[go: up one dir, main page]

WO2017179071A1 - Dispositif intégré d'emballage, de reconstitution et d'administration pour vaccins oraux et médicaments contenant des composants multiples - Google Patents

Dispositif intégré d'emballage, de reconstitution et d'administration pour vaccins oraux et médicaments contenant des composants multiples Download PDF

Info

Publication number
WO2017179071A1
WO2017179071A1 PCT/IN2017/050134 IN2017050134W WO2017179071A1 WO 2017179071 A1 WO2017179071 A1 WO 2017179071A1 IN 2017050134 W IN2017050134 W IN 2017050134W WO 2017179071 A1 WO2017179071 A1 WO 2017179071A1
Authority
WO
WIPO (PCT)
Prior art keywords
reconstitution
delivery device
device system
integrated packing
chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IN2017/050134
Other languages
English (en)
Inventor
Atul Sardana
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2017179071A1 publication Critical patent/WO2017179071A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015—Devices specially adapted for taking medicines
    • A61J7/0053—Syringes, pipettes or oral dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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

Definitions

  • the present invention relates to the field of medical devices.
  • the invention relates to a device for delivery of vaccines/drugs.
  • the invention relates to a device for delivery of vaccines/drugs which enhances the shelf live.
  • the invention relates to a device for delivery of vaccines/drugs which is capable of holding the vaccines/drugs under conditions without losing integrity even at normal room temperature for extended time.
  • the invention relates to an integrated reconstitution and delivery device for oral vaccines and drugs which consists of two or more components, of which one or more is essentially a liquid and other is solid or in powder form, which need to be reconstituted or mixed prior to oral delivery.
  • Immunization describes the process whereby an individual is made resistant to an infectious disease, typically by administering vaccine.
  • Vaccine stimulates the body's own immune system to protect the person against subsequent infection or disease.
  • Immunizing a person means he is exposed with a weakened form of disease causing agent that triggers the body's immune response, causing it to either produce antibodies (Abs) against that particular ailment or induce other processes that enhance immunity. Therefore, if he is ever again exposed to the actual disease- causing organism, his immune system is prepared to fight the infection.
  • Oral delivery of vaccines is an attractive mode of immunization because of its acceptability and its ease of administration.
  • Orally delivered vaccines especially particulates, are recognized by Microfold(M) Cells in the Peyer's Patches of the intestine and by dendritic cells that reside there.
  • M Microfold
  • few vaccines are administered orally, and most of these are based on live attenuated pathogens.
  • Oral delivery of non-living vaccines has proved to be extremely challenging, owing to poor stability of proteins, peptides and DNA in the acidic and enzyme-rich environment of the gastrointestinal tract.
  • the present invention aims to provide a novel integrated packing, reconstitution and delivery device for oral vaccines and drugs containing multiple components.
  • the present invention is directed to an oral active agent delivery system and method for delivering discrete units of an active agent to a patient.
  • An elongate tubular member having first and second ends comprises first and second flow paths. Either or both of said flow paths contains an active agent. Liquid is drawn up into the first end of the member, and the liquid and active agent is drawn out of the second end of the member and into the patient's mouth.
  • a two-part double syringe or double cartridge having associated, isolated containers with respective outlets which are connected to each other by a connecting element, the connecting element forming a unit that includes a holder with two container receptacles, a support wall, and a one-piece retaining flange, the support wall having recesses for receiving the container outlets and the container receptacles having respective guiding sleeves, and the outlet side being configured as a fastening area for the attachment of a mixer or accessory.
  • Such a double syringe allows the containers to be filled separately, is very solid, and can be operated like a one-piece double syringe.
  • a fully assembled dual chamber prefillable syringe cylinder for the administration of two components having a syringe barrel which, in both its single cylinder and dual chamber cylinder embodiments, is connected to both a syringe head featuring a tip cap as well as to the finger grips and which is closed at its base by means of a moveable plunger with a plunger rod and into which an intermediate plunger is positioned with the intent of separating first and second chambers from each other and which features a bypass located in a first chamber, as well as to a method for the manufacture and filling of said fully assembled prefillable syringe.
  • a combination mixing and flush syringe is disclosed whereby a mixing and a flush capability is provided within a conventional syringe.
  • Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade within the wall to release the drug to produce a therapeutic effect.
  • the preparation can be coupled to a delivery mechanism having one or more balloons or other expandable devices which are expandable responsive to a condition in the small intestine or other GI lumen to advance the preparation out of the capsule into the intestinal wall.
  • a delivery mechanism having one or more balloons or other expandable devices which are expandable responsive to a condition in the small intestine or other GI lumen to advance the preparation out of the capsule into the intestinal wall.
  • Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.
  • the invention provides a solution to the problem of delivering molecules in a physiologically relevant manner to direct cell fate.
  • a Notch ligand molecule is presented in a microenvironment that mimics the environment encountered in vivo.
  • the invention features a cell delivery vehicle comprising a biocompatible hydrogel or polymer and a composition that binds to a Notch receptor and methods of directing cell fate, e.g., stem cell differentiation, using such compositions.
  • Devices, methods, and systems are described for controlling pathogenic condition or disease in a subject.
  • Devices are described that include one or more bone cages.
  • the device including one or more bone cages can be configured to include one or more immunogens and one or more adjuvants.
  • the device including one or more bone cages can be configured to, and/or structured to at least partially or completely surround one or more cells or tissues that produce one or more immunogens and/or one or more adjuvants.
  • the device is useful in a method for treating a pathogenic condition or disease in the subject.
  • kits and compositions for producing an alginate gel are disclosed.
  • the kits and compositions comprise soluble alginate and insoluble alginate/gelling ion particles.
  • Methods for dispensing a self-gelling alginate dispersion are disclosed.
  • the methods comprise forming a dispersion of insoluble alginate/gelling ion particles in a solution containing soluble alginate, and dispensing the dispersion whereby the dispersion forms an alginate gel matrix.
  • the methods may include dispensing the dispersion into the body of an individual.
  • An alginate gel having a thickness of greater than 5 mm and a homogenous alginate matrix network and homogenous alginate gels free of one or more of: sulfates citrates, phosphates, lactates, EDTA or lipids are disclosed.
  • Implantable devices comprising a homogenous alginate gel coating are disclosed. Methods of improving the viability of pancreatic islets, or other cellular aggregates or tissue, following isolation and during storage and transport are disclosed.
  • none of the inventions in prior art comprise novel and unique process for packaging, storing, reconstituting and oral delivery of vaccines and drugs that comprise of two or more components as comprised in the present invention
  • the present invention provides a better, efficient, easy to use, cost effective delivery device for oral vaccines and drugs containing multiple components.
  • the present invention relates to an integrated packing, reconstitution and delivery device for oral vaccines or drug delivery containing multiple-chambers to contain two or more components of the vaccine or drug that are to be kept separate, unmixed and if required in vacuum or special conditions and in sterile condition.
  • the components generally are a liquid solution(s) and dry powder(s) which in case of oral vaccines or drugs are required to be reconstituted just prior to use.
  • the present invention provides a low cost, integrated and effective solution to package oral drugs and vaccines meant for reconstitution with minimal footprint and enabling automation of the filling lines.
  • the invention also provides means for reconstitution and delivery of these oral vaccines and drugs effectively with minimal steps and without the chance of any contamination .
  • the main objective of the present invention is to provide multiple-chamber device with the chambers comprising of two or more components that are to be kept in sterile condition.
  • Another objective of the present invention is to provide a multiple-chamber device, the contents of the chambers are liquid solution(s) and dry powder(s) which are intended to be kept unmixed during storage and transportation.
  • Yet another objective is to provide a multiple-chamber device, the contents of the chambers are liquid solution(s) and dry powder(s) which are intended to be mixed and or reconstituted just prior to their administration .
  • Another objective is to provide a multiple-chamber device, the contents of the chambers are liquid solution(s) and dry powder(s) which are mixed and then administered by oral route either by self-administration or by a trained healthcare worker.
  • Another objective is to provide a multiple-chamber device, the contents of the chambers are liquid solution(s) and dry powder(s) which are mixed and then administered by oral route either as a single dose to one recipient or as multiple doses to single recipient over a period of time or as multiply repeated single doses to multiple recipients.
