ES1296080U - A printable formulation (Machine-translation by Google Translate, not legally binding) - Google Patents
A printable formulation (Machine-translation by Google Translate, not legally binding) Download PDFInfo
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- ES1296080U ES1296080U ES202231370U ES202231370U ES1296080U ES 1296080 U ES1296080 U ES 1296080U ES 202231370 U ES202231370 U ES 202231370U ES 202231370 U ES202231370 U ES 202231370U ES 1296080 U ES1296080 U ES 1296080U
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- 239000000203 mixture Substances 0.000 title claims abstract description 43
- 238000009472 formulation Methods 0.000 title claims abstract description 38
- 239000000796 flavoring agent Substances 0.000 claims abstract description 32
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 12
- 239000003349 gelling agent Substances 0.000 claims abstract description 12
- 239000002562 thickening agent Substances 0.000 claims abstract description 12
- 235000013355 food flavoring agent Nutrition 0.000 claims abstract description 10
- 239000003002 pH adjusting agent Substances 0.000 claims abstract description 10
- 239000003755 preservative agent Substances 0.000 claims abstract description 10
- 239000002904 solvent Substances 0.000 claims abstract description 10
- 108010010803 Gelatin Proteins 0.000 claims abstract description 8
- 239000008273 gelatin Substances 0.000 claims abstract description 8
- 229920000159 gelatin Polymers 0.000 claims abstract description 8
- 235000019322 gelatine Nutrition 0.000 claims abstract description 8
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 8
- 229920001817 Agar Polymers 0.000 claims abstract description 6
- 239000008272 agar Substances 0.000 claims abstract description 6
- 235000010419 agar Nutrition 0.000 claims abstract description 6
- 239000001913 cellulose Substances 0.000 claims abstract description 6
- 229920002678 cellulose Polymers 0.000 claims abstract description 6
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 6
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 5
- 229930195725 Mannitol Natural products 0.000 claims abstract description 5
- 239000000594 mannitol Substances 0.000 claims abstract description 5
- 235000010355 mannitol Nutrition 0.000 claims abstract description 5
- 239000004373 Pullulan Substances 0.000 claims abstract description 4
- 229920001218 Pullulan Polymers 0.000 claims abstract description 4
- 239000000679 carrageenan Substances 0.000 claims abstract description 4
- 235000010418 carrageenan Nutrition 0.000 claims abstract description 4
- 229920001525 carrageenan Polymers 0.000 claims abstract description 4
- 229940113118 carrageenan Drugs 0.000 claims abstract description 4
- 235000019423 pullulan Nutrition 0.000 claims abstract description 4
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims abstract description 4
- 235000019634 flavors Nutrition 0.000 claims description 22
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 15
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 241000287828 Gallus gallus Species 0.000 claims description 3
- 210000004185 liver Anatomy 0.000 claims description 3
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 2
- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 claims description 2
- 244000208874 Althaea officinalis Species 0.000 claims description 2
- 235000006576 Althaea officinalis Nutrition 0.000 claims description 2
- 235000019687 Lamb Nutrition 0.000 claims description 2
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 2
- 235000015241 bacon Nutrition 0.000 claims description 2
- 235000015278 beef Nutrition 0.000 claims description 2
- 235000013351 cheese Nutrition 0.000 claims description 2
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims description 2
- 239000001630 malic acid Substances 0.000 claims description 2
- 235000011090 malic acid Nutrition 0.000 claims description 2
- 235000001035 marshmallow Nutrition 0.000 claims description 2
- 235000013379 molasses Nutrition 0.000 claims description 2
- 235000021400 peanut butter Nutrition 0.000 claims description 2
- 239000004302 potassium sorbate Substances 0.000 claims description 2
- 235000010241 potassium sorbate Nutrition 0.000 claims description 2
- 229940069338 potassium sorbate Drugs 0.000 claims description 2
- 244000144977 poultry Species 0.000 claims description 2
- 239000001509 sodium citrate Substances 0.000 claims description 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 2
- 239000004334 sorbic acid Substances 0.000 claims description 2
- 235000010199 sorbic acid Nutrition 0.000 claims description 2
- 229940075582 sorbic acid Drugs 0.000 claims description 2
- 239000008371 vanilla flavor Substances 0.000 claims description 2
- 239000007958 cherry flavor Substances 0.000 claims 1
- 239000003026 cod liver oil Substances 0.000 claims 1
- 235000012716 cod liver oil Nutrition 0.000 claims 1
- 238000007639 printing Methods 0.000 description 14
- 238000010146 3D printing Methods 0.000 description 5
