Molnupiravir taste-masking particles and preparation method thereof

A technology of taste-masking granules and granules, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. The effect of drug stability and improving drug taste

Pending Publication Date: 2022-04-12
ZENJI RES LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Another object of the present invention is to provide a method for preparing Molnupiravir taste-masking granules, which can effectively solve the prob

Method used

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  • Molnupiravir taste-masking particles and preparation method thereof
  • Molnupiravir taste-masking particles and preparation method thereof
  • Molnupiravir taste-masking particles and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0025] Example 1

[0026] Molnupiravir particle prescription composition is as follows:

[0027]

[0028] The process of Molnupiravir particles includes the following steps:

[0029] (1) Pre-treatment: molnupiravir gas flow crushing;

[0030] (2) Preparation of adhesive: dissolve the sodium carboxymethylcellulose sodium in 95% as a binder;

[0031] (3) Preparation of Software: Place the molnupiravir, pH regulatory agent, and other excipient compositions in the high shear wet method, and the material is added to the binder solution in a mixed state, and the adhesive solution is atomized. Add in the form, continue to mix evenly, make soft materials;

[0032] (4) Preparation of the particles: prepared a moving flat machine for preparing wet particles, the screen is 40 mesh;

[0033] (5) Drying of the particles: drying the particles by fluidized bed, the control material temperature is 30-50 ° C, controlling the particles of 1% -3%, using a 30 mesh screen.

[0034] (6) Fluidized bed...

Example Embodiment

[0040] Example 2-7

[0041] Example 2-7 The formulation and preparation method of Example 1 were designed to separately designed different pH regulators, different amounts of different binder solutions and weight gains.

[0042]

Example Embodiment

[0043] Example 8

[0044] Explain the effect of Molnupiravir, the effect, the degree of dissolution, the content, uniformity, particle size, solubilization quality indicators, and related content, the detection results of the detection of the effect, dissolution, content of particle size, solubilization quality indicators, and related content:

[0045] 1. Effect of Molnupiravir particle in Example 1 and waterless swallowing

[0046] Sampling method: adult men and women swallow, a total of 20 people

[0047] Detection method: granules oral, waterless swallow

[0048] Test results

[0049]

[0050]

[0051] Conclusion: Molnupiravir particles have a good taste of water, and there is no difficulty in swallowing.

[0052] 2. Study on Molnupiravir Particle Dissolution in Example 1

[0053] Sampling method: in water, pH1.2 hydrochloric acid buffer, pH4.5 acetate buffer, pH 6.8 phosphate buffer is released medium,

[0054] Dissolution measuring method: slurry method, speed of 100R / m...

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Abstract

The invention discloses a Molnupiravir taste masking particle and a preparation method of the Molnupiravir taste masking particle. Molnupiravir is bitter in taste, large in dosage and poor in stability, and Molnupiravir taste-masking particles are prepared by adopting a volatile adhesive solution and a weakly acidic pH (Potential of Hydrogen) regulator and adopting a low-temperature drying technology. According to the present invention, the quality is stable, the stability problem that the bulk drugs are easily degraded during the preparation process is effectively solved, the water-free oral administration can be achieved, the medication convenience and the medication compliance of patients are improved, the adaptive population of the patients is increased, and the medication compliance of the patients, especially children, can be easily improved.

Description

technical field [0001] The invention relates to a medicine preparation and a preparation method thereof, in particular to a Molnupiravir taste-masking granule and a preparation method thereof. Background technique [0002] Molnupiravir, an orally bioactive prodrug of the ribonucleoside analog β-d-N4-hydroxycytidine (NHC; EIDD-1931), inhibits the replication of a variety of RNA viruses, including the novel coronavirus (SARS-CoV-2 ). Molnupiravir has broad-spectrum antiviral activity against the pathogens of SARS-CoV-2, MERS-CoV, SARS-CoV and COVID-19 and has the chemical formula C 13 h 19 N 3 o 7 , the chemical name is uridine 5′-methylpropionate-4-oxime, the molecular weight is 329.31, and the molecular structure is as follows: [0003] [0004] The new crown epidemic is raging, and researchers are currently stepping up the research on Molnupiravir, and they are facing many difficulties. The first is that the raw material drug of Molnupiravir is unstable, and how to ...

Claims

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Application Information

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IPC IPC(8): A61K9/58A61K9/62A61K31/7072A61K47/32A61K47/38A61P31/14
Inventor 罗林蒋荷康振华钟国锋
Owner ZENJI RES LAB
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