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Novel loratadine oral quickly soluble film and preparation method thereof

A technology of oral instant film and loratadine, which is applied in the direction of medical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of drug use in young patients and patients with achlorhydria Considering the adjustability of children's medication and other issues, the process of taking medicine is easy and pleasant, convenient to carry and transport, and to meet the fast-paced effect

Inactive Publication Date: 2017-05-10
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The oral instant film can realize rapid melting and dispersion at the entrance, and has a good taste, but it does not consider the adjustability of children's medication, nor does it study the medication of elderly patients and patients with achlorhydria

Method used

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  • Novel loratadine oral quickly soluble film and preparation method thereof
  • Novel loratadine oral quickly soluble film and preparation method thereof
  • Novel loratadine oral quickly soluble film and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Loratadine oral cavity instant film, comprises the composition of following percentage by weight:

[0057]

[0058]

[0059] The preparation method comprises the following steps:

[0060] (1) Add the prescribed amount of surfactant into water under heating conditions at 62°C, and stir to obtain an aqueous solution as the water phase;

[0061] (2) Add the prescribed amount of medicine and surfactant into an appropriate amount of ethanol under heating conditions at 62°C, and stir to dissolve the medicine as an oil phase;

[0062] (3) Add the oil phase at 62°C to the water phase at the same temperature, stir with a high-speed disperser at 10,000rpm for 30 minutes while adding, try to control the constant speed of addition, and then use a high-pressure homogenizer to homogenize at 750bar for 10 times, Obtain a uniform film intermediate;

[0063] (4) After the intermediate is cooled to room temperature, the film-forming material, plasticizer and other paving material...

Embodiment 2

[0067] Loratadine oral cavity instant film, comprises the composition of following percentage by weight:

[0068]

[0069] The preparation method comprises the following steps:

[0070] (1) Add the prescribed amount of surfactant into water under heating conditions at 62°C, and stir to obtain an aqueous solution as the water phase;

[0071] (2) Add the prescribed amount of medicine and surfactant into an appropriate amount of ethanol under heating conditions at 62°C, and stir to dissolve the medicine as an oil phase;

[0072] (3) Add the oil phase at 62°C to the water phase at the same temperature, stir with a high-speed disperser at 750rpm for 30 minutes while adding, control the addition at a constant speed as much as possible, and then use a high-pressure homogenizer to homogenize at 1000bar for 10 times, Obtain a uniform film intermediate;

[0073] (4) After the intermediate is cooled to room temperature, the film-forming material, plasticizer and other auxiliary mate...

Embodiment 3

[0077] Loratadine oral cavity instant film, comprises the composition of following percentage by weight:

[0078]

[0079] The preparation method comprises the following steps:

[0080] (1) Add the surfactant of the prescription amount into water under the heating condition of 70° C., and stir to obtain an aqueous solution as the water phase;

[0081] (2) Add the prescribed amount of medicine and surfactant into an appropriate amount of ethanol under heating conditions at 70°C, and stir to dissolve the medicine as an oil phase;

[0082] (3) Add the oil phase at 70°C to the water phase at the same temperature, stir at 750rpm for 15 minutes while adding, try to control the constant speed of addition, and then use a high-pressure homogenizer to homogenize at 1000bar for 15 times to obtain a uniform film intermediates;

[0083] (4) After the intermediate is cooled to room temperature, the film-forming material, plasticizer and other auxiliary materials are added. In order to ...

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Abstract

The invention relates to a novel loratadine oral quickly soluble film and a preparation method thereof. The oral quickly soluble film comprises the following components: loratadine, a surfactant, a film-forming material, a flavoring agent, a corrigent and a small amount of ethanol. The invention further provides a preparation method of the novel loratadine oral quickly soluble film. The oral quickly soluble film is small in size and convenient to carry; the dosage is convenient to control, a preparation process is simple and controllable, special production equipment is not required, the novel loratadine oral quickly soluble film is suitable for industrial massproduction, can be quickly dissolved in the oral cavity of a patient who does not need to drink water or chew, and tastes good; compliance of medication for children is greatly improved; the dissolution condition of the novel loratadine oral quickly soluble film in a citric acid-disodium hydrogen phosphate buffer solution with pH of 4.0 is remarkably better than the dissolution condition of commercially available tablets; and the novel loratadine oral quickly soluble film has significance on gerontal patients and other patients with achlorhydria.

Description

technical field [0001] The invention relates to a novel loratadine oral instant film, which can meet the needs of children, adult patients and elderly patients, and specifically relates to a loratadine oral instant film and a preparation method thereof. Background technique [0002] Drug use in children is an issue of great concern worldwide. Due to the difficulty, high cost, and high safety requirements in the development of children's medicines, the development of the children's medicine industry is still at a primary level, and special medicines for children are scarce. At present, the problems of few suitable varieties of children's medicines in my country, lack of suitable dosage forms and specifications, weak foundation of drug clinical trials, irregular prescription behavior and irrational drug use are still relatively prominent and need to be resolved urgently. Children have higher requirements on the taste of medicines. Some adult medicines taste bad when taken to ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4545A61K47/10A61K47/38A61K47/36A61P37/08
CPCA61K9/7007A61K9/0002A61K9/006A61K31/4545A61K47/10A61K47/36A61K47/38
Inventor 葛亮卢欣陈跃坚朱颖任圆何新怡
Owner CHINA PHARM UNIV
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