Ondansetron water-free-swallowing granules

A technology of ondansetron and granules is applied in the field of ondansetron anhydrous swallowing granules, which can solve the problem that the raw material drug ondansetron tastes bitter and numb, the production cost and storage conditions of injections are relatively high, and the Patients take pain and other problems, and achieve the effects of solving the degradation of ondansetron, solving the bitter taste, and solving the inconvenience of taking

Pending Publication Date: 2018-01-26
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

The preparation of oral tablets by conventional technology cannot effectively solve the bitter and numb characteristics of the raw material drug ondansetron, which makes it inconvenient for patients to take it
The preparation of ondansetron into injections solves the problem of oral taste, but the production cost and storage conditions of injections are relatively high, and the route and method of administration of this dosage form cause great pain and inconvenience to patients.

Method used

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  • Ondansetron water-free-swallowing granules
  • Ondansetron water-free-swallowing granules
  • Ondansetron water-free-swallowing granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Ondansetron granules in the amount of 6000 unit preparation:

[0055]

[0056]

[0057] Preparation Process:

[0058] 1. Pill core application—raw and auxiliary materials include: ondansetron hydrochloride, hydroxypropyl cellulose, talcum powder, and ethanol to prepare a drug-containing suspension for pill core application.

[0059] Drug-containing suspension preparation:

[0060]

[0061] Process: adopt the fluidized bed medicine process to prepare ondansetron-coated pill cores, and control the temperature of the material at 35-40°C. After preparation, take the pill cores between 20-30 mesh sieves for later use to prepare drug-containing pill cores.

[0062] 2. Isolation layer packaging - raw and auxiliary materials include: hydroxypropyl methylcellulose, talc powder, purified water, prepared into an isolation layer suspension for isolation layer packaging.

[0063] Preparation of the isolation layer coating suspension:

[0064]

[0065] Process: adopt t...

Embodiment 2

[0081] Influence of isolation gown weight gain (4%, 6%, 10%) on sample dissolution and related substances

[0082]

[0083]

[0084] Preparation technology is the same as embodiment 1

[0085] Isolation gown weight gain test sample dissolution results:

[0086]

5min

15min

30min

4％

54.9％

80.3％

94.4％

6％

52.1％

81.3％

93.2％

10％

51.6％

82.1％

93.8％

[0087] Conclusion: The weight gain of the gown between 4% and 6% has no obvious effect on the dissolution rate of the sample.

[0088] The influence of different weight gain of isolation gowns on the growth trend of related substances in the samples was investigated. The weight gain of the gowns was 4%, 6%, and 10%. The samples were placed at 40°C and 75% Rh for 60 days. After 15 days, 30 days, and 60 days, take samples and compare the changing trend of related substances in the samples.

[0089] The result is as follows:

[0090]

[0091] in conclusion: ...

Embodiment 3

[0095] The impact of smooth layer weight gain (7%, 10%, 15%) on sample dissolution and related substances

[0096]

[0097] Preparation technology is the same as embodiment 1

[0098] Smooth layer weight gain to investigate the dissolution rate results of samples:

[0099]

5min

15min

30min

7％

55.9％

83.3％

93.4％

10％

53.1％

81.3％

95.2％

15％

51.5％

85.1％

94.8％

[0100] Conclusion: 1. The weight gain of the smooth layer of the sample is between 7% and 15%, which has no obvious influence on the dissolution rate of the sample.

[0101] 2. The weight gain of the smooth layer of the comparative sample is between 7% and 15%, and the taste of the sample is swallowed. With the increase of the weight gain of the smooth layer, the smooth feeling of the sample in the oral cavity increases.

[0102] 3. The weight gain of the smooth layer of the sample is between 7% and 15%, and the dissolution and swallowing effect of th...

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Abstract

The present invention provides ondansetron water-free-swallowing granules, which comprise ondansetron granules and flavoring granules, wherein the ondansetron granule sequentially comprises a pill core, a drug-containing layer, a separation layer and a smooth layer from inside to outside, and the ondansetron granules and the flavoring granules are mixed and filled in a two-channel filling manner.According to the present invention, the ondansetron water-free-swallowing granules can be easily and rapidly swallowed in the oral cavity, wherein the taste of the preparation is good during the wholeprocess, the technical characteristic of water-free-swallowing is achieved, the taking compliance of patients is improved, the stability of bulk drugs is improved, the problem of ondansetron degradation of ondansetron or salt preparations thereof is solved, the increase of related substances is effectively reduced, and the stability and the safety of the preparation are ensured.

Description

technical field [0001] The invention provides a new pharmaceutical dosage form of ondansetron hydrochloride, specifically, anhydrous swallowable ondansetron granules. The ondansetron anhydrous swallowable granule of the present invention stimulates saliva secretion in the oral cavity to facilitate rapid swallowing, and ensures good mouthfeel of the preparation in the whole process, realizes the technical characteristics of anhydrous swallowing, and improves the compliance of patients in taking it. Background technique [0002] Ondansetron is a selective 5-HT 3 Receptor antagonist for the prophylactic treatment of nausea and vomiting induced by cancer chemotherapy, nausea and / or vomiting after radiation therapy and surgery. The existing preparations of ondansetron are mainly ordinary tablets, orally disintegrating tablets and injections. The conventional process is to granulate the ondansetron raw materials and excipients into tablets or to prepare the solution of the raw m...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K31/4178A61K47/38A61P1/08
Inventor 公冶祥鑫
Owner 北京科信聚润医药科技有限公司
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