CA2231363A1 - Medicament conversion system - Google Patents
Medicament conversion system Download PDFInfo
- Publication number
- CA2231363A1 CA2231363A1 CA 2231363 CA2231363A CA2231363A1 CA 2231363 A1 CA2231363 A1 CA 2231363A1 CA 2231363 CA2231363 CA 2231363 CA 2231363 A CA2231363 A CA 2231363A CA 2231363 A1 CA2231363 A1 CA 2231363A1
- Authority
- CA
- Canada
- Prior art keywords
- container
- medicament
- stopper
- liquid
- medicament container
- 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.)
- Abandoned
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
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- 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
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/062—Carpules
-
- 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
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
Abstract
A system (10) for converting a medicament (12) from a storage form to an administrable form comprises an evacuated medicament container (11), a container (17) for a liquid (18), and means in the form of a hollow needle (19) for establishing communication between said containers (11 and 17) and thereby causing liquid (18) to be drawn by suction from the liquid container (17) to the medicament container (11). By establishing communication between an evacuated container (11) and an unevacuated container (17), there is an instant, reliable and controlled addition of liquid (18) to the medicament (12) from the liquid container (17). The system (10) has particular application to lyophilised medicaments.
Description
W O 97/09025 PCT~E96/00058 Description Medicament conversion system Technical Field This invention relates to systems for converting medicaments from a storage form to an aflmini~trable form.
Back~round Art It is often desired to store a medicament in a form other than the form in which it is to be ~lmini~tered. There may be a number of reasons for this. Certain me~lic:~ments may be unstable in liquid form, and accordingly, if they are to be injected, they must be reconstituted from a solid or semi-solid form. Of particular interest at present are a wide range of medicaments produced by biochemical processes which are most stable when stored in a lyophilised form. Lyophili~tion provides a product which is easily reconstitutable by the addition of a suitable solvent. Other medicaments may be provided as microparticles or nanoparticles which can be injected in a suspension formed by the addition of a suitable fluid thereto. ~torage of medicaments in dry form can also be advantageous not only in terms of storage stability but also in terms of handling prior to use. Shipping costs and storage space can be reduced dramatically by employing a solid medicament form which is reconstituted, dissolved or diluted before use by, for example, the addition of water for injection.
Reconstituting solid or semi-solid medicaments can be troublesome and can involve the possibility of cont~minz-tion of the medicament during reconstitution. For example, if a syringe is used to transfer a diluent or solvent to the medicament, cont~min~tion can occur, and there is also an inherent risk associated with the use of syringes. A number of systems are available for self a~lmini~tration by a patient such as, for example, pen-type injectors used for insulin zl~lmini~tration, and controllable delivery devices such as those disclosed in our own ~7O ~5113~38. f~e ris~s o~ inc~rree~ procedure o~ dosin~, as well as the possibility of co~t~min,,tion occllF$in~. ~re obviously ~ncre~sed wh~r~ ~t? re~ons~tu~ion ste~ i~ to be effe~t~ by- ~n unt~airled lay persor:L rather ~an a s~illed pro~ssio S Disclosu~e of thP InYen~ion The inven~orl proYides a system for conver~in~ :~ m~ic~ment from a stora~e torm to ~ inis~a~le l~orm, compri~in an e~/acuated n~edicament ~ r, a container fo~ a ~iquid, ~nd m~ans ~or esta~lishing commllnic~i~n between said cont~iners and thereby 10 e~}sln~ liqu~ to be drawn by suc~ion f~om the liquid container to thc medi~ament conta~ner, whe~ein the liquid ~ont~iner ~ompnses ~
c~llapsible body and the mearls fo~ e~tabl~shing communication between the containers comprises a h~llow neeclle extendi~g ~r~m the collapsi~Le body.
The system acc~dina to ~e invention is ex~e~nely sirnple t~ ~lse and i~xpensive to ma~e. By establi~hing comm.mication between ev~cuated container ~d an une~acuated container, there is an in~unt~
reliable and controlled addition of liquid to the medica~ent frorxl the lic~uid container.
O
The skille~ person will appreciate th~t the invenhon filnds par~icul~ application in relation to lyop~Iised medicam~nts, as an ine~pensiYe eva~uation of the medicament c~ntai~er is alr~a~y preser~t du~g the Iyaph~l~sat~on process. Thus, the conta~n~r can be seal~d when ~11 oIC che so~Yent has ~een clr~wn off unc~er vacuum during ~S lyophilis~tion.
A seale~ ev~ua~ed container is a sterile and s~able environment for a m~ ent~ so ad~ ges a~ise not orlly ~s a result o~ the ease w~th which ~e medicament is rec~ tituted, but also as a result of the ~u~teec~ quali~ and 3terility of the ~edicarnent prior to A~lE~D S~
reconstitl~t~on. If the liquid ~n~iner is ~lso sealed durin~
m;;mufac~ure, ~en cont~min~ion ris~s are reduced ~ en ~uI~her.
~ referabl~ he medic~ment cs~ntainer i~ ~e~led und~ uum by a ~n~able SlOp ~ r.