- 235000010980 cellulose Nutrition 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 239000004615 ingredient Substances 0.000 description 4
- 229940079593 drug Drugs 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 2
- 239000008108 microcrystalline cellulose Substances 0.000 description 2
- 229940016286 microcrystalline cellulose Drugs 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 230000008719 thickening Effects 0.000 description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 235000021028 berry Nutrition 0.000 description 1
- 235000019516 cod Nutrition 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 239000008369 fruit flavor Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Classifications
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- 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
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/341—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/549—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/554—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
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- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
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- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- 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
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
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- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
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- Reproductive Health (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
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- Endocrinology (AREA)
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Abstract
Description
DESCRIPCIÓNDESCRIPTION
Una formulación imprimibleA printable formulation
CampoField
La presente divulgación se refiere a formulaciones de que son adecuadas para la impresión en 3D. La divulgación se refiere también a procedimientos para la impresión en 3D usando las formulaciones.The present disclosure relates to formulations that are suitable for 3D printing. The disclosure also refers to methods for 3D printing using the formulations.
AntecedentesBackground
La impresión tridimensional (3D) es una tecnología que ofrece la posibilidad de fabricar formas personalizadas de dosificación de medicamentos. La principal ventaja del uso de la tecnología de impresión 3D para productos farmacéuticos personalizados es la posibilidad de producir pequeños lotes con dosis, formas, tamaños y características de liberación cuidadosamente adaptadas a medida. También permite incorporar sabores a un comprimido sin necesidad de un recubrimiento de película, enmascarando por completo el sabor de los compuestos químicos. Las impresoras 3D se pueden instalar en farmacias, hospitales, clínicas y lugares remotos, lo que permite la producción bajo demanda de medicamentos, en particular de aquellos con poca estabilidad o que tienen requisitos de almacenamiento en cadena de frío. Para las empresas farmacéuticas, la impresión 3D puede reducir considerablemente los costes, los residuos y la carga medioambiental, ya que las impresoras solo depositan la cantidad exacta de materias primas necesarias.Three-dimensional (3D) printing is a technology that offers the possibility of manufacturing personalized dosage forms of medicines. The main advantage of using 3D printing technology for personalized pharmaceuticals is the ability to produce small batches with carefully tailored doses, shapes, sizes and release characteristics. It also allows flavors to be incorporated into a tablet without the need for a film coating, completely masking the taste of chemical compounds. 3D printers can be installed in pharmacies, hospitals, clinics and remote locations, enabling on-demand production of medicines, particularly those with poor stability or cold chain storage requirements. For pharmaceutical companies, 3D printing can significantly reduce costs, waste, and the environmental burden, as printers only deposit the exact amount of raw materials needed.
El principal reto del proceso de impresión 3D es el desarrollo de la tinta misma, ya que sus propiedades fisicoquímicas podrían afectar en gran medida a la imprimibilidad. La tinta debe poder imprimirse a una temperatura moderada y sólida a temperatura ambiente.The main challenge of the 3D printing process is the development of the ink itself, since its physicochemical properties could greatly affect printability. The ink should be printable at a moderate temperature and solid at room temperature.
En consecuencia, todavía se necesitan más formulaciones imprimibles para los medicamentos.Consequently, more printable formulations for drugs are still needed.
ResumenResume
Se observó que cuando una formulación contenía determinados agentes gelificantes y espesantes, la formulación era imprimible con impresoras 3D comerciales. It was observed that when a formulation contained certain gelling and thickening agents, the formulation was printable with commercial 3D printers.
