Loratadine oral quickly-soluble film and preparation method thereof

A technology of oral instant film and loratadine, which is applied in the field of medicine and can solve the problems of no obvious anticholinergic and central inhibitory effects

Inactive Publication Date: 2015-10-07
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Loratadine is a commonly used anti-allergic drug, which belongs to the second-generation long-acting tricyclic antihistamine drug. It has a fast onset, strong effect, and does not ...

Method used

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  • Loratadine oral quickly-soluble film and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Loratadine 10%

[0041] Polyvinyl alcohol 36%

[0042] Hypromellose 36%

[0043] Macrogol 400 20%

[0044] Fumed silica 4%

[0045] Coating powder 4%

[0046] Aspartame 0.5%

[0047] Citric Acid 1.5%

[0048] water 20%

[0049] Absolute Ethanol 6%

[0050] ① Take the raw and auxiliary materials in parts by weight;

[0051] ② Add polyethylene glycol and polyvinyl alcohol into water, heat and stir in a water bath at 70°C to dissolve;

[0052] ③ Add hypromellose to the above solution, and stir magnetically to dissolve;

[0053] ④ Add 6ml of ethanol to the above solution and heat it at 60°C for about 30 minutes for defoaming;

[0054] ⑤ Add loratadine and fumed silica to the above solution, and stir slowly with magnetic force to make the dispersion uniform;

[0055] ⑥ Add white coating powder, aspartame and citric acid to the above solution and stir magnetically to dissolve;

[0056] ⑦ Coating, coating the liquid medicine on the stainless...

Embodiment 2

[0061] Loratadine 10%

[0062] Polyvinyl alcohol 36%

[0063] Hypromellose 36%

[0064] Macrogol 400 20%

[0065] Fumed silica 4%

[0066] Titanium dioxide 4%

[0067] Aspartame 0.5%

[0068] Citric Acid 1.5%

[0069] water 20%

[0070] Absolute Ethanol 6%

[0071] ① Take the raw and auxiliary materials in parts by weight;

[0072] ② Add polyethylene glycol and polyvinyl alcohol into water, heat and stir in a water bath at 70°C to dissolve;

[0073] ③ Add hypromellose to the above solution, and stir magnetically to dissolve;

[0074] ④ Add 6ml of ethanol to the above solution and heat it at 60°C for about 30 minutes for defoaming;

[0075] ⑤ Add loratadine and fumed silica to the above solution, and stir magnetically to make the dispersion even;

[0076] ⑥ Add titanium dioxide, aspartame, and citric acid to the above solution and stir magnetically to dissolve;

[0077] ⑦ Coating, coating the liquid medicine on the stainless steel backing plate; ...

Embodiment 3

[0082] Loratadine 10%

[0083] Polyvinyl alcohol 36%

[0084] Hypromellose 36%

[0085] Macrogol 400 20%

[0086] Fumed silica 4%

[0087] Opadry 4%

[0088] Aspartame 0.5%

[0089] Citric Acid 1.5%

[0090] 50% ethanol 25%

[0091] ① Take the raw and auxiliary materials according to parts by weight;

[0092] ② Add polyethylene glycol and polyvinyl alcohol into water, heat and stir in a water bath at 70°C to dissolve;

[0093] ③ Add the hypromellose to the above solution, and magnetically stir to dissolve;

[0094] ④ Add loratadine and fumed silica to the above solution, and stir magnetically to make the dispersion uniform;

[0095] ⑤ Add titanium dioxide, aspartame and citric acid to the above solution and stir magnetically to dissolve;

[0096] ⑥Coating, coating the liquid medicine on the stainless steel backing plate; drying at 60°C for 2 hours;

[0097] ⑦Cut, cut into 3*2cm2;

[0098] ⑧Aluminum-plastic single-piece packaging.

[0099] The o...

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Abstract

The invention discloses a loratadine oral quickly-soluble film and a preparation method thereof. By controlling parameters such as particle size of a loratadine drug, proportion of a film-forming material, content of water of a film product and the like, the product dissolution is improved, the bioavailability can be improved, the preparation can effectively prevent and cure such as allergic rhinitis, chronic idiopathic urticaria, allergic asthma, atopic dermatitis and associated symptoms caused by allergy such as skin diseases (eczema, dermatitis, pruritus cutanea), and the drug effect can be sufficiently realized. The loratadine oral quickly-soluble film does not need water, can be rapidly dissolved in the oral cavity and is convenient to take by patients and particularly suitable for the old people and children patients; moreover, the loratadine oral quickly-soluble film has characteristics of high dispersity, rapidness in absorption, fastness in effect, favorability for improving the bioavailability, and the like.

Description

technical field [0001] The invention relates to a loratadine oral instant film preparation and a preparation method thereof, in particular to a method of adopting a combination of specific film-forming materials and controlling the particle size of raw materials to promote drug dissolution and improve bioavailability, and belongs to the field of medicine. Background technique [0002] Loratadine is a commonly used anti-allergic drug, which belongs to the second-generation long-acting tricyclic antihistamine drug. It has a fast onset, strong effect, and does not contain hormones. Hedine inhibits the allergic symptoms caused by histamine by competitively inhibiting histamine H1 receptors, and has no obvious anticholinergic and central inhibitory effects. Clinically used to relieve symptoms associated with allergic rhinitis, such as sneezing, runny nose and nasal itching, as well as ocular itching and burning. It is also used to relieve the symptoms of chronic urticaria and ot...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4545A61K47/38A61K47/32A61P37/08
Inventor 冯慧刁媛媛马苏峰
Owner AVENTIS PHARMA HAINAN
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