WO1999025629A1 - Multicompartment container for combination products - Google Patents

Multicompartment container for combination products Download PDF

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Publication number
WO1999025629A1
WO1999025629A1 PCT/US1998/024512 US9824512W WO9925629A1 WO 1999025629 A1 WO1999025629 A1 WO 1999025629A1 US 9824512 W US9824512 W US 9824512W WO 9925629 A1 WO9925629 A1 WO 9925629A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
vial
compartments
combination
wall
Prior art date
Application number
PCT/US1998/024512
Other languages
French (fr)
Inventor
Steven S. Lee
Original Assignee
Merck & Co., Inc.
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
Priority claimed from GBGB9806035.3A external-priority patent/GB9806035D0/en
Application filed by Merck & Co., Inc. filed Critical Merck & Co., Inc.
Priority to AU14149/99A priority Critical patent/AU1414999A/en
Publication of WO1999025629A1 publication Critical patent/WO1999025629A1/en

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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
    • B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
    • B65D1/04—Multi-cavity bottles
    • 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/40—Heating or cooling means; Combinations thereof
    • A61J2200/44—Cooling means

Definitions

  • the invention relates to a multicompartment container in which two or more different substances which must remain separated until use, can be freeze-dried and stored separately.
  • the present invention relates to a multicompartment container which comprises a standard wide-mouth vial made of glass, plastic or other suitable material of construction having a single septum or plurality of septa to separate the vial into at least two compartments.
  • the container may comprise a vial with a smaller open vial or plurality of small open vials with different diameters placed within it in a concentric manner in order to allow for the separation of two or more individual components.
  • the vial may be used on a existing filling line in which multiple filling heads are desired.
  • the septa or inner container would allow for filling of different components, e.g., for a combination vaccine such as Merck's M-M-R® II-V, which consists of the mumps, measles and rubella vaccine, M-M-R®, in combination with their chicken pox vaccine, VARIVAX®.
  • the different components may be filled simultaneously or separately.
  • the container prevents interaction of the two or more therapeutic compounds which could result in a loss of potency. By doing this, it eliminates the time and expense of developing a new, non-reactive formulation or one of less potency. While the invention is contemplated for use with combination vaccines, it would be useful for any type of combination product in which the components interact during processing and/or storage prior to use.
  • Fig. 1 shows a cross section of a partially filled two compartment vial with a vertical septum attached at two points dividing the vial into two compartments.
  • Fig. 2 shows a cross section of a partially filled two compartment vial with a smaller open-ended container attached to the bottom of the larger vial dividing the vial concentrically into two compartments.
  • Fig. 3 shows a cut-away view of the base of the Fig. 1 vial.
  • Fig. 4 shows a cut-away view of the base of the Fig. 2 vial.
  • a multicompartment vial for combination products which comprises a container having an inner wall and an open top which communicates the outside of the container with the inside of the container, a bottom which closes off the container and walls which circumscribe the top and bottom of the container; the container further having a wall which is parallel to the sides of the container and perpendicular to the bottom and top of the container and which is attached to the wall of the container in at least two places to divide the container into compartments; the wall extending from the bottom of the container to a position which is from about 5% to 95% of the container height, the compartments being sealed along the bottom and sides and open at the top such that the integrity of each compartment is preserved and such that compartments are capable of holding liquids without spillage from one compartment to another.
  • a multicompartment vial for combination products which comprises a container having an inner wall and an open top which communicates the outside of the container with the inside of the container, a bottom which closes off the container and walls which circumscribe the top and bottom of the container; the container further having a smaller container attached to the inside base of the larger container to divide the container into compartments; the smaller container extending from the bottom of the container to a position which is from about 5% to 95% of the container height, the compartments being sealed along the bottom such that the integrity of each compartment is preserved and such that compartments are capable of holding liquids without spillage from one compartment to another.
  • the container of the invention while applicable for use in any field where combination products must be kept separate until just prior to use, is particularly useful for pharmaceutical and veterinary products. In this use, combination products often contain substances which react with each other and must only be mixed immediately prior to use.
  • Figure 1 shows a cross section of the container (10) including a wide mouth (12) optionally containing a standard stopper (40) and a septum (14) down the middle of the container separating the container into two distinct regions (16).
  • the septum can be from about 5% to about 95% of the height of the container and can be made of any suitable material.
  • the ends of the septum (24) are attached at two points to the base (18) of the container (10).
  • the mouth of the container is wide in order to allow two or more filling heads to fill the compartments simultaneously.
  • Container (10) are the components and which are required to be separated prior to use.
  • Container (10) can be placed on a filling line and the components can be filled, either simultaneously or separately, using filling heads. Following filling, the container can be placed in a lyophilization chamber for freeze-drying and processed accordingly.
  • Figure 2 shows a cross section of an alternate embodiment of the invention.
  • container (10) Within container (10) is a second container (20) having an opening (22) for filling one component of the combination product.
  • Figure 4 shows the base (28) of the container and the separation of the interior of the container.
  • the second container (20) is attached to the base by any means suitable to prevent the second container from moving within the main container.
  • the container can be placed in a filling line, filled and then transferred to a lyophilization chamber without the necessity of special handling or fear of mixing of the two components prior to freeze drying.
  • the container can be capped with a standard stopper, packed and shipped without fear of mixing of the solid components.
  • This invention allows sterile processing of products employing existing equipment and process without signifi- cant modifications.
  • the end users may use combination products in this new container following current procedures without additional training.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Ceramic Engineering (AREA)
  • Mechanical Engineering (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

