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Instant film preparation containing phenylephrine hydrochloride

A technology of phenylephrine hydrochloride and film preparation, which is applied in the direction of medical preparations containing active ingredients, organic active ingredients, chemical instruments and methods, etc., which can solve the problems of non-existence and achieve high yield and easy manufacturing.

Inactive Publication Date: 2009-05-06
KOWA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Thus, the fact is that there is no instant film formulation combining phenylephrine hydrochloride, HPC and / or HPMC

Method used

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  • Instant film preparation containing phenylephrine hydrochloride
  • Instant film preparation containing phenylephrine hydrochloride
  • Instant film preparation containing phenylephrine hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0483] Manufacture of 6-layer film preparation

[0484] Dissolve 157.5g phenylephrine hydrochloride, 60g d-chlorpheniramine maleate, 6g belladonna total alkaloids, 30g erythritol, 30g sodium saccharin and 6g sodium bisulfite in 540g water, add 360g absolute ethanol. 318 g of HPC (d) was added to this solution to obtain a drug-containing layer preparation.

[0485] Dissolve 25g of powdered reduced maltose syrup in 168g of water. Add 15g of titanium oxide and 0.1g of edible blue No. 1 aluminum precipitation colorant dispersed in 112g of absolute ethanol to this liquid, add 60g of HPMC (b) again, obtain the first shielding layer preparation liquid.

[0486] Dissolve 6g of 1-menthol in 150g of absolute ethanol, add 150g of water in this liquid. 97 g of HPMC (a) was added to this solution to obtain a second masking layer preparation solution.

[0487] Next, fix the polyethylene terephthalate film (PET film) with silicone release treatment on the back side to the unwinding shaft...

Embodiment 2

[0496] Production of 4-layer film preparation

[0497] Dissolve 157.5g phenylephrine hydrochloride, 60g d-chlorpheniramine maleate, 6g belladonna total alkaloids, 30g erythritol, 30g sodium saccharin and 6g sodium bisulfite in 540g water, add 360g absolute ethanol and 1.8g 1-menthol. 316.2 g of HPC (d) was added to this solution to obtain a drug-containing layer preparation.

[0498] 20 g of pullulan was added to 40 g of water to obtain a masking layer preparation solution.

[0499] Next, the PET film on the back surface of which the silicone release treatment was performed was fixed on the unwinding shaft of the coater, the masking layer preparation solution was supplied to the weir portion, and the masking layer preparation solution was coated on the non-release-treated surface of the PET film. Dry with hot air to form an edible masking layer with a thickness of 20 μm.

[0500] Then, on the unwinding shaft, fix again the PET film that is formed with the masking layer. 2 ...

Embodiment 3

[0505] Production of 4-layer film preparation

[0506] Dissolve 157.5g phenylephrine hydrochloride, 60g d-chlorpheniramine maleate, 6g belladonna total alkaloids, 30g erythritol, 30g sodium saccharin and 6g sodium bisulfite in 540g water, add 360g absolute ethanol and 1.8g 1-menthol. 316.2 g of HPC (d) was added to this solution to obtain a drug-containing layer preparation.

[0507] Add 20 g of PVP (K-90) to 80 g of water to obtain a masking layer preparation solution.

[0508] Next, the PET film on the back surface of which the silicone release treatment was performed was fixed on the unwinding shaft of the coater, the masking layer preparation solution was supplied to the weir portion, and the masking layer preparation solution was coated on the non-release-treated surface of the PET film. Dry with hot air to form an edible masking layer with a thickness of 25 μm.

[0509] Then, on the unwinding shaft, fix again the PET film that is formed with the masking layer. 2 ) to...

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Abstract

The present invention provides a membrane preparation which is combined with phenylephrine hydrochloride, hydroxypropyl cellulose and / or hydroxypropyl methyl cellulose and can be quickly dissolved in oral cavity. The rapidly soluble membrane preparation 1 comprising phenylephrine hydrochloride 1 according to the invention is characterized by comprising a resin film 3, one layer or more than two layers of shielding layer 5, and one layer or more than two layers of medicine-containing layer 7. The shielding layer 5 is formed on the resin film 3 and comprises edible macromolecular substance and does not contain phenylephrine hydrochloride. Additionally the medicine-containing layer 7 is formed on the shielding layer 5 and comprises at least one component selected from hydroxypropyl cellulose and hydroxypropyl methyl cellulose. Furthermore the rapidly soluble membrane preparation 1 comprising phenylephrine hydrochloride 1 according to the invention can comprise one layer or more than two layers of shielding layer 5 that comprises edible macromolecular substance and does not contain phenylephrine hydrochloride according to expectation.

Description

technical field [0001] The present invention relates to a fast-dissolving film preparation containing phenylephrine hydrochloride and a production method thereof. Background technique [0002] Phenylephrine hydrochloride is also known as PhenylephrineHydrochloride or phenylephrine hydrochloride in the Japanese Pharmacopoeia. The peripheral vasoconstriction produced by the stimulation of sympathetic nerve endings shows a boosting effect, and is used as a sympathetic nerve stimulant, a vasopressor, a vascular Shrinking drugs, mydriatic drugs, etc. [0003] Conventionally, oral preparations containing phenylephrine hydrochloride are, for example, those disclosed in Patent Documents 1 to 4, which are almost compression molded by a tablet machine. In Example 2 of Patent Document 1, the composition containing phenylephrine hydrochloride was granulated into granules, and then compressed into tablets using a tablet machine. In addition, Patent Documents 2 to 4 exemplify phenylephr...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/137A61P25/00A61P9/00
CPCB32B27/08B32B27/18
Inventor 西川久信粟村努
Owner KOWA CO LTD
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