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Sildenafil oral fast dissolving film and preparation method thereof

An oral instant film, sildenafil technology, which is applied in the directions of non-active medical preparations, pharmaceutical formulations, inorganic non-active ingredients, etc., can solve problems such as drugs that are not suitable for large doses

Inactive Publication Date: 2017-12-15
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantages are: a new production line must be established, taste masking is a challenge for film formulations, and it is not suitable for large doses of drugs

Method used

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  • Sildenafil oral fast dissolving film and preparation method thereof
  • Sildenafil oral fast dissolving film and preparation method thereof
  • Sildenafil oral fast dissolving film and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1 prepares sildenafil oral cavity instant film

[0036] A total of 1,000 tablets, with a specification of 50 mg (calculated as sildenafil, containing 70.2 mg of sildenafil citrate), and its raw material composition is as follows:

[0037]

[0038] Disperse sildenafil citrate and sodium chloride in 280.8g of water to obtain a uniform suspension solution, then add HPMC-E15, polyethylene glycol 400, sodium salicylate, and sucralose, stir evenly, defoam, and coat Film, dry at 40-80°C, cut and pack.

[0039] The film has a good appearance, milky white, smooth to the touch, a thickness of 80±5μm, a tensile strength of 9.2±1Mpa, a slightly sweet taste, and a melting time of 25s.

Embodiment 2

[0040] Embodiment 2 prepares sildenafil oral cavity instant film

[0041] A total of 1,000 tablets, with a specification of 50 mg (calculated as sildenafil, containing 70.2 mg of sildenafil citrate), and its raw material composition is as follows:

[0042]

[0043] Disperse sildenafil citrate and sodium chloride in 280.8g of water to obtain a uniform suspension solution, then add pullulan, polyethylene glycol 400, sodium salicylate, and sucralose, stir evenly, and defoam. Coated film, dried at 40-80°C, cut and packaged.

[0044] The film has a good appearance, milky white, smooth to the touch, a thickness of 80±5μm, a tensile strength of 8.5±1Mpa, a slightly sweet taste, and a melting time of 28s.

Embodiment 3

[0045] Embodiment 3 prepares sildenafil oral cavity instant film

[0046] A total of 1,000 tablets, with a specification of 50 mg (calculated as sildenafil, containing 70.2 mg of sildenafil citrate), and its raw material composition is as follows:

[0047]

[0048] Disperse sildenafil citrate and sodium chloride in 280.8g of water to obtain a uniform suspension solution, then add HPMC-E15, polyethylene glycol 400, sodium salicylate, and sucralose, stir evenly, defoam, and coat Film, dry at 40-80°C, cut and pack.

[0049] The film has a good appearance, milky white, smooth to the touch, a thickness of 80±5μm, a tensile strength of 10.7±1Mpa, a slightly bitter taste, and a melting time of 35s.

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Abstract

The invention discloses a sildenafil oral fast dissolving film and a preparation method thereof. The sildenafil oral fast dissolving film comprises raw materials as follows: sildenafil citrate, a polymer film-forming material and auxiliary materials, wherein the auxiliary materials comprise a first auxiliary material which comprises a taste masking agent, a plasticizing agent and a penetration enhancer. According to the sildenafil oral fast dissolving film, sodium chloride is use as the special taste masking agent, so that the bad taste of sildenafil citrate is completely masked, and the rate of sildenafil citrate penetrating through oral mucosae of animals is obviously increased after the penetration enhancer is added; the film is prepared with a casting method, and the taste masking agent in the finished film can effectively mask bitterness of sildenafil citrate. The film in the dosage form has the characteristics of rapid disintegration property, good drug compliance, low production energy consumption, little dust, low cost and high efficiency, can be taken without water, and is better than most oral solid preparations.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a sildenafil oral instant film and a preparation method thereof. Background technique [0002] With the increasingly intensified social competition and increasingly serious environmental pollution, the incidence of male erectile dysfunction is on the rise. These sexual dysfunctions include loss of libido, erectile dysfunction, premature ejaculation and others. The overall prevalence of men with erectile dysfunction (ED) is increasing year by year. [0003] Sildenafil citrate (Sildenafil; trade name Viagra, Viagra) was the first FDA-approved oral formulation for the treatment of erectile dysfunction. During sexual stimulation, the nerves and endothelial cells of the spongy body of the penis release nitric oxide (NO), which activates guanylate cyclase (guanylate cyclase) to generate cyclic guanylate (aGMP), resulting in arterioles, arterioles and penis The sm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/519A61K47/02A61K47/38A61K47/12A61K47/36A61P15/10
CPCA61K9/006A61K9/7007A61K31/519A61K47/02A61K47/12A61K47/36A61K47/38
Inventor 张亮亮何勇杨贤龙吴宗好
Owner HEFEI HUAFANG PHARMA SCI & TECH
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