AR040157A1 - A FORMULATION IN MICROGRANULES FOR ORAL ADMINISTRATION IN WATERPROOF SUSPENSION - Google Patents
A FORMULATION IN MICROGRANULES FOR ORAL ADMINISTRATION IN WATERPROOF SUSPENSIONInfo
- Publication number
- AR040157A1 AR040157A1 ARP030102011A AR040157A1 AR 040157 A1 AR040157 A1 AR 040157A1 AR P030102011 A ARP030102011 A AR P030102011A AR 040157 A1 AR040157 A1 AR 040157A1
- Authority
- AR
- Argentina
- Prior art keywords
- active ingredient
- formulation
- particles
- coating
- layer
- Prior art date
Links
Classifications
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
- A61K9/10—Dispersions; Emulsions
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Composición en partículas para resuspender en una solución acuosa para el tratamiento de enfermedades y método para su obtención, donde las partículas comprenden por lo menos un principio activo de entre 10 y 90 micrones de tamano de partícula y entre un 10% y 70% p/p respecto del peso total de la composición de una capa de recubrimiento lipídica. Además se refiere a una formulación en forma de partículas recubiertas que puede ser usada para obtener una suspensión acuosa para el tratamiento de enfermedades o para administración durante un método de diagnóstico. Más particularmente, la composición comprende una formulación en forma de micro gránulos para administración oral en una suspensión acuosa, siendo la formulación capaz de resistir su dilución o disolución mientras se encuentra en la solución acuosa pero siendo capaz de liberar rápidamente un ingrediente activo en un medio gastrointestinal con bajo pH, comprendiendo la formulación un sistema multi-capas para el enmascaramiento del sabor del ingrediente activo. Reivindicación 2: La composición en partículas de acuerdo con la reivindicación 1, caracterizada porque el producto farmacéutico es seleccionado del grupo comprendido por fosfatos, bifosfonatos, analgésicos, anti-inflamatorios no esteroides, y corticoides. Reivindicación 3: La composición en partículas de acuerdo con la reivindicación 1, caracterizada porque el recubrimiento lipídico es un lípido con un punto de fusión entre 38°C y 75°C. Reivindicación 10: Un método para preparar la composición en partículas de la reivindicación 1, caracterizada porque, comprende las siguientes etapas: i. Secar y moler un producto farmacéutico para obtener partículas de un tamano entre 10 y 90 micrones; ii. recubrir el principio activo en partículas con un material lípido de recubrimiento; iii. introducir el principio activo recubierto obtenido en la etapa ii) en un equipo de secado por rocío impulsado por una corriente de gas a una temperatura entre 0°C y 55°C; y iv. tamizar las partículas recubiertas para obtener partículas que tienen un tamano uniforme deseado. Reivindicación 19: Una formulación de gránulos para administrarse en una suspensión acuosa, capaz de enmascarar el sabor de un ingrediente activo y proveer una rápida liberación del ingrediente activo en el medio gastrointestinal, la formulación comprende gránulos, caracterizada porque cada gránulo comprende: i. Un núcleo central de azúcar que tiene un tamano entre alrededor de 200 y alrededor de 600 micrones; ii. una capa adhesiva polimérica que rodea y recubre al núcleo central; iii. una capa de ingrediente activo que comprende al menos un ingrediente activo en polvo que tiene un tamano de partícula menor de 100nm, y iv. una capa para enmascarar el sabor que comprende un recubrimiento que es soluble a un pH entre alrededor de 7.0 y alrededor de 2.5, en donde el recubrimiento es capaz de resistir la disolución en una suspensión acuosa para enmascarar el sabor del ingrediente activo y es capaz de proveer una rápida liberación del ingrediente activo en el medio gastrointestinal.Composition in particles to resuspend in an aqueous solution for the treatment of diseases and method for obtaining them, where the particles comprise at least one active ingredient of between 10 and 90 microns of particle size and between 10% and 70% w / p with respect to the total weight of the composition of a layer of lipid coating. It also refers to a formulation in the form of coated particles that can be used to obtain an aqueous suspension for the treatment of diseases or for administration during a diagnostic method. More particularly, the composition comprises a formulation in the form