  • Yet another objective of this invention is to provide a multiple-chamber device, the contents of the chambers are liquid solution(s) and dry powder(s) which are mixed by way of mechanical action of a flangable seal or a burstable seal which separates the various components.
  • Yet another objective of this invention is to provide a multiple-chamber device, the contents of the chambers are liquid solution(s) and dry powder(s) which are mixed by way of mechanical action of a flangable seal or a burstable seal which separates the various components and the sequence of such mixing can be controlled or preprogrammed.
  • Another objective of this invention is to provide a multiple-chamber device with Minimal Footprint, which is Economically Designed Integrated Device having an Intuitive Design the operation of which is a single handed.
  • Another objective of this invention is to provide a multiple-chamber device which has just Three Steps to Administer (Mix: Shake: Deliver) with just one Action.
  • Yet another objective of this invention is to provide a multiple-chamber device which has an Independent Powder and Liquid Filling Compartments (Can be Filled at Different Sites as Well) and avoids of Contamination During Product Filling, Mixing and Delivery.
  • Another objective of this invention is to provide a multiple-chamber device which can be Individually Packed Single Use Device (To Be Disposed after Administration) but also can be designed into a Multi-Dose Device with fixed or Interchangeable delivery spouts/ tips
  • Yet another objective of this invention is to provide a multiple-chamber device with an inbuilt Poke Yoke (Failure Protection) and is Tamper Evident having a transparent Mixing Chamber for Visual Confirmation
  • Another objective of this invention is to provide a multiple-chamber device which is Not Compatible to Injectable Accessories to Prevent Inadvertent Parenteral Use.
  • Yet another objective of this invention is to provide a multiple-chamber device in which one or more chambers may contain Lyophilized Powder(s) that can be Packed and Stored in Vacuum.
  • Yet another object of the present invention is to provide a integrated Packing, Reconstitution And Delivery Device For Oral Vaccines and Drugs which practical, versatile, economical and easy to make.
  • the present invention relates to an integrated Packing, Reconstitution and Delivery Device
  • the components generally are a liquid solution(s) and dry powder(s) which in case of oral vaccines or drugs are required to be reconstituted just prior to use.
  • the present invention provides a low cost, integrated and effective solution to package oral drugs and vaccines meant for reconstitution with minimal footprint and enabling automation of the filling lines.
  • the invention also provides means for reconstitution and delivery of these oral vaccines and drugs effectively with minimal steps and without the chance of any contamination .
  • Figure 1 is an exploded axonometric view illustrating the integrated Packing, Reconstitution and Delivery Device according to the present invention with Two Chambers.
  • Figure 2 is an isometric view illustrating the integrated Packing, Reconstitution and Delivery Device according to the present invention .
  • Figure 3 is a frontal view illustrating the integrated Packing, Reconstitution and Delivery Device according to the present invention .
  • Figure 4 is a cross sectional view illustrating the integrated Packing, Reconstitution and Delivery Device according to the present invention with Two Chambers.
  • Figure 5 is a cross sectional view illustrating the Bursting Mechanism.
  • Figure 6 is a cross sectional view illustrating the integrated Packing, Reconstitution and Delivery Device according to the present invention at the end of the mixing stroke of the plunger with Two Chambers.
  • Figure 7 is a cross sectional view illustrating the integrated Packing, Reconstitution and Delivery Device according to the present invention at the end of the delivery stroke of the plunger with Two Chambers.
  • Figure 8 is an exploded axonometric view illustrating the integrated Packing, Reconstitution and Delivery Device according to the present invention with more than Two Chambers.
  • Figure 9 is a cross sectional view illustrating a comparison between the proximal chamber(s) of a Two Chamber Device and a more than Two Chambers Device.
  • Figure 10 is a cross sectional view illustrating a variant of the integrated Packing, Reconstitution and Delivery Device with the Elastomeric Bulb is replaced with a Plunger Rod with Thumb Rest.
  • Figure 11 is a cross sectional view illustrating a variant of the integrated Packing, Reconstitution and Delivery Device with a Liquid Reservoir placed in the Distal Chamber
  • the present invention provides an integrated packing, reconstitution and delivery device system for oral vaccines and drugs and a method of constructing thereof; wherein said device comprises multiple number of chambers with an elastomeric bulb fitted above said chambers, a thumb rest identification, an external profile at the distal end of the elastomeric bulb, internal profile, a locking groove, a bursting mechanism, air vent and a body cover, wherein said device is capable of packing, reconstitution and delivering oral vaccines and drugs consisting of two or more components.
