CN107343880B - Warfarin sodium orally disintegrating tablet capable of being individually administrated and prepared by 3D printing and preparation method thereof - Google Patents
Warfarin sodium orally disintegrating tablet capable of being individually administrated and prepared by 3D printing and preparation method thereof Download PDFInfo
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- CN107343880B CN107343880B CN201710507922.5A CN201710507922A CN107343880B CN 107343880 B CN107343880 B CN 107343880B CN 201710507922 A CN201710507922 A CN 201710507922A CN 107343880 B CN107343880 B CN 107343880B
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- disintegrating tablet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
- A61K31/37—Coumarins, e.g. psoralen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y10/00—Processes of additive manufacturing
Abstract
The invention discloses a warfarin sodium orally disintegrating tablet capable of being individually administrated and prepared by 3D printing, which is mainly prepared from the following components in percentage by mass by adopting a 3D printing technology: 1-10% of warfarin sodium, 90-99% of filler, 0.1-1.0% of superfine silica powder and 0-2% of flavoring agent, wherein the sum of the mass percentages of the components is equal to 100%. The invention also discloses a preparation method of the warfarin sodium orally disintegrating tablet. The warfarin sodium orally disintegrating tablet provided by the invention has the advantages that the drug release speed is high, the content of the tablet is determined by taking the number of printing layers as a variable under the condition that the prescription and the process parameters are the same, namely, the dosage of the tablet can be individually designed by changing the number of printing layers, the dosage suitable for a patient can be customized according to the individual difference of the patient, the individual administration and the precise treatment are realized, the number of tablets taken by the patient is reduced or the steps of cutting the tablet by a pharmacist are reduced, the medicinal preparation can exert the maximum curative effect, and the toxic and side effects of the medicine are reduced to the minimum.
Description
Technical Field
The invention relates to a warfarin sodium orally disintegrating tablet, in particular to a warfarin sodium orally disintegrating tablet which is prepared by 3D printing and can be individually administrated. The invention also relates to a preparation method of the warfarin sodium orally disintegrating tablet.
Background
Three-dimensional printing (3 DP) is a rapid prototyping technique that uses a digital model as a basis to build an object by layer-by-layer printing with bondable materials such as powdered metals or plastics. The Sachs, the national institute of technology and technology for the technology and technology, at the earliest, proposes to rapidly and precisely manufacture an object with a special shape or a complex internal structure by stacking materials according to the concept of "printing layer by layer and stacking layer by layer" under the control of a computer and according to data such as a CAD model or CT of the object. In recent years, a number of scientists have conducted a series of studies in this field, focusing mainly on the development of printing devices, drug synthesis and printing of pharmaceutical preparations. On 31/7/2015, the U.S. food and drug administration approved Spritam (levetiracetam) fast dissolving tablets prepared by 3D printing technology for the first money of Aprecia pharmaceutical companies, and marked that 3D printing becomes a new preparation processing technology.
Warfarin sodium is an important oral anticoagulant at present, is widely applied to treatment of deep vein thrombosis, pulmonary embolism, atrial fibrillation and the like, and has the prescription amount of 0.5-1.5% of population number, the individual difference of curative effects of patients using warfarin is large, the clinical medication dosage can be about 20 times different, the blood concentration is easily influenced by other factors, the treatment window is narrow, even if the small dosage is changed in response, thrombus or bleeding can be caused, and most patients are old people, and the administration is difficult and the compliance is poor. The existing common tablet specifications on the market are only 2.5mg, 3.0mg and 5.0mg, most patients need to cut the tablet into smaller dose before taking the tablet, and the disintegration time is as long as 3min, so that the requirements of the patients cannot be met.
The warfarin sodium orally disintegrating tablet which can be individually administrated and prepared by adopting a 3D printing technology has great significance.
Disclosure of Invention
The invention aims to overcome the defects of the existing warfarin sodium dosage form at present and provides a warfarin sodium orally disintegrating tablet which is prepared by 3D printing and can be individually administrated.