En consecuencia, es un objetivo de la presente invención proporcionar una formulación imprimible que comprendaAccordingly, it is an object of the present invention to provide a printable formulation comprising
o 2 - 30 % en peso de uno o más agentes gelificantes, or 2 - 30% by weight of one or more gelling agents,
o 9 - 40 % en peso de uno o más agentes espesantes, or 9 - 40% by weight of one or more thickening agents,
o 40 - 70 % en peso de uno o más disolventes, y opcionalmente or 40 - 70% by weight of one or more solvents, and optionally
uno o más conservantes, agentes de ajuste del pH y agentes aromatizantes del peso,one or more preservatives, pH adjusting agents and weight flavoring agents,
en la que los agentes gelificantes se seleccionan de un grupo que consiste en gelatina, pullulán, carragenina y agar, y los agentes espesantes se seleccionan del grupo que consiste en manitol, celulosa y sílice.wherein the gelling agents are selected from the group consisting of gelatin, pullulan, carrageenan, and agar, and the thickening agents are selected from the group consisting of mannitol, cellulose, and silica.
En las reivindicaciones dependientes adjuntas se describen varias realizaciones a modo de ejemplo y no limitantes de la invención.Various exemplary and non-limiting embodiments of the invention are disclosed in the appended dependent claims.
Varias realizaciones ilustrativas y no limitantes de la invención y de los procedimientos de funcionamiento, junto con los objetivos y ventajas adicionales de la misma, se entienden mejor a partir de la siguiente descripción de realizaciones ilustrativas específicas cuando se leen en relación con las figuras adjuntas.Various illustrative and non-limiting embodiments of the invention and methods of operation, along with additional objects and advantages thereof, are best understood from the following description of specific illustrative embodiments when read in connection with the accompanying figures.
Los verbos "comprender" e "incluir" se usan en este documento como limitaciones abiertas que no excluyen ni exigen la existencia de otras características no enumeradas. Las características enumeradas en las reivindicaciones dependientes son mutuamente combinables a menos que se indique explícitamente lo contrario. Además, debe entenderse que el uso de "un" o "una", es decir, una forma singular, a lo largo de este documento no excluye un plural.The verbs "comprise" and "include" are used in this document as open-ended constraints that do not exclude or require the existence of other features not listed. The features listed in the dependent claims are mutually combinable unless explicitly stated otherwise. Furthermore, it should be understood that the use of "a" or "an", that is, a singular form, throughout this document does not exclude a plural.
DescripciónDescription
Los ejemplos específicos proporcionados en la descripción que se ofrece a continuación no deben interpretarse como una limitación del alcance y/o de la aplicabilidad de las reivindicaciones acompañantes. Las listas y los grupos de ejemplos proporcionados en la descripción que se ofrece a continuación no son exhaustivos, a menos que se indique explícitamente lo contrario.The specific examples provided in the description below are not to be construed as limiting the scope and/or applicability of the accompanying claims. The lists and sets of examples provided in the description below are not exhaustive, unless explicitly stated otherwise.
Según un aspecto, la presente divulgación se refiere a una formulación que comprende 2 - 30 % en peso de uno o más agentes gelificantes,According to one aspect, the present disclosure relates to a formulation comprising 2 - 30% by weight of one or more gelling agents,
9 - 40 % en peso de uno o más agentes espesantes,9 - 40% by weight of one or more thickening agents,
30 - 70 % en peso de uno o más disolventes, y opcionalmente30 - 70% by weight of one or more solvents, and optionally
uno o más conservantes, agentes de ajuste del pH y agentes aromatizantes.one or more preservatives, pH adjusting agents and flavoring agents.
Los agentes gelificantes se seleccionan de un grupo que consiste en gelatina, pullulán, carragenina y agar, y los agentes espesantes se seleccionan de un grupo que consiste en manitol, celulosa y sílice. La celulosa puede ser celulosa microcristalina (MCC).Gelling agents are selected from the group consisting of gelatin, pullulan, carrageenan, and agar, and thickening agents are selected from the group consisting of mannitol, cellulose, and silica. The cellulose may be microcrystalline cellulose (MCC).
Según una realización, el agente gelificante es la gelatina, y la formulación comprende entre el 5 % y el 30 % de peso de gelatina. Según otra realización, el agente gelificante es el agar, y la formulación comprende un 6 % en peso de agar.According to one embodiment, the gelling agent is gelatin, and the formulation comprises between 5% and 30% by weight of gelatin. According to another embodiment, the gelling agent is agar, and the formulation comprises 6% by weight of agar.
