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A method for preparing oral rapidly disintegrating tablets for the treatment of hypokalemia by 3D printing technology

An oral rapidly disintegrating tablet and 3D printing technology, applied in the field of medicine, can solve the problems of poor taste, potassium chloride 3D printing drug formula and printing process for the treatment of hypokalemia, and difficulty swallowing, etc., and achieve a single tablet dosage High, high market application prospects, good taste effect

Active Publication Date: 2020-06-23
XIAN DI JIA BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For potassium chloride, the current clinically used drugs are mainly injections, oral preparations, and tablets; for tablets, the oral potassium chloride tablets currently on the market have disadvantages such as poor taste and difficulty in swallowing.
[0005] At present, there are literature reports and commercialized products prepared by different 3D printing tablets, but there are no reports on the 3D printing drug formulation and printing process of potassium chloride for the treatment of hypokalemia

Method used

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  • A method for preparing oral rapidly disintegrating tablets for the treatment of hypokalemia by 3D printing technology
  • A method for preparing oral rapidly disintegrating tablets for the treatment of hypokalemia by 3D printing technology
  • A method for preparing oral rapidly disintegrating tablets for the treatment of hypokalemia by 3D printing technology

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] (1) Prescription (tablet)

[0034]

[0035]

[0036] Note: The amount of each component added in the prescription is based on the current amount ± 0.1g

[0037] (2) 3D printing process:

[0038] 1) Potassium chloride raw material (micronized potassium chloride raw material) and mannitol are passed through a 150-mesh sieve before weighing, and the viscous powder (mainly refers to potassium chloride) is put into a 50°C oven before being sieved Dry in medium temperature for 15 minutes to facilitate the mixing of viscous powder;

[0039] 2) Mix the prepared powder, stir and mix thoroughly to obtain the drug powder, ready to print;

[0040] 3) Preparation of adhesive (spray solution): 10% ethanol+(1.0% glycerin, 0.5% polysorbate 80)+1.5% Plasdone-K30 as adhesive; that is, the adhesive is 10% ethanol by volume percentage The aqueous solution is used as a solvent, and glycerin, polysorbate 80, and Plasdone-K30 are dissolved in it, and the mass fractions of glycerin, p...

Embodiment 2

[0050] (1) Prescription (tablet)

[0051]

[0052]

[0053] Note: The amount of each component added in the prescription is based on the current amount ± 0.1g.

[0054] (2) 3D printing process

[0055] Except following conditions, other is identical with embodiment 1:

[0056] ① 10% ethanol + (1.0% glycerin, 0.5% polysorbate 80) + 1.5% Plasdone K29 / 32 as a binder

[0057] ②The number of layers is 55, and the layer height is 0.15mm;

[0058] After inspection: the weight of the tablet is 1.862g, the hardness is 14.262kg, and the disintegration time limit is 7-9 seconds.

Embodiment 3

[0060] (1) Prescription (tablet)

[0061]

[0062] Note: The amount of each component added in the prescription is based on the current amount ± 0.1g.

[0063] (2) 3D printing process

[0064] Except following conditions, other is identical with embodiment 1:

[0065] ① 10% ethanol + (1.0% glycerin, 0.5% polysorbate 80) + 1.5% Plasdone K29 / 32 as a binder

[0066] ②The number of layers is 55, and the layer height is 0.15mm;

[0067] After inspection: tablet weight 1.95g, hardness 15.73kg, disintegration time limit: 10-17 seconds.

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Abstract

The invention provides a method for preparing orally disintegrating tablets for treating hypokalemia by 3D printing. The method includes: well mixing medicinal potassium chloride raw powder and auxiliary materials, and adopting mixed solution of ethanol water, glycerin, polysorbate 80 and Plasdone-k29 / 32 (or Plasdone-K30) to prepare tablets by powder-liquid 3D printing. The tablets prepared according to the method are great in taste, easy to disintegrate, high in hardness, portable and simple in preparation process, and the foundation is laid for individual accurate medication.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an orally rapidly disintegrating tablet for treating hypokalemia prepared by 3D printing technology and a preparation method thereof. Background technique [0002] 3D printing first originated in the United States at the end of the 19th century, but it did not develop until the 1980s. 3D printing technology was initially used in the fields of manufacturing, aerospace and industrial design. With the development and maturity of 3D printing technology, this emerging technology began to enter the field of medicine, and has been used in medical model manufacturing, tissue and organ regeneration, and clinical repair treatment. A series of research results have been achieved in drug research and development experiments. On July 31, 2015, the U.S. Food and Drug Administration approved the marketing of Spritam (levetiracetam) fast-dissolving tablets, the first Spritam (levetiracetam) ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K33/14A61K47/26A61P3/12
CPCA61K9/0056A61K9/2018A61K9/2095A61K33/14
Inventor 卜昕王鑫桐鲁再丰赵伟
Owner XIAN DI JIA BIOTECH CO LTD
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