of micro granules for oral administration in an aqueous suspension, the formulation being able to resist dilution or dissolution while in the aqueous solution but being able to rapidly release an active ingredient in a medium. gastrointestinal with low pH, the formulation comprising a multi-layer system for masking the flavor of the active ingredient. Claim 2: The particulate composition according to claim 1, characterized in that the pharmaceutical product is selected from the group consisting of phosphates, bisphosphonates, analgesics, non-steroidal anti-inflammatories, and corticosteroids. Claim 3: The particulate composition according to claim 1, characterized in that the lipid coating is a lipid with a melting point between 38 ° C and 75 ° C. Claim 10: A method for preparing the particulate composition of claim 1, characterized in that it comprises the following steps: i. Dry and grind a pharmaceutical product to obtain particles of a size between 10 and 90 microns; ii. coating the active ingredient in particles with a lipid coating material; iii. introducing the coated active ingredient obtained in step ii) in a spray drying equipment driven by a gas stream at a temperature between 0 ° C and 55 ° C; and iv. screen the coated particles to obtain particles that have a desired uniform size. Claim 19: A formulation of granules to be administered in an aqueous suspension, capable of masking the taste of an active ingredient and providing rapid release of the active ingredient in the gastrointestinal medium, the formulation comprises granules, characterized in that each granule comprises: i. A central sugar core that has a size between about 200 and about 600 microns; ii. a polymeric adhesive layer that surrounds and covers the central core; iii. an active ingredient layer comprising at least one active ingredient powder having a particle size of less than 100 nm, and iv. a layer for masking the taste that comprises a coating that is soluble at a pH between about 7.0 and about 2.5, wherein the coating is able to resist dissolution in an aqueous suspension to mask the taste of the active ingredient and is capable of provide a rapid release of the active ingredient in the gastrointestinal environment.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ARP030102011 AR040157A1 (en) | 2003-06-06 | 2003-06-06 | A FORMULATION IN MICROGRANULES FOR ORAL ADMINISTRATION IN WATERPROOF SUSPENSION |
| PCT/US2004/017862 WO2004108089A2 (en) | 2003-06-06 | 2004-06-07 | A micro granulate formulation for oral administration in aqueous suspension |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ARP030102011 AR040157A1 (en) | 2003-06-06 | 2003-06-06 | A FORMULATION IN MICROGRANULES FOR ORAL ADMINISTRATION IN WATERPROOF SUSPENSION |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR040157A1 true AR040157A1 (en) | 2005-03-16 |
Family
ID=33494452
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP030102011 AR040157A1 (en) | 2003-06-06 | 2003-06-06 | A FORMULATION IN MICROGRANULES FOR ORAL ADMINISTRATION IN WATERPROOF SUSPENSION |
Country Status (2)
| Country | Link |
|---|---|
| AR (1) | AR040157A1 (en) |
| WO (1) | WO2004108089A2 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101340733B1 (en) * | 2012-12-31 | 2013-12-12 | (주) 에프엔지리서치 | Novel microgranule preparations |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6214386B1 (en) * | 1995-11-22 | 2001-04-10 | Recordati, S.A. | Prompt-release oral pharmaceutical compositions for extemporaneous suspensions |
| US20030086972A1 (en) * | 2000-08-09 | 2003-05-08 | Appel Leah E. | Hydrogel-driven drug dosage form |
| US8071133B2 (en) * | 2001-08-20 | 2011-12-06 | Stiefel Laboratories, Inc. | Oral dosage forms of water insoluble drugs and methods of making the same |
| US6986901B2 (en) * | 2002-07-15 | 2006-01-17 | Warner-Lambert Company Llc | Gastrointestinal compositions |
-
2003
- 2003-06-06 AR ARP030102011 patent/AR040157A1/en unknown
-
2004
- 2004-06-07 WO PCT/US2004/017862 patent/WO2004108089A2/en active Application Filing
Also Published As
| Publication number | Publication date |
|---|---|
| WO2004108089A3 (en) | 2005-03-24 |
| WO2004108089A2 (en) | 2004-12-16 |
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Legal Events
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|---|---|---|---|
| FB | Suspension of granting procedure |