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Perampanel freeze-dried oral disintegrating tablet and preparation method thereof

An orally disintegrating tablet and freeze-drying technology, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems affecting patients' emotions, esophageal discomfort, and difficulties in taking coated tablets, etc. question

Inactive Publication Date: 2015-06-17
BEIJING SUNHO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Epilepsy patients may find it difficult to take coated tablets due to their different conditions. They need to be taken with water during the taking process. If taken improperly, it may cause esophageal discomfort and affect the patient’s mood.

Method used

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  • Perampanel freeze-dried oral disintegrating tablet and preparation method thereof
  • Perampanel freeze-dried oral disintegrating tablet and preparation method thereof
  • Perampanel freeze-dried oral disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The dosage of each component in the preparation:

[0048]

[0049]

[0050] Add the skeleton proppant mannitol, binder gelatin, and freeze-drying protective agent dextran into water to fully dissolve, add perampanel, stir evenly, and dissolve to 0.2L;

[0051] Draw the liquid medicine and inject 0.2ml into each blister model;

[0052] Place the mold in a -50°C environment for quick freezing;

[0053] Put the solid liquid medicine into the freeze-drying box, vacuumize at -30℃ low temperature environment, and keep the vacuum for 3 hours at a vacuum degree of 10-20Pa;

[0054] Raise the temperature to -10℃~-15℃ and keep it for 3 hours;

[0055] Raise the temperature to 5°C-15°C and keep it for 1 hour;

[0056] Raise the temperature to 20°C-30°C and keep it for 1 hour;

[0057] Out of the box, laminating, cutting, and printing the batch number.

Embodiment 2

[0059] The dosage of each component in the preparation:

[0060]

[0061] Add the skeleton proppant mannitol, binder gelatin, freeze-drying protective agent dextran, and flavoring agent aspartame into water to fully dissolve, add perampanel, stir well, and dissolve to 0.2L;

[0062] Draw the liquid medicine and inject 0.2ml into each blister model;

[0063] Place the mold in a -40°C environment for quick freezing;

[0064] Put the solid liquid medicine into the freeze-drying box, vacuumize at -20 ℃ low temperature environment, vacuum degree 10-20Pa, keep for 3 hours;

[0065] Raise the temperature to -10℃~-15℃ and keep it for 4 hours;

[0066] Raise the temperature to 5°C-15°C and keep it for 2 hours;

[0067] Raise the temperature to 20°C-30°C and keep it for 2 hours;

[0068] Out of the box, laminating, cutting, and printing the batch number.

Embodiment 3

[0070] The dosage of each component in the preparation:

[0071]

[0072] Add the skeleton proppant mannitol, binder hydrolyzed gelatin, freeze-drying protective agent dextran, and flavoring agent sucralose into water to fully dissolve, add perampanel, stir evenly, and settle to 0.2L;

[0073] Draw the liquid medicine and inject 0.2ml into each blister model;

[0074] Place the mold in a -60°C environment for quick freezing;

[0075] Put the solid liquid medicine into the freeze-drying box, vacuumize at -50℃ low temperature environment, the vacuum degree is 10-20Pa, keep for 3 hours;

[0076] Raise the temperature to -10℃~-15℃ and keep it for 4 hours;

[0077] Raise the temperature to 5°C-15°C and keep it for 1 hour;

[0078] Raise the temperature to 20°C-30°C and keep it for 2 hours;

[0079] Out of the box, laminating, cutting, and printing the batch number.

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Abstract

The invention relates to a perampanel freeze-dried oral disintegrating tablet and a preparation method thereof. The perampanel freeze-dried oral disintegrating tablet comprises, by weight, 1-20 parts of a framework propping agent, 1-50 parts of an adhesive, 0.1-8 parts of a freeze drying protection agent and 2-12 parts of perampanel. The perampanel freeze-dried oral disintegrating tablet is convenient for patients to take and improves the medicine taking compliance of epilepsy patients, and the preparation method has the advantages of simplicity and short time.

Description

technical field [0001] The invention relates to the field of oral preparations, in particular to perampanel orally disintegrating tablets and a preparation method thereof, more specifically to perampanel freeze-dried orally disintegrating tablets and a preparation method thereof. Background technique [0002] Partial seizures are also called focal epileptic seizures. The initial clinical and EEG changes suggest that some neurons in the cerebral hemisphere are first activated, followed by synchronous rapid discharges, which rapidly spread to the surrounding normal brain areas, resulting in a series of electrophysiological and neurological disorders. Neurochemical changes leading to neuronal energy depletion and decreased metabolism automatically terminate seizures. [0003] Perampanel is a noncompetitive amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid (AMPA) glutamate receptor antagonist indicated for the treatment of 12-year-olds and 12-year-olds patients with partial-o...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K31/444A61P25/08
Inventor 张寒颜克序修勇
Owner BEIJING SUNHO PHARMA
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