This a~lows for a p~rticul~rlv sirnple ~e:lns f~r e~t.~ nO
comm~lnic~iorL be~-e~n the cont~n~rs, namely by pen~tra~in~
pe~etrable stopp~.
As stated aboYe, ~e n:leans ~r est~bli~hin~ commur~ication betwe~n the c~nt~iners compris~s a hollow n~edle. Such ~ holl~w 1~ needle can be used to pierce bc~h the pene~a~le stopper ar~d a seal on the liqu}d con~inçr, or it earl be akeady in communi~ation ~lth the liquid ch~mber and pene~rate ~nly thè pe~etrable stopper on th~
medicament chamber.
Preferably, the tip of the ne~dle is elllbedded in a seal before use.
L5 This arrangement is p~e~elTed fo~ ~ea~ons ~f ste~ y~ and al30 ~or reasons o~ s~fety to prevent ~isk of injury from an exposed needle.
Acco~ding to a first embQdiment7 the medicamen~ cont~iner is removal~ly mounted on said seal. In this embodlment. the system can be s~pplied as a sel~ontaine~ unit~ with the rnedic~ment bein~
~0 re~onstituted by pushing the needle thro~gh the se~ and the ~stopper ~n~
subsequently ~emo~ing the corltainer from the seal.
Accordir~g to a~other em~ ment, the medic~nent container is ~emovabl~ mulmted on a plug wh~h acco~odates said ~eal. Thi~
embodiment will ~e fu~ther desc;lbed ~elo~, ~nd provides adYantages in 3110wing for more effic~ent ~n~-lf~c~lre and ~ssembIy of the respecti~fe containers.
. .
Ah1E~E~ Sl~ET
CA Oi231363 1998-03-06 Suitably, the mounting c~f ~he container on ~e plu~ is ~fected by me:~s of complemerlt~ ormation~ on the stopper and the pluo.
.~ccordi~ to a prefe~d ernbod~m~nt, the liquid ~ont~in~ i.s 5 p~o~de~ with a g~ide ~ the m~dic~m~nt container to ~rlsure c~rrect penetra~ion o~ ~he s~opper.
~ he guide ~l~ows a medicament corlt~iner tO be pushed ont~ the ne~ e causing pene~ation of th~ stopper and suc~on of liquid from ~he liquid c~ntainer Yl~ the needle. It ~educ~s even fur~her the possibility 10 of operator error arising when reconst~ ing the ~neclic~men~.
Preferably, the medicament co~ain~r c~mprises ~ ol~ss ~
.~cc~rdingly, the system in one ernbodiment can ~e dcscribed as a "via~ d pouch" system comprisi~g a glass vial and ~ collapsible pouch. The vial used can be of any type desired. including ~tand~rd 15 vials for use with a syringe7 ''insulin-type" vials for use with pen injecto~s, or custom-made YialS adapted for use with any other type of medicament deli~ery device.
Suit~bly, the medicament c~ntaine~ is cylind~ical a~d the stopper mal~es a ~eakproaf sliding ~lt with ~he ~nterior thereof.
Such ~ vi~l c~n be used t~ a medicamen~ delivery device by pll~hin~ ~he container onto ~ ~Illing mc~h~ni~m compri~ing a rod h~ving a hollow needle extendin~ there~rom such ~h~t the needl~
penetrates ~he stopper ~nd the stc~ppe~ abuts ~ga~nst the rod. C3ntinued m~Yement o~ the cylTnder causes the stopper tO ~lCt as a piston deli~erin~ medic~llent via the holl~w needle through an intemal conduit in the ~d. The ~illing mechanism c~n be inte~ral with or separ~te from the m~ ment ~cliv~ry device AME~ED Sl~~ET
A~cording to a pref~rred embociiment~ the ~t~pper or the rnedicarnent c~ntainer is pros~ided w~ a ~orm~ti~n providin_ a ~pour path when the stopper is part~lly ~nse~ed into the cont~iner~ ch p~lth i3 bloc~ed ~y the totaL inse~tion ~f the stopper irlto the con~n~r.
As will ~e describe~i below, ~ rr3ngemeIIt i~ particllL~r~y ntageous lor use with a lyvphil~sed ~cdi~ nt, ~ the ~ pper c~n be p~rtially inserted ~nto ~e container during the l~;ophilisa~lon process, ~llow~ng the vap~r~sed solYent to be drawn off from ~he medicament. W~en lyoph~ tion is ~mplete~ ~he stopper is irseste~
fu~ly into ~e cont~ er, ~ereby blo~ing the vapour path and ~ealing the contents of ~he container under Yacuum.
In another aspect, ~e inYention p~ovides ~ liquid conta~n~ ~or use in ~ system a~co~ding to the inYention, comprisin~, ~ collapsible bady having ~ hollow needle extendin~ therefrom.
Preferab1y, the ~Leedle is embedded in ~ se~l be~fore use, and tlhe liquid cs~nt~iner further eclmprises a guide f~r a medi~meIlt con~ai~er having a penetrable stopper, the guide ensuring the ~;orre~t penetr~tion of the stopper.
