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Coated solid hyponotic

A solid and preparation technology, applied in the field of coated solid hypnotic preparations, can solve problems such as difficulty in drug preservation

Inactive Publication Date: 2003-10-22
SS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Although it is possible to prevent this phenomenon of discoloration by light-shielding boxes and packaging containers, it is generally difficult for patients to always store medicines in packaging containers.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Coated Tablets (1)

[0032] 2500g of diphenhydramine hydrochloride, 6700g of lactose, 2000g of cornstarch, 1000g of crystalline cellulose, 250g of sodium carboxymethylcellulose and 300g of polyvinylpyrrolidone were mixed and granulated according to conventional methods to obtain granules for tableting. 122.5 g of talc and 122.5 g of magnesium stearate were added to 12495 g of the granules for tableting, mixed and then compressed to form 48,000 plain tablets each weighing 260 mg with a diameter of 9 mm and a thickness of 4.2 mm.

[0033] Then, 3000 plain tablets were coated with 10% aqueous coating solution containing 75g hydroxypropyl methylcellulose 2910, 5g polyethylene glycol 6000, 11g titanium oxide and 9g talcum powder in a high-speed coating machine (Floint Industry Co., Ltd. ) in spray coating to make 5 mg / tablet coated tablet (1) after drying. The film thickness of the coated tablet was measured with a scanning electron microscope, and the measured value was 41...

Embodiment 2

[0035] Coated Tablets (2)

[0036] 3000 plain tablets obtained in Example 1 were spray-coated in a high-speed coating machine (Floint Industry) with 10% of the same composition of the water-based coating solution in Example 1, and made into a coating of 2.5 mg / tablet after drying Tablets (2). The film thickness of the coated tablet was measured with a scanning electron microscope, and the measured value was 22.1 μm (average value of n=20)

Embodiment 3

[0038] Coated Tablets (3)

[0039] 3000 plain tablets obtained in Example 1 were spray-coated in a high-speed coating machine (Floint Industry) with 10% of the same composition of the water-based coating solution in Example 1 to make a coating of 3.8 mg / tablet after drying Tablets (3). The film thickness of the coated tablet was measured with a scanning electron microscope, and the measured value was 32.8 μm (average value of n=20).

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PUM

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Abstract

The invention provides a preparation which comprises diphenhydramine or its acid addition salt as the pharmaceutical component of hypnotic / sedative action, has no discoloration, is stable, masks bitterness in administration and causes quick and secure effect. The coated solid hypnotic preparation is obtained by coating a solid agent comprising diphenhydramine or its acid addition salt as the pharmaceutical component having hypnotic / sedative action with a coating film containing a lightproof substance and a water-soluble polymer.

Description

technical field [0001] The present invention relates to the solid hypnotic preparation of coating, specifically, relate to diphenhydramine or its acid addition salt as the medicinal ingredient with hypnotic and sedative effect, which is stable and does not change color, covers the bitter taste when taken and has a fast onset of action Coated solid hypnotic preparation. Background technique [0002] In the past, diphenhydramine or its acid addition salt has been used as an active ingredient in rhinitis, skin disease, cold medicine and antitussive expectorant because of its antihistamine effect and central action, but it has the side effect of drowsiness. shortcoming. [0003] For example, diphenhydramine hydrochloride and diphenhydramine citrate are known to have hypnotic effects equivalent to mild hypnotic agents. Moreover, because it disappears quickly in the blood and does not produce tolerance, it is used as an over-the-counter hypnotic drug equivalent to Japanese gener...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/16A61K9/28A61K9/36A61K9/48A61K31/135A61K47/02A61K47/32A61K47/34A61K47/38A61K47/42A61P25/20
CPCA61K9/16A61K9/20A61K31/135
Inventor 菅田晴夫冈田実神户英芳
Owner SS PHARMA CO LTD
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