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Oral sticking tablet and method of preparing the same

An adhesive sheet and oral cavity technology, which is applied in the field of oral adhesive sheet and its preparation, can solve the problems of short adhesion time, bad foreign body sensation, etc., and achieve the effect of increasing the sticking time, simple preparation method, and easy industrial implementation

Inactive Publication Date: 2008-01-23
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the particularity of chewing and swallowing functions in the oral cavity, it is still a challenge to develop pharmaceutical preparations that can remain in the mouth for a longer period of time. There are still some unsolved problems in the adhesive dosage forms prepared according to the above-mentioned prior art. problems, including: shorter adhesion times and poor foreign body sensation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Fluconazole Oral Adhesive Tablets (Amount of 1 tablet)

[0043] Fluconazole 5mg

[0044] Pregelatinized starch 20mg

[0045] Carbopol 974P 5mg

[0046] Croscarmellose Sodium 29mg

[0047] Micronized silica gel 0.5mg

[0048] Magnesium stearate 0.5mg

[0049] Mix the powder evenly in a multi-dimensional mixer, and pass through an 80-mesh nylon sieve, under 6 to 8 kilograms of force, use a flat punch with a diameter of 6 mm, and use the powder direct compression method to directly compress it into a tablet with a total weight of 60 mg. A pharmaceutical composition that releases medicine on both sides of the layer.

Embodiment 2

[0051] Itraconazole Oral Adhesive Tablets (Amount of 1 tablet)

[0052] Itraconazole 15mg

[0053] Pregelatinized starch 30mg

[0054] Dextrin 15mg

[0055] Carbopol 974P 10mg

[0056] Croscarmellose Sodium 30mg

[0057] Mix the powder evenly in a multi-dimensional mixer, and pass through an 80-mesh nylon sieve, under 6 to 8 kilograms of force, use a flat punch with a diameter of 8 mm, and use the powder direct compression method to directly press into tablets with a total weight of 100 mg. A pharmaceutical composition that releases medicine on both sides of the layer.

Embodiment 3

[0059] Fluconazole Oral Adhesive Tablets (Amount of 1 tablet)

[0060] Fluconazole 15mg

[0061] Pregelatinized starch 25mg

[0062] Carbopol 974P 5mg

[0063] Low-substituted hydroxypropyl cellulose 14.5mg

[0064] Proper amount of ethanol

[0065] Micronized silica gel 0.25mg

[0066] Magnesium stearate 0.25mg

[0067] Using the wet granule tableting method, wet fluconazole, pregelatinized starch, Carbopol 974P, and low-substituted hydroxypropyl cellulose with an appropriate amount of ethanol, squeeze through a 24-mesh nylon sieve, dry at 60°C to remove ethanol, and pass through 24 After mesh sieving, add micropowder silica gel and magnesium stearate and mix evenly. Under 6 to 8 kilograms of force, use a flat punch with a diameter of 6 mm to directly press into a tablet with a total weight of 60 mg. It is used as a single-layer double-sided drug release drug combination.

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PUM

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Abstract

The invention relates to an oral cavity plaster, which has effective dosage of active drug ingredient, 1 per cent to 40 per cent bioadhesion ingredient, 0 per cent to 85 per cent (w / w) diluted filling ingredient, 0 per cent to 5 per cent (w / w) lubricant glidant ingredient and 0.5 per cent to 89 per cent (w / w) water absorption carrier ingredient. Wherein, the active drug ingredient comprises fluconazole, itraconazole, clotrimazole or Nystatin. Therefore, the oral cavity plaster in the invention can be adhered to the medication position, is able to continuously and stably release drug in during a long time (within 9 hours) as well as maintain effective and safe drug concentration and prevent the impact on medication resulted from eating, drinking and swallow action of oral cavity.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an oral adhesive sheet and a preparation method thereof. The oral adhesive sheet is used for local treatment of oropharyngeal candidiasis, or for systemic fungal infection through mucosal absorption. Background technique [0002] Oropharyngeal and esophageal candidiasis (oral candidiasis) is a disease caused by fungal Candida infection, which is highly common in people with dysbacteriosis or weakened immunity, including HIV-infected patients, cancer patients, and those who use immunosuppressants Organ transplant patients, patients with low endocrine function, diabetics, malnutrition and congenital immunocompromised patients. In addition, the abuse of some drugs such as broad-spectrum antibiotics and corticosteroids (SH) also increases the incidence of oropharyngeal candidiasis. Patients with oropharyngeal candidiasis mainly present with ulcers, burning sensatio...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4196A61K31/496A61K31/4164A61K31/7048A61K47/32A61K47/36A61K47/38A61P1/02A61P31/10
Inventor 王亚静李章才
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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