Supercharge Your Innovation With Domain-Expert AI Agents!

Coated solid dosage form

A solid preparation and coating technology, applied in the direction of anhydride/acid/halide active ingredients, etc., can solve the problems of non-existence and deliquescence, and achieve the effects of preventing deliquescence, improving stability, and excellent stability

Inactive Publication Date: 2016-11-30
TORAY IND INC
View PDF5 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, valproic acid is highly hygroscopic and will deliquesce even if it is only left at room temperature, so there is no formulation suitable for one-dose packs

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Coated solid dosage form
  • Coated solid dosage form
  • Coated solid dosage form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] 10.0 parts by mass of polyvinyl alcohol (EG-05; Nippon Gosei Kagaku) ​​and 312.5 parts by mass of bentonite solution were added to 177.5 parts by mass of water, and stirred with a homogenizer (Polytron Model KR) to obtain a coating material. 3.2% bentonite solution The following solution was used: Add 32 parts by mass of bentonite (Kunipia-F; Kunimine Industries Co. Ltd., cation exchange capacity: 115meq / 100g) to 968 parts by mass of stirred water, and make it Uniformly disperse the solution after suction filtration with filter paper. Hereinafter, polyvinyl alcohol is abbreviated as PVA, and bentonite is abbreviated as BT, respectively.

[0063] The sodium valproate sustained-release tablet (Selenica R200mg; Xinghe Co., Ltd.) of 200g is put into a coating pan (DRC-200; Powrex company), and the coating material prepared in Example 1 is coated on the tablet to make it The thickness reaches 20 μm. The obtained coated solid preparation was observed for changes in the exte...

Embodiment 6

[0076] (Example 6) To 17.32 parts by mass of water and 390.0 parts by mass of ethanol, add 5.28 parts by mass of PVA, 385.0 parts by mass of BT solution, and 2.4 parts by mass of sorbitan monolaurate, and stir with a homogenizer , to obtain the coating material. The film was obtained by the method of Example 1, and the water vapor permeability was measured. Hereinafter, sorbitan monolaurate may be abbreviated as Span20.

Embodiment 7

[0085] (Example 7) A dissolution test was performed on the coated tablet obtained in Example 6 and the tablet obtained by leaving the present tablet under the conditions of 25° C. and 60% RH. In the dissolution test, according to the second method of the dissolution test method of the fifteenth revision of the Japanese Pharmacopoeia, the tablet was put into 900 mL of distilled water, and the dissolution rate of the drug was quantified by HPLC at 8 hours, 11 hours, and 20 hours after the start of dissolution.

[0086] (HPLC conditions)

[0087] Mobile phase: 50mM sodium dihydrogen phosphate / acetonitrile=5 / 5(v / v)

[0088] Column: Devolosil ODS-5 (4.6×150mm)

[0089] Detection wavelength: 210nm.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The object of the present invention is to provide a kind of valproic acid or its pharmacologically acceptable salt that can keep the stability to humidity even in the unpackaged state, and deliquescence is suppressed Coated solid dosage forms for single-dose packaging applications. The invention provides a coated solid preparation, wherein, containing valproic acid or a pharmacologically acceptable salt thereof as an active ingredient, coated with a coating layer containing polyvinyl alcohol and swelling clay, the quality of polyvinyl alcohol and swelling clay The ratio is 8:2~3:7, and the expanded clay is dispersed in the form of a laminated structure.

Description

technical field [0001] The present invention relates to coated solid preparations. Background technique [0002] Valproic acid is useful as an antiepileptic drug, and it is widely administered for the treatment of epilepsy and the prevention of seizures of epilepsy. However, valproic acid is highly hygroscopic and will deliquesce even if it is only left at room temperature, so there is no preparation suitable for one-dose packs. Therefore, it is desired to develop a formulation that is stable against humidity and does not deliquesce under normal storage conditions. [0003] As methods for improving the deliquescent properties of valproic acid, there are known a method of compounding a non-hygroscopic excipient in a solid preparation (Patent Document 1), a method of sugar coating (Patent Document 2), and a film-coated method with a polymer material. A method of coating (Patent Document 3), a method of packaging with a packaging material having high water vapor barrier prope...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/19
Inventor 林有纪吉井良二堀内保秀
Owner TORAY IND INC
Features
  • R&D
  • Intellectual Property
  • Life Sciences
  • Materials
  • Tech Scout
Why Patsnap Eureka
  • Unparalleled Data Quality
  • Higher Quality Content
  • 60% Fewer Hallucinations
Social media
Patsnap Eureka Blog
Learn More

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2025 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com