The second purpose of the invention is to provide a preparation method of the warfarin sodium orally disintegrating tablet.
In order to realize the first purpose of the invention, the invention adopts the following technical scheme:
the warfarin sodium orally disintegrating tablet capable of being individually administrated and prepared by 3D printing is mainly prepared from the following components in percentage by mass by adopting a 3D printing technology: 1-10% of warfarin sodium, 90-99% of filler, 0.1-1.0% of superfine silica powder and 0-2% of flavoring agent, wherein the sum of the mass percentages of the components is equal to 100%.
Preferably, the weight percentages of the components are as follows: 1-5% of warfarin sodium, 90-99% of filler, 0.1-1.0% of superfine silica powder and 0-2% of flavoring agent, wherein the sum of the mass percentages of the components is equal to 100%.
More preferably, the weight percentages of the components are as follows: warfarin sodium 1.3%, filler 97.7%, and silica gel micropowder 1.0%.
The filler includes, but is not limited to, sucrose, dextrin, lactose, pregelatinized starch, microcrystalline cellulose, mannitol, sorbitol, or xylitol.
The flavoring agent includes but is not limited to sucralose, stevioside, aspartame, maili sweet or essence.
The second invention purpose of the invention is realized by the following technical scheme: the preparation method of the warfarin sodium orally disintegrating tablet capable of being individually administrated comprises the following steps:
(1) modeling by using software according to preset parameters, converting the parameters into stl format files and importing the stl format files into an LTY software control system of the 3D printer;
(2) according to the mass percentage, warfarin sodium, a filling agent, micro-powder silica gel and a flavoring agent are uniformly mixed to be used as medicinal powder and put into a powder box of a 3D printing rapid forming machine;
(3) loading the adhesive into the cartridge;
(4) the control system outputs an instruction to control the 3D printing rapid forming machine to print the warfarin sodium orally disintegrating tablets: the powder laying device firstly lays a layer of medicinal powder on a powder bed, then the printing nozzle moves in a selected area in the X-Y axis direction and sprays adhesive, and the first layer of the orally disintegrating tablet is formed; then, in the Z-axis direction, the powder bed is lowered to the height of the spraying layer integrally through the motion of the shaft body, the powder spreading device spreads a second layer of powder on the powder bed, the operation is repeated, and the printing is carried out layer by layer until the number of the spraying layers is reached, so that the printing of the orally disintegrating tablets is completed;
(5) taking out after the orally disintegrating tablet is bonded, removing redundant powder around the orally disintegrating tablet, and drying.
In the parameters of the step (1), the three-dimensional parameters of the orally disintegrating tablet are as follows: radius of 3-6mm, thickness of 2.00-6.00mm, powder thickness of 0.15-0.25mm in each layer, and layer number of 10-30 layers, wherein the parameters of the adhesive are as follows: spraying speed of 4nL 12kz, and spraying times of 1-3.
The adhesive is 0-50% ethanol solution, or water or ethanol solution of polyvidone.
The invention has the beneficial effects that:
1. the warfarin sodium orally disintegrating tablet printed by the 3D printing technology has the characteristics of high drug release speed, capability of improving the compliance of patients taking drugs and the like, and is particularly convenient for the old, children and dysphagia patients.
2. Compared with the prior art, the invention determines the content of the tablets by taking the number of printing layers as variables under the condition of the same prescription and process parameters, namely, the dosage of the tablets can be individually designed by changing the number of the printing layers (see table 1), so that the dosage suitable for patients can be customized according to individual differences of the patients, individual administration and accurate treatment are realized, the number of tablets taken by the patients is reduced or the steps of cutting the tablets by pharmacists are reduced, the medicinal preparation can exert the maximum curative effect, and the toxic and side effects of the medicaments are reduced to the minimum.
