Method for Storing an Emulsion-Adjuvanted Vaccine in a Lubricated Medical Injection Device

Provided herein is a method for storing an emulsion-adjuvanted vaccine in a medical injection device having a lubricant coating, said method including the steps of: (a) providing a medical injection device having a barrel having an inner surface; (b) forming a silicone oil layer on at least a part of the inner surface of the barrel that is intended to be in contact with the vaccine; (c) carrying out an oxidizing plasma treatment of the layer so as to crosslink at least part of the silicone oil layer and form a lubricant coating; and (d) filling the barrel with the emulsion-adjuvanted vaccine. The invention also relates to a medical injection device obtained directly from this method and to the use of plasma-treated silicone oil as a lubricant coating. 1. A method for storing an emulsion-adjuvanted vaccine in a medical injection device comprising a lubricant coating , said method comprising:(a) providing a medical injection device comprising a barrel having an inner surface;(b) forming a silicone oil layer on at least a part of the inner surface of the barrel that is intended to be in contact with the vaccine, (c) carrying out an oxidizing plasma treatment of said layer so as to crosslink at least part of the silicone oil layer and form a lubricant coating, (d) filling the barrel with the emulsion-adjuvanted vaccine.2. The method of claim 1 , wherein the emulsion is an oil-in-water emulsion.3. The method of claim 2 , wherein the oil phase of the adjuvant comprises squalene.4. The method of claim 1 , wherein the barrel is made of glass.5. The method of claim 1 , wherein the silicone oil has a viscosity between 900 and 1200 centiStokes at 25° C. before the plasma treatment.6. The method of claim 1 , wherein the coating has a thickness between 90 and 400 nm claim 1 , measured by reflectometry.7. The method of claim 1 , wherein the medical injection device comprises a syringe having an internal volume of 1 ml.8. The method of claim 7 , wherein the silicone oil layer has ...

"Medical Articles Coated With Organopolysiloxane Containing a Protein Solution"

This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and non-ionic surfactant. 1. A medical article , comprising:(a) a container comprising a chamber for receiving a solution, wherein the inner surface of the chamber has a coating thereon prepared from a composition comprising an organopolysiloxane; and (i) at least one proteinaceous material;', '(ii) at least one non-ionic surfactant; and', '(iii) at least one sugar., '(b) a solution comprising2. The medical article according to claim 1 , wherein the chamber is selected from the group consisting of a syringe barrel claim 1 , drug cartridge container claim 1 , needleless injector container claim 1 , liquid dispensing device container claim 1 , and liquid metering device container.3. The medical article according to claim 2 , wherein the chamber is a syringe barrel.4. The medical article according to claim 1 , wherein the chamber is formed from glass claim 1 , metal claim 1 , ceramic claim 1 , plastic claim 1 , rubber claim 1 , or combinations thereof.5. The medical article according to claim 1 , wherein the chamber is prepared from an olefinic polymer selected from the group consisting of polyethylene claim 1 , polypropylene claim 1 , poly(1-butene) claim 1 , poly(2-methyl-1-pentene) claim 1 , and cyclic polyolefins.6. The medical article according to claim 1 , wherein the organopolysiloxane is polydimethylsiloxane.7. The medical article according to claim 1 , further comprising a sealing member having an exterior surface in sliding engagement with at least a portion of the interior surface of the chamber.8. The medical article according to claim 1 , wherein the sugar is selected from the group consisting of monosaccharides claim 1 , disaccharides claim 1 , trisaccharides claim 1 , oligosaccharides and mixtures thereof.9. A ...

Method to Evaluate the Stability of a Protein-Based Formulation

The invention relates to a method to evaluate the stability of a protein-based formulation comprising a protein, a peptide and/or a protein derivative and a buffer relative to a lubricant of a lubricated container in which said formulation is intended to be stored, comprising: a) Evaluating a decrease over time of interfacial tension between the buffer and the lubricant, b) Evaluating a decrease over time of interfacial tension between the protein-based formulation and the lubricant, c) Identifying at least one component of the protein-based formulation interacting with the lubricant by comparing the decrease evaluated in step b) with the decrease evaluated in step a). 1. A method to evaluate the stability of a protein-based formulation comprising a protein , a peptide and/or a protein derivative and a buffer relative to a lubricant of a lubricated container in which said formulation is intended to be stored , the method comprising:a) evaluating a decrease over time of interfacial tension between the buffer and the lubricant;b) evaluating a decrease over time of interfacial tension between the protein-based formulation and the lubricant; andc) identifying at least one component of the protein-based formulation interacting with the lubricant by comparing the decrease evaluated in step b) with the decrease evaluated in step a).2. The method according to claim 1 , further comprising evaluating a decrease of interfacial tension between each component of the buffer and the lubricant in step a).3. A method to improve the stability of a protein-based formulation relative to a lubricant of a lubricated container in which said formulation is to be stored claim 1 , comprising:{'claim-ref': {'@idref': 'CLM-00001', 'claim 1'}, 'a) evaluating the stability of a protein-based formulation relative to said lubricant by the method according to ;'}b) selecting an adjuvant bringing a higher decrease over time of interfacial tension with the lubricant than the protein-based formulation ...

