ES1304501U - 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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- ES1304501U ES1304501U ES202330146U ES202330146U ES1304501U ES 1304501 U ES1304501 U ES 1304501U ES 202330146 U ES202330146 U ES 202330146U ES 202330146 U ES202330146 U ES 202330146U ES 1304501 U ES1304501 U ES 1304501U
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- 239000000203 mixture Substances 0.000 title claims abstract description 60
- 238000009472 formulation Methods 0.000 title claims abstract description 52
- 150000002632 lipids Chemical class 0.000 claims abstract description 16
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 16
- 239000002904 solvent Substances 0.000 claims abstract description 11
- 239000003349 gelling agent Substances 0.000 claims abstract description 9
- 239000002562 thickening agent Substances 0.000 claims abstract description 9
- 239000000796 flavoring agent Substances 0.000 claims description 28
- 235000019634 flavors Nutrition 0.000 claims description 22
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 9
- 108010010803 Gelatin Proteins 0.000 claims description 7
- 239000008273 gelatin Substances 0.000 claims description 7
- 229920000159 gelatin Polymers 0.000 claims description 7
- 235000019322 gelatine Nutrition 0.000 claims description 7
- 235000011852 gelatine desserts Nutrition 0.000 claims description 7
- 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
- 235000013355 food flavoring agent Nutrition 0.000 claims description 6
- 239000003755 preservative agent Substances 0.000 claims description 6
- 229920001817 Agar Polymers 0.000 claims description 5
- 239000008272 agar Substances 0.000 claims description 5
- 235000010419 agar Nutrition 0.000 claims description 5
- 235000019868 cocoa butter Nutrition 0.000 claims description 5
- 229940110456 cocoa butter Drugs 0.000 claims description 5
- 239000003002 pH adjusting agent Substances 0.000 claims description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 4
- 239000003240 coconut oil Substances 0.000 claims description 4
- 235000019864 coconut oil Nutrition 0.000 claims description 4
- -1 fatty acid esters Chemical class 0.000 claims description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims description 4
- 235000000346 sugar Nutrition 0.000 claims description 4
- 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 description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- 239000001913 cellulose Substances 0.000 claims description 3
- 229920002678 cellulose Polymers 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 229920005862 polyol Polymers 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
- 241000287828 Gallus gallus Species 0.000 claims description 2
- 235000019687 Lamb Nutrition 0.000 claims description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- 239000004373 Pullulan Substances 0.000 claims description 2
- 229920001218 Pullulan Polymers 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
- 235000021028 berry Nutrition 0.000 claims description 2
- 239000000679 carrageenan Substances 0.000 claims description 2
- 235000010418 carrageenan Nutrition 0.000 claims description 2
- 229920001525 carrageenan Polymers 0.000 claims description 2
- 229940113118 carrageenan Drugs 0.000 claims description 2
- 235000013351 cheese Nutrition 0.000 claims description 2
- 239000007958 cherry flavor Substances 0.000 claims description 2
- 235000012716 cod liver oil Nutrition 0.000 claims description 2
- 239000003026 cod liver oil Substances 0.000 claims description 2
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 2
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims description 2
- 239000000194 fatty acid Substances 0.000 claims description 2
- 229930195729 fatty acid Natural products 0.000 claims description 2
- 239000008369 fruit flavor Substances 0.000 claims description 2
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims description 2
- 210000004185 liver Anatomy 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
- 235000019423 pullulan Nutrition 0.000 claims description 2
- 239000000377 silicon dioxide Substances 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
- 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 description 2
- 238000007639 printing Methods 0.000 description 16
- 238000010146 3D printing Methods 0.000 description 4
- 239000008186 active pharmaceutical agent Substances 0.000 description 4
- 239000007787 solid Substances 0.000 description 4
- 239000004615 ingredient Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 239000000758 substrate Substances 0.000 description 3
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 2
- 235000010980 cellulose Nutrition 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000001125 extrusion Methods 0.000 description 2
- 230000002349 favourable effect Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000002483 medication 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
- 239000002699 waste material Substances 0.000 description 2
- 239000004386 Erythritol Substances 0.000 description 1
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 description 1
- 239000008346 aqueous phase Substances 0.000 description 1
- 235000014633 carbohydrates Nutrition 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 description 1
- 235000019414 erythritol Nutrition 0.000 description 1
- 229940009714 erythritol Drugs 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000013020 final formulation Substances 0.000 description 1
- 235000003599 food sweetener Nutrition 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
- 239000000463 material Substances 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 238000000935 solvent evaporation Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
Classifications
-
- 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
- B33Y70/00—Materials specially adapted for additive manufacturing
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
-
- 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
- A61K31/395—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
-
- 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
- A61K31/395—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
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- 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
- A61K31/395—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
-
- 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
- A61K31/56—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
-
- 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
- A61K31/56—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Materials Engineering (AREA)
- Manufacturing & Machinery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
Abstract
Una formulación imprimible que comprende - el 2 - 30% en peso de uno o más agentes gelificantes, - el 1 - 10% en peso de uno o más agentes espesantes, - el 1 - 40% en peso, preferentemente el 10 - 35% en peso uno o más excipientes a base de lípidos, y - el 40- 70% en peso de uno o más disolventes.A printable formulation comprising - 2 - 30% by weight of one or more gelling agents, - 1 - 10% by weight of one or more thickening agents, - 1 - 40% by weight, preferably 10 - 35% by weight one or more lipid-based excipients, and - 40-70% by weight of one or more solvents.
