Pregabalin orally disintegrating tablet and dispersible tablet and preparation method thereof

A technology of pregabalin and dispersible tablets, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., which can solve the problem of long-term storage and inconvenient carrying of pregabalin solution by patients and other issues to achieve good stability

Inactive Publication Date: 2013-09-04
SHANGHAI AUCTA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, pregabalin solution is inconvenient for patient

Method used

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  • Pregabalin orally disintegrating tablet and dispersible tablet and preparation method thereof
  • Pregabalin orally disintegrating tablet and dispersible tablet and preparation method thereof
  • Pregabalin orally disintegrating tablet and dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1. Pregabalin orally disintegrating tablets

[0029] The prescription of pregabalin orally disintegrating tablets is shown in Table 1:

[0030] Table 1 Prescription of pregabalin orally disintegrating tablets:

[0031] .

[0032] Preparation:

[0033] 1. Pregabalin, sucralose, mannitol, citric acid, microcrystalline cellulose and crospovidone were mixed in a wet granulator;

[0034] 2. Add appropriate amount of water for granulation;

[0035] 3. The obtained granules are dried and sieved;

[0036] 4. The sieved granules are mixed with other external phases (strawberry essence, mannitol, microcrystalline cellulose, crospovidone, silicon dioxide and sodium stearyl fumarate);

[0037] 5. The final mixture is compressed with a 12mm die to obtain tablets of the required hardness.

[0038] Disintegration Time Study

[0039] Disintegration time is an important indicator of orally disintegrating tablets. The orally disintegrating tablet of pregabalin of th...

Embodiment 2

[0048] Example 2. Pregabalin Dispersible Tablets

[0049] The composition of the pregabalin dispersible tablet is shown in Table 4. It has certain similarities with the commercially available pregabalin solution and can replace the pregabalin solution.

[0050] Table 4 Composition of Pregabalin Dispersible Tablets

[0051] .

[0052] Preparation:

[0053] 1. Pregabalin, sucralose, mannitol, citric acid, microcrystalline cellulose and crospovidone were mixed in a wet granulator;

[0054] 2. Add appropriate amount of water for granulation;

[0055] 3. The obtained granules are dried and sieved;

[0056] 4. The sieved granules are mixed with other external phases (strawberry essence, mannitol, microcrystalline cellulose, crospovidone, silicon dioxide and sodium stearyl fumarate);

[0057] 5. The final mixture is compressed with a 12mm die to obtain tablets of the required hardness.

[0058] Disintegration Time Study

[0059]Disintegration time is also an important in...

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Abstract

The invention belongs to technical field of medicine, and particularly relates to a pregabalin orally disintegrating tablet and a dispersible tablet and the preparation method thereof. A prescription of the pregabalin orally disintegrating tablet and dispersible tablet contains at least one disintegrating agent and insoluble auxiliary material at a certain ratio, so that the disintegration time of six pregabalin orally disintegrating tablets is less than three minutes in one hundred ml of water at the temperature of 2o DEG C, while the disintegration time of pregabalin dispersible table is less than 30 seconds in 2 ml of water at the temperature of 24 DEG C. The bulk pharmaceutical chemicals of pregabalin orally disintegrating tablet and dispersible tablet are controlled in smaller grain size (74 to 250 microns). Combined with the technology of wet granulation, the problem of poor compressibility of pregabalin powder is solved. The solubility of pregabalin orally disintegrating tablet and dispersible tablet can reach more than 85 percent within 15 minutes in different PH mediums.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to pregabalin orally disintegrating tablets and dispersible tablets and a preparation method thereof. Background technique [0002] Pregabalin is a white crystalline powder with pKa values ​​of 4.2 and 10.6, and is a drug that is readily soluble in water. Pregabalin Capsules was launched in the United States in 2004, mainly for the treatment of diabetic peripheral neuralgia, postherpetic neuralgia and auxiliary treatment of partial seizures. Pregabalin solution (20 mg / ml) was launched in the United States in 2010 and is mainly suitable for patients who have difficulty swallowing. But pregabalin solution is inconvenient for patients to carry, and it is not helpful for long-term preservation. [0003] In order to facilitate the patient's taking and improve the stability of the drug, the present invention develops a dispersible tablet of pregabalin to replace the pregaba...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/197A61K47/38A61K47/32A61P25/02A61P25/08
Inventor 卢恩先李守峰马红岩王众勤
Owner SHANGHAI AUCTA PHARMA CO LTD
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