Connector for Connecting a Medical Injection Device to a Container

The present disclosure relates to a connector for connecting a medical injection device to a container closed by a septum. The connector has a distal tip and a sleeve extending around the tip. The sleeve has an inner threaded portion. The connector includes a proximal part configured to engage the tip of the injection device. The proximal part includes an outer threaded portion configured to be removably screwed to the inner threaded portion of the sleeve, distal part configured to be connected to the container, and a hollow spike extending from the proximal part. The hollow spike has an internal volume in fluidic connection with the injection device and perforates the septum of the container when the distal part is connected to the container. The spike includes an opening in a distal end being configured to create a connection between the medical injection device and the container. 1. A connector for connecting a medical injection device having a distal tip and a sleeve extending around the tip , the sleeve being provided with an inner threaded portion , to a container closed by a pierceable septum , the connector comprising:a proximal part configured to sealingly engage the distal tip of the injection device, the proximal part comprising an outer threaded portion configured to be removably screwed to the inner threaded portion of the sleeve;a distal part configured to be connected to the container; anda hollow spike extending distally from the proximal part, having an internal volume configured to be in fluidic connection with the injection device, the hollow spike being configured to perforate the pierceable septum of the container when the distal part is connected to the container, the hollow spike comprising an opening in a distal end, the opening being configured to create a fluidic connection between the medical injection device and the container.2. The connector of claim 1 , wherein the distal part comprises a skirt extending around the hollow spike claim 1 ...

Method for Reducing an Amount of Subvisible Particles in a Pharmaceutical Composition

The invention relates to a method for reducing an amount of sub visible particles in a pharmaceutical composition contained in a medical injection device comprising a container ( 1 ) including a barrel ( 10 ) lubricated with a lubricant coating ( 2 ) in contact with the pharmaceutical composition, and a stopper ( 14 ) in sliding engagement within the barrel ( 10 ), the container comprising a region ( 130, 121, 123 ) extending distally from the distal end ( 100 ) of the barrel which is not accessible to the stopper. During formation of said lubricant coating ( 2 ) on the inner wall of the barrel, the method comprises limiting lubricant from being deposited into said region ( 130, 121, 123 ) extending distally from the distal end ( 100 ) of the barrel.

Assessment of Stability of Biological Product in Prefilled Syringes

Provided herein is a method to mimic and assess the chemical degradation risk of a biological product, in prefilled syringes (PFS), using a custom-designed mimetic peptide. Such method is also able to predict the susceptibility to degradation of biological product in solution in a container for medical usage. 2. The method according to further comprising after step iv) claim 1 , a measurement step v) by mass spectrometry and a step vi) of identification of the chemical degradation.3. The method according to wherein R claim 1 , R claim 1 , Rand Reach represent CH claim 1 , and X═H claim 1 , n=1 and m=1.4. The method according to wherein the aqueous solution prepared at step i) comprises from 30 to 100% of water claim 1 , mass percentage.5. The method according to wherein the aqueous solution prepared at step i) further contains excipients claim 1 , buffering agents claim 1 , acids claim 1 , bases claim 1 , salts claim 1 , preservatives claim 1 , solubilizers claim 1 , surfactants claim 1 , chelating agents claim 1 , sugars claim 1 , amino acids claim 1 , peptides claim 1 , solvents and combinations thereof.6. The method according to wherein the aqueous solution prepared at step i) comprises at least 5 μg/ml of the compound of formula (I).7. The method according to wherein the part of the container for medical usage is a syringe claim 1 , a prefillable syringe claim 1 , part of a prefillable syringe claim 1 , a prefilled syringe or part of a prefilled syringe.8. The method according to wherein the part of the container for medical usage is a barrel claim 1 , a tip cap claim 1 , a cap claim 1 , a needle or a plunger stopper.9. The method according to wherein the part of the container for medical usage is glass claim 1 , rubber claim 1 , adhesive claim 1 , silicon oil claim 1 , plastic claim 1 , or metal.10. The method according to wherein the duration of step ii) is in a range from 4 hours to 2 months.11. The method according to wherein step ii) is carried out at a ...

Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution

This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and a non-ionic surfactant.

Method to evaluate the stability of a protein-based formulation

Disclosed herein is a method to evaluate the stability of a protein-based formulation including a protein, a peptide and/or a protein derivative and a buffer relative to a lubricant of a lubricated container in which the formulation is intended to be stored, including: a) Evaluating a decrease over time of interfacial tension between the buffer and the lubricant, b) Evaluating a decrease over time of interfacial tension between the protein-based formulation and the lubricant, c) Identifying at least one component of the protein-based formulation interacting with the lubricant by comparing the decrease evaluated in step b) with the decrease evaluated in step a).

Method for storing an emulsion-adjuvanted vaccine in a lubricated medical injection device

The invention relates to a method for storing an emulsion-adjuvanted vaccine in a medical injection device comprising a lubricant coating, said method comprising: (a) providing a medical injection device (1) comprising a barrel (2) having an inner surface (21); (b) forming a silicone oil layer on at least a part of the inner surface (21) of the barrel that is intended to be in contact with the vaccine, (c) carrying out an oxidizing plasma treatment of said layer so as to crosslink at least part of the silicone oil layer and form a lubricant coating (5), (d) filling the barrel with the emulsion-adjuvanted vaccine (6). The invention also relates to a medical injection device obtained directly from this method and to the use of plasma-treated silicone oil as a lubricant coating (5) in a medical injection device (1) comprising a barrel (2), for preventing migration of silicone from said lubricant coating (5) to an emulsion-adjuvanted vaccine (6) during storage of said vaccine in said medical injection device.

Method for storing an emulsion-adjuvanted vaccine in a lubricated medical injection device

The invention relates to a method for storing an emulsion-adjuvanted vaccine in a medical injection device comprising a lubricant coating, said method comprising: (a) providing a medical injection device (1) comprising a barrel (2) having an inner surface (21); (b) forming a silicone oil layer on at least a part of the inner surface (21) of the barrel that is intended to be in contact with the vaccine, (c) carrying out an oxidizing plasma treatment of said layer so as to crosslink at least part of the silicone oil layer and form a lubricant coating (5), (d) filling the barrel with the emulsion-adjuvanted vaccine (6). The invention also relates to a medical injection device obtained directly from this method and to the use of plasma-treated silicone oil as a lubricant coating (5) in a medical injection device (1) comprising a barrel (2), for preventing migration of silicone from said lubricant coating (5) to an emulsion-adjuvanted vaccine (6) during storage of said vaccine in said medical injection device.

Evaluation of the stability of a biological product in pre-filled syringes

Método para determinar el porcentaje de degradación de un compuesto de fórmula (I) mediante el contacto con parte de un recipiente para uso médico, que comprende las etapas sucesivas siguientes: i) preparar una disolución acuosa que comprende un compuesto de fórmula (I) a continuación: **(Ver fórmula)** en la que: R1, R2, R4 y R5 representan cada uno independientemente de otro H o un grupo alquilo (C1-C6), alquenilo (C2-C6) o alquinilo (C2-C6); X representa H o un grupo alquilo (C1-C6), alquenilo (C2-C6), alquinilo (C2-C6), alcoxicarbonilo (C1-C6), arilo o un grupo protector; n y m representan cada uno independientemente de otro un número entero de 0 a 10; R3 representa -(CH2)2-COOH, -CH2-COOH, -(CH2)4-COOH, -CH2-OH, -C(OH)-CH3, -CH2-CO-NH2, 20 CH2-SH, -(CH2)4-NH2, -(CH2)2-CO-NH2, -CH2-CH2-S-CH3, -(CH2)3-NH-C(NH)-NH2; **(Ver fórmula)** o R3 representa un grupo de fórmula (II) a continuación: **(Ver fórmula)** con R6, R7, R8 y R9 representando cada uno independientemente de otro H o un grupo alquilo (C1-C6), alquenilo (C2-C6) o alquinilo (C2-C6); X representa H o un grupo alquilo (C1-C6), alquenilo (C2-C6), alquinilo (C2-C6), alcoxicarbonilo (C1-C6), arilo o un grupo protector; r y p representan cada uno independientemente de otro un número entero de 0 a 10; ii) añadir a la disolución preparada en la etapa i) parte de un recipiente para uso médico durante un periodo de tiempo de 1 hora a 2 meses, a una temperatura en un intervalo de 5 a 80ºC; iii) analizar mediante cromatografía líquida la disolución obtenida en la etapa ii); y iv) determinar el porcentaje de degradación. Method for determining the percentage of degradation of a compound of formula (I) by contact with part of a container for medical use, comprising the following successive steps: i) preparing an aqueous solution comprising a compound of formula (I) a continuation: ** (See formula) ** in which: R1, R2, R4 and R5 each independently represent H or an alkyl (C1-C6), alkenyl (C2-C6) or alkynyl (C2-C6) ...

