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

An oral fast disintegrating tablet, 3D printing technology, applied in the field of medicine, can solve the problems of lanthanum carbonate 3D printing drug formula printing process of hyperphosphatemia, which has not been reported, the production process is cumbersome, and it is difficult to take, etc., and achieves high market application prospects. , the preparation process is simple, the effect of high drug loading

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

At present, the clinically used lanthanum carbonate drugs are mainly chewable tablets, but they have disadvantages such as poor taste, difficulty in swallowing, cumbersome production process, etc., and it is difficult for some patients to take them.
[0005] At present, although there are literature reports and commercialized products prepared by different 3D printing tablets, there are no reports on the lanthanum carbonate 3D printing drug formulation and printing process for the treatment of hyperphosphatemia.

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] (1) Prescription (tablet)

[0035]

[0036]

[0037] Note: The amount of each component added in the prescription is based on the current amount ± 0.1g.

[0038] (2) 3D printing process:

[0039] 1) Pass lanthanum carbonate raw material (micronized lanthanum carbonate raw material) and mannitol through a 150-mesh sieve before weighing, and dry the viscous powder (mainly lanthanum carbonate) in an oven at 50°C before sieving 15 minutes, it is convenient to mix the viscous powder;

[0040] 2) Mix the prepared powder, stir and mix thoroughly to obtain the drug powder, ready to print;

[0041] 3) Preparation of adhesive (spray solution): 10% ethanol+(1.0% glycerol, 0.5% polysorbate 80)+2% Plasdone S-630 as adhesive; that is, adhesive is 10% ethanol by volume percentage The aqueous solution is used as a solvent, and glycerin, polysorbate 80, and Plasdone S-630 are dissolved therein, and the mass fractions of glycerin, polysorbate 80, and Plasdone S-630 in the adhesi...

Embodiment 2

[0051] (1) Prescription (tablet)

[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] Condition is identical with embodiment 1;

[0056] After inspection: the weight of the tablet is 1.08g, the hardness is 3.48kg, and the disintegration time limit is 3-7 seconds.

Embodiment 3

[0058] (1) Prescription (tablet)

[0059]

[0060] Note: The amount of each component added in the prescription is based on the current amount ± 0.1g.

[0061] (2) 3D printing process

[0062] Except following conditions, other is identical with embodiment 1:

[0063] ①Single-layer liquid spraying twice, the number of layers is 61;

[0064] After inspection: the tablet weighs 1.62g, the hardness is 4.71kg, and the disintegration time limit is 4-5 seconds.

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Abstract

The invention provides a method for preparing oral rapidly disintegrating tablets for the treatment of hyperphosphatemia by 3D printing technology: fully mix the raw powder of lanthanum carbonate pharmaceutical grade and auxiliary materials, and use ethanol aqueous solution, glycerin, polysorbate, and copovidone The mixed solution of S-630 is made into tablets by powder-liquid 3D printing technology. The tablet prepared by the invention has a large drug loading capacity, is easy to disintegrate, can improve patient compliance, and is suitable for treating hyperphosphatemia with precise doses for patients with chronic renal failure.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an orally rapidly disintegrating tablet for treating hyperphosphatemia 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 (levetirac...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K33/244A61P3/12B33Y80/00
CPCA61K9/0002A61K9/0056A61K9/2054A61K9/2077B33Y80/00A61K33/244
Inventor 卜昕王鑫桐鲁再丰赵伟
Owner XIAN DI JIA BIOTECH CO LTD
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