There is disclosed a multicompartment vial (10, 28) containing two or more compartments (16, 22) that is useful for physically separating combination products such as vaccines and other pharmaceutical combination products which can interact during processing and therefore must be kept separate prior to administration.

Description

TITLE OF THE INVENTION:
MULTICOMPARTMENT CONTAINER FOR COMBINATION
PRODUCTS
BACKGROUND OF THE INVENTION
The invention relates to a multicompartment container in which two or more different substances which must remain separated until use, can be freeze-dried and stored separately.
In the past, products composed of more than one component generally required separate packages or new formulations to combine all components. This is particularly true in the case of combination vaccines where undesirable interactions between different components such as live viruses often lead to degradation and loss of potency. This can also be true for certain pharmaceutically active compounds which while effective when dispensed together, are not stable when mixed. As a result, separate containers have been used to freeze- dry various products which are individually reconstituted and mixed just prior to use. An alternative to this approach has been to develop formulations which stabilize each component in the presence of the others. This latter option can be expensive, time consuming and difficult especially for live virus vaccines.
It has been found that a multicompartment container design which is able to physically and completely separate the components during filling and lyophilization processes overcomes some of the problems associated with multicomponent products.
Existing multicompartment containers and vials such as those disclosed in U.S. 4,089,432, WO 95/01285 and WO 92/06898 lack the simplicity, ease and readiness for process, consumer-friendliness and economy of the container of the invention.
SUMMARY OF THE INVENTION:
The present invention relates to a multicompartment container which comprises a standard wide-mouth vial made of glass, plastic or other suitable material of construction having a single septum or plurality of septa to separate the vial into at least two compartments. Alternatively, the container may comprise a vial with a smaller open vial or plurality of small open vials with different diameters placed within it in a concentric manner in order to allow for the separation of two or more individual components.
The vial may be used on a existing filling line in which multiple filling heads are desired. The septa or inner container would allow for filling of different components, e.g., for a combination vaccine such as Merck's M-M-R® II-V, which consists of the mumps, measles and rubella vaccine, M-M-R®, in combination with their chicken pox vaccine, VARIVAX®. The different components may be filled simultaneously or separately.
It is therefore an object of the invention to provide an inexpensive container for combination products, such as vaccines, which physically separates two or more substituents throughout the filling and lyophilization processes. The container prevents interaction of the two or more therapeutic compounds which could result in a loss of potency. By doing this, it eliminates the time and expense of developing a new, non-reactive formulation or one of less potency. While the invention is contemplated for use with combination vaccines, it would be useful for any type of combination product in which the components interact during processing and/or storage prior to use.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 shows a cross section of a partially filled two compartment vial with a vertical septum attached at two points dividing the vial into two compartments.
Fig. 2 shows a cross section of a partially filled two compartment vial with a smaller open-ended container attached to the bottom of the larger vial dividing the vial concentrically into two compartments. Fig. 3 shows a cut-away view of the base of the Fig. 1 vial.
Fig. 4 shows a cut-away view of the base of the Fig. 2 vial.
DETAILED DESCRIPTION OF THE INVENTION