O The invention will be further i~lustr~ted ~y the following description of emb~dimen~s :hereof _iven by ~v~y of ex~nple only with reference to ~e accompanying drawin~gs.
Brief ~escription of the Dr~uin~s Fig. 1 i~Iustr~tes a system according to the invention, before use;
Fig. 2 illustrates a system ~cordin;~ to ~he invenEion.
during the step of reconstitu~on ~f ~ ~edicament;
A~AEP~ED S~I~ET
.
Fig. 3 illustrates the same system as depicted in Fig. 2, after reconstitution;
Fig. 4 illustrates an alternative system according to the invention, before use; and Fig. S shows the medicament container of the system of Fig. 4, illustrated during lyophilis~tion, before being assembled as part of a complete system.
Modes for Carryin~ out the Invention In Fig. 1, there is illustrated, generally at 10, a system according to the invention for converting a medic~ment from a storage forrn to an ~lmini~trable form. The system 10 comprises a medicament cont~iner 11 having a quantity of lyophilised medicament 12 therein. C~ontainer 11 is sealed by an elastomeric stopper 13 under vacuum such that enclosed space 14 is evacuated.
Medicament container 11 is mounted on a plug 15 positioned in a guide 16 which is provided on a liquid container 17. Container 17 is a flexible foil pouch holding a quantity of solvent 18 suitable to fill medicament container 11 and dissolve lyophilised medicament 12. A
hollow needle 19 leads from liquid container 17 and penetrates into but not through plug lS.
Referring additionally to Fig. 2, it can be seen that in use, medicament container 11 and liquid container 17 are pushed together such that container 11 moves within guide 16 causing needle 19 to pierce through plug 15 and stopper 13, thereby effecting commllnication between the two containers 11,17. This communication causes solvent 18 to be drawn from liquid container 17 into medicament container 11 by suction as a result of the vacuum which has been established in medicament container 1 l. ~olvent 18 dissolves lyophilised medicament 12, resulting in medicament container 11 being filled with a solution of medicament 12 which is suitable for injection.
As medicament container 11, needle 19 and liquid container 17 formed a completely enclosed system from the time of supply until the dissolution of substance 12, no cont~min~tion of the medicament can have occurred.
Fig. 3 illustrates the removal of container 11 from guide 16.
Container 11 is pulled in the direction indicated by the arrow, whereupon it draws plug lS back to its starting position concealing needle 19. Continued movement of container 11 disengages it from plug 15, resulting in a filled medicament container 11 and a safely disposable and empty liquid container 17 which comprises a flattened pouch having a concealed needle extending therefrom embedded in a plug.
The entire process of reconstituting medicament 12 is fast and efficient. When container 11 is pushed onto needle 19, the vacuum lS causes the immediate filling of the medicament container 11 which can then be pulled away from container 17 without delay. It will be apparent to the skilled person that the mech~ni~m illustrated in Figs. 1-3 is extremely simple, free of potential problems, reliable and above all inexpensive to manufacL-ure and easy to use. The simplicity of manufacture and use are emphasised by comparing the present invention with embodiments of prior art lyophilisation reconstitution devices which usually involve intricate mech~nism~ for storing and mixing the liquid and solid components of the system.
Referring now to Fig. 4, an altemative alTangement which operates on the same principle as that involved in the case of the arrangement of Figs. 1-3 is illustrated. In this system, indicated generally at 20, it can be seen that needle 21 extending from liquid container 22 is protected by a seal 23 which is accommodated within a plug 24 upon which a container 25 is mounted by means of complementary formations 26 between plug 24 and a stopper 27 accommodated within container 25. It will be appreciated that medicament 28 contained within container 25 is reconstituted in exactly the same way as in the system of Figs. 1-3. In other words, container W O 97/09025 PCT~E96/00058 25 is pushed Itowards container 22, causing the piercing of seal 23, plug 24 and stopper 27. This allows commllnication between the two containers and causes the suction of liquid 29 into medicament container 25 and the consequent reconstitution of medicament 28.
5 When container 25 is pulled away, plug 24 moves back to its original position, thereby completely concealing needle 21, and subsequent movement of container 25 disengages stopper 27 and plug 24.
Fig. 5 illustrates an additional feature of the system of Fig. 4 which allows for increased efficiency in evacuating container 25. It can 10 be seen that stopper 27 is provided with a groove 30 which allows communication between the interior and exterior of the device when stopper 27 is only partially inserted into container 25 (as shown).
Thus, if container 25 is to be filled with a lyophilised substance, the substance can, prior to lyophili.~Ation, be capped by stopper 27 in the lS configuration shown in Fig. S. Lyophilisation can then proceed, with groove 30 providing a vapour path to allow the freeze drying of the substance within container 25, and when evaporation of the solvent is complete, while container 25 is still within a vacuum, plug 24 and stopper 27 can be pushed home, thereby sealing the contents of 20 cont~iner 25 in a sterile condition under vacuum, allowing container 25 to be fitted to a liquid container such as container 22 illustrated in Fig.
