Ketotifen fumarate tablet and application thereof

A technology for ketotifen fumarate and tablets, which is applied in the fields of pill delivery, medical preparations containing active ingredients, respiratory diseases, etc., and can solve the problems of decreased dissolution rate, poor stability, and insufficient mixing uniformity of tablets, etc. problem, to achieve the effect of dissolution stability

Inactive Publication Date: 2020-01-10
仁和堂药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The mixing uniformity of the above tablets is insufficient, the dissolution rate needs to be improved, and the stabi...

Method used

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  • Ketotifen fumarate tablet and application thereof
  • Ketotifen fumarate tablet and application thereof
  • Ketotifen fumarate tablet and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] A kind of ketotifen fumarate tablet, its prescription (5000 tablets) is shown in Table 1:

[0040] Table 1

[0041]

Embodiment 2

[0043] The preparation process of ketotifen fumarate tablet:

[0044] 1. Weighing

[0045] Weigh ketotifen fumarate, lactose monohydrate, cornstarch, and pregelatinized starch according to the prescription, and set aside.

[0046] 2. mix

[0047] Put 30% lactose monohydrate and ketotifen fumarate in sequence in a wet granulator for mixing, rotation speed: stirring 200rpm, mixing time: 5min;

[0048] Continue to add 30% lactose, rotation speed: stirring at 200rpm, chopping at 300rpm, mixing for 10min, taking samples from the upper, middle and lower parts respectively, and the mixing uniformity RSD should be ≤3%;

[0049] Add the remaining amount of lactose, pregelatinized starch, and cornstarch. Speed: Stir at 200rpm, chop at 300rpm, mix for 5min, stir at 400rpm, chop at 1200rpm, mix for 5min, take samples from the upper, middle, and lower parts for testing, and mix Uniformity RSD should be ≤ 3%.

[0050] 3. Preparation of 6% hydroxypropyl cellulose aqueous solution

[005...

Embodiment 3

[0066] The key steps of this product are mixing, granulating, drying, total blending and tabletting. The key steps and process parameters are shown in Table 2.

[0067] Table 2

[0068]

[0069] Table 3 Test results of finished products

[0070]

[0071]Table 4 Dissolution curve results of the finished product in four media

[0072]

[0073] Stability test under high temperature and high humidity conditions:

[0074] The product was placed in a drug stability test chamber (temperature 40°C ± 2°C, relative humidity 75% ± 5%) for 3 months, with pH 1.2 hydrochloric acid solution as the dissolution medium, the results showed that: under the accelerated test conditions There is no change in the dissolution rate of this product after placing it for 3 months, which shows that the tablet prepared according to the technical scheme of the present invention is stable in dissolution and is not affected by high temperature and high humidity.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and discloses a ketotifen fumarate tablet. The ketotifen fumarate tablet is prepared from the following formulation compositions: ketotifen fumarate, lactose monohydrate, pregelatinized starch, corn starch, hydroxy propyl cellulose, water and magnesium stearate. The ketotifen fumarate tablet has stable performance, controllable quality and high dissolution rate.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a ketotifen fumarate tablet and its application. Background technique [0002] Ketotifen fumarate (ketotifen fumarate) is an oral potent allergic transmitter release agent, an anti-allergic drug, clinically used for the prevention and treatment of allergic rhinitis and allergic bronchial asthma. Ketotifen fumarate is a highly soluble and highly permeable drug with a half-life of 3-5 hours. It can be rapidly and completely absorbed through the gastrointestinal tract after oral administration, with a bioavailability of 3-4%. Chinese invention patent "CN100471495C" discloses a ketotifen fumarate dispersible tablet and its preparation method, its prescription components include ketotifen fumarate, microcrystalline cellulose, lactose, starch, L-hydroxypropyl cellulose stevioside, talc, magnesium stearate and ethanol. Chinese invention patent "CN106420637A" disclo...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4535A61P11/02A61P11/06A61P37/08
CPCA61K9/2095A61K31/4535A61P11/02A61P11/06A61P37/08
Inventor 林凡友孙永喜王美成宿晓法
Owner 仁和堂药业有限公司
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