Method for preparing dispersible tablets of tamibarotene

A technology for tamibarotene and dispersible tablets, which is applied in the field of preparation of tamibarotene dispersible tablets, can solve the problems of unqualified content uniformity, dry and itchy skin, and main drug dust floating, and achieves fluidity and reliability. Good pressure, avoid adverse reactions, improve the effect of bioavailability

Inactive Publication Date: 2011-07-20
深圳万乐药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The Tamibarotene Tablets currently on the market only contain 2 mg of Tamibarotene, accounting for only 1.3% of the total tablet weight. Poor, using ordinary physical mixing method to prepare Tamibarotene Tablets, there are problems of unqualified content uniformity and low dissolution rate
In addition, Tamibarotene belongs to retinoic acid compounds, which can cause common adverse reactions of retinoic acids, mainly including cheilitis, dry mouth, dry skin and other skin and mucous membrane symptoms. General physical mixing method was used to prepare Tamibarotene Tablets , the dust floating of the main drug is relatively serious, often causing adverse reactions such as dry skin, itching, peeling and allergic erythema for operators

Method used

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  • Method for preparing dispersible tablets of tamibarotene
  • Method for preparing dispersible tablets of tamibarotene
  • Method for preparing dispersible tablets of tamibarotene

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1 Comparison of physical mixing method and solvent deposition method for preparing Tamibarotene Tablets

[0019] Process A: Preparation by physical mixing method

[0020]

[0021] Preparation process: all auxiliary materials (except magnesium stearate) pass through a 80-mesh sieve, and mix evenly. Magnesium stearate through a mesh sieve, further mixed evenly, and directly compressed into tablets.

[0022] Process B: Preparation by solvent deposition

[0023]

[0024] Preparation process: pass all excipients (except magnesium stearate) through 80-mesh sieve, mix evenly, dissolve tamibarotene raw material in ethanol, spray evenly on the above-mentioned excipients mixed uniformly, at 30-40°C Dry to dryness, pass through an 80-mesh sieve and mix evenly, then add magnesium stearate that has passed through an 80-mesh sieve, further mix evenly, and directly compress into tablets.

[0025] Comparing the two preparation processes, the properties of Tamibarote...

Embodiment 2

[0029]

[0030] Preparation process: pass all excipients (except magnesium stearate) through 80-mesh sieve, mix evenly, dissolve tamibarotene raw material in medicinal absolute ethanol to make tamibarotene ethanol solution, and then spray evenly In the uniformly mixed auxiliary materials, dry to dry at 30-50°C, pass through an 80-mesh sieve and mix evenly, then add magnesium stearate that has passed through an 80-mesh sieve, further mix evenly, and directly compress into tablets.

Embodiment 3

[0032]

[0033] Preparation process: Dissolve the tamibarotene raw material in medicinal absolute ethanol to make a tamibarotene / ethanol solution, and then evenly spray it on the pregelatinized starch that has passed through a 80-mesh sieve, mix well, Dry to dry at 30-50°C, pass through 80-mesh sieve for later use, pass lactose and hydroxypropyl cellulose through 80-mesh sieve, mix evenly with the mixed powder treated by solvent deposition method by equal volume addition method, and then add Magnesium stearate with 80-mesh sieve, further mixed evenly, and directly compressed into tablets.

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Abstract

The invention discloses a method for preparing dispersible tablets of tamibarotene. The process in the method adopts the solvent deposition method, and the dispersible tablets of tamibarotene, prepared by the method, are good in stability, high in content uniformity and also high in dissolution rate; the method is operated according to the requirements of the Chinese Pharmacopoeia on the dissolution rate of the dispersible tablets, and the dispersible tablets are completely disintegrated within 3 minutes and can pass the No 2 screen(24 meshes), so that the dispersible tablets can enhance the absorption in the human body and improve the biological utilization rate; the preparation method is simple in operation and causes little pollution; by dissolving the tamibarotene in the organic solvents and depositing the tamibarotene in the auxiliary materials, the dust problem in operation can be solved, the caused pollution can be lessened, the untoward reactions of operators are avoided; and the mixed powder of raw materials and auxiliary materials, prepared by the method, can be tabletted directly, so that the cost is saved, and the requirement for being suitable for industrialized production is met.

Description

technical field [0001] The present invention relates to a preparation method of the pharmaceutical composition, and further relates to a preparation method of Tamibarotene dispersible tablets. Background technique [0002] Tamibarotene is a retinoic acid compound discovered and synthesized for the first time by Professor Suto of the University of Tokyo (Jpn J CancerRes 79: 473-483, 1988; J Med Chem 31: 2182-2192, 1988, etc.), November 1988 On the 27th, the compound was designated as a drug for rare diseases due to its predictable effect on acute promyelocytic leukemia patients. Nippon Shinyaku first developed it into tablets and released it in Japan in June 2005. Listed (trade name: Amnolake), it is a new type of drug for the treatment of APL designed and developed to eliminate the drug resistance and toxic side effects of ATRA. It is a third-generation RARα receptor selective agonist with high efficiency, low drug resistance and side effects Clinical studies have shown tha...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/192A61P35/02
Inventor 卓秋琪曾嘉铨张汉利宝玉荣郭才旺
Owner 深圳万乐药业有限公司
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