A kind of disulfiram enteric-coated tablet and preparation method thereof

A technology of disulfiram and enteric-coated tablets, which is applied in the directions of pharmaceutical formulation, drug delivery, drug combination, etc., can solve the problems of unreported disulfiram preparation products, studies on disulfiram-free enteric-coated tablets, etc., and achieve biological High utilization, easy to scale up industrial production, and enhanced stability

Inactive Publication Date: 2016-12-28
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] According to patent and literature search, there is no report on the preparation of disulfiram for the treatment of tumors, and there is no research on disulfiram enteric-coated tablets

Method used

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  • A kind of disulfiram enteric-coated tablet and preparation method thereof
  • A kind of disulfiram enteric-coated tablet and preparation method thereof
  • A kind of disulfiram enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Table 1 Raw and auxiliary materials used in Example 1 and their consumption

[0053]

[0054] Preparation Process

[0055] 1) Preparation of disulfiram solid dispersion:

[0056] Take the prescribed amount of disulfiram API and the prescribed amount of copovidone PVP / VA64 and mix them evenly, then add them to the feeding hopper of the hot-melt extruder; set the host frequency to 3Hz, the feeding frequency to 2.5Hz, and the temperature to 130°C; After smoothing, turn on the oil pump and turn on the main machine and feed at the same time to prepare a solid dispersion; collect the extruded product into a stainless steel pan, cool at room temperature for 24 hours, crush, and sieve to obtain powdered disulfiram with a particle size between 60 and 80 Solid dispersion. The DSC figure of disulfiram solid dispersion sees attached figure 1 .

[0057] 2) Preparation of tablet core

[0058] After uniformly mixing the prepared disulfiram solid dispersion with the prescribed ...

Embodiment 2

[0062] Table 2 Raw materials used in Example 2 and their consumption

[0063]

[0064] The preparation process is the same as in Example 1.

Embodiment 3

[0066] Table 3 The raw materials used in Example 3 and their consumption

[0067]

[0068] The preparation process is the same as in Example 1.

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Abstract

The purpose of the present invention is to provide an anti-tumor disulfiram enteric-coated tablet with good stability, high bioavailability and little side effects by using modern pharmaceutical technology. The disulfiram enteric-coated tablet is composed of the following components in turn from the inside to the outside: a. a tablet core composed of disulfiram and pharmaceutically acceptable excipients; b. an intermediate isolation layer composed of an isolation material; c. an enteric-coated An enteric-coated layer composed of raw materials and pharmaceutically acceptable excipients; it is characterized in that: the tablet core is made of disulfiram bulk drug, diluent, and disintegrant that have been processed to increase solubility, and are directly compressed into tablets or made into granules before adding The disintegrating agent is compressed; wherein, the diluent is selected from one or more of LubriTose lactose series, sucrose, lactose, mannitol, precrossified starch, microcrystalline cellulose, and calcium carbonate in traditional excipients, and the dosage is 30% to 50% of the total weight of the tablet core; the disintegrant is selected from one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, and cross-linked povidone kind.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and particularly provides an enteric-coated tablet of an antineoplastic drug disulfiram and a preparation method thereof. Background technique [0002] Disulfiram (disulfiram, DSF), also known as disulfide tetraethylthiuram, disulfiram, was originally used as a catalyst for rubber vulcanization in the rubber industry; in the 1930s, DSF was first used as a drug for scabies Treatment; In 1948, two doctors in Copenhagen, Hald and Jacobsen, accidentally discovered that taking disulfiram and drinking a small amount of alcohol could immediately cause symptoms such as facial flushing, headache, abdominal pain, sweating, palpitations, and dyspnea, called disulfiram-like reactions . Based on disulfiram-like reactions, disulfiram has been used as an alcohol withdrawal drug for more than half a century. [0003] In the 1870s, Lewison's first research showed that DSF had anti-breast cancer activi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/30A61K31/145A61P35/00
Inventor 唐星张宇荆广会
Owner SHENYANG PHARMA UNIVERSITY
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