AR038370A1 - PROCEDURE FOR PREPARING SOLID DISPERSIONS PHARMACY DRIED HOMOGENEOUS AMORPHES USING A SPRAY DRYING DEVICE USING A MODIFIED SPRAYING AND PRODUCT DRYING DEVICE - Google Patents
PROCEDURE FOR PREPARING SOLID DISPERSIONS PHARMACY DRIED HOMOGENEOUS AMORPHES USING A SPRAY DRYING DEVICE USING A MODIFIED SPRAYING AND PRODUCT DRYING DEVICEInfo
- Publication number
- AR038370A1 AR038370A1 ARP030100269A AR038370A1 AR 038370 A1 AR038370 A1 AR 038370A1 AR P030100269 A ARP030100269 A AR P030100269A AR 038370 A1 AR038370 A1 AR 038370A1
- Authority
- AR
- Argentina
- Prior art keywords
- drying
- gas
- drying device
- drug
- feed solution
- Prior art date
Links
- 238000001035 drying Methods 0.000 title abstract 14
- 238000000034 method Methods 0.000 title abstract 4
- 239000007962 solid dispersion Substances 0.000 title abstract 3
- 238000001694 spray drying Methods 0.000 title abstract 3
- 238000005507 spraying Methods 0.000 title 1
- 239000003814 drug Substances 0.000 abstract 5
- 229940079593 drug Drugs 0.000 abstract 5
- 230000002708 enhancing effect Effects 0.000 abstract 4
- 239000012527 feed solution Substances 0.000 abstract 4
- 229920000642 polymer Polymers 0.000 abstract 4
- 239000006185 dispersion Substances 0.000 abstract 3
- 239000002245 particle Substances 0.000 abstract 3
- 238000000889 atomisation Methods 0.000 abstract 2
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 239000007787 solid Substances 0.000 abstract 1
- 239000000243 solution Substances 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
Landscapes
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Procedimientos de secado por pulverización convencionales mediante la incorporación de una tobera de presión, una placa difusora para mejorar el flujo del gas de secado y una extensión de la cámara de secado para aumentar el tiempo de secado, conduciendo dichas mejoras a la formación de dispersiones sólidas homogéneas de fármacos en polímeros potenciadores de la concentración. Reivindicación 1: Un proceso para producir una composición farmacéutica que comprende las etapas de: (a) formar una solución de alimentación que comprende un fármaco, un polímero potenciador de la concentración y un disolvente; (b) dirigir la citada solución de alimentación a un dispositivo de secado por pulverización que comprende: (i) una cámara de secado con un volumen Vsecador y una altura H; (ii) un medio de atomización para atomizar la citada solución de alimentación en gotas; (iii) una fuente de gas de secado calentado para secar las citadas gotas, suministrando la citada fuente el citado gas de secado a la citada cámara de secado a un caudal de G; y (iv) un medio de dispersión de gas para dispersar el citado gas de secado en la citada cámara de secado, causando el citado medio de dispersión de gas un flujo pistón organizado del citado gas de secado, en el que Vsecador se mide en m3; H es la menos 1m; G se mide en m3/s; Y en el que se satisface la siguiente relación matemática: ; (c) atomizar la citada solución de alimentación en gotas en la citada cámara de secado mediante el citado medio de atomización, teniendo las citadas gotas un diámetro medio de al menos 50 micrones y un D10 de al menos 10 micrones; (d) poner en contacto las citadas gotas con el citado gas de secado calentado, formado partículas de una dispersión sólida amorfa del citado fármaco y el citado polímero potenciador de la concentración; y (e) recoger las citadas partículas, en el que el citado polímero potenciador de la concentración está presente en la citada solución en una cantidad suficiente para que la citada dispersión sólida amorfa proporcione una potenciación de la concentración del citado fármaco en un entorno de uso respecto de una composición control constituida esencialmente por una cantidad equivalente del citado fármaco solo. Reivindicación 11: El proceso de la reivindicación 1, en el que al menos un 80% en volumen de las citadas partículas tienen diámetros mayores de 10 micrones.Conventional spray drying procedures by incorporating a pressure nozzle, a diffuser plate to improve the flow of the drying gas and an extension of the drying chamber to increase the drying time, leading such improvements to the formation of solid dispersions homogeneous drugs in concentration enhancing polymers. Claim 1: A process for producing a pharmaceutical composition comprising the steps of: (a) forming a feed solution comprising a drug, a concentration enhancing polymer and a solvent; (b) directing said feed solution to a spray drying device comprising: (i) a drying chamber with a Vsequencer volume and a height H; (ii) an atomization means for atomizing said drop feed solution; (iii) a source of heated drying gas for drying said drops, said source supplying said drying gas to said drying chamber at a flow rate of G; and (iv) a gas dispersion means for dispersing said drying gas in said drying chamber, said gas dispersion means causing an organized piston flow of said drying gas, in which Vsecador is measured in m3 ; H is the least 1m; G is measured in m3 / s; And in which the following mathematical relationship is satisfied:; (c) atomizing said drop feed solution in said drying chamber by means of said atomization means, said drops having an average diameter of at least 50 microns and a D10 of at least 10 microns; (d) contacting said drops with said heated drying gas, formed particles of a solid amorphous dispersion of said drug and said concentration enhancing polymer; and (e) collecting said particles, wherein said concentration enhancing polymer is present in said solution in an amount sufficient for said amorphous solid dispersion to provide a potentiation of said drug concentration in an environment of use with respect to a control composition consisting essentially of an equivalent amount of said drug alone. Claim 11: The process of claim 1, wherein at least 80% by volume of said particles have diameters greater than 10 microns.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ARP030100269 AR038370A1 (en) | 2003-01-30 | 2003-01-30 | PROCEDURE FOR PREPARING SOLID DISPERSIONS PHARMACY DRIED HOMOGENEOUS AMORPHES USING A SPRAY DRYING DEVICE USING A MODIFIED SPRAYING AND PRODUCT DRYING DEVICE |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ARP030100269 AR038370A1 (en) | 2003-01-30 | 2003-01-30 | PROCEDURE FOR PREPARING SOLID DISPERSIONS PHARMACY DRIED HOMOGENEOUS AMORPHES USING A SPRAY DRYING DEVICE USING A MODIFIED SPRAYING AND PRODUCT DRYING DEVICE |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR038370A1 true AR038370A1 (en) | 2005-01-12 |
Family
ID=42777092
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP030100269 AR038370A1 (en) | 2003-01-30 | 2003-01-30 | PROCEDURE FOR PREPARING SOLID DISPERSIONS PHARMACY DRIED HOMOGENEOUS AMORPHES USING A SPRAY DRYING DEVICE USING A MODIFIED SPRAYING AND PRODUCT DRYING DEVICE |
Country Status (1)
| Country | Link |
|---|---|
| AR (1) | AR038370A1 (en) |
-
2003
- 2003-01-30 AR ARP030100269 patent/AR038370A1/en unknown
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