Assessment of stability of biological product in prefilled syringes

Medical device and smooth coating therefor

The invention relates to a medical device (1) comprising at least one first part (2; 3) coated with a coating (8) having a composition comprising at least one polymer material comprising polymer chains having the following repeat unit Formula (I): in which X represents a halogen, for example F, or a hydrogen, and in which Y1, Y2, Y3, Y4 each independently represent a halogen, for example Cl, or a hydrogen, characterized in that the outer surface of said coating (8) has a mean roughness Ra of less than 2.5 μm. The invention also relates to a part (2; 3) for a medical device (1) intended to cooperate with another part (3; 2) and provided with such a coating (8).

Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution

This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and non-ionic surfactant.

Method for Reducing an Amount of Subvisible Particles in a Pharmaceutical Composition

The invention relates to a method for reducing an amount of sub visible particles in a pharmaceutical composition contained in a medical injection device comprising a container (1) including a barrel (10) lubricated with a lubricant coating (2) in contact with the pharmaceutical composition, and a stopper (14) in sliding engagement within the barrel (10), the container comprising a region (130, 121, 123) extending distally from the distal end (100) of the barrel which is not accessible to the stopper. During formation of said lubricant coating (2) on the inner wall of the barrel, the method comprises limiting lubricant from being deposited into said region (130, 121, 123) extending distally from the distal end (100) of the barrel.

Connector for connecting a medical injection device to a container

Method for reducing an amount of subvisible particles in a pharmaceutical composition

The invention relates to a method for reducing an amount of sub visible particles in a pharmaceutical composition contained in a medical injection device comprising a container (1) including a barrel (10) lubricated with a lubricant coating (2) in contact with the pharmaceutical composition, and a stopper (14) in sliding engagement within the barrel (10), the container comprising a region (130, 121, 123) extending distally from the distal end (100) of the barrel which is not accessible to the stopper. During formation of said lubricant coating (2) on the inner wall of the barrel, the method comprises limiting lubricant from being deposited into said region (130, 121, 123) extending distally from the distal end (100) of the barrel.

Connector for connecting a medical injection device to a container

Connector for connecting a medical injection device to a container

The present disclosure relates to a connector for connecting a medical injection device to a container closed by a septum. The connector has a distal tip and a sleeve extending around the tip. The sleeve has an inner threaded portion. The connector includes a proximal part configured to engage the tip of the injection device. The proximal part includes an outer threaded portion configured to be removably screwed to the inner threaded portion of the sleeve, distal part configured to be connected to the container, and a hollow spike extending from the proximal part. The hollow spike has an internal volume in fluidic connection with the injection device and perforates the septum of the container when the distal part is connected to the container. The spike includes an opening in a distal end being configured to create a connection between the medical injection device and the container.

Conector para conectar un dispositivo médico de inyección a un recipiente

La presente invención se refiere a un conector (2) para conectar un dispositivo médico de inyección (40) que tiene una punta distal (42) y un manguito (44) que se extiende alrededor de la punta, estando provisto el manguito (44) de una porción roscada interior (45), a un recipiente (60) cerrado por un tabique perforable (63), comprendiendo dicho conector (2): - una parte proximal (10) configurada para acoplarse de forma sellada a la punta (42) del dispositivo de inyección (40), la parte proximal (10) que comprende una parte roscada exterior (13) configurada para atornillarse de forma extraíble a la parte roscada interior (45) del manguito, - una parte distal (20) configurada para conectarse al recipiente (60), - una punta hueca (30) que se extiende distalmente desde la parte proximal (10), que tiene un volumen interno (32) configurado para estar en conexión fluídica con el dispositivo de inyección (40), estando configurada la punta (30) para perforar el tabique perforable (63).) del recipiente (60) cuando la parte distal (20) está conectada al recipiente, comprendiendo la púa (30) una abertura (34) en un extremo distal, estando configurada dicha abertura (34) para crear una conexión fluídica entre el dispositivo médico de inyección (40) y el recipiente (60). (Traducción automática con Google Translate, sin valor legal)