  • the present invention also provides a method of constructing said device comprises fitting of elastomeric bulb, arranging the chambers, sealing the distal end and proximal end, arranging the components, arrangement of lock and extending the body cover.
  • the present invention provides an integrated Packing, Reconstitution And Delivery Device For oral vaccines or drug delivery containing multiple-chambers to contain two or more components of the vaccine or drug that are to be kept separate, unmixed and if required in vacuum or special conditions in sterile condition.
  • the components generally are a liquid solution(s) and dry powder(s) which in case of oral vaccines or drugs are required to be reconstituted just prior to use.
  • the present invention provides a low cost, integrated and effective solution to package oral drugs and vaccines meant for reconstitution with minimal footprint and enabling automation of the filling lines.
  • the invention also provides means for reconstitution and delivery of these oral vaccines and drugs effectively with minimal steps and without the chance of any contamination.
  • the proximal end of the elastomeric bulb may have an indentation built into it for serving as a thumb rest (12).
  • the distal end of the elastomeric bulb is open with external profile (13) with a groove to lock securely with the reciprocal internal profile (14) on the proximal part of the Body Cover (5) as described below.
  • the Proximal Chamber is a Hollow tube closed at the proximal end with another telescoping hollow tube, the diameter of which is less than that of the proximal chamber itself.
  • This hollow tube is called the bursting mechanism (11) as is described in details below.
  • This bursting mechanism (11) is placed in extended condition within the elastomeric bulb (1) .
  • the distal end of the proximal tube is sealed with flangable/burstable seal (15) of desirable material and physical properties after the tube is filled with desired solid or liquid component of the drug/vaccine.
  • the Distal Chamber (3) is a conical or teat shaped with the end having a larger diameter placed proximally. This diameter and more specifically the inner diameter of this side should be such that it is similar or larger to the inner diameter of proximal chamber so that it abuts the proximal chamber when placed co-axially and the Bursting Mechanism (11) can enter into it when it is pressed axially forward.
  • the Distal Chamber is closed at the distal end with a breakaway seal (4) integrally processed with Distal Chamber but such that it can be easily broken away neatly leaving an aperture or hole of desired diameter or size in the distal end of the distal chamber.
  • the distal end of the distal chamber may be securely sealed using a threaded cap or a snap in or snap on elastomeric cap.
  • the proximal end of the Distal Chamber tube is sealed with flangable/burstable seal (16) of desirable material and physical properties after the tube is filled with desired solid or liquid component of the drug/vaccine.
  • Both these steps of filling the Proximal Chamber (2) and Distal Chamber (3) with desired solid or liquid component of the drug/vaccine prior to sealing it with flangable/burstable seal (15, 16) of desirable material and physical properties may be done in air or vacuum or special condition as required to maintain the stability of the drug/vaccine. Also, these may be carried out on different equipments and at different sites if desired.
  • the three parts viz. the elastomeric bulb (1), the proximal chamber(2) and the distal chamber(3) are placed co-axially and held in place by a Body Cover (5) which is slid over from the elastomeric bulb side and lock via thread or a press fit/ snap fit arrangement (17) built on the distal side of the Body Cover (5) to a reciprocal feature built on external surface (18) of the proximal side of the Distal Chamber (3) thereby holding all three parts tightly, inline and securely.
  • the proximal part of the Body Cover (5) has an extension radially extending outwards that serves as finger flange(s) (6) while holding the device for use.
  • Figure 2 to 4 show the Integrated Packing, Reconstitution And Delivery Device For Oral Vaccines and Drugs (99) according to a First embodiment of the present invention comprising of an elastomeric bulb (1) fitted above two chambers viz. the Proximal Chamber (2) and the Distal Chamber (3) all of which are arranged co- axially, in a state wherein the vaccine/drug comprising of two components of which one or more is essentially a liquid and other(s) are in solid or in powder form wherein either of the two may be filled in any of the Chambers (2,3) prior to sealing it with flangable/burstable seal (15,16) in air or vacuum or special condition as required to maintain the stability of the drug/vaccine when packed.
  • the vaccine/drug comprising of two components of which one or more is essentially a liquid and other(s) are in solid or in powder form wherein either of the two may be filled in any of the Chambers (2,3) prior to sealing it with flangable/burstable seal (15,16) in air
  • Figure 5 shows the Bursting Mechanism (11) which is a hollow Tubular structure having a sharp tip profile (8) at the distal end. Just at the termination of the cylindrical part above the sharp tip profile (8) there are two rows of elastomeric "0" ring seals (19,20) which are used to seal the Proximal Chamber (2) at its proximal end.
