Palonosetron hydrochloride orally disintegrating tablet and preparation method thereof

A technology of palonosetron hydrochloride and orally disintegrating tablets, which is applied in the field of palonosetron hydrochloride orally disintegrating tablets and its preparation, can solve the problems not related to orally disintegrating tablets, and reach the disintegration time limit quickly , More absorption points, less sandy feeling

Active Publication Date: 2011-05-11
QILU PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dosage forms involved in the preparation patents are mostly injections and powder injections, and the new dosage form of orally disintegrating tablets has not yet been involved.

Method used

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  • Palonosetron hydrochloride orally disintegrating tablet and preparation method thereof
  • Palonosetron hydrochloride orally disintegrating tablet and preparation method thereof
  • Palonosetron hydrochloride orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Palonosetron hydrochloride orally disintegrating tablets are prescribed as:

[0037]

[0038] Preparation: The dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by direct compression process. The specific preparation method is as follows: sweet orange essence, citric acid, aspartame, palonosetron hydrochloride, low-substituted hydroxypropyl Cellulose and cross-linked polyvinylpyrrolidone were finely ground and passed through 80 mesh sieve, and mixed uniformly to obtain mixture A; mannitol 200SD and mannitol 100SD were respectively passed through 40 mesh sieve, weighed according to the amount, and mixed uniformly to obtain mixture B: Mixture B is added to mixture A in an equal amount increasing manner to obtain mixture C. Then add the magnesium stearate of prescription quantity, sieve and mix, carry out intermediate content detection. After determining the weight of the tablet, the tablet is compressed by direct compression tech...

Embodiment 2

[0040] Palonosetron hydrochloride orally disintegrating tablets are prescribed as:

[0041]

[0042]

[0043] Preparation: The dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by direct compression process. The specific preparation method is as follows: sweet orange essence, citric acid, aspartame, palonosetron hydrochloride, low-substituted hydroxypropyl Cellulose and croscarmellose sodium were respectively ground and passed through 80 mesh sieves, and mixed uniformly to obtain mixture A; mannitol 200SD and microcrystalline cellulose were respectively passed through 40 mesh sieves, weighed respectively, and made Mix evenly to obtain mixture B; add mixture B to mixture A in an equal and incremental manner to obtain mixture C. Then add the prescribed amount of talcum powder, sieve and mix evenly, and detect the intermediate content. After determining the weight of the tablet, the tablet is compressed by direct compression technolog...

Embodiment 3

[0045] Palonosetron hydrochloride orally disintegrating tablets are prescribed as:

[0046]

[0047] Preparation: Grind assorted flavors, aspartame, palonosetron hydrochloride, and crospovidone separately and pass through a 80-mesh sieve, and mix them uniformly to obtain mixture A; Weigh to obtain B; add the prescribed amount of B to mixture A by means of equal increments to obtain mixture C. Then add the colloidal silicon dioxide and calcium stearate of the prescription amount, sieve and mix, and carry out the detection of the intermediate content. After determining the weight of the tablet, the tablet is compressed by direct compression technology, and the product is obtained.

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Abstract

The invention belongs to the field of pharmacy and medical technology, and relates to a palonosetron hydrochloride orally disintegrating tablet and a preparation method thereof. The orally disintegrating tablet comprises the following components in percentage by mass: palonosetron hydrochloride 0.16 to 1.5, mannite 70 to 95, disintegrating agent 1.5 to 15, taste correcting agent 1 to 3, lubricating agent 0.5 to 2, and other auxiliary materials 0 to 15. The manufacturing technology can adopt dry direct tablet compressing. The palonosetron hydrochloride orally disintegrating tablet has the advantages of simple manufacturing technology, low cost and quick effect on indications, is convenient to take, can be disintegrated into fine grains or powder in oral cavity quickly after oral administration, and is particularly suitable for patients who swallow hard and tumor patients with weak physical fitness. The preparation exists in a form of fine grain or powder before reaching the gastrointestinal tract, and the medicine dissolves out in an accelerating manner and is distributed in the gastrointestinal tract in a large area for more absorption points, so that the bioavailability can be improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a palonosetron hydrochloride orally disintegrating tablet and a preparation method thereof. Background technique [0002] my country's epidemiological survey shows that in 2003, the mortality rate of malignant tumors among urban residents was 94.71 per 100,000, and cancer became the number one cause of death. The 10 cancers with the highest mortality rates were lung cancer, liver cancer, gastric cancer, esophageal cancer, colon cancer, and rectum cancer. and anal cancer, leukemia, breast cancer, nasopharyngeal cancer, cervical cancer, and bladder cancer; the mortality rate of malignant tumor patients in rural residents is higher, 104.01 / 100,000, ranking first among all death diseases, among which the 10 cancers with the highest mortality rate They are liver cancer, stomach cancer, lung cancer, esophagus cancer, colon, rectum and anal cancer, leukemia, breast cancer, nasop...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/473A61K47/10A61P1/08
Inventor 李伯涛王晶翼李长军杨清敏李颖张明会
Owner QILU PHARMA HAINAN
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