4. The invention is not, however, limited to the reconstitution o~
lyophilised medic~ment~. It also covers the dissolution, dilution and suspension of any suitable solid, semi-solid or concentrated 25 medicament, as well as the mixing of the components of a medication having two active ingredients.
Back~round Art It is often desired to store a medicament in a form other than the form in which it is to be ~lmini~tered. There may be a number of reasons for this. Certain me~lic:~ments may be unstable in liquid form, and accordingly, if they are to be injected, they must be reconstituted from a solid or semi-solid form. Of particular interest at present are a wide range of medicaments produced by biochemical processes which are most stable when stored in a lyophilised form. Lyophili~tion provides a product which is easily reconstitutable by the addition of a suitable solvent. Other medicaments may be provided as microparticles or nanoparticles which can be injected in a suspension formed by the addition of a suitable fluid thereto. ~torage of medicaments in dry form can also be advantageous not only in terms of storage stability but also in terms of handling prior to use. Shipping costs and storage space can be reduced dramatically by employing a solid medicament form which is reconstituted, dissolved or diluted before use by, for example, the addition of water for injection.
Reconstituting solid or semi-solid medicaments can be troublesome and can involve the possibility of cont~minz-tion of the medicament during reconstitution. For example, if a syringe is used to transfer a diluent or solvent to the medicament, cont~min~tion can occur, and there is also an inherent risk associated with the use of syringes. A number of systems are available for self a~lmini~tration by a patient such as, for example, pen-type injectors used for insulin zl~lmini~tration, and controllable delivery devices such as those disclosed in our own ~7O ~5113~38. f~e ris~s o~ inc~rree~ procedure o~ dosin~, as well as the possibility of co~t~min,,tion occllF$in~. ~re obviously ~ncre~sed wh~r~ ~t? re~ons~tu~ion ste~ i~ to be effe~t~ by- ~n unt~airled lay persor:L rather ~an a s~illed pro~ssio S Disclosu~e of thP InYen~ion The inven~orl proYides a system for conver~in~ :~ m~ic~ment from a stora~e torm to ~ inis~a~le l~orm, compri~in an e~/acuated n~edicament ~ r, a container fo~ a ~iquid, ~nd m~ans ~or esta~lishing commllnic~i~n between said cont~iners and thereby 10 e~}sln~ liqu~ to be drawn by suc~ion f~om the liquid container to thc medi~ament conta~ner, whe~ein the liquid ~ont~iner ~ompnses ~
c~llapsible body and the mearls fo~ e~tabl~shing communication between the containers comprises a h~llow neeclle extendi~g ~r~m the collapsi~Le body.
The system acc~dina to ~e invention is ex~e~nely sirnple t~ ~lse and i~xpensive to ma~e. By establi~hing comm.mication between ev~cuated container ~d an une~acuated container, there is an in~unt~
reliable and controlled addition of liquid to the medica~ent frorxl the lic~uid container.
O
The skille~ person will appreciate th~t the invenhon filnds par~icul~ application in relation to lyop~Iised medicam~nts, as an ine~pensiYe eva~uation of the medicament c~ntai~er is alr~a~y preser~t du~g the Iyaph~l~sat~on process. Thus, the conta~n~r can be seal~d when ~11 oIC che so~Yent has ~een clr~wn off unc~er vacuum during ~S lyophilis~tion.
A seale~ ev~ua~ed container is a sterile and s~able environment for a m~ ent~ so ad~ ges a~ise not orlly ~s a result o~ the ease w~th which ~e medicament is rec~ tituted, but also as a result of the ~u~teec~ quali~ and 3terility of the ~edicarnent prior to A~lE~D S~
reconstitl~t~on. If the liquid ~n~iner is ~lso sealed durin~
m;;mufac~ure, ~en cont~min~ion ris~s are reduced ~ en ~uI~her.
~ referabl~ he medic~ment cs~ntainer i~ ~e~led und~ uum by a ~n~able SlOp ~ r.
This a~lows for a p~rticul~rlv sirnple ~e:lns f~r e~t.~ nO
comm~lnic~iorL be~-e~n the cont~n~rs, namely by pen~tra~in~
pe~etrable stopp~.
As stated aboYe, ~e n:leans ~r est~bli~hin~ commur~ication betwe~n the c~nt~iners compris~s a hollow n~edle. Such ~ holl~w 1~ needle can be used to pierce bc~h the pene~a~le stopper ar~d a seal on the liqu}d con~inçr, or it earl be akeady in communi~ation ~lth the liquid ch~mber and pene~rate ~nly thè pe~etrable stopper on th~
medicament chamber.
Preferably, the tip of the ne~dle is elllbedded in a seal before use.
L5 This arrangement is p~e~elTed fo~ ~ea~ons ~f ste~ y~ and al30 ~or reasons o~ s~fety to prevent ~isk of injury from an exposed needle.
