ES2606545T3 - Método de almacenar una vacuna que contiene un adyuvante de aluminio - Google Patents
Método de almacenar una vacuna que contiene un adyuvante de aluminio Download PDFInfo
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- ES2606545T3 ES2606545T3 ES11772945.9T ES11772945T ES2606545T3 ES 2606545 T3 ES2606545 T3 ES 2606545T3 ES 11772945 T ES11772945 T ES 11772945T ES 2606545 T3 ES2606545 T3 ES 2606545T3
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- syringes
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- hbsag
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- 229960005486 vaccine Drugs 0.000 title abstract description 6
- 239000002671 adjuvant Substances 0.000 title abstract description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 title description 2
- 229910052782 aluminium Inorganic materials 0.000 title description 2
- 239000000203 mixture Substances 0.000 abstract description 5
- 101000874347 Streptococcus agalactiae IgA FC receptor Proteins 0.000 abstract 1
- 229920002313 fluoropolymer Polymers 0.000 abstract 1
- 208000002672 hepatitis B Diseases 0.000 abstract 1
- FAHBNUUHRFUEAI-UHFFFAOYSA-M hydroxidooxidoaluminium Chemical compound O[Al]=O FAHBNUUHRFUEAI-UHFFFAOYSA-M 0.000 abstract 1
- 238000003795 desorption Methods 0.000 description 13
- 229920001296 polysiloxane Polymers 0.000 description 6
- 238000001179 sorption measurement Methods 0.000 description 4
- 239000011521 glass Substances 0.000 description 3
- 230000032683 aging Effects 0.000 description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 1
- 101000894412 Mycolicibacterium paratuberculosis (strain ATCC BAA-968 / K-10) Bacterioferritin Proteins 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 239000007983 Tris buffer Substances 0.000 description 1
- 239000000427 antigen Substances 0.000 description 1
- 102000036639 antigens Human genes 0.000 description 1
- 108091007433 antigens Proteins 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
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- A—HUMAN NECESSITIES
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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- A61J1/06—Ampoules or carpules
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K39/02—Bacterial antigens
- A61K39/05—Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/08—Clostridium, e.g. Clostridium tetani
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/099—Bordetella
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
- A61K39/29—Hepatitis virus
- A61K39/292—Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- B65B7/00—Closing containers or receptacles after filling
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- B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55505—Inorganic adjuvants
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- B65D2539/00—Details relating to closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
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- C12N2730/00—Reverse transcribing DNA viruses
- C12N2730/00011—Details
- C12N2730/10011—Hepadnaviridae
- C12N2730/10111—Orthohepadnavirus, e.g. hepatitis B virus
- C12N2730/10134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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Abstract
Un recipiente para almacenar y/o administrar una composición de vacuna, en donde el recipiente contiene una composición de vacuna que comprende un antígeno de la hepatitis B adsorbido sobre un adyuvante de oxihidróxido de aluminio y está cerrado por un dispositivo que actúa como un tapón, en donde la superficie del dispositivo contactable con la composición está revestida con un polímero fluorado.
Description
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A T (tiempo) = 0, el nivel de adsorción de HbsAg era idéntico en las tres categorías (se adsorbió el 98% del total de HBsAg). A T = 2 meses se observó una desorción en todas las categorías, pero el porcentaje de desorción difería dependiendo de la categoría. El porcentaje de desorción más alto se encontró en la categoría (1) (a T = 1 y 2 meses, se adsorbió 55 y 50% del HBsAg total, respectivamente), mientras que el porcentaje más bajo se encontró en la categoría (3) (A T = 1 y 2 meses, se adsorbieron 72 y 69% del total de HBsAg, respectivamente).
B -Una gran parte de la composición de vacuna descrita en A -se distribuyó en dos categorías de una dosis única de jeringas de 1 mL, cuyas características eran las siguientes:
- (1)
- jeringas de vidrio siliconizadas estándares (silicona libre); y
- (2)
- jeringas no siliconizadas.
La mayor parte se distribuyó en dosis únicas de 0,5 mL, conteniendo cada una de las dosis 10 µg de HBsAg, 30 Lf de Dt, 10 Lf de Tt, 25 µg de Pt, 25 µg de FHA, 40 DU (Unidad de antígeno D) de IPV1, 8 DU de IPV2, 32 DU de IPV3, 12 µg de PRP (en forma conjugada PRP-Tt), 0,6 mg de Al, 55 mM de iones fosfato, 20 mM de iones carbonato y tampón Tris sacarosa, 2,5 mM, 2,125%, a pH 6,8-7,2.
Todas las jeringas de las dos categorías fueron almacenadas horizontalmente a 25°C durante dos meses (envejecimiento acelerado). La desorción de HBsAg se midió en cada una de las dos categorías a T = 0 (justo después de cargar las jeringas) y luego después de dos meses, tal como se describe en A -arriba.
A T (tiempo) = 0, el nivel de adsorción de HbsAg era idéntico en las dos categorías (se adsorbió el 98% del total de HBsAg). A T = 2 meses se observó una desorción en todas las categorías, pero el porcentaje de desorción difería dependiendo de la categoría. El porcentaje de desorción más alto se encontró en la categoría (1) (a T = 1 y 2 meses, se adsorbió 69 y 68% del HBsAg total, respectivamente), mientras que el porcentaje de desorción más bajo se encontró en la categoría (2) (A T = 1 y 2 meses, se adsorbió 73% del total de HBsAg). Esto indica claramente que la adsorción del antígeno sobre un adyuvante de aluminio es sensible a la silicona libre.
