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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 problems of easy decomposition and poor stability of Molnupiravir during production, thereby improving the quality and stability of the preparation product

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

Embodiment 1

[0026] Molnupiravir granules prescription composition is as follows:

[0027]

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

[0029] (1) Pretreatment: Molnupiravir jet milling;

[0030] (2) Preparation of adhesive: dissolving sodium carboxymethyl cellulose in 95% ethanol solution as adhesive;

[0031] (3) Preparation of soft material: put the prescription amount of Molnupiravir, pH regulator and other auxiliary material compositions in a high-shear wet granulator and mix evenly. Add in the form of , continue to mix evenly, and make a soft material;

[0032] (4) Preparation of granules: a mobile granulator is used to prepare wet granules, and the sieve is 40 mesh;

[0033] (5) Drying of granules: adopt fluidized bed to carry out granule drying, control material temperature to be 30-50 ℃, control granule moisture to be 1%-3%, granulate with 30 mesh sieves;

[0034] (6) Fluidized bed coating:

[0035] a. Coating the taste-masking layer: disso...

Embodiment 2-7

[0041] Examples 2-7 adopt the formulation and preparation method of Example 1, respectively design the dosage of different pH regulators, the dosage of different binder solutions and the dosage of coating weight gain.

[0042]

Embodiment 8

[0044] Investigate the mouthfeel of Molnupiravir taste-masking granules and the effect of anhydrous swallowing, dissolution rate, content uniformity, particle size, solubility quality index and related content. The test results are as follows:

[0045] 1. Molnupiravir particle mouthfeel and the effect of anhydrous swallowing among the embodiment 1

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

[0047] Detection method: oral administration of granules, swallowing without water

[0048] Test results

[0049]

[0050]

[0051] Conclusion: Molnupiravir granules have a good taste when swallowed without water, and there is no dysphagia phenomenon.

[0052] 2. Study on the dissolution rate of Molnupiravir granules in Example 1

[0053] Sampling method: use water, pH1.2 hydrochloric acid buffer, pH4.5 acetate buffer, pH6.8 phosphate buffer as the release medium,

[0054] Dissolution test method: paddle method, rotation speed 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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