Acco~ding to a first embQdiment7 the medicamen~ cont~iner is removal~ly mounted on said seal. In this embodlment. the system can be s~pplied as a sel~ontaine~ unit~ with the rnedic~ment bein~
~0 re~onstituted by pushing the needle thro~gh the se~ and the ~stopper ~n~
subsequently ~emo~ing the corltainer from the seal.
Accordir~g to a~other em~ ment, the medic~nent container is ~emovabl~ mulmted on a plug wh~h acco~odates said ~eal. Thi~
embodiment will ~e fu~ther desc;lbed ~elo~, ~nd provides adYantages in 3110wing for more effic~ent ~n~-lf~c~lre and ~ssembIy of the respecti~fe containers.
. .
Ah1E~E~ Sl~ET
CA Oi231363 1998-03-06 Suitably, the mounting c~f ~he container on ~e plu~ is ~fected by me:~s of complemerlt~ ormation~ on the stopper and the pluo.
.~ccordi~ to a prefe~d ernbod~m~nt, the liquid ~ont~in~ i.s 5 p~o~de~ with a g~ide ~ the m~dic~m~nt container to ~rlsure c~rrect penetra~ion o~ ~he s~opper.
~ he guide ~l~ows a medicament corlt~iner tO be pushed ont~ the ne~ e causing pene~ation of th~ stopper and suc~on of liquid from ~he liquid c~ntainer Yl~ the needle. It ~educ~s even fur~her the possibility 10 of operator error arising when reconst~ ing the ~neclic~men~.
Preferably, the medicament co~ain~r c~mprises ~ ol~ss ~
.~cc~rdingly, the system in one ernbodiment can ~e dcscribed as a "via~ d pouch" system comprisi~g a glass vial and ~ collapsible pouch. The vial used can be of any type desired. including ~tand~rd 15 vials for use with a syringe7 ''insulin-type" vials for use with pen injecto~s, or custom-made YialS adapted for use with any other type of medicament deli~ery device.
Suit~bly, the medicament c~ntaine~ is cylind~ical a~d the stopper mal~es a ~eakproaf sliding ~lt with ~he ~nterior thereof.
Such ~ vi~l c~n be used t~ a medicamen~ delivery device by pll~hin~ ~he container onto ~ ~Illing mc~h~ni~m compri~ing a rod h~ving a hollow needle extendin~ there~rom such ~h~t the needl~
penetrates ~he stopper ~nd the stc~ppe~ abuts ~ga~nst the rod. C3ntinued m~Yement o~ the cylTnder causes the stopper tO ~lCt as a piston deli~erin~ medic~llent via the holl~w needle through an intemal conduit in the ~d. The ~illing mechanism c~n be inte~ral with or separ~te from the m~ ment ~cliv~ry device AME~ED Sl~~ET
A~cording to a pref~rred embociiment~ the ~t~pper or the rnedicarnent c~ntainer is pros~ided w~ a ~orm~ti~n providin_ a ~pour path when the stopper is part~lly ~nse~ed into the cont~iner~ ch p~lth i3 bloc~ed ~y the totaL inse~tion ~f the stopper irlto the con~n~r.
As will ~e describe~i below, ~ rr3ngemeIIt i~ particllL~r~y ntageous lor use with a lyvphil~sed ~cdi~ nt, ~ the ~ pper c~n be p~rtially inserted ~nto ~e container during the l~;ophilisa~lon process, ~llow~ng the vap~r~sed solYent to be drawn off from ~he medicament. W~en lyoph~ tion is ~mplete~ ~he stopper is irseste~
fu~ly into ~e cont~ er, ~ereby blo~ing the vapour path and ~ealing the contents of ~he container under Yacuum.
In another aspect, ~e inYention p~ovides ~ liquid conta~n~ ~or use in ~ system a~co~ding to the inYention, comprisin~, ~ collapsible bady having ~ hollow needle extendin~ therefrom.
Preferab1y, the ~Leedle is embedded in ~ se~l be~fore use, and tlhe liquid cs~nt~iner further eclmprises a guide f~r a medi~meIlt con~ai~er having a penetrable stopper, the guide ensuring the ~;orre~t penetr~tion of the stopper.
O The invention will be further i~lustr~ted ~y the following description of emb~dimen~s :hereof _iven by ~v~y of ex~nple only with reference to ~e accompanying drawin~gs.
Brief ~escription of the Dr~uin~s Fig. 1 i~Iustr~tes a system according to the invention, before use;
Fig. 2 illustrates a system ~cordin;~ to ~he invenEion.
during the step of reconstitu~on ~f ~ ~edicament;
A~AEP~ED S~I~ET
.
Fig. 3 illustrates the same system as depicted in Fig. 2, after reconstitution;
Fig. 4 illustrates an alternative system according to the invention, before use; and Fig. S shows the medicament container of the system of Fig. 4, illustrated during lyophilis~tion, before being assembled as part of a complete system.
Modes for Carryin~ out the Invention In Fig. 1, there is illustrated, generally at 10, a system according to the invention for converting a medic~ment from a storage forrn to an ~lmini~trable form. The system 10 comprises a medicament cont~iner 11 having a quantity of lyophilised medicament 12 therein. C~ontainer 11 is sealed by an elastomeric stopper 13 under vacuum such that enclosed space 14 is evacuated.