  • the air vent (9) may be single or multiple and the size of which may vary depending on the requirement of the device.
  • the air vent (9) may be replaced by a one-way valve made of elastomeric material if it is desirable to prevent the movement of the mixed contents of the chambers to the elastomeric bulb (1).
  • FIG. 6 is an Integrated Packing, Reconstitution And Delivery Device For Oral Vaccines and Drugs (99) according to a First embodiment of the present invention show the position of the Bursting Mechanism (11) when the elastomeric bulb (1) has been pressed once moving the Bursting Mechanism (11) to axially slide forward through the Proximal Chamber (2) and advancing its sharp tip profile (8) at the distal end to burst or rupture the flangable/burstable seals(15,16) of both the Proximal Chamber (2) and the Distal Chamber (3) thereby allowing the components of the Vaccine/Drug kept in the chambers respectively to freely mix with each other.
  • the axial advancement of the Bursting Mechanism (11) forward through the Proximal Chamber (2) is limited by a profile (21) placed at the proximal end of the Bursting Mechanism (11) radially extending outward such that it abuts the proximal edge of Proximal Chamber (2) .
  • the travel is limited by design to allow the distal row of the "0" ring seals (20) and the slot for air vent (9) to enter into the Distal Chamber (3).
  • the mixing of the components of the Vaccine/Drug can further be aided by shaking the device at this stage and proper mixing can be visually checked by viewing through the Distal Chamber (3) if it is made of transparent plastic.
  • FIG. 7 is an Integrated Packing, Reconstitution And Delivery Device For Oral Vaccines and Drugs (99) according to a First embodiment of the present invention shows the last step of administering the vaccine/drug which is achieved through the distal end of the Distal Chamber (3) which is conical or teat shaped by removing the threaded cap or a snap in or snap on elastomeric cap or by breaking the breakaway seal (4) all of which leaves an aperture or hole of desired diameter or size in the distal end of the Distal Chamber (3) .
  • the elastomeric bulb (1) is to be compressed once again to generate the desired positive pressure in order to expel or purge the mixed components of both the Chambers out through the said aperture or hole at the distal end of the Distal Chamber (3) for oral delivery.
  • there are three chambers to pack a vaccine more so a vaccines containing more than two components which provide antigen exposure against two or more distinct pathogens.
  • the two part proximal chamber may be replaced with three or more parts to accommodate more than two components in order to pack, store, reconstitute and deliver a vaccine that can provide antigen exposure against two or more distinct pathogens.
  • Figure 9 more clearly shows the way the Proximal Chamber (2) can be redesigned to contain more than one Proximal Chambers (2a,2b,2c,2d) which are separated with flangable/burstable seals and is not limited to the numbers shown in the drawing.
  • the Proximal Chamber(s) (2a, 2b, 2c,2d) and the contents of the Proximal Chamber(s) (2a,2b,2c,2d) and the Distal Chamber (3) may be rearranged to regulate the order of mixing of various components of the drug/vaccine.
  • Figure 10 shows a variant of the integrated Packing, Reconstitution and Delivery Device where the elastomeric bulb (1) is be replaced by a solid plastic rod (23) directly connected to the Bursting Mechanism (8) like that of the plunger of a syringe with a Thumb Rest (24) on it and have the same functions as of the elastomeric bulb as defined above. In such embodiment as shown in Figure 10, there will be no slots for air vent (9) .
  • Figure 11 shows an alternative way to pack liquid components in either the proximal chamber (2) or distal chamber (3).
  • the Liquid(s) components of varying capacity can be packed in a Reservoir(s) (22) as shown in Figure 11, of adequate size such that it is merely placed in the proximal or distal chamber(s) and the reservoir (22) can be burst using the bursting mechanism to mix with the other components kept in the proximal or distal chamber(s) .
  • the wall of the reservoir is made of gelatin or other organic material or of a suitable polymer film depending on its compatibility with the liquid and its desired stability. The shape and wall thickness of the reservoir is determined by the material of construction, force required to burst it and the method of application of that force.
  • the invention is not limited to the above embodiments and also these the embodiment described above can also be used in spirit and form to replace and/or modify the components described above including their function and placement amongst each other or in forms other than these but the desired result of keeping the two or more components of the oral vaccine of which one is essentially a liquid and other is solid or in powder form, is achieved during the shelf life of the vaccine and they may be packed in an integrated form such that they can be reconstituted or mixed prior to oral delivery.
  • the same concept and mechanism can be used to pack, reconstitute and deliver other medicinal, pharmaceuticals and vaccines by routes other than oral such as parenteral, nasal, spray etc. in humans and veterinary applications.
