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Granisetron hydrochloride freeze-drying tablet and preparation method thereof

A technology of granisetron hydrochloride and freeze-dried tablets, which is applied in the direction of pharmaceutical formula, medical preparations containing active ingredients, pill delivery, etc. It can solve the problems of complex production process, obvious side effects, and low bioavailability of granisetron hydrochloride

Active Publication Date: 2012-05-16
BEIJING QUANTUM HI TECH PHARMA TECHCO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is the low bioavailability of granisetron hydrochloride, the shortcomings of obvious side effects, and the shortcomings of complicated production process and difficult drying when gelatin is used as the adhesive.

Method used

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  • Granisetron hydrochloride freeze-drying tablet and preparation method thereof
  • Granisetron hydrochloride freeze-drying tablet and preparation method thereof
  • Granisetron hydrochloride freeze-drying tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0121] The preparation formula of the present invention is made up of following components:

[0122]

[0123]

[0124] A total of 1000 pieces were made

[0125] The specific preparation method is as follows: mix granisetron hydrochloride, glycine, pullulan, acesulfame potassium, and pineapple essence evenly, add the purified water of the prescribed amount to it, and mix to form a homogeneous solution; vacuum degas the solution Finally, pour it into the mold accurately; pre-freeze at -40°C to -170°C for 1 to 60 minutes, then transfer to a freeze dryer, and freeze dry at a pressure of 0.01mbar to 10mbar and at a temperature of -30°C to 30°C 1~10h, obtain the granisetron hydrochloride freeze-dried tablet of the present invention; In the above-mentioned method, after the pre-freezing step, the step of ice crystal incubation can also be added before being transferred to the lyophilizer, that is, the mold that is filled with the solution after the pre-freezing, put Into the l...

Embodiment 2

[0127] The preparation formula of the present invention is made up of following components:

[0128]

[0129] A total of 1000 pieces were made

[0130] The specific preparation method is as follows: mix the granisetron hydrochloride, mannitol, pullulan, aspartame, and sweet orange essence in the above-mentioned dosages evenly, add the purified water of the prescribed amount to it, and mix to form a homogeneous solution; All the other preparation methods are the same as in Example 1.

Embodiment 3

[0132] The preparation formula of the present invention is made up of following components:

[0133]

[0134] A total of 1000 pieces were made

[0135] The specific preparation method is as follows: mix the granisetron hydrochloride, glycine, sodium alginate, and sucralose in the above-mentioned amounts evenly, add the purified water of the prescribed amount to it, and mix to make a homogeneous solution; the rest of the preparation methods are the same as in the examples 1.

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Abstract

The invention relates to a granisetron hydrochloride freeze-drying tablet, and a prescription and a technology for preparing the granisetron hydrochloride freeze-drying tablet by a lyophilization method. The granisetron hydrochloride freeze-drying tablet is prepared from a main drug of granisetron hydrochloride and pharmaceutic adjuvants. The granisetron hydrochloride freeze-drying tablet can be administered without water and disintegrate immediately after entering mouth, and is suitable for the elder and children patients that have difficulty in swallowing; the granisetron hydrochloride freeze-drying tablet has advantages of convenient administration, fast absorption, small first pass effect and mall excitant to alimentary canal mucous membrane and has wide market application prospect; as no water is needed during administration, symptoms of nausea and vomit will not be aggravated; therefore, the granisetron hydrochloride freeze-drying tablet has better compliance and treatment effect than other dosage forms on nausea and vomit caused by chemotherapy, radiotherapy or operation and can obviously reduce side-effect of granisetron hydrochloride. In addition, the invention also relates to a preparation method of the granisetron hydrochloride freeze-drying tablet.

Description

Technical field: [0001] The invention relates to a granisetron hydrochloride freeze-dried tablet and a preparation method thereof, in particular to a granisetron hydrochloride freeze-dried tablet prepared by a freeze-drying method. Background technique: [0002] Chemotherapy and radiotherapy are important and effective means of tumor treatment, but 20% to 30% of patients will experience nausea and vomiting while receiving chemotherapy and radiotherapy, and patients often reduce or even stop treatment due to intolerance. The highly selective 5-HT3 receptor antagonist developed in the 1990s is used for antiemetic in the process of tumor chemotherapy and radiotherapy. breakthrough progress. [0003] Granisetron hydrochloride is a potent and highly selective peripheral and central nervous system 5-HT3 receptor antagonist. It is highly selective to peripheral and central nervous system 5-HT3 receptors. Its anti-emetic mechanism is highly Selectively block the abdominal vagus ne...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/439A61P1/08
Inventor 王丛威王洪飞王丽滨王彦峰周立运
Owner BEIJING QUANTUM HI TECH PHARMA TECHCO
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