Medicament container 11 is mounted on a plug 15 positioned in a guide 16 which is provided on a liquid container 17. Container 17 is a flexible foil pouch holding a quantity of solvent 18 suitable to fill medicament container 11 and dissolve lyophilised medicament 12. A
hollow needle 19 leads from liquid container 17 and penetrates into but not through plug lS.
Referring additionally to Fig. 2, it can be seen that in use, medicament container 11 and liquid container 17 are pushed together such that container 11 moves within guide 16 causing needle 19 to pierce through plug 15 and stopper 13, thereby effecting commllnication between the two containers 11,17. This communication causes solvent 18 to be drawn from liquid container 17 into medicament container 11 by suction as a result of the vacuum which has been established in medicament container 1 l. ~olvent 18 dissolves lyophilised medicament 12, resulting in medicament container 11 being filled with a solution of medicament 12 which is suitable for injection.
As medicament container 11, needle 19 and liquid container 17 formed a completely enclosed system from the time of supply until the dissolution of substance 12, no cont~min~tion of the medicament can have occurred.
Fig. 3 illustrates the removal of container 11 from guide 16.
Container 11 is pulled in the direction indicated by the arrow, whereupon it draws plug lS back to its starting position concealing needle 19. Continued movement of container 11 disengages it from plug 15, resulting in a filled medicament container 11 and a safely disposable and empty liquid container 17 which comprises a flattened pouch having a concealed needle extending therefrom embedded in a plug.
The entire process of reconstituting medicament 12 is fast and efficient. When container 11 is pushed onto needle 19, the vacuum lS causes the immediate filling of the medicament container 11 which can then be pulled away from container 17 without delay. It will be apparent to the skilled person that the mech~ni~m illustrated in Figs. 1-3 is extremely simple, free of potential problems, reliable and above all inexpensive to manufacL-ure and easy to use. The simplicity of manufacture and use are emphasised by comparing the present invention with embodiments of prior art lyophilisation reconstitution devices which usually involve intricate mech~nism~ for storing and mixing the liquid and solid components of the system.
Referring now to Fig. 4, an altemative alTangement which operates on the same principle as that involved in the case of the arrangement of Figs. 1-3 is illustrated. In this system, indicated generally at 20, it can be seen that needle 21 extending from liquid container 22 is protected by a seal 23 which is accommodated within a plug 24 upon which a container 25 is mounted by means of complementary formations 26 between plug 24 and a stopper 27 accommodated within container 25. It will be appreciated that medicament 28 contained within container 25 is reconstituted in exactly the same way as in the system of Figs. 1-3. In other words, container W O 97/09025 PCT~E96/00058 25 is pushed Itowards container 22, causing the piercing of seal 23, plug 24 and stopper 27. This allows commllnication between the two containers and causes the suction of liquid 29 into medicament container 25 and the consequent reconstitution of medicament 28.
5 When container 25 is pulled away, plug 24 moves back to its original position, thereby completely concealing needle 21, and subsequent movement of container 25 disengages stopper 27 and plug 24.
Fig. 5 illustrates an additional feature of the system of Fig. 4 which allows for increased efficiency in evacuating container 25. It can 10 be seen that stopper 27 is provided with a groove 30 which allows communication between the interior and exterior of the device when stopper 27 is only partially inserted into container 25 (as shown).
Thus, if container 25 is to be filled with a lyophilised substance, the substance can, prior to lyophili.~Ation, be capped by stopper 27 in the lS configuration shown in Fig. S. Lyophilisation can then proceed, with groove 30 providing a vapour path to allow the freeze drying of the substance within container 25, and when evaporation of the solvent is complete, while container 25 is still within a vacuum, plug 24 and stopper 27 can be pushed home, thereby sealing the contents of 20 cont~iner 25 in a sterile condition under vacuum, allowing container 25 to be fitted to a liquid container such as container 22 illustrated in Fig.
4. The invention is not, however, limited to the reconstitution o~
lyophilised medic~ment~. It also covers the dissolution, dilution and suspension of any suitable solid, semi-solid or concentrated 25 medicament, as well as the mixing of the components of a medication having two active ingredients.
Claims (14)
1. A system for converting a medicament from a storage form to an administrable form. comprising an evacuated medicament container, a container for a liquid, and means for establishing communication between said containers and thereby causing liquid to be drawn by suction from the liquid container to the medicament container, wherein the liquid container comprises a collapsible body and the means for establishing communication between the containers comprises a hollow needle extending from the collapsible body.
2. A system according to Claim 1, wherein the medicament container is sealed under vacuum by a penetrable stopper.
3. A system according to Claim 1 or 2. wherein the tip of the needle is embedded in a seal before use.
4. A system according to Claim 3, wherein the medicament container is removably mounted on said seal.
5. A system according to Claim 3, wherein the medicament container is removably mounted on a plug which accommodates said seal.
6. A system according to Claim 5, wherein the mounting of the container on the plug is effected by means of complementary formations on the stopper and the plug.