As shown in Figure 1, there is disclosed a multicompartment vial for combination products which comprises a container having an inner wall and an open top which communicates the outside of the container with the inside of the container, a bottom which closes off the container and walls which circumscribe the top and bottom of the container; the container further having a wall which is parallel to the sides of the container and perpendicular to the bottom and top of the container and which is attached to the wall of the container in at least two places to divide the container into compartments; the wall extending from the bottom of the container to a position which is from about 5% to 95% of the container height, the compartments being sealed along the bottom and sides and open at the top such that the integrity of each compartment is preserved and such that compartments are capable of holding liquids without spillage from one compartment to another.
As shown in Figure 2, there is also disclosed a multicompartment vial for combination products which comprises a container having an inner wall and an open top which communicates the outside of the container with the inside of the container, a bottom which closes off the container and walls which circumscribe the top and bottom of the container; the container further having a smaller container attached to the inside base of the larger container to divide the container into compartments; the smaller container extending from the bottom of the container to a position which is from about 5% to 95% of the container height, the compartments being sealed along the bottom such that the integrity of each compartment is preserved and such that compartments are capable of holding liquids without spillage from one compartment to another. The container of the invention, while applicable for use in any field where combination products must be kept separate until just prior to use, is particularly useful for pharmaceutical and veterinary products. In this use, combination products often contain substances which react with each other and must only be mixed immediately prior to use.
Figure 1 shows a cross section of the container (10) including a wide mouth (12) optionally containing a standard stopper (40) and a septum (14) down the middle of the container separating the container into two distinct regions (16). The septum can be from about 5% to about 95% of the height of the container and can be made of any suitable material. As shown in Figure 3, the ends of the septum (24) are attached at two points to the base (18) of the container (10). The mouth of the container is wide in order to allow two or more filling heads to fill the compartments simultaneously. Within container
(10) are the components and which are required to be separated prior to use. Container (10) can be placed on a filling line and the components can be filled, either simultaneously or separately, using filling heads. Following filling, the container can be placed in a lyophilization chamber for freeze-drying and processed accordingly.
Figure 2 shows a cross section of an alternate embodiment of the invention. Within container (10) is a second container (20) having an opening (22) for filling one component of the combination product. Figure 4 shows the base (28) of the container and the separation of the interior of the container. The second container (20) is attached to the base by any means suitable to prevent the second container from moving within the main container.
In principle, the container can be placed in a filling line, filled and then transferred to a lyophilization chamber without the necessity of special handling or fear of mixing of the two components prior to freeze drying. Following lyophilization, the container can be capped with a standard stopper, packed and shipped without fear of mixing of the solid components. This invention allows sterile processing of products employing existing equipment and process without signifi- cant modifications. In addition, the end users may use combination products in this new container following current procedures without additional training.
The principles, preferred embodiments and modes of operation of the present invention have been described in the foregoing specification. However, the invention which is intended to be protected is not to be construed as limited to the particular embodiments disclosed. The embodiments are to be construed as illustrative rather than restrictive. Variations and changes may be made by others without departing from the spirit of the present invention. Accordingly, all such variations and changes which fall with the spirit and scope of the present invention as defined in the following claims are expressly intended to be embraced thereby.

