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Easily-swallowed drug-loaded microsphere and preparation method thereof

A technology of drugs and microspheres, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, pill delivery, etc., and can solve problems such as restricting applications and blocking drug release.

Active Publication Date: 2015-01-14
北京科信聚润医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, if the particle size is too small, the drug will be adsorbed on the active ingredient and block the release of the drug, which greatly limits the application of this technology (Barra et al., 1999)

Method used

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  • Easily-swallowed drug-loaded microsphere and preparation method thereof
  • Easily-swallowed drug-loaded microsphere and preparation method thereof
  • Easily-swallowed drug-loaded microsphere and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Acetaminophen Granules / Fine Granules (1000 bags)

[0038]

[0039] Preparation Process:

[0040] 1) Weigh each component of the prescription amount for later use;

[0041] 2) Dissolve the components of the smooth structure in water to make a coating liquid;

[0042] 3) Put the drug acetaminophen into the fluidized bed, control the temperature at 50°C±2, and carry out coating.

[0043] 4) Dried, filled, and ready to serve.

[0044] During the coating process, samples were taken when the weight gain was 1%, 2%, 3%, 5%, 8%, 10%, 15%, 20%, 30%, 50%, and 100%, respectively, and set aside. The smoothing effect is evaluated by the experimenter's scoring method after oral administration. The score ranges from 0 to 5 points. 0 points for no smoothing effect, and there is no significant difference from the unwrapped smoothing structure. 5 points for the best, and the smoothing effect is obvious. No need The experimenter can swallow it smoothly by taking it with water or ot...

Embodiment 2

[0048] Azithromycin Granules (1000 bags)

[0049] Drug-loaded pellets:

[0050] Azithromycin

500.0g

MCC101

160.0g

lactose

160.0g

water

1000.0g

[0051] Smooth structure:

[0052]

[0053] Preparation Process:

[0054] 1) Weigh each component of the prescription amount for later use;

[0055] 2) According to the prescription of drug-loaded pellets, prepare pellets by extrusion and spheronization, dry at 30°C, and screen out pellets with a particle size not higher than 1000 microns for use;

[0056] 3) Dissolve each component of the smooth structure in 95% ethanol to make a coating solution;

[0057] 4) Put the drug-loaded pellets into the fluidized bed, control the temperature at 50°C±2, and carry out coating.

[0058] 5) Dried, filled, and ready to serve.

[0059] During the coating process, samples were taken when the weight gain was 1%, 2%, 3%, 5%, 8%, 10%, 15%, 20%, 30%, 50%, and 100%, respectively, and set asi...

Embodiment 3

[0063] Nifedipine Granules (1000 bags)

[0064]

[0065] Preparation

[0066] 1) Weigh each component of the prescription amount for later use;

[0067] 2) Dissolve each component of the smooth structure in 100ML water to make a coating liquid;

[0068] 3) Put the medicine into the fluidized bed, control the temperature at 50℃±2, and carry out coating.

[0069] 4) Dried, filled, and ready to serve.

[0070] During the coating process, samples were taken at 1%, 2%, 3%, 5%, 8%, 10%, 12%, 15%, 30%, and 50% of the weight gain, and they were set aside.

[0071] Prescription smoothing effect evaluation form

[0072] prescription

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Abstract

The invention provides an easily-swallowed drug-loaded microsphere. After the surface of the microsphere enters the oral cavity, a smoothing effect can be achieved by virtue of extremely little water, namely, in a saliva environment, so that the microsphere can quickly enter the esophagus along with swallowing actions, therefore, the microsphere is especially suitable for patients with dysphagia. The drug-loaded microsphere comprises a drug or a drug-loaded mini-pill, the outside surface of the microsphere is coated with a smoothing structure, and in terms of the weight of the drug or the drug-loaded mini-pill, the weight of the smoothing structure is increased by 1-100%; the drug-loaded microsphere has a better protection effect on the stability of the drug, such as preventing outside light, moisture and air from affecting the drug; and the bad smell of the drug can be hidden.

Description

technical field [0001] The invention belongs to the field of oral solid preparations, in particular to an oral drug particle suitable for patients with dysphagia and a preparation method thereof. Background technique [0002] Oral administration is the most commonly used method of administration, and its advantages are safety, convenience, and easy acceptance and adoption by patients. Commonly used oral preparations include tablets, capsules, granules, oral liquids and other dosage forms. For children and elderly patients who have difficulty swallowing, the first two are not suitable. [0003] Studies have shown that dysphagia does not only refer to children, the elderly and other people whose autonomous swallowing ability has not yet fully developed / regressed, but also includes temporary or long-term dysphagia that may be caused by congenital imperfections, diseases, physical injuries, etc. For example, due to the imperfect development of hiccups in a small number of peopl...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/20A61K9/48A61K47/38A61K47/36A61K47/34A61K47/32A61K47/26A61K47/10
Inventor 王锦刚蒋海松徐国徽朱广辉左晧元
Owner 北京科信聚润医药科技有限公司
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