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Paroxetine hydrochloride suspension and preparation method thereof

A technology for paroxetine hydrochloride and suspensions, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, and medical preparations containing active ingredients. Limited type, increased plasma concentration of paroxetine, etc., to achieve the effect of increased drug loading, easy swallowing, and improved drug release behavior

Active Publication Date: 2021-08-06
SHANGHAI MEIYOU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The recovered dose of intact drug in feces is less than 1%, indicating that paroxetine is almost completely absorbed. The mean elimination half-life of paroxetine is about 24 hours (9 to 30 hours). Elderly depressed patients, patients with severe renal failure and patients with liver cirrhosis, Increased paroxetine plasma concentrations and prolonged terminal elimination half-life
[0008] But the type of paroxetine hydrochloride oral suspension disclosed in the prior art is also very limited, therefore, it is very meaningful to develop another paroxetine hydrochloride preparation suitable for the elderly, children and patients with dysphagia

Method used

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  • Paroxetine hydrochloride suspension and preparation method thereof
  • Paroxetine hydrochloride suspension and preparation method thereof
  • Paroxetine hydrochloride suspension and preparation method thereof

Examples

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Embodiment 1

[0054] The present embodiment provides a kind of paroxetine hydrochloride suspension (10mL specification), comprises following preparation raw material:

[0055]

[0056]

[0057] Its preparation method is as follows:

[0058] (1) Mix Amberlite IRP69, Amberlite IRP88, and Amberlite IRP64 with water and then mix them with paroxetine hydrochloride, take samples regularly, and measure the concentration of the drug in the solution. When the concentration of the drug in the solution does not change with time, the equilibrium is reached, the unbound drug on the surface of the resin is washed away with deionized water, and dried at 50°C to obtain the drug-loaded resin complex;

[0059] (2) Add the drug-loaded resin complex obtained in step (1) to an aqueous solution of PEG4000 (10%) and PEG3350 (15%), stir at 60°C for 30min, and dry at 50°C to obtain an impregnated drug-loaded resin Complex;

[0060] (3) Mix the impregnated drug-loaded resin complex obtained in step (2) with ...

Embodiment 2

[0062] The present embodiment provides a kind of paroxetine hydrochloride suspension (10mL specification), comprises following preparation raw material:

[0063]

[0064]

[0065] Its preparation method is as follows:

[0066] (1) Mix Amberlite IRP69, Amberlite IRP88, and Amberlite IRP64 with water and place them in the chromatography column, then add the paroxetine hydrochloride solution into the chromatography column for chromatography, and take samples at regular intervals until the drug concentration of the added liquid is equal to that of the effluent. At the same time, the equilibrium is reached, the unbound drug on the surface of the resin is washed away with deionized water, and dried at 45°C to obtain the drug-loaded resin complex;

[0067] (2) Add the drug-loaded resin complex obtained in step (1) to an aqueous solution of PEG4000 (15%) and PEG3350 (10%), stir at 55°C for 40min, and dry at 45°C to obtain an impregnated drug-loaded resin Complex;

[0068] (3) ...

Embodiment 3

[0070] The present embodiment provides a kind of paroxetine hydrochloride suspension (10mL specification), comprises following preparation raw material:

[0071]

[0072]

[0073] Its preparation method is as follows:

[0074] (1) Mix Amberlite IRP69, Amberlite IRP88, and Amberlite IRP64 with water and place them in the chromatography column, then add the paroxetine hydrochloride solution into the chromatography column for chromatography, and take samples at regular intervals until the drug concentration of the added liquid is equal to that of the effluent. At the same time, the equilibrium is reached, the unbound drug on the resin surface is washed away with deionized water, and dried at 60°C to obtain the drug-loaded resin complex;

[0075] (2) Add the drug-loaded resin complex obtained in step (1) to an aqueous solution of PEG4000 (15%) and PEG3350 (10%), stir at 65°C for 20min, and dry at 60°C to obtain an impregnated drug-loaded resin Complex;

[0076] (3) Mix the...

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Abstract

The invention relates to a paroxetine hydrochloride suspension and a preparation method thereof. The paroxetine hydrochloride suspension is prepared from the following raw materials: paroxetine hydrochloride, cation exchange resin, an impregnant and pharmaceutic adjuvants; and the cation exchange resin is composed of strong acid cation exchange resin and weak acid cation exchange resin. According to the paroxetine hydrochloride suspension disclosed by the invention, the cation exchange resin composed of the strong acid cation exchange resin and the weak acid cation exchange resin is creatively adopted as a carrier of the medicine paroxetine hydrochloride; the medicine is loaded on a resin material; the bitter taste of the medicine can be covered; the paroxetine hydrochloride suspension is easier to swallow by a patient; meanwhile, the drug loading capacity of paroxetine hydrochloride is improved; and the stability, the redispersibility and the drug release behaviour are further improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a paroxetine hydrochloride suspension and a preparation method thereof, in particular to a paroxetine hydrochloride suspension with good drug stability, high drug loading and good compliance and its preparation method. Background technique [0002] Paroxetine Hydrochloride (Paroxetine Hydrochloride, PX) is a new type of serotonin reuptake inhibitor (SSRI) antidepressant, mainly used in the treatment of severe depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, anxiety disorder, post-traumatic Stress disorder etc. Compared with traditional tricyclic and monoamine oxidase inhibitor antidepressants, it has stronger selectivity and fewer adverse reactions. Paroxetine hydrochloride is well tolerated by the body and has a high therapeutic index. The therapeutic effect of paroxetine hydrochloride is to inhibit the reuptake of seroton...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/4525A61K47/10A61K47/32A61P25/00A61P25/22A61P25/24
CPCA61K31/4525A61K9/10A61K9/0053A61K47/10A61K47/32A61P25/24A61P25/22A61P25/00Y02A50/30
Inventor 邢志刚赵丽敏郅晓珂吕欣兰悦宋晓雪
Owner SHANGHAI MEIYOU PHARMA
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