La formulación comprende uno o más agentes espesantes. Una composición espesante a modo de ejemplo de la formulación consiste en el 5-19 % en peso de celulosa y el 0,8-1,5 % en peso de sílice del peso total de la formulación. Otra composición espesante a modo de ejemplo de la formulación consiste en el 33-34 % en peso de manitol y el 0,8-1,5 % en peso de sílice del peso total de la formulación.The formulation comprises one or more thickening agents. An exemplary thickening composition of the formulation consists of 5-19% by weight of cellulose and 0.8-1.5% by weight of silica of the total weight of the formulation. Another exemplary thickening composition of the formulation consists of 33-34% by weight of mannitol and 0.8-1.5% by weight of silica of the total weight of the formulation.
La formulación comprende uno o más disolventes. Los disolventes preferentes son el agua y el glicerol. Según una realización a modo de ejemplo, la formulación comprende un 44 59 % en peso de agua y un 5-6 % en peso de glicerol.The formulation comprises one or more solvents. Preferred solvents are water and glycerol. According to an exemplary embodiment, the formulation comprises 44-59% by weight of water and 5-6% by weight of glycerol.
Sin embargo, si se usa el infrarrojo cercano para el control de calidad de la formulación, debe evitarse la presencia de niveles de disolventes demasiado elevados, especialmente de agua, pero también de uno o más elementos absorbentes del infrarrojo cercano, tales como espesantes, otros disolventes y cargas.However, if near-infrared is used for formulation quality control, the presence of too high levels of solvents should be avoided, especially water, but also one or more near-infrared absorbing elements, such as thickeners, other solvents and fillers.
La formulación puede comprender también uno o más conservantes, agentes de ajuste del pH y agentes aromatizantes. Los agentes de ajuste del pH a modo de ejemplo son ácido cítrico, citrato de sodio y ácido málico. Los conservantes a modo de ejemplo son ácido sórbico, sorbato de potasio y parabenos. Los agentes aromatizantes a modo de ejemplo se seleccionan entre el sabor a carne de vacuno, el sabor a tocino ahumado, el sabor a cordero, el sabor a pollo, el sabor a hígado de ave, el sabor a queso, el sabor a hígado de bacalao, el sabor a malvavisco, el sabor a melaza, el sabor a vainilla, el sabor a mantequilla de cacahuete, el sabor a fruta y el sabor a bayas. The formulation may also comprise one or more preservatives, pH adjusting agents, and flavoring agents. Exemplary pH adjusting agents are citric acid, sodium citrate and malic acid. Exemplary preservatives are sorbic acid, potassium sorbate and parabens. Exemplary flavoring agents are selected from beef flavor, smoked bacon flavor, lamb flavor, chicken flavor, poultry liver flavor, cheese flavor, chicken liver flavor, cod, marshmallow flavor, molasses flavor, vanilla flavor, peanut butter flavor, fruit flavor, and berry flavor.
Por lo general, la formulación puede comprender hasta un 1 % en peso de conservantes, hasta un 1 % en peso de agentes de ajuste del pH y hasta un 5 % en peso de agentes aromatizantes del peso total de la formulación.In general, the formulation may comprise up to 1% by weight of preservatives, up to 1% by weight of pH adjusting agents and up to 5% by weight of flavoring agents of the total weight of the formulation.
Es esencial que la formulación de impresión sea termorreversible. Su viscosidad a la temperatura de impresión debe permitir la impresión a una temperatura moderada, tal como a 40-50 °C, mientras que debe ser sólida a temperatura ambiente. La viscosidad de la formulación de la presente divulgación a 50 °C (tasa de cizallamiento de 150-800) es preferentemente de 2-4 Pas.It is essential that the impression formulation be thermoreversible. Its viscosity at printing temperature should allow printing at a moderate temperature, such as 40-50 °C, while it should be solid at room temperature. The viscosity of the formulation of the present disclosure at 50°C (150-800 shear rate) is preferably 2-4 Pas.
Es esencial que la mezcla se caliente a 37 °C o más para garantizar una impresión adecuada. La temperatura de impresión está preferentemente entre 37 °C y 55 °C. Una temperatura de impresión a modo de ejemplo es de 40 °C. Otro ejemplo de temperatura de impresión es de 45 °C.It is essential that the mix be heated to 37°C or higher to ensure proper printing. The printing temperature is preferably between 37°C and 55°C. An example printing temperature is 40°C. Another example of printing temperature is 45 °C.
