Oral film-form base and preparation

一种口腔内、薄膜状的技术，应用在口腔内薄膜状基剂及制剂领域

Inactive Publication Date: 2013-07-17
NITTO DENKO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, different from these means, as a method of improving the feeling of ingestion, for example, Patent Document 10, Patent Document 11, etc. also report a rapidly dissolving formulation that utilizes a foaming component that foams when it comes into contact with water. From the point of view of properties, there is a problem that it has a two-layer structure (Patent Document 10), and a foaming agent that has the possibility of foaming in a protic solvent such as ethanol is combined as a foaming component (Patent Document 11)

Method used

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  • Oral film-form base and preparation
  • Oral film-form base and preparation
  • Oral film-form base and preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0122] Add 5 parts by weight of polyethylene glycol (PEG400) to 240 parts by weight of ethanol, 10 parts by weight of sodium bicarbonate microparticles (manufactured by Wako Pure Chemical Industry Co., Ltd.) of previously controlled particle size, and L-potassium hydrogen tartrate microparticles (manufactured by Komatsuya Co., Ltd. ) 10 parts by weight, which is beneficial to ultrasonic waves to disperse them more fully, then add about 30,000 molecular weight, 53.4 to 77.5% HPC (manufactured by Nippon Soda Corporation, trade name: Nisso HPC SSL) 75 The parts by weight were stirred and dissolved by a rolling mixer to prepare a dispersion. The dispersion liquid was fully defoamed, and then spread and dried on a polyester release film to obtain a film with a thickness of about 70 μm.

[0123] The resulting film was peeled off from the polyester release film and cut into 4 cm 2 rectangle, the oral film-form base of Example 1 was obtained.

Embodiment 2

[0125] Except using PVP with a molecular weight of 1.05 million to 1.2 million (manufactured by Wako Pure Chemical Industries, Ltd., reagent name: POLYVINYLPYRROLIDONE K90) instead of HPC, and following the composition shown in Table 3, the oral cavity of Example 2 was obtained by the same steps as in Example 1. Inner film-like base.

Embodiment 3

[0127] The oral film-form base of Example 3 was obtained by the same procedure as in Example 1 except that acetone was used instead of ethanol and the composition shown in Table 3 was followed.

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Abstract

The present invention provides an oral film-form base which has a rapid dissolution profile in the mouth and sufficient film strength, and gives an improved taking property by foaming in the mouth. The oral film-form base includes an edible polymer soluble both in water and in an organic solvent having a solubility parameter of 9.7 or higher, a foaming agent, and an auxiliary foaming agent, wherein the foaming agent is foamable in the presence of water, and the foaming agent and the auxiliary foaming agent each are insoluble in the organic solvent, have an average particle size of 0.1 to 60 [mu]m, and are included in particle states.

Description

technical field [0001] The present invention relates to an oral film-form base that dissolves rapidly in the oral cavity, and a preparation containing a drug in the oral film-form base. Oral film base and preparation made of foaming foaming component particles and monosaccharide ~ hexasaccharide or their sugar alcohol particles, which dissolve and foam rapidly in the oral cavity, so that the drug can be absorbed by the digestive organs Or the oral mucosa is well absorbed. Background technique [0002] As current orally applicable pharmaceuticals, solid preparations such as bare tablets, coated tablets, capsules, powders, and granules, and liquid preparations such as liquids and emulsions have appeared on the market. In addition, orally disintegrating tablets and fast-dissolving oral film preparations are already on the market as preparations that disintegrate in the oral cavity and are absorbed in the digestive tract. [0003] Preparations in the form of films, strips, or ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K47/38A61K47/32
CPCA61K9/0007A61K9/006A61K47/02A61K9/70A61K47/34A61K47/38
Inventor 浅利大介堀光彦宍户卓矢
Owner NITTO DENKO CORP
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