  • the present invention provides an integrated packing, reconstitution and delivery device system for oral vaccines and drugs and a method of constructing thereof; wherein said device comprises multiple number of chambers with an elastomeric bulb fitted above said chambers, a thumb rest identification, an external profile at the distal end of the elastomeric bulb, internal profile, a locking groove, a bursting mechanism, air vent and a body cover, wherein said device is capable of packing, reconstitution and delivering oral vaccines and drugs consisting of two or more components.
  • said multiple chambers are two in number are provided to contain two components of the vaccine or drug, and are proximal and distal arranged co- axially.
  • said multiple-chambers are provided to contain more than two components of the vaccine or drug.
  • said multiple-chambers may also contain liquid reservoir(s) made of gelatin or other organic material or of a suitable polymer film.
  • At least one of the said components is a liquid solution(s) and others may be dry powder(s) which in case of oral vaccines or drugs are required to be reconstituted just prior to use.
  • said device comprises a dropper bulb shaped elastomeric bulb fitted above the multiple chambers.
  • said device is capable of comprising a solid plastic rod instead of elastomeric bulb as per requirement, wherein the solid plastic rod will be directly connected to the bursting mechanism.
  • said proximal chamber is a hollow tube closed at the proximal end with another telescoping hollow tube, the diameter of which is lesser than that of the proximal chamber.
  • said distal chamber is a conical or teat shaped with the end having a larger diameter placed proximally.
  • said elastomeric bulb comprises an -indentation built into it for serving as a thumb rest.
  • said proximal tube is sealed with flangable/burstable seal of desirable material and physical properties after the tube is filled with desired solid or liquid component of the drug/vaccine.
  • said distal chamber is closed at the distal end with a breakaway seal integrally processed with distal Chamber but such that it can be easily broken away neatly leaving an aperture or hole of desired diameter.
  • said distal end of the elastomeric bulb is open with external profile.
  • said device comprises an internal profile which is securely locked with external profile.
  • said device comprises a locking groove to lock the external profile securely with the reciprocal internal profile.
  • said device comprises a bursting mechanism placed in extended condition within the elastomeric bulb.
  • said device comprises a slot for air vent to ensure venting of any positive pressure created in the Proximal Chamber and Distal Chamber while the bursting mechanism is pressed.
  • said device comprises a body cover to hold and cover the various components.
  • said method of constructing said device comprises fitting of elastomeric bulb, arranging the chambers, sealing the distal end and proximal end, arranging the components, arrangement of lock and extending the body cover.
  • said method comprises fitting of elastomeric bulb above two chambers viz. the Proximal Chamber and the Distal Chamber.
  • said method comprises arranging the Proximal Chamber and the Distal Chamber co-axially.
  • said method comprises sealing the distal end and proximal end of the distal chamber with flangable/burstable seal.
  • said method comprises arranging the different components namely elastomeric bulb, proximal chamber and the distal chamber which are placed co-axially and held in place by a Body Cover.
  • said method comprises extending the body cover radially outwards which serves as a finger flange while holding the device for use.
  • said device is capable of comprising liquid reservoirs of varying capacity in either the proximal chamber or distal chamber.
  • the present invention provides an integrated packing, reconstitution and delivery device system for oral vaccines and drugs and a method of constructing thereof, as claimed in above claims is capable of delivering oral vaccines or drug delivery while holding them separately into the chambers for efficient use with increased shelf life of the contained vaccine or drug.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne un dispositif intégré d'emballage, de reconstitution et d'administration pour des vaccins oraux et médicaments contenant des composants multiples. Le dispositif selon la présente invention peut contenir le vaccin et le médicament qui doivent être conditionnés dans plus d'un composant qui sont sous forme de liquide et/ou de poudre. Les différents composants du vaccin ou du médicament peuvent être contenus dans des compartiments séparés qui sont agencés de façon coaxiale. Le dispositif selon la présente invention présente une durée de conservation longue, évite la contamination et est un dispositif intuitif, intégré et inviolable pour un dispositif d'emballage, de reconstitution et d'administration de vaccins et de médicaments oraux en une seule étape.
PCT/IN2017/050134 2016-04-15 2017-04-06 Dispositif intégré d'emballage, de reconstitution et d'administration pour vaccins oraux et médicaments contenant des composants multiples Ceased WO2017179071A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN3333DE2015 2016-04-15
IN3333/DEL/2015 2016-04-15