C -Una gran parte de la composición de la vacuna descrita en A -se distribuyó en tres tipos de jeringas de dosis única de 1 mL, cuyas características eran las siguientes:
- (1)
- jeringas de vidrio poco siliconizadas (50-100 µg de silicona libre/jeringa);
- (2)
- jeringas de vidrio altamente siliconizadas estándares ((jeringa RTF Luercone™ de Gerresheimer): 800 µg a 1 mg de silicona libre/jeringa); y
- (3)
- jeringas que tenían la superficie interior recubierta con silicona polimerizada (50-100 µg/jeringa).
Jeringas de la categoría (1) son operativas solamente si el émbolo utilizado para la inyección también está siliconizado, porque la cantidad de silicona que recubre la superficie interior de la jeringa es demasiado baja para permitir el deslizamiento por sí misma.
Todas las jeringas (tipos 1 a 3) se cerraron con el mismo tipo de tapón no siliconizado.
La vacuna a granel se distribuyó en dosis únicas de 0,5 mL, siendo cada una de las dosis como se describe en A y
B.
Todas las jeringas de los tres tipos fueron almacenadas verticalmente a 25°C durante dos meses (envejecimiento acelerado). La desorción de HBsAg se midió en cada uno de los tres tipos a T = 0 (justo después de llenar las jeringas) y luego después de dos meses, tal como se describe en A -arriba.
A T (tiempo) = 0, el nivel de adsorción de HbsAg era idéntico en los tres tipos (se adsorbió el 94% del total de HBsAg). A T = 2 meses, se observó una desorción en todas las jeringas, pero el porcentaje de desorción difería dependiendo del tipo. El porcentaje de desorción más alto se encontró en el tipo (2) (a T = 1 y 2 meses, se adsorbió 60 y 58% del HBsAg total, respectivamente), mientras que el porcentaje de desorción se encontró similar en los tipos
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Claims (1)
-
imagen1
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR1058464A FR2966044B1 (fr) | 2010-10-18 | 2010-10-18 | Procede de conditionnement d'un vaccin contenant un adjuvant d'aluminium |
FR1058464 | 2010-10-18 | ||
US201161454248P | 2011-03-18 | 2011-03-18 | |
US201161454248P | 2011-03-18 | ||
PCT/EP2011/068090 WO2012052394A1 (en) | 2010-10-18 | 2011-10-17 | Method of storing a vaccine containing an aluminum adjuvant |
Publications (1)
Publication Number | Publication Date |
---|---|
ES2606545T3 true ES2606545T3 (es) | 2017-03-24 |
Family
ID=44059027
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES11772945.9T Active ES2606545T3 (es) | 2010-10-18 | 2011-10-17 | Método de almacenar una vacuna que contiene un adyuvante de aluminio |
Country Status (33)
Country | Link |
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US (2) | US9066895B2 (es) |
EP (1) | EP2629792B1 (es) |
JP (2) | JP5890837B2 (es) |
KR (1) | KR101875828B1 (es) |
CN (2) | CN103140239A (es) |
AP (1) | AP2013006876A0 (es) |
AR (2) | AR084491A1 (es) |
AU (1) | AU2011317649B2 (es) |
BR (1) | BR112013009524B1 (es) |
CA (1) | CA2811075C (es) |
CR (1) | CR20130223A (es) |
CY (1) | CY1118557T1 (es) |
DK (1) | DK2629792T3 (es) |
EA (1) | EA026876B1 (es) |
ES (1) | ES2606545T3 (es) |
FR (1) | FR2966044B1 (es) |
GE (1) | GEP20156238B (es) |
GT (1) | GT201300094A (es) |
HR (1) | HRP20161637T1 (es) |
HU (1) | HUE031210T2 (es) |
IL (1) | IL225431A (es) |
LT (1) | LT2629792T (es) |
ME (1) | ME02614B (es) |
MX (1) | MX342345B (es) |
NZ (1) | NZ609973A (es) |
PE (1) | PE20140850A1 (es) |
PL (1) | PL2629792T3 (es) |
PT (1) | PT2629792T (es) |
RS (1) | RS55520B1 (es) |
SI (1) | SI2629792T1 (es) |
UA (1) | UA113049C2 (es) |
WO (1) | WO2012052394A1 (es) |
ZA (1) | ZA201303164B (es) |
Families Citing this family (15)
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---|---|---|---|---|
US8627816B2 (en) | 2011-02-28 | 2014-01-14 | Intelliject, Inc. | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
US8939943B2 (en) | 2011-01-26 | 2015-01-27 | Kaleo, Inc. | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
EP3858405B1 (en) | 2012-06-01 | 2023-04-05 | Novartis AG | Syringe |
EP2861526A4 (en) * | 2012-06-18 | 2015-12-16 | Innova Dynamics Inc | AGGLOMERATE REDUCTION IN A NANODRAHUSUSPENSION STORED IN A CONTAINER |
JOP20200175A1 (ar) | 2012-07-03 | 2017-06-16 | Novartis Ag | حقنة |
CN103471902A (zh) * | 2013-09-22 | 2013-12-25 | 北京智飞绿竹生物制药有限公司 | 一种解吸附方法及其应用 |
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