Claims

WHAT IS CLAIMED IS:
1. A multicompartment vial for combination products which comprises a container having an inner wall and an open top which communicates the outside of the container with the inside of the container, a bottom which closes off the container and walls which circumscribe the top and bottom of the container; the container further having a wall which is parallel to the sides of the container and perpen- dicular to the bottom and top of the container and which is attached to the wall of the container in at least two places to divide the container into compartments; the wall extending from the bottom of the container to a position which is from about 5% to about 95% of the container height, the compartments being sealed along the bottom and sides and open at the top such that the integrity of each compartment is preserved and such that compartments are capable of holding liquids without spillage from one compartment to another.
2. A multicompartment vial for combination products which comprises a container having an inner wall and an open top which communicates the outside of the container with the inside of the container, a bottom which closes off the container and walls which circumscribe the top and bottom of the container; the container further having a smaller container attached to the inside bottom of the larger container to divide the container into compartments; the smaller container extending from the bottom of the container to a position which is from about 5% to about 95% of the container height, the compartments being sealed along the bottom such that the integrity of each compart- ment is preserved and such that compartments are capable of holding liquids without spillage from one compartment to another.
3. The vial of Claim 1 wherein the compartments are formed by single septum which produces two compartments.
4. The vial of Claim 1 wherein the compartments are formed by a plurality of septums which produce multiple compartments.
5. The vial of Claim 2 wherein the compartments are formed by the introduction of a cylinder which is fused to the bottom of the vessel and is surrounded by, but not connected to the sides of the vessel.
6. The vial of Claim 2 wherein the compartments are formed by the introduction of many cylinders which are fused to the bottom of the vessel and are surrounded by, but not connected to, the sides of the vessel.
7. The vial of Claim 1 wherein the combination product contained within is a pharmaceutical product.
8. The vial of Claim 1 wherein the combination product contained within is a combination vaccine.
9. The vial of Claim 2 wherein the combination product contained within is a pharmaceutical product.
10. The vial of Claim 2 wherein the combination product contained within is a combination vaccine.
11. The vial of Claim 9 wherein the combination vial contained within is M-M-R® II-V.
PCT/US1998/024512 1997-11-17 1998-11-16 Multicompartment container for combination products WO1999025629A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU14149/99A AU1414999A (en) 1997-11-17 1998-11-16 Multicompartment container for combination products

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US6577897P 1997-11-17 1997-11-17
US60/065,778 1997-11-17
GB9806035.3 1998-03-20
GBGB9806035.3A GB9806035D0 (en) 1998-03-20 1998-03-20 Multicompartment container for combination products

Publications (1)

Publication Number Publication Date
WO1999025629A1 true WO1999025629A1 (en) 1999-05-27

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ID=26313328

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/024512 WO1999025629A1 (en) 1997-11-17 1998-11-16 Multicompartment container for combination products

Country Status (2)

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AU (1) AU1414999A (en)
WO (1) WO1999025629A1 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006019211A1 (en) 2004-08-19 2006-02-23 Jong Suk Oh Medecine bottle for injection
WO2010054446A1 (en) 2008-11-11 2010-05-20 Ademovic Zlatko Combination of two or more peptides in a single stable lyophilized pharmaceutical compound
US9237985B2 (en) 2013-07-18 2016-01-19 Tokitae Llc Multi-compartment pharmaceutical vials
US11969393B2 (en) 2014-06-17 2024-04-30 Tokitae Llc Affixed groups of pharmaceutical vials including frangible connectors

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US462990A (en) * 1891-11-10 William oppenheimek
US2494456A (en) * 1946-03-18 1950-01-10 Kathleen S Still Container
US5232108A (en) * 1991-02-09 1993-08-03 Nissei Asb Machine Co., Ltd. Preform having inner partition wall and process of making plastic vessel having inner partition wall
US5242066A (en) * 1988-11-16 1993-09-07 Whitbread & Company Plc Plastic bottles and similar containers having internal spiders

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US462990A (en) * 1891-11-10 William oppenheimek
US2494456A (en) * 1946-03-18 1950-01-10 Kathleen S Still Container
US5242066A (en) * 1988-11-16 1993-09-07 Whitbread & Company Plc Plastic bottles and similar containers having internal spiders
US5232108A (en) * 1991-02-09 1993-08-03 Nissei Asb Machine Co., Ltd. Preform having inner partition wall and process of making plastic vessel having inner partition wall

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006019211A1 (en) 2004-08-19 2006-02-23 Jong Suk Oh Medecine bottle for injection
EP1781357A1 (en) * 2004-08-19 2007-05-09 Jong Suk Oh Medecine bottle for injection
EP1781357A4 (en) * 2004-08-19 2009-11-18 Jong Suk Oh Medecine bottle for injection
WO2010054446A1 (en) 2008-11-11 2010-05-20 Ademovic Zlatko Combination of two or more peptides in a single stable lyophilized pharmaceutical compound
US9237985B2 (en) 2013-07-18 2016-01-19 Tokitae Llc Multi-compartment pharmaceutical vials
US11969393B2 (en) 2014-06-17 2024-04-30 Tokitae Llc Affixed groups of pharmaceutical vials including frangible connectors

Also Published As

Publication number Publication date
AU1414999A (en) 1999-06-07

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