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Fluoxetine hydrochloride capsule and preparation method thereof

A technology of fluoxetine hydrochloride capsules and fluoxetine hydrochloride, which can be used in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve problems affecting clinical compliance, etc.

Active Publication Date: 2021-05-04
SHANXI C&Y PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Capsules are different from tablets. Capsules have no flavoring agents and are not affected by stress factors. They are rapidly dispersed, dissolved and absorbed in the gastrointestinal tract. The local concentration in the stomach is too high, which can easily stimulate the gastric mucosa and cause nausea, vomiting and other adverse effects. response, which in turn affects clinical compliance

Method used

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  • Fluoxetine hydrochloride capsule and preparation method thereof
  • Fluoxetine hydrochloride capsule and preparation method thereof
  • Fluoxetine hydrochloride capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 2

[0061] The preparation of embodiment 1 simethicone emulsion

[0062] According to the type of material designed by the prescription shown in Table 2, the simethicone emulsion is weighed according to the design amount of prescription 1 to 3. The auxiliary material is operated according to the process control parameters in Table 3, and the water that is weighed is heated to a constant temperature. When the temperature exceeds 80°C, add polyoxyl 40 stearate, stir and disperse with a high-shear dispersing emulsifier, then add simethicone oil, and adjust the stirring speed of the high-shear dispersing emulsifier to 5000rpm-20000rpm to obtain a simethicone emulsion , it does not stratify after standing for 24 hours.

[0063] Table 2 Pregelatinized starch lubricant formulation screening

[0064]

[0065] Table 3 Process Screening of Pregelatinized Starch Lubricants

[0066] Process Control Parameters existing prescription Prescription 1 Prescription 2 Prescripti...

Embodiment 2

[0067] The preparation of embodiment 2 fluoxetine hydrochloride capsules

[0068] According to the type of materials designed according to the prescription shown in Table 4, the process control parameters in Table 5 are used to operate. Pulverize the fluoxetine hydrochloride, and control the particle size distribution D90 at 20 μm to 100 μm; pass the pregelatinized starch and silicon dioxide through a 60-mesh sieve. Weigh the raw materials and excipients according to the design quantities of prescriptions 1 to 3. Add the pregelatinized starch into the wet granulator, set the stirring speed of the wet granulator to 70rpm-100rpm and the cutting speed to 1200rpm-1800rpm, then start the wet granulator, and add simethicone emulsion and water to granulate by spray technology. Then use a 6.0mm×6.0mm square hole screen for wet sizing. After unloading, use a fluidized bed to dry and measure the moisture content of the material. When the moisture content is less than 9.0%, the material...

Embodiment 3

[0080] Example 3 Comparison of the in vitro dissolution curves of fluoxetine hydrochloride capsules (A, B, C) prepared by the present invention, existing product (X) and reference preparation (R)

[0081] Get each 12 of fluoxetine hydrochloride capsules (A, B, C) prepared in Example 2, existing product (X) and reference preparation (R), detect its hydrochloric acid solution at pH1.0, pH4 by the following method .5 in vitro dissolution profiles of acetate buffer solution, pH 6.8 phosphate buffer solution and water. The detection method is shown in Table 7.

[0082] The method of table 7 fluoxetine hydrochloride capsules in 4 different dissolution media

[0083] Dissolution medium method Rotating speed Surfactant pH1.0 hydrochloric acid solution Paddle 50 rpm none pH4.5 acetate buffer solution Paddle 50 rpm none pH6.8 phosphate buffer solution Paddle 50 rpm none water Paddle 50 rpm none

[0084] The measurement re...

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Abstract

The invention discloses a fluoxetine hydrochloride capsule, a preparation method thereof and application of the fluoxetine hydrochloride capsule in quality and curative effect consistency evaluation. The preparation method comprises the following steps: crushing fluoxetine hydrochloride, sieving auxiliary materials, spraying dimethicone emulsion to the surface of pregelatinized starch, carrying out granulating to obtain pregelatinized starch blank particles, uniformly mixing the pregelatinized starch blank particles with the fluoxetine hydrochloride, the pregelatinized starch and silicon dioxide, then filling capsules with the mixture, and carrying out packaging by aluminum plastic. The content, content uniformity, related substances, dissolution rate and the like of the prepared fluoxetine hydrochloride capsule are consistent with those of a reference preparation (fluoxetine hydrochloride capsule, Prozac, 20 mg, applicant holder LILLY FRANCE); multiple in-vitro dissolution curves are similar to those of the reference preparation; the fluoxetine hydrochloride capsule is biologically equivalent to the reference preparation, and is high in safety and compliance; and the product is high in stability within 24 months under the condition of not increasing the packaging cost.

Description

technical field [0001] The present invention relates to a kind of fluoxetine hydrochloride capsule and preparation method thereof, and the application in the field of generic drug consistency evaluation. Background technique [0002] Traditional antidepressants are represented by cyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs), including amitriptyline, clomipramine, etc. Due to the many adverse reactions of traditional antidepressants, they are rarely used at present and are gradually replaced by new antidepressants. As a selective 5-HT reuptake inhibitor, fluoxetine is a new type of antidepressant drug widely used in clinical practice. Absorption, increase the level of 5-HT bound to the synaptic cleft and post-synaptic receptors, thereby playing an antidepressant effect. Fluoxetine hydrochloride belongs to BCS Class I drugs. [0003] According to the FDA database, the dosage forms involved in fluoxetine hydrochloride include tablets, dispersible ta...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/137A61K47/36A61K47/34A61K47/04A61P25/24
CPCA61K9/1611A61K9/1652A61K9/1641A61K31/137A61P25/24
Inventor 李福高赵志良虞英民李俊峰贾佩骞谢齐昂刘东华宣燕红
Owner SHANXI C&Y PHARMACEUTICAL GROUP CO LTD