Description
DESCRIPCIÓNDESCRIPTION
Una formulación imprimibleA printable formulation
CampoField
La presente divulgación se refiere a formulaciones que son adecuadas para la impresión 3D, en particular a las formulaciones que comprenden uno o más excipientes a base de lípidos.The present disclosure relates to formulations that are suitable for 3D printing, in particular to formulations comprising one or more lipid-based excipients.
AntecedentesBackground
La impresión tridimensional (3D) es una tecnología que ofrece la posibilidad de fabricar formas farmacéuticas personalizadas. La principal ventaja de usar 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 personalizados. También permite incorporar sabores a un comprimido sin necesidad de recubrirlo con una película, enmascarando por completo el sabor de los compuestos químicos. Las impresoras 3D pueden instalarse en farmacias, hospitales, clínicas y lugares remotos, lo que permite la producción a demanda de medicamentos, en particular de aquellos con poca estabilidad o que tienen requisitos de almacenamiento en cadenas 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 pharmaceutical forms. The main advantage of using 3D printing technology for personalized pharmaceutical products is the ability to produce small batches with carefully customized dosages, shapes, sizes and release characteristics. It also allows flavors to be added to a tablet without the need to coat it with a film, completely masking the taste of the chemical compounds. 3D printers can be installed in pharmacies, hospitals, clinics and remote locations, enabling on-demand production of medications, particularly those with poor stability or that have cold chain storage requirements. For pharmaceutical companies, 3D printing can significantly reduce costs, waste and 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 propia tinta, ya que sus propiedades fisicoquímicas podrían afectar en gran medida a la capacidad de impresión. La tinta debe ser imprimible a 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 the printing capacity. The ink should be printable at moderate temperature and solid at room temperature.
Por lo tanto, todavía se necesitan más formulaciones imprimibles para medicamentos.Therefore, more printable formulations for medications are still needed.
SumarioSummary
Se observó que cuando se sustituía parte de los agentes espesantes de una formulación por uno o más excipientes a base de lípidos, se podía mejorar la imprimibilidad 3D de la formulación. It was observed that when part of the thickening agents in a formulation was replaced by one or more lipid-based excipients, the 3D printability of the formulation could be improved.
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
- el 2 - 30 % en peso de uno o más agentes gelificantes,- 2 - 30% by weight of one or more gelling agents,
- el 1- 10 % en peso uno o más agentes espesantes,- 1- 10% by weight one or more thickening agents,
- el 1 - 40 % en peso, preferentemente el 10-35 % en peso uno o más excipientes a base de lípidos, y- 1 - 40% by weight, preferably 10-35% by weight, one or more lipid-based excipients, and
- el 40 - 70 % en peso de uno o más disolventes.- 40 - 70% by weight of one or more solvents.
En las reivindicaciones dependientes que se acompañan se describen varias realizaciones a modo de ejemplo y no limitantes de la invención.Various exemplary and non-limiting embodiments of the invention are described in the accompanying dependent claims.
Varias realizaciones ilustrativas y no limitantes de la invención y procedimientos de funcionamiento, junto con objetivos y ventajas adicionales de las misma, se entienden mejor a partir de la siguiente descripción de realizaciones ilustrativas específicas cuando se leen en conexión con las figuras adjuntas.Various illustrative and non-limiting embodiments of the invention and methods of operation, together with additional objectives and advantages thereof, are better 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 mencionadas. Las características enumeradas en las reivindicaciones dependientes se pueden combinar libremente entre sí, 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 una pluralidad.The verbs "comprehend" and "include" are used in this document as open limitations that do not exclude or require the existence of other characteristics not mentioned. The features listed in the dependent claims may be freely combined with each other, unless otherwise explicitly stated. Furthermore, it should be understood that the use of "a" or "an", that is, a singular form, throughout this document does not exclude a plurality.