Table 1:
| target dose (mg) | Number of print layers | Actual content (mg/tablet) | |
| Example 1 | 2.50 | 15 layers of | 2.32±0.09 |
| Example 2 | 3.00 | 18 layers of | 2.85±0.08 |
| Example 3 | 5.00 | 30 layers of | 5.37±0.34 |
3. The invention is also suitable for the medicine which has small dosage and needs to be quickly disintegrated.
Detailed Description
The present invention will be further described with reference to the following examples, which should not be construed as limiting the scope of the invention.
Example 1
(target dose: 2.50mg)
The formula is as follows:
the 3D printing parameters were as follows:
the preparation method comprises the following steps:
(1) and modeling by utilizing software such as CAD (computer-aided design) and the like according to preset parameters, converting the parameters into stl format files, and importing the stl format files into an LTY software control system of the 3D printer.
(2) The warfarin sodium, the sucrose and the micro silica gel powder are uniformly mixed and are filled into a powder box of a 3D printing rapid forming machine as medicinal powder.
(3) The cartridge was filled with a 50% ethanol solution.
(4) The control system outputs an instruction to control the 3D printing rapid forming machine to print the warfarin sodium orally disintegrating tablets: the powder spreading device firstly spreads a layer of 0.20mm thick powder on a powder bed, and then a printing nozzle moves in a selected area in the X-Y axis direction and sprays adhesive, which is the first layer of the orally disintegrating tablet; and then, in the Z-axis direction, the whole powder bed is lowered by 0.20mm through the motion of the shaft body, the powder spreading device spreads a second layer of powder on the powder bed, the operations are repeated, and the layer-by-layer printing is carried out until the number of spraying layers is reached, so that the printing of the orally disintegrating tablet is completed.
(5) Taking out after the orally disintegrating tablet is bonded, removing the redundant powder around, and drying.
The quality inspection of the warfarin sodium orally disintegrating tablets is as follows:
the content of warfarin sodium in the warfarin sodium orally disintegrating tablet is determined to be 2.32 +/-0.09 mg/tablet by adopting High Performance Liquid Chromatography (HPLC).
The disintegration time test of the warfarin sodium orally disintegrating tablet comprises the following steps:
the disintegration time limit of the warfarin sodium orally disintegrating tablet is determined according to the disintegration time limit determination method of 'Chinese pharmacopoeia' 2015 edition. The disintegration time is 6 +/-1 s, and meets the requirements of 'Chinese pharmacopoeia' 2015 edition.
Example 2
(target dose: 3.00mg)
The preparation method and the raw material ratio are the same as example 1, except that the number of printing layers is 18, and the thickness is 3.60 mm. The quality inspection of the warfarin sodium orally disintegrating tablets is as follows:
the content of warfarin sodium in the warfarin sodium orally disintegrating tablet is determined to be 2.85 +/-0.08 mg/tablet by High Performance Liquid Chromatography (HPLC).
The disintegration time test of the warfarin sodium orally disintegrating tablet comprises the following steps:
the disintegration time limit of the warfarin sodium orally disintegrating tablet is determined according to the disintegration time limit determination method of 'Chinese pharmacopoeia' 2015 edition. The disintegration time is 8 +/-2 s, and the requirement of 'Chinese pharmacopoeia' 2015 edition is met.
Example 3
(target dose: 5.00mg)
The preparation method and the raw material ratio are the same as those of example 1, except that the number of printing layers is 30 and the thickness is 6.00 mm. The quality inspection of the warfarin sodium orally disintegrating tablets is as follows:
the content of warfarin sodium in the warfarin sodium orally disintegrating tablet is determined to be 5.37 +/-0.34 mg/tablet by adopting High Performance Liquid Chromatography (HPLC).
The disintegration time test of the warfarin sodium orally disintegrating tablet comprises the following steps:
the disintegration time limit of the warfarin sodium orally disintegrating tablet is determined according to the disintegration time limit determination method of 'Chinese pharmacopoeia' 2015 edition. The disintegration time is 10 +/-2 s, and the requirement of 'Chinese pharmacopoeia' 2015 edition is met.
