CA2002643A1 - Antioxidant-free epinephrine solution for ophthalmic use - Google Patents
Antioxidant-free epinephrine solution for ophthalmic useInfo
- Publication number
- CA2002643A1 CA2002643A1 CA 2002643 CA2002643A CA2002643A1 CA 2002643 A1 CA2002643 A1 CA 2002643A1 CA 2002643 CA2002643 CA 2002643 CA 2002643 A CA2002643 A CA 2002643A CA 2002643 A1 CA2002643 A1 CA 2002643A1
- Authority
- CA
- Canada
- Prior art keywords
- solution
- epinephrine
- amount
- accordance
- hydrochloric acid
- 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
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
ABSTRACT OF THE DISCLOSURE
An epinephrine-containing solution useful in cata-ract surgery in provided by a sulfite or antioxidant-free epinephrine solution. Before use, the sulfite or antioxidant-free epinephrine solution is contained in an ampule or similar airtight container under a blanket of oxygen-free nitrogen gas. Suitable sulfite or anti-oxidant-free epinephrine solution include a sterile, aqueous epinephrine solution wherein each mL thereof contains epinephrine in the amount 1.0 mg, hydrochloric acid in the amount 0.0005 mL and sodium chloride in the amount about 9.0 mg to render said solution substantial-ly isotonic, the solution having been adjusted to a pH
of 7.0 ? 0.1 with sodium citrate and/or citric acid.
Another useful epinephrine solution contains per mL
epinephrine in the amount 1.0 mg, hydrochloric acid in the amount 0.0005 mL, sodium chloride in the amount about 9.0 mg, the pH of said solution having been ad-justed to a value in the range 2.2-5.0 with sodium hydroxide and/or hydrochloric acid. Still another useful epinephrine-containing solution has the composi-tion per mL epinephrine in the amount 1.0 mg, hydrochloro-ric acid in the amount 0.0005 mL, the remainder being sterile or bacteriostatic water, the pH of said solution having been adjusted to a value in the range 2.2-5.0 with sodium hydroxide and/or hydrochloric acid.
An epinephrine-containing solution useful in cata-ract surgery in provided by a sulfite or antioxidant-free epinephrine solution. Before use, the sulfite or antioxidant-free epinephrine solution is contained in an ampule or similar airtight container under a blanket of oxygen-free nitrogen gas. Suitable sulfite or anti-oxidant-free epinephrine solution include a sterile, aqueous epinephrine solution wherein each mL thereof contains epinephrine in the amount 1.0 mg, hydrochloric acid in the amount 0.0005 mL and sodium chloride in the amount about 9.0 mg to render said solution substantial-ly isotonic, the solution having been adjusted to a pH
of 7.0 ? 0.1 with sodium citrate and/or citric acid.
Another useful epinephrine solution contains per mL
epinephrine in the amount 1.0 mg, hydrochloric acid in the amount 0.0005 mL, sodium chloride in the amount about 9.0 mg, the pH of said solution having been ad-justed to a value in the range 2.2-5.0 with sodium hydroxide and/or hydrochloric acid. Still another useful epinephrine-containing solution has the composi-tion per mL epinephrine in the amount 1.0 mg, hydrochloro-ric acid in the amount 0.0005 mL, the remainder being sterile or bacteriostatic water, the pH of said solution having been adjusted to a value in the range 2.2-5.0 with sodium hydroxide and/or hydrochloric acid.
Description
`` ~ Z~Z~
Pl~XRINE
Thi~ lnvRntlon r~ t~ epipneph~ine ~ompo~ltlon~
o~ ~olu~lon~ ~or ophth~lmlc purpo~. For example, the intr~camQxal us~ o~ ~pinephrine, dlluted o~ u~dilut~d, in th~ tnte~lor chamber ~a~ beon recomman~d ~or the control o~ interior Yeg~n~ ~ie~ding o~ lnad~quat~ pupillary dlla~tion ln rou~in~ round pupll cataract extrnctlon and ph~coamul~PIca~n. How~r, ~h~re ~re hazard~ in~ol~a~
in the U$2 0~ in~rAo~ular ep~naphrlne #olutlon~ ln ~t~-r~ct ~urger~. ~or ~xampl~, aee the work r~portad in the pap~ by ~. O. ~chwartz et al ent~tled "Hazards o~ ~ntra-ocular Irri~a~lng Solution~ '~n~ P~Q~h~ c~taract S~r~e~y", publl~hed ln Curr~nt::co~ t~ _~n _ ~a~act Surqary, ~leG~ed Proceedin~ o~ th~_5th Bl~nnlal ~ata-, S~. ~ouis, Mo., ~. V~ Mosby Co.
