. So far, pharmaceuticals containing scopolamine as an active ingredient have been developed. For example, "HYSCO (ハイスコ) (registered trademark) subcutaneous injections containing scopolamine hydrobromide hydrate, which is a salt of scopolamine, as an active ingredient are manufactured and sold in Japan. Injection, Kyorin Pharmaceutical Co., Ltd., "TransdermScop (registered trademark), Novartis", a patch containing scopolamine free base as an active ingredient, is manufactured and sold overseas. [0003] As we all know, there is a lipid bilayer (lipid bilayer) around t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/46A61K9/70A61K47/32A61K47/34A61P25/02A61P43/00
CPCA61P43/00A61P25/02A61K31/46A61K9/7061A61K47/18A61K47/32
Inventor 小川孝行西村健太上野洋明谷悠平
Owner NOBELPHARMA CO LTD
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