Example 4
The formula is as follows:
the 3D printing parameters were as follows:
the preparation method comprises the following steps:
(1) according to preset parameters, modeling by utilizing software such as CAD (computer-aided design) and the like, converting the parameters into stl format files and importing the stl format files into an LTY (low temperature Y) software control system of the 3D printer;
(2) the warfarin sodium, the sucrose, the pregelatinized starch, the micropowder silica gel and the sucralose are uniformly mixed in proportion and used as medicinal powder to be filled into a powder box of a 3D printing rapid forming machine.
(3) The cartridge was filled with a 30% ethanol solution.
(4) The control system outputs an instruction to control the 3D printing rapid forming machine to print the warfarin sodium orally disintegrating tablets: the powder spreading device firstly spreads a layer of 0.15mm thick powder on a powder bed, and then a printing nozzle moves in a selected area in the X-Y axis direction and sprays adhesive, which is the first layer of the orally disintegrating tablet; and then, in the Z-axis direction, the whole powder bed is lowered by 0.15mm through the motion of the shaft body, the powder spreading device spreads a second layer of powder on the powder bed, the operations are repeated, and the layer-by-layer printing is carried out until the number of spraying layers is reached, so that the printing of the orally disintegrating tablet is completed.
(5) Taking out after the orally disintegrating tablet is bonded, removing the redundant powder around, and drying.
The quality inspection of the warfarin sodium orally disintegrating tablets is as follows:
the content of warfarin sodium in the warfarin sodium orally disintegrating tablet is determined to be 3.06 +/-0.16 mg/tablet by adopting High Performance Liquid Chromatography (HPLC).
The disintegration time test of the warfarin sodium orally disintegrating tablet comprises the following steps:
the disintegration time limit of the warfarin sodium orally disintegrating tablet is determined according to the disintegration time limit determination method of 'Chinese pharmacopoeia' 2015 edition. The disintegration time is 14 +/-1 s, and the requirement of 'Chinese pharmacopoeia' 2015 edition is met.
Example 5
The formula is as follows:
the 3D printing parameters were as follows:
the preparation method comprises the following steps:
(1) and modeling by utilizing software such as CAD (computer-aided design) and the like according to preset parameters, converting the parameters into stl format files, and importing the stl format files into an LTY software control system of the 3D printer.
(2) The warfarin sodium, the sucrose, the dextrin, the micro-powder silica gel and the stevioside are uniformly mixed in proportion and are filled into a powder box of a 3D printing rapid forming machine as medicinal powder.
(3) The cartridge was filled with a 50% ethanol solution containing 1% povidone.
(4) The control system outputs an instruction to control the 3D printing rapid forming machine to print the warfarin sodium orally disintegrating tablets: the powder spreading device firstly spreads a layer of 0.25mm thick powder on a powder bed, and then a printing nozzle moves in a selected area in the X-Y axis direction and sprays adhesive, which is the first layer of the orally disintegrating tablet; and then, in the Z-axis direction, the whole powder bed is lowered by 0.25mm through the motion of the shaft body, the powder spreading device spreads a second layer of powder on the powder bed, the operations are repeated, and the layer-by-layer printing is carried out until the number of spraying layers is reached, so that the printing of the orally disintegrating tablet is completed.
(5) Taking out after the orally disintegrating tablet is bonded, removing the redundant powder around, and drying.
The quality inspection of the warfarin sodium orally disintegrating tablets is as follows:
the content of warfarin sodium in the warfarin sodium orally disintegrating tablet is measured to be 4.36 +/-0.07 mg/tablet by adopting High Performance Liquid Chromatography (HPLC).
The disintegration time test of the warfarin sodium orally disintegrating tablet comprises the following steps:
the disintegration time limit of the warfarin sodium orally disintegrating tablet is determined according to the disintegration time limit determination method of 'Chinese pharmacopoeia' 2015 edition. The disintegration time is 13 +/-1 s, and the requirement of 'Chinese pharmacopoeia' 2015 edition is met.