7. A system according to any preceding claim, wherein the needle extends from the liquid container and the liquid container is provided with a guide for the medicament container to ensure correct penetration of the stopper
8. A system according to any preceding claim, wherein the medicament container comprises a glass vial.
9. A system according to any one of Claims 2-8, wherein the medicament container is cylindrical and the stopper makes a leakproof sliding fit with the interior thereof.
10. A system according to any one of claims 2-9, wherein the stopper or the medicament container provided with a formation providing a vapour path when the stopper is partially inserted into the container, which path is blocked by the total insertion of the stopper into the container.
11. A liquid container for use in a system according to any one of claims 1-10, comprising a collapsible body having a hollow needle extending therefrom.
12. A liquid container according to Claim 11, wherein the needle is embedded in a seal before use, and further comprising a guide for a medicament container having a penetrable stopper the guide ensuring correct penetration of the stopper.
13. A system for converting a medicament from a storage form to an administrable form, substantially as hereinbefore described with particular reference to and as illustrated in Figs. 1-3 and Fig. 4 of the accompanying Drawings.
14. A medicament container substantially as hereinbefore described with particular reference to and as illustrated in Fig. 5 of the accompanying Drawings.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US355995P | 1995-09-07 | 1995-09-07 | |
| US60/003,559 | 1995-09-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2231363A1 true CA2231363A1 (en) | 1997-03-13 |
Family
ID=21706439
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2231363 Abandoned CA2231363A1 (en) | 1995-09-07 | 1996-08-30 | Medicament conversion system |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US5791466A (en) |
| EP (1) | EP0848605A1 (en) |
| JP (1) | JPH11512014A (en) |
| AU (1) | AU7093396A (en) |
| CA (1) | CA2231363A1 (en) |
| TW (1) | TW372196B (en) |
| WO (1) | WO1997009025A1 (en) |
| ZA (1) | ZA967444B (en) |
Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2749169B1 (en) * | 1996-06-04 | 1998-08-21 | Delab | PROCESS FOR CONSTITUTING AN INJECTABLE PREPARATION AND DEVICE FOR CARRYING OUT SAID METHOD |
| US6410511B2 (en) * | 1997-01-08 | 2002-06-25 | Amylin Pharmaceuticals, Inc. | Formulations for amylin agonist peptides |
| US7312196B2 (en) * | 1997-01-08 | 2007-12-25 | Amylin Pharmaceuticals, Inc. | Formulations for amylin agonist peptides |
| ES1037919Y (en) * | 1997-07-16 | 1998-11-01 | Inibsa Lab | TWO LIQUID CONTAINER CARTRIDGE. |
| US6719719B2 (en) | 1998-11-13 | 2004-04-13 | Elan Pharma International Limited | Spike for liquid transfer device, liquid transfer device including spike, and method of transferring liquids using the same |
| FR2790948B1 (en) * | 1999-03-18 | 2001-06-22 | Sedat | DEVICE FOR BIDIRECTIONAL TRANSFER OF A LIQUID BETWEEN A BOTTLE AND A CAPSULE |
| JP2005538773A (en) * | 2002-09-12 | 2005-12-22 | チルドレンズ ホスピタル メディカル センター | Method and apparatus for injecting drugs without pain |
| US7678333B2 (en) * | 2003-01-22 | 2010-03-16 | Duoject Medical Systems Inc. | Fluid transfer assembly for pharmaceutical delivery system and method for using same |
| CA2513165C (en) * | 2003-01-22 | 2011-11-08 | Duoject Medical Systems Inc. | Pharmaceutical delivery systems and methods for using same |
| WO2005079441A2 (en) * | 2004-02-17 | 2005-09-01 | Children's Hospital Medical Center | Injection device for administering a vaccine |
| EP1787667A4 (en) * | 2004-08-04 | 2010-07-07 | Ajinomoto Kk | Communicating needle used to cause two or more containers to communicate |
| US7533701B2 (en) * | 2005-06-21 | 2009-05-19 | Andrew Gadzic | Method and apparatus for the storage and preservation of liquids compounds |
| CA2834152C (en) | 2006-05-25 | 2016-07-05 | Bayer Healthcare Llc | Reconstitution device |
| EP2371342A1 (en) * | 2010-04-01 | 2011-10-05 | Siemens Healthcare Diagnostics Products GmbH | Device for storing and metering a solution |
| EP2717899A4 (en) * | 2011-06-06 | 2015-07-29 | Kineta One Llc | Shk-based pharmaceutical compositions and methods of manufacturing and using the same |
| US20140224376A1 (en) * | 2013-02-14 | 2014-08-14 | Onpharma, Inc. | Methods and systems for buffering solutions with controlled tonicity |
| US11260177B1 (en) * | 2014-03-18 | 2022-03-01 | Yasser Sadek | Dental anesthetic buffer system |
