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Carbamazepine dispersible tablet preparation method

A technology of dispersible tablets and carbamazepine, which is applied in the field of preparation of carbamazepine dispersible tablets, can solve the problems of easy energy consumption, unfavorable large-scale production, cumbersome process, etc., and achieve the goal of reducing process steps, reducing input costs, and increasing dissolution Effect

Inactive Publication Date: 2017-01-04
CHENGDU BAOKE BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] When the existing carbamazepine dispersible tablets are prepared, the raw materials and auxiliary materials are mixed, after the soft material is made, they are evenly dried, and then crushed and then granulated with a binder, and dried; two-step mixing and two-step drying, the process is cumbersome and unfavorable for large-scale production , and it is easy to consume energy and increase the cost

Method used

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  • Carbamazepine dispersible tablet preparation method
  • Carbamazepine dispersible tablet preparation method
  • Carbamazepine dispersible tablet preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The selection test of embodiment 1 carbamazepine dissolving solvent

[0026] Take about 20 mg of the raw materials and put them in a beaker, gradually add ethanol solutions of different concentrations (50%, 75%, 95%), observe while shaking until the solution is clear, and weigh the amount of solvent added. According to the amount of different ethanol concentrations, 180 mg of mixed auxiliary materials were used to make soft materials, and the humidity of the soft materials was observed, and sieved with a 20-mesh sieve. The results are shown in Table 1.

[0027] Table 1 The selection and investigation results of the main ingredient dissolving solvent

[0028]

[0029] Results: The above-mentioned ethanol solutions with different concentrations can dissolve 20mg of raw materials well under a certain amount, have a good wetting effect on 180mg, and have good formability on material particles. It is determined that 50-95% ethanol is used as the granulation solvent for th...

experiment example 2

[0031] The prescription of carbamazepine tablets consists of the ingredients shown in Table 2.

[0032] Table 2 Prescription of Carbamazepine Tablets

[0033]

[0034] The preparation method of above-mentioned carbamazepine dispersible tablet is as follows:

[0035] Preparation Process:

[0036] 1. The carbamazepine of recipe quantity, povidone are ultrasonically dissolved in the 75% ethanol solution of about 60g simultaneously, as the binding agent containing principal agent, this binding agent is colorless and transparent, without agglomerate and bubble.

[0037] 2. Take the prescribed amount of sodium carboxymethyl starch, pregelatinized starch, talcum powder, and sodium saccharin and mix them through a 100-mesh sieve for 3 times.

[0038] 3. Add the binder containing the main ingredient to the mixture in step 2, prepare the soft material and granulate it with a 20-mesh sieve, and dry it in an oven at 60°C.

[0039] 4. The granules are passed through a 24-mesh sieve f...

experiment example 3

[0042] The prescription of carbamazepine tablets consists of the ingredients shown in Table 3.

[0043] Table 3 Prescription of Carbamazepine Tablets

[0044]

[0045]

[0046] The preparation method of above-mentioned carbamazepine dispersible tablet is as follows:

[0047] Preparation Process:

[0048] 1. Dissolve the prescribed amount of carbamazepine and hydroxypropyl methylcellulose in about 60g of 50% ethanol solution at the same time, and use it as a binder containing the main drug. The binder is colorless and transparent without lumps Blocks and bubbles.

[0049] 2. Take the prescribed amount of microcrystalline cellulose, cross-linked polyvinylpyrrolidone, talcum powder, and aspartame and mix them through a 100-mesh sieve for 3 times.

[0050] 3. Add the binder containing the main ingredient to the mixture in step 2, prepare the soft material and granulate it with a 20-mesh sieve, and dry it in an oven at 40°C.

[0051] 4. The granules are passed through a 2...

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Abstract

The invention provides a carbamazepine dispersible tablet preparation method, which comprises: (a) weighing raw materials and auxiliary materials according to a certain weight ratio, wherein the raw materials and the auxiliary materials comprise, by weight, 10-20 parts of carbamazepine, 30-80 parts of a disintegrating agent, 100-200 parts of a filler, 1-3 parts of an adhesive, 1.5-2.5 parts of a glidant, and 1-3 parts of a lubricant; b, dissolving the carbamazepine and the disintegrating agent in 50-95% ethanol to prepare a drug-containing adhesive; c, taking the mixture of the filler, the lubricant and the adhesive, screening, and mixing; and d, adding the drug-containing adhesive prepared in the step b to the mixture prepared in the step c, granulating, drying, pelletizing, blending, and tableting to prepare the tablet. According to the present invention, with the carbamazepine dispersible tablet preparation method, the drug content uniformity can be ensured, the control of the raw material particle size does not require the micronization, the dissolution of the poorly soluble drug can be increased, and the operation steps of the process are reduced with the co-dissolving so as to save the energy source and reduce the cost.

Description

technical field [0001] The invention relates to a preparation method of carbamazepine dispersible tablets, belonging to the field of pharmaceutical preparations. Background technique [0002] Carbamazepine (CBZ) is the drug of choice for the treatment of epilepsy, and it is also commonly used in the treatment of trigeminal neuralgia, manic depression, and arrhythmia. It is a commonly used drug in clinical practice and has a huge market. It was synthesized by Schneider in Switzerland in 1961. In 1968, Novartis was listed in tablets, and the dosage forms on the market have also developed from simple tablets to chewable tablets, suspensions and sustained-release preparations. In 1997, Shire developed a sustained-release capsule consisting of immediate-release, sustained-release, and enteric-coated pellets, which promoted the development of dosage forms of carbamazepine. In 2004, Shire's Carbamazepine Sustained-release Capsules was approved by the US FDA, which is currently the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/55A61K47/38A61K47/32A61K47/36A61K47/26
Inventor 陈立春
Owner CHENGDU BAOKE BIOTECH
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