DescripciónDescription
Los ejemplos específicos proporcionados en la descripción que figura a continuación no deben interpretarse como limitativos del alcance y/o de la aplicabilidad de las reivindicaciones adjuntas. Las listas y los grupos de ejemplos que figuran en la descripción no son exhaustivos, a menos que se indique explícitamente lo contrario.The specific examples provided in the description below should not be construed as limiting the scope and/or applicability of the appended claims. The lists and groups of examples given in the description are not exhaustive, unless explicitly stated otherwise.
Según un aspecto, la presente divulgación se refiere a una formulación que comprende - el 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,
- el 1-10 % en peso uno o más agentes espesantes,- 1-10% by weight one or more thickening agents,
- el 1-40 % en peso, preferentemente el 10-35 % en peso uno o más excipientes a base de lípidos,- 1-40% by weight, preferably 10-35% by weight, one or more lipid-based excipients,
- el 40 - 70 % en peso de uno o más disolventes, y opcionalmente - 40 - 70% by weight of one or more solvents, and optionally
- uno o más conservantes, agentes de ajuste del pH y/o agentes aromatizantes.- one or more preservatives, pH adjustment agents and/or flavoring agents.
Los agentes gelificantes se seleccionan preferentemente del grupo formado por la gelatina, el pululano, el carragenano y el agar. Según una realización, el agente gelificante es gelatina, y la formulación comprende el 5-30 % en peso de gelatina. Según otra realización, el agente gelificante es agar, y la formulación comprende el 5-10 % de agar, por ejemplo el 6 % en peso de agar.The gelling agents are preferably selected from the group consisting of gelatin, pullulan, carrageenan and agar. According to one embodiment, the gelling agent is gelatin, and the formulation comprises 5-30 % by weight of gelatin. According to another embodiment, the gelling agent is agar, and the formulation comprises 5-10% agar, for example 6% by weight of agar.
Los agentes espesantes se seleccionan preferentemente del grupo formado por manitol, celulosa y sílice. La celulosa puede ser celulosa microcristalina (MCC).The thickening agents are preferably selected from the group consisting of mannitol, cellulose and silica. The cellulose may be microcrystalline cellulose (MCC).
La formulación comprende uno o más excipientes a base de lípidos. Algunos excipientes a base de lípidos adecuados para la formulación son la manteca de cacao, el aceite de coco, la gelatina glicerinada, los aceites vegetales hidrogenados, las mezclas de polietilenglicoles de diversos pesos moleculares y los ésteres de ácidos grasos de polietilenglicol. Los excipientes preferentes a base de lípidos son la manteca de cacao y el aceite de coco. También se pueden usar mezclas de uno o más excipientes a base de lípidos.The formulation comprises one or more lipid-based excipients. Some suitable lipid-based excipients for formulation are cocoa butter, coconut oil, glycerinated gelatin, hydrogenated vegetable oils, mixtures of polyethylene glycols of various molecular weights, and polyethylene glycol fatty acid esters. Preferred lipid-based excipients are cocoa butter and coconut oil. Mixtures of one or more lipid-based excipients can also be used.
La formulación comprende uno o más disolventes. Los disolventes preferentes son agua y glicerol. Según una realización a modo de ejemplo, la formulación comprende el 40-50 % en peso de agua y el 5-6 % en peso de glicerol. Una mayor cantidad de disolvente, tal como el 50 % en peso o más, puede ser preferente cuando es necesario conseguir una alta solubilización del API en la formulación. Sin embargo, debe evitarse la presencia de niveles demasiado altos de disolvente, especialmente de agua, pero también de uno o más elementos absorbentes del infrarrojo cercano (NIR), tales como espesantes, disolventes adicionales y cargas, si se usa el NIR para el control de calidad de la formulación.The formulation comprises one or more solvents. Preferred solvents are water and glycerol. According to an exemplary embodiment, the formulation comprises 40-50% by weight of water and 5-6% by weight of glycerol. A larger amount of solvent, such as 50% by weight or more, may be preferred when it is necessary to achieve high solubilization of the API in the formulation. However, the presence of too high levels of solvent, especially water, but also one or more near-infrared (NIR) absorbing elements, such as thickeners, additional solvents and fillers, should be avoided if NIR is used for control. formulation quality.