La mezcla se imprime en un sustrato de impresión que se coloca preferentemente en el interior de la impresora 3D. Una vez finalizada la impresión, la mezcla se solidifica al enfriarse, por ejemplo, reduciendo la temperatura a 25 °C o menos.The mixture is printed on a printing substrate that is preferably placed inside the 3D printer. After printing is complete, the mixture solidifies upon cooling, for example by reducing the temperature to 25°C or below.
El uno o más disolventes se seleccionan preferentemente entre el agua y el glicerol. Según una realización, la formulación comprende hasta un 1 % en peso de conservantes, hasta un 1 % en peso de agentes de ajuste del pH y/o hasta un 5 % en peso de agentes aromatizantes, y/o un 1-10 % en peso de uno o más ingredientes farmacéuticos activos.The one or more solvents are preferably selected from water and glycerol. According to one embodiment, the formulation comprises up to 1% by weight of preservatives, up to 1% by weight of pH adjusting agents and/or up to 5% by weight of flavoring agents, and/or 1-10% in weight of one or more active pharmaceutical ingredients.
Parte experimentalexperimental part
Impresión 3D3d print
La impresión se realizó con una impresora 3D comercial (Foodini by Natural Machines) equipada con cartuchos de suministro de tinta, elementos de calentamiento, boquillas, software de control y una base de impresión. Los parámetros típicos de impresión fueron los siguientes:Printing was done with a commercial 3D printer (Foodini by Natural Machines) equipped with ink supply cartridges, heating elements, nozzles, control software, and a build platform. Typical printing parameters were as follows:
Tamaño de la boquilla 1,5 mmNozzle size 1.5mm
Velocidad de impresión 1500-4000 mm/minPrinting speed 1500-4000mm/min
Velocidad del flujo de ingredientes 2 m/minIngredient flow speed 2 m/min
Temperatura del flujo de ingredientes 40-50 °C Ingredient flow temperature 40-50 °C
Temperatura de precalentamiento 40-50 °CPreheat temperature 40-50 °C
Retención de ingredientes 0,2-2,5 mmIngredient retention 0.2-2.5 mm
Tiempo de precalentamiento 30-60 sWarm-up time 30-60 s
Altura de la boquilla de la primera capa 10 mmFirst layer nozzle height 10 mm
Distancia entre capas 1,4 mmDistance between layers 1.4 mm
Pruebas de impresiónprint tests
Se prepararon las siguientes formulaciones. En la tabla 1, solo se indica la cantidad de gelificantes y espesantes. El resto de las formulaciones estaban compuestas por agua y glicerol. La impresión se realizó a 45 °C.The following formulations were prepared. In table 1, only the amount of gelling agents and thickeners is indicated. The rest of the formulations were composed of water and glycerol. Printing was done at 45 °C.
Tabla 1. Formulaciones de prueba de impresión Table 1 . Print Test Formulations
Las tablas 2 y 3 enumeran los ingredientes de dos formulaciones imprimibles a modo de ejemplo y sus propiedades reológicas. Tables 2 and 3 list the ingredients of two exemplary printable formulations and their rheological properties.
Tabla 2; impresión a 45 °C; precalentamiento a 40 °C Table 2 ; printing at 45 °C; preheat to 40 °C
Tabla 3Table 3
Claims (7)
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2025247979A1 (en) | 2024-05-30 | 2025-12-04 | Mb Therapeutics | Extrusion-printable pharmaceutical formulation, print cartridge containing such a formulation and method for preparing a medicament using same |
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- 2022-08-17 ES ES202231370U patent/ES1296080Y/en active Active
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2025247979A1 (en) | 2024-05-30 | 2025-12-04 | Mb Therapeutics | Extrusion-printable pharmaceutical formulation, print cartridge containing such a formulation and method for preparing a medicament using same |
| FR3162625A1 (en) | 2024-05-30 | 2025-12-05 | Mb Therapeutics | Extrusion-printable pharmaceutical formulation, printing cartridge containing such a formulation, and process for preparing a medicinal product using it |
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| ES1296080Y (en) | 2023-03-22 |
| DE202022104671U1 (en) | 2022-10-17 |
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