Publications (1)

Publication Number Publication Date
WO2017179071A1 true WO2017179071A1 (fr) 2017-10-19

Family

ID=60041471

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2017/050134 Ceased WO2017179071A1 (fr) 2016-04-15 2017-04-06 Dispositif intégré d'emballage, de reconstitution et d'administration pour vaccins oraux et médicaments contenant des composants multiples

Country Status (1)

Country Link
WO (1) WO2017179071A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB628675A (en) * 1945-08-31 1949-09-02 Abbott Lab Sterile medicament cartridge and insufflator, and method of preparing the cartridge
EP0904763A2 (fr) * 1997-09-25 1999-03-31 Becton Dickinson France S.A. Connecteur à collier de verrouillage pour ampoule
US20090013994A1 (en) * 2007-07-06 2009-01-15 Manta Devices, Llc Delivery device and related methods

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB628675A (en) * 1945-08-31 1949-09-02 Abbott Lab Sterile medicament cartridge and insufflator, and method of preparing the cartridge
EP0904763A2 (fr) * 1997-09-25 1999-03-31 Becton Dickinson France S.A. Connecteur à collier de verrouillage pour ampoule
US20090013994A1 (en) * 2007-07-06 2009-01-15 Manta Devices, Llc Delivery device and related methods

Similar Documents

Publication Publication Date Title
US6932791B2 (en) Single dose delivery device
ES2203805T3 (es) Dispositivo de reconstitucion de un medicamento inyectable.
CN108136128B (zh) 多腔室注射器单元和制备多腔室注射器的方法
ES2699587T3 (es) Montaje y método para liofilizar un agente activo
ES2500494T3 (es) Sistema de suministro para tapa de recipiente
KR20140124828A (ko) 동결 건조 의약품을 수용하기 위한 장치 및 동결 건조 의약품을 수용하는 밀봉 용기의 제조방법
ES2626275T3 (es) Dispositivo compacto de reconstitución de medicamentos y método
CN108348685B (zh) 预填充有可复溶试剂的一次性输送装置
KR102512255B1 (ko) 2가지 성분을 혼합 및 분배하기 위한 용기
EP2809291B1 (fr) Adaptateur à coupler à un récipient médical
WO2013115730A1 (fr) Adaptateur pourvu d'un dispositif d'injection et s'accouplant à un contenant médical
CN106999346A (zh) 容器以及封闭件
WO2014004211A1 (fr) Seringues de mélange pré-remplies à compartiments multiples pourvues d'une dérivation
JP6769990B2 (ja) 点眼液滴分配装置の製造方法
WO2014145959A1 (fr) Système de mélange et d'administration de médicament détachable et portable et méthode
WO2017179071A1 (fr) Dispositif intégré d'emballage, de reconstitution et d'administration pour vaccins oraux et médicaments contenant des composants multiples
US20160158716A1 (en) Novel reconstitution assembly
ATE397954T1 (de) Arzneiverabreichungssystem mit halter und arzneimittelbehälter
US12343310B2 (en) Device for transferring a liquid from a first vial to a second vial
WO2011114344A1 (fr) Cartouche multidose pour solution de médicament liquide homogène
GB2418616A (en) Injection device with a piston having needle and plunger attachments.
JP2010063737A (ja) 動物用投薬容器及び動物用投薬容器の使用方法
HK1255970B (en) Multi chamber syringe unit and method of preparing a multi chamber syringe

Legal Events

Date Code Title Description
NENP Non-entry into the national phase

Ref country code: DE

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17782065

Country of ref document: EP

Kind code of ref document: A1

122 Ep: pct application non-entry in european phase

Ref document number: 17782065

Country of ref document: EP

Kind code of ref document: A1