La formulación puede comprender también uno o más conservantes, uno o más agentes de ajuste del pH y uno o más agentes aromatizantes. Los agentes de ajuste del pH a modo de ejemplo son el ácido cítrico, el citrato sódico y el ácido málico. Los conservantes a modo de ejemplo son el ácido sórbico, el sorbato potásico y los parabenos. Los aromatizantes pueden ser, por ejemplo, sabor a carne de vacuno, sabor a panceta, sabor a cordero, sabor a pollo, sabor a hígado de ave, sabor a queso, aceite de hígado de bacalao, sabor a malvavisco, sabor a melaza, sabor a vainilla, sabor a mantequilla de cacahuete, sabor a frutas, sabor a cerezas y sabor a bayas. The formulation may also comprise one or more preservatives, one or more pH adjusting agents and one or more flavoring agents. Exemplary pH adjusting agents are citric acid, sodium citrate and malic acid. Examples of preservatives are sorbic acid, potassium sorbate and parabens. The flavorings may be, for example, beef flavor, bacon flavor, lamb flavor, chicken flavor, poultry liver flavor, cheese flavor, cod liver oil, marshmallow flavor, molasses flavor, vanilla flavor, peanut butter flavor, fruit flavor, cherry flavor and berry flavor.
Normalmente, la formulación puede contener 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.Typically, the formulation may contain 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.
Según una realización preferente, la formulación comprende uno o más agentes edulcorantes seleccionados del grupo de los azúcares poliol, que no se metabolizan de la misma manera que los hidratos de carbono normales y tienen menos calorías que el azúcar. Un ejemplo de azúcar poliol es el eritritol.According to a preferred embodiment, the formulation comprises one or more sweetening agents selected from the group of polyol sugars, which are not metabolized in the same way as normal carbohydrates and have fewer calories than sugar. An example of a sugar polyol is erythritol.
Es esencial que la formulación de impresión sea termorreversible. Su viscosidad a la temperatura de impresión debe permitir la impresión a 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 (velocidad de cizallamiento 150-800) es preferentemente de 2-4 Pas.It is essential that the printing formulation be thermoreversible. Its viscosity at the printing temperature should allow printing at moderate temperatures, 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 (shear rate 150-800) is preferably 2-4 Pas.
El nivel de excipiente a base de lípidos es preferentemente del 10-35 % en peso para un control más preciso del comportamiento viscoelástico y de la facilidad de procesamiento. Si la proporción es inferior, la consistencia es menos favorable debido a las bajas viscosidades a temperaturas de procesamiento óptimas. Con porcentajes en peso más elevados, es más probable que se produzca la separación de las fases oleosa y acuosa. Además, se pueden necesitar temperaturas más altas debido al aumento de la viscosidad. Además, un porcentaje en peso demasiado alto de excipiente a base de lípidos en la preparación oral puede dar lugar a una consistencia y un sabor desagradables.The level of lipid-based excipient is preferably 10-35% by weight for more precise control of viscoelastic behavior and ease of processing. If the ratio is lower, the consistency is less favorable due to low viscosities at optimal processing temperatures. At higher weight percentages, separation of the oil and aqueous phases is more likely to occur. Additionally, higher temperatures may be needed due to increased viscosity. Furthermore, too high a weight percentage of lipid-based excipient in the oral preparation may result in an unpleasant consistency and taste.
La formulación de dosificación sólida puede prepararse mediante un procedimiento que comprendeThe solid dosage formulation can be prepared by a process comprising
- proporcionar una formulación que comprenda- provide a formulation that includes
- el 2 - 30 % en peso de uno o más agentes gelificantes,- 2 - 30% by weight of one or more gelling agents,
- el 1 - 10 % en peso de uno o más agentes espesantes,- 1 - 10% by weight of one or more thickening agents,
- el 1 - 40 % en peso, preferentemente el 10 - 35 % en peso uno o más excipientes a base de lípidos,- 1 - 40% by weight, preferably 10 - 35% by weight, one or more lipid-based excipients,
- el 40 - 70 % en peso de uno o más disolventes, y- 40 - 70% by weight of one or more solvents, and
- el 0,1-10 % en peso de uno o más ingredientes farmacéuticos activos (API), - calentar la formulación a una temperatura de al menos 37 °C,- 0.1-10% by weight of one or more active pharmaceutical ingredients (API), - heat the formulation to a temperature of at least 37 °C,
- mediante el uso de una impresora 3D, imprimir la formulación al menos a 37 °C en un sustrato de impresión, - using a 3D printer, print the formulation at least 37 °C on a printing substrate,
- enfriar la formulación a 30 °C o menos, y- cool the formulation to 30 °C or less, and
- liberar la formulación del sustrato de impresión, proporcionando así la formulación de dosificación sólida.- releasing the formulation from the printing substrate, thus providing the solid dosage formulation.
