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Freeze-dried orally disintegrating tablets of pediatric ribavirin composition, and preparation method thereof

A technology of orally disintegrating tablets and compositions, which is applied in the direction of non-active ingredients of polymer compounds, pharmaceutical formulas, and medical preparations containing active ingredients, etc., which can solve the problems of inconvenient taking for children, high tablet hardness, and unsuitability for children, etc. problem, to achieve the effect of improving bioavailability, accelerating absorption and shortening dissolution time

Active Publication Date: 2013-06-12
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, oral preparations often need to be taken with water or the tablets are very hard, which will be difficult for patients with difficulty swallowing or taking water, especially for children. It is very inconvenient to take. Ribavirin sold on the market disintegrates Tablets are made of a variety of excipients and disintegrants, and are compressed using a traditional tablet press. It takes at least 30 seconds to disintegrate in the human oral cavity, and there is a sandy feeling in the mouth, which is not suitable for children.

Method used

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  • Freeze-dried orally disintegrating tablets of pediatric ribavirin composition, and preparation method thereof
  • Freeze-dried orally disintegrating tablets of pediatric ribavirin composition, and preparation method thereof
  • Freeze-dried orally disintegrating tablets of pediatric ribavirin composition, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Prescription: 1000 tablets

[0043]

[0044] Dissolve the prescribed amount of ribavirin in purified water of 80% of the total amount of prescription water, heat to 55°C under stirring, continue stirring and add the prescribed amount of mannitol and sucralose, and dissolve the prescribed amount of gelatin in the prescription Heat the purified water with 20% water consumption until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, and freeze-dry orally disintegrating tablets according to the specifications of the children’s ribavirin composition, After determining the loading amount, the combined medicinal solution is divided into drug-containing dishes according to the loading amount, and placed in a freeze-drying box, and the medicinal solution is frozen, and the pediatric ribavirin composition freeze-dried orally disintegrating tablet is dried Finally, it is sealed in a freeze-drying box, ...

Embodiment 2

[0046] Prescription: 1000 tablets

[0047]

[0048] Dissolve the prescribed amount of ribavirin in purified water of 80% of the total amount of prescription water, heat to 55°C under stirring, continue stirring and add the prescribed amount of mannitol and sucralose, and dissolve the prescribed amount of gelatin in the prescription Heat the purified water with 20% water consumption until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, and freeze-dry orally disintegrating tablets according to the specifications of the children’s ribavirin composition, After determining the loading amount, the combined medicinal solution is divided into drug-containing dishes according to the loading amount, and placed in a freeze-drying box, and the medicinal solution is frozen, and the pediatric ribavirin composition freeze-dried orally disintegrating tablet is dried Finally, it is sealed in a freeze-drying box, ...

Embodiment 3

[0050] Prescription: 1000 tablets

[0051]

[0052] Dissolve the prescribed amount of ribavirin in purified water of 80% of the total amount of prescription water, heat to 55°C under stirring, continue stirring and add the prescribed amount of mannitol and sucralose, and dissolve the prescribed amount of gelatin in the prescription Heat the purified water with 20% water consumption until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, and freeze-dry orally disintegrating tablets according to the specifications of the children’s ribavirin composition, After determining the loading amount, the combined medicinal solution is divided into drug-containing dishes according to the loading amount, and placed in a freeze-drying box, and the medicinal solution is frozen, and the pediatric ribavirin composition freeze-dried orally disintegrating tablet is dried Finally, it is sealed in a freeze-drying box, ...

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Abstract

The invention discloses freeze-dried orally disintegrating tablets of a pediatric ribavirin composition, and a preparation method thereof, and relates to the technical fields of a drug and a drug preparation method. The pediatric ribavirin composition comprises the following components, by weight, 6.0-16.32% of ribavirin, 81.62-90.01% of mannitol, 1.96-3.84% of gelatin, and 0.09-0.14% of sucralose. The invention further discloses freeze-dried orally disintegrating tablets of the pediatric ribavirin composition, and a preparation method thereof, wherein the pediatric ribavirin composition is prepared from the components. The freeze-dried orally disintegrating tablets have the following characteristics that: the components are simple; no water is required during taking; no chewing is required; the disintegrating time in the human oral cavity is less than 2 seconds; the absorption is rapid; the biological availability is high; the residue in the intestinal tract is less; the side effect is low; the liver first pass effect is low; the taste is good; and the tablets are especially suitable for infant patient taking.

Description

Technical field: [0001] The invention relates to the technical field of medicines and preparation methods of medicines, in particular to a freeze-dried orally disintegrating tablet of a ribavirin composition for children and a preparation method thereof. Background technique: [0002] Ribavirin is a broad-spectrum antiviral drug. Rapid oral absorption, ribavirin is clinically applicable to viral pneumonia caused by respiratory syncytial virus, bronchitis, influenza, skin herpes virus infection, herpetic stomatitis, mumps, epidemic hemorrhagic fever, children Adenovirus pneumonia, autumn diarrhea and other viral diseases. [0003] Ribavirin has the effect of inhibiting the growth of respiratory syncytial virus, influenza virus, hepatitis A virus, adenovirus and other viruses, but it does not change the adsorption, invasion and shedding of viruses, and does not induce the production of interferon. After the drug enters the cells infected by the virus, it is rapidly phosphory...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7056A61K9/20A61K47/42A61P31/12
Inventor 汪金灿李祖红汪六一
Owner HAINAN WEI KANG PHARMA QIANSHAN
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