| EP3240593B1 (en) | 2014-12-30 | 2019-04-03 | 3M Innovative Properties Company | Container for mixing and dispensing components |
| EP3240592B1 (en) | 2014-12-30 | 2023-08-09 | Kindeva Drug Delivery L.P. | Container for mixing and dispensing two components |
| JP6985141B2 (en) | 2014-12-30 | 2021-12-22 | キンデーバ ドラッグ デリバリー リミティド パートナーシップ | Container for mixing and dispensing fluid drug components |
| IL237788B (en) | 2015-03-16 | 2019-10-31 | Kriheli Marino | Septum holders for use in syringe connectors |
| CA2986981A1 (en) * | 2015-07-03 | 2017-01-12 | Ferrosan Medical Devices A/S | Syringe for mixing two components and for retaining a vacuum in a storage condition |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3490437A (en) * | 1966-10-17 | 1970-01-20 | Thomas T Bakondy | Embryonic organ cells in a state of preservation and methods for preserving the same |
| BE759374A (en) * | 1970-06-08 | 1971-04-30 | Ims Ltd | MEDICINE PACKAGING |
| SE8501656D0 (en) * | 1985-04-03 | 1985-04-03 | Mediplast Ab | OVERFORINGSANORDNING |
| US5169388A (en) * | 1990-06-07 | 1992-12-08 | Gensia Pharmaceuticals, Inc. | Pressure-activated medication dispenser |
| IT223172Z2 (en) * | 1991-04-09 | 1995-06-13 | Tecnomedica Ricerche Srl | DEVICE FOR THE ADMINISTRATION OF DRUGS, PARTICULARLY TWO-COMPONENT PHARMA-CI |
| EP0664137B1 (en) * | 1994-01-25 | 1999-03-31 | Becton, Dickinson and Company | Syringe and method for lyophilizing and reconstituting injectable medication |
| US5489266A (en) * | 1994-01-25 | 1996-02-06 | Becton, Dickinson And Company | Syringe assembly and method for lyophilizing and reconstituting injectable medication |
| US5466220A (en) * | 1994-03-08 | 1995-11-14 | Bioject, Inc. | Drug vial mixing and transfer device |
-
1996
- 1996-08-30 JP JP51103997A patent/JPH11512014A/en not_active Ceased
- 1996-08-30 EP EP19960931954 patent/EP0848605A1/en not_active Withdrawn
- 1996-08-30 WO PCT/IE1996/000058 patent/WO1997009025A1/en not_active Application Discontinuation
- 1996-08-30 AU AU70933/96A patent/AU7093396A/en not_active Abandoned
- 1996-08-30 CA CA 2231363 patent/CA2231363A1/en not_active Abandoned
- 1996-09-03 ZA ZA967444A patent/ZA967444B/en unknown
- 1996-09-06 US US08/709,486 patent/US5791466A/en not_active Expired - Fee Related
- 1996-09-10 TW TW085111049A patent/TW372196B/en active
Also Published As
| Publication number | Publication date |
|---|---|
| US5791466A (en) | 1998-08-11 |
| TW372196B (en) | 1999-10-21 |
| AU7093396A (en) | 1997-03-27 |
| WO1997009025A1 (en) | 1997-03-13 |
| EP0848605A1 (en) | 1998-06-24 |
| JPH11512014A (en) | 1999-10-19 |
| ZA967444B (en) | 1997-03-10 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA2231363A1 (en) | Medicament conversion system | |
| US3872867A (en) | Wet-dry additive assembly | |
| EP0207544B1 (en) | Multi-compartment syringe | |
| US4722733A (en) | Drug handling apparatus and method | |
| JP2801207B2 (en) | Syringe and method of assembling syringe | |
| KR920000436B1 (en) | Drug delivery system | |
| US5902298A (en) | Medicament container stopper with integral spike access means | |
| KR0160306B1 (en) | Suction transfer assembly | |
| US5897526A (en) | Closed system medication administering system | |
| JP4284441B2 (en) | Pharmaceutical container lid with integral spike insertion means with recesses | |
| US5817082A (en) | Medicament container closure with integral spike access means | |
| JP2022081582A (en) | Liquid transfer devices comprising integral telescopic vial adapter for use with infusion liquid containers and discrete injection vials | |
| CZ302559B6 (en) | Syringe-type device and method of filling reservoir thereof | |
| JPH0236261B2 (en) | ||
| WO1993025175A1 (en) | Medical container | |
| WO1983003586A1 (en) | Closed drug delivery system | |
| JP2002539891A (en) | Containers for packing medical liquids | |
| JPH04329956A (en) | Germ-free holding/mixing apparatus for medicine held in individual sealed container | |
| CN111278403B (en) | Container adapter, delivery assembly and method of delivering liquid to a patient | |
| JP2015524317A (en) | Reconstruction device | |
| JP2021517055A (en) | Dual lumen IV liquid transfer device with spikes | |
| EP0327519B1 (en) | An appliance for the mixing and/or transfer of a substance | |
| WO1992019295A1 (en) | Injection container | |
| NL8800529A (en) | Liq.-transferring needle unit | |
| JP3025851B2 (en) | Aseptic holding and mixing device for two drugs housed in individually sealed containers |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Dead |