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Gliclazide oral instant membrane and preparation method thereof

An oral instant film and film-forming material technology, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, metabolic diseases, etc., can solve problems such as difficulty in swallowing and poor compliance, and achieve convenient use, light weight, and accurate content Effect

Inactive Publication Date: 2018-01-19
HENAN TIANSHENG TAIFENG PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Most diabetic patients are middle-aged and elderly people, and a considerable part of them will have difficulty swallowing, and the medication compliance of ordinary oral preparations is poor

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Gliclazide oral instant film, comprising the following composition by weight percentage:

[0030] Gliclazide 35%

[0031] Poloxamer 12%

[0032] Hypromellose 30%

[0033] Polyethylene glycol 4%

[0034] Fragrance 1%

[0035] Sucralose 1%

[0036] water 10%

[0037] Proper amount of ethanol

[0038] The preparation method is as follows:

[0039] (1) Add the prescribed amount of surfactant into water under the heating condition of 65°C, and stir evenly as the water phase;

[0040] (2) Add the prescribed amount of medicine into an appropriate amount of ethanol under heating conditions at 65°C, and stir to dissolve the medicine as an oil phase;

[0041] (3) Add the oil phase at 65°C to the water phase at the same temperature, stir with a high-speed disperser at 10,000 rpm for 30 minutes while adding, and then use a high-pressure homogenizer to homogenize at 900 bar for 15 times to obtain a uniform film in the middle body;

[0042] (4) After the intermediate is coo...

Embodiment 2

[0046] Gliclazide oral instant film, comprising the following composition by weight percentage:

[0047] Gliclazide 20%

[0048] Poloxamer 9%

[0049] Hypromellose 50%

[0050] Polyethylene glycol 2%

[0051] Fragrance 1%

[0052] Sucralose 2%

[0053] water 10%

[0054] Proper amount of ethanol

[0055] The preparation method is as follows:

[0056] (1) Add the prescribed amount of surfactant into water under heating at 60°C, and stir evenly as the water phase;

[0057] (2) Add the prescribed amount of medicine into an appropriate amount of ethanol under heating conditions at 60°C, and stir to dissolve the medicine as an oil phase;

[0058] (3) Add the oil phase at 60°C to the water phase at the same temperature, stir with a high-speed disperser at 9000rpm for 40min while adding, and then use a high-pressure homogenizer to homogenize at 700bar for 15 times to obtain a uniform film in the middle body;

[0059] (4) After the intermediate is cooled to room temperature,...

Embodiment 3

[0063] Gliclazide oral instant film, comprising the following composition by weight percentage:

[0064] Gliclazide 30%

[0065] Poloxamer 15%

[0066] Hypromellose 34%

[0067] Polyethylene glycol 2%

[0068] Fragrance 1%

[0069] Sorbitol 2%

[0070] water 15%

[0071] Proper amount of ethanol

[0072] The preparation method is as follows:

[0073] (1) Add the prescribed amount of surfactant into water under the heating condition of 70°C, and stir evenly as the water phase;

[0074] (2) Add the prescribed amount of medicine into an appropriate amount of ethanol under the heating condition of 70°C, and stir to dissolve the medicine as an oil phase;

[0075] (3) Add the oil phase at 70°C to the water phase at the same temperature, stir with a high-speed disperser at 11,000 rpm for 20 minutes while adding, and then use a high-pressure homogenizer to homogenize at 900 bar for 8 times to obtain a uniform film in the middle body;

[0076] (4) After the intermediate is cool...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and in particular relates to a prescription of a gliclazide oral instant membrane and a preparation method of the gliclazide oral instant membrane. The gliclazide oral instant membrane is prepared from the following components: gliclazide, a surface active agent, a film-forming material, a corrective, a plasticizer, and a necessaryand pharmaceutically acceptable filling agent; a coloring agent and the like also can be added into the gliclazide oral instant membrane according to the need. The gliclazide oral instant membrane prepared by the method can be rapidly dissolved in the oral cavity without needing drinking water, is rapid in drug release rate and better in taste, and can help to improve the medication compliance ofpatients, especially elderly patients. Furthermore, the product has the characteristics of being accurate in dose, quick in response and high in bioavailability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a gliclazide oral instant film and a preparation method thereof. Background technique [0002] Diabetes has become the third major disease that seriously endangers human health after cardiovascular and cerebrovascular diseases and malignant tumors. Gliclazide, as the second-generation oral sulfonylurea hypoglycemic drug, mainly stimulates the secretion of insulin by the pancreatic β cells, especially after eating glucose, and enhances the effect of insulin on the target tissue, so that it can effectively Lower blood sugar concentration. In addition to the hypoglycemic effect on adults with diabetes, it can also reduce platelet adhesion, reduce plasma viscosity, and reduce ADP-induced platelet aggregation. It is an effective and safe first-line drug for the treatment of non-insulin-dependent diabetes. [0003] Most diabetic patients are middle-aged and elde...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/64A61K47/38A61K47/32A61K47/10A61P3/10
Inventor 沙薇李亚平张兴爽
Owner HENAN TIANSHENG TAIFENG PHARM TECH CO LTD
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