Claims (7)
1. The warfarin sodium orally disintegrating tablet capable of being individually administrated and prepared by 3D printing is characterized by being mainly prepared from the following components in percentage by mass by adopting a 3D printing technology: the preparation method comprises the following steps of 1-10% of warfarin sodium, 90-99% of filler, 0.1-1.0% of superfine silica gel powder and 0-2% of flavoring agent, wherein the sum of the mass percentages of the components is equal to 100%, the adhesive used in the preparation is 0-50% of ethanol solution, and water or ethanol solution of povidone, and the filler comprises one or more of sucrose, dextrin, lactose, pregelatinized starch, microcrystalline cellulose, mannitol, sorbitol and xylitol.
2. The warfarin sodium orally disintegrating tablet capable of being individually administrated and prepared by 3D printing according to claim 1, wherein the warfarin sodium orally disintegrating tablet comprises the following components in percentage by mass: 1-5% of warfarin sodium, 90-99% of filler, 0.1-1.0% of superfine silica powder and 0-2% of flavoring agent, wherein the sum of the mass percentages of the components is equal to 100%.
3. The warfarin sodium orally disintegrating tablet capable of being individually administrated and prepared by 3D printing according to claim 1, wherein the warfarin sodium orally disintegrating tablet comprises the following components in percentage by mass: warfarin sodium 1.3%, filler 97.7%, and silica gel micropowder 1.0%.
4. The warfarin sodium orally disintegrating tablet capable of being individually administrated and prepared by 3D printing according to claim 1, wherein the flavoring agent comprises sucralose, stevioside, aspartame, maiware or essence.
5. A method for preparing the warfarin sodium orally disintegrating tablet capable of being individualized according to any one of claims 1 to 4, which is characterized by comprising the following steps:
(1) modeling by using software according to preset parameters, converting the parameters into stl format files and importing the stl format files into an LTY software control system of the 3D printer;
(2) according to the mass percentage, warfarin sodium, a filling agent, micro-powder silica gel and a flavoring agent are uniformly mixed to be used as medicinal powder and put into a powder box of a 3D printing rapid forming machine;
(3) loading the adhesive into the cartridge;
(4) the control system outputs an instruction to control the 3D printing rapid forming machine to print the warfarin sodium orally disintegrating tablets: the powder laying device firstly lays a layer of medicinal powder on a powder bed, then the printing nozzle moves in a selected area in the X-Y axis direction and sprays adhesive, and the first layer of the orally disintegrating tablet is formed; then, in the Z-axis direction, the powder bed is lowered to the height of the spraying layer integrally through the motion of the shaft body, the powder spreading device spreads a second layer of powder on the powder bed, the operation is repeated, and the printing is carried out layer by layer until the number of the spraying layers is reached, so that the printing of the orally disintegrating tablets is completed;
(5) taking out after the orally disintegrating tablet is bonded, removing redundant powder around the orally disintegrating tablet, and drying.
6. The preparation method of the warfarin sodium orally disintegrating tablet capable of being individually administrated according to claim 5, wherein the parameters of the step (1) comprise three-dimensional parameters of the orally disintegrating tablet: radius of 3-6mm, thickness of 2.00-6.00mm, powder thickness of 0.15-0.25mm in each layer, and layer number of 10-30 layers, wherein the parameters of the adhesive are as follows: spraying speed of 4nL 12kz, and spraying times of 1-3.
7. The preparation method of the warfarin sodium orally disintegrating tablet capable of being individually administrated according to claim 5, wherein the flavoring agent in the step (2) comprises sucralose, stevioside, aspartame, alitame or essence.
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| WO2023280816A1 (en) * | 2021-07-08 | 2023-01-12 | Merck Patent Gmbh | Process for the manufacture of a solid pharmaceutical administration form |
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