Es esencial que la mezcla se caliente a 37 °C o más para garantizar una impresión adecuada. La temperatura de impresión se sitúa preferentemente a entre 37 °C y 55 °C. Un ejemplo de temperatura de impresión es de 40 °C. Otro ejemplo de temperatura de impresión es de 45 °C.It is essential that the mixture 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, se solidifica la mezcla al enfriarse, por ejemplo, reduciendo la temperatura a 30 °C o menos.The mixture is printed on a printing substrate that is preferably placed inside the 3D printer. Once printing is complete, the mixture is solidified by cooling, for example by reducing the temperature to 30°C or lower.
ExperimentalExperimental
Impresión 3D3d print
La impresión se realizó usando una impresora 3D comercial (Foodini de Natural Machines) equipada con cartuchos de suministro de tinta, elementos calefactores, boquillas, software de control y una base de impresión. Los parámetros típicos de impresión fueron los siguientes:Printing was performed using a commercial 3D printer (Foodini from Natural Machines) equipped with ink supply cartridges, heating elements, nozzles, control software, and a print bed. Typical printing parameters were as follows:
Tamaño de boquilla 1,5 mmNozzle size 1.5mm
Velocidad de impresión 1500-4000 mm/minPrint speed 1500-4000 mm/min
Velocidad del flujo de ingredientes 2 m/minIngredient flow speed 2 m/min
Temperatura del flujo de ingredientes 40-50 °CIngredient flow temperature 40-50°C
Temperatura de precalentamiento 40-50 °CPreheating temperature 40-50°C
Retención de ingredientes 0,2-2,5 mmIngredient retention 0.2-2.5 mm
Tiempo de precalentamiento 30-60 sPreheat time 30-60s
Altura de la boquilla de la primera capa 10 mmFirst layer nozzle height 10mm
Distancia entre capas 1,4 mmDistance between layers 1.4 mm
En la Tabla 1 se muestra una formulación imprimible a modo de ejemplo según la presente divulgación. La formulación comparativa era como la mostrada en la Tabla 1, pero la manteca de cacao se sustituyó por manitol. An exemplary printable formulation according to the present disclosure is shown in Table 1. The comparative formulation was as shown in Table 1, but the cocoa butter was replaced by mannitol.
Cuadro 1Table 1
ObservacionesObservations
• La formulación imprimible con excipiente a base de lípidos produjo una impresión más uniforme de un comprimido a otro. La extrusión fue más controlable y el chorro de material que sale de la boquilla se corta de forma controlada/uniforme sin goteos indeseados, lo que conduce a una deposición sin fisuras de la formulación. Además, hubo una extrusión significativamente menor de la formulación en el contenedor de residuos antes del inicio de cada trabajo de impresión.• The printable formulation with lipid-based excipient produced a more uniform printing from tablet to tablet. Extrusion was more controllable and the material stream coming out of the nozzle is cut in a controlled/uniform manner without unwanted drips, leading to seamless deposition of the formulation. Additionally, there was significantly less extrusion of the formulation into the waste container prior to the start of each print job.
• La adición del excipiente a base de lípidos no impide la solubilidad de los API hidrosolubles. La formulación es homogénea y no se separa durante un mes a temperatura ambiente. Las propiedades mecánicas también son favorables, facilitando la manipulación y haciéndola menos pegajosa.• The addition of the lipid-based excipient does not impede the solubility of the water-soluble APIs. The formulation is homogeneous and does not separate for a month at room temperature. The mechanical properties are also favorable, facilitating handling and making it less sticky.
• También se han mejorado la variación de masa, el aspecto físico y la sensación en boca.• Mass variation, physical appearance and mouthfeel have also been improved.
• La calidad de retención de agua (evaporación de agua/disolvente de la formulación es mucho menor) de la formulación final ha aumentado considerablemente. Las formulaciones pueden mantener su integridad física y sus propiedades mecánicas durante más tiempo cuando se exponen al aire libre en comparación con la formulación comparativa. • The water retention quality (water/solvent evaporation of the formulation is much lower) of the final formulation has increased considerably. Formulations can maintain their physical integrity and mechanical properties for longer when exposed to open air compared to the comparative formulation.
Claims (11)
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