(19~5), pp. 26~-~76, ~horeln lt is r~por~ed that commer-cial ~pinephrin~ in a 1:1,000 concent~tion wa3 cl3~rly d~ma~ing t~ corne~l ~ndothellum. ;Accordlng ~ ~hi~
~rti~l~ lt wa~ ~oun~ that sodlum bi~ul ite p~ese~vative u~ed in con~n~ra~on~ pre~en~ in oo~m~rcial epinbph~in~
~olutlons dama~d th~ c~rn~l en~othellum. Such da~age, how~r, co~l:d ~ pr~van~ed ir commerclal e~in~ph~ne i~
dlluted at least ~vo ti~.~s, i.e. a conoHntrat~on no~ ~o exceed 1:5,000. Fur~h~r, ac~ording ~o this ar~icl~, a relati~ely no~mal endothalial truct~r~ c~n b~ o~served:
~ ~ on ~anni~g and t~an6m~s~ion microscopy ~hen th~ n~
i~ ~XpOs~d ~o dilute eplnephrlne or 1:1,000 conc~n~r~-tlon o~ ~plnephrlne wi~hout a p~e~rvative which, ~ccord ing to tha 4rticle, d~onstrateo ths ~fect o~ diluting th~ pre~erYati~e~ ra~her tha~ d~lut~nq ~he epln~phrlne it~
.
, .
:
~%~43 - -2~
Commercially a~a~lable ~pinephrlne in~eo~lon solu-tiosl~ O~ 000 t l mg~m~) ar~ ~vallA~le ~O~ ophthalm~c purposes ~ut, ~9 ln~ic~d, mU8~ 4e ~lluted tQ 1:5~000 (0.2 mq~L) .or l:lO,OOo (0. ~. mg/mL) due eo the low pH o~
~uch ~p~n~ph~n~ lnj~c~ion solution~ ~3.0-4.0) and ~he pre~an~e the~e~n o~ sodium blsul~lte. The concentratlon o~ s~dium ~lsul~lt~ ~0.5-2.0 ~/m~ comm~roial ~pl-nephrin~ ~olu~lon~ h~l been ~ound to ~ toxic ~o the oorn~l endoth~lium and at a p~ o~ 4.0 has produced corn~al ~de~a ln the cornea O~ al~lno r~b~lt~.
~ cord~r,qly, lt is ~n ob~ect o~ t~ls lnventlon to p~o~de epin~ph~lne solutions or eplnephrin~ ln~Qct~ons whic~ can b~ ~a~Qly employed ln ophthalmlc p~oa~dura~, suc~ ~ ln cataxact extractions.
It 18 another objact o~ ~i9 lnvention to provld~
epln~phrine solu~ions whi~h do no~ cau~ corn4al damag0 or a~ toxic to the corneal endothQlium~
~ yet ~noth~r objectlon o~ thl~ inven~lon to provld~ ~Able epinephrine injRc~lon~ or ~plnephrine -solu~on~ &ult~la for ophthalmic u~e.
H~w the~ ~nd oth~ ob~e~ts of ~hi~ l~v~n~ion ~r~
~chieved ~ill b~o~e apparen~ in ~he llght o~ th~ accom-p~ny~hg di~clo~ur~ In ~t l~a~ one embodlm~n~ ~ th~
p~a:~tlce~ oP ~ lnv~ntio~ at l~ast one o~ th~ ~oregolng o~j~c~s w~ll b~ achie~ad.
~ plne~h~lne lnj~ct~on~ or epinephrin~ ~olut~ons, p~rticularly ~uit~bl~ ~or opht~al~i~ u~e, cuch as ln ca~a~ac~ operatlons, hav2 be~n pr~pared whlc~ ar~ r~se o~
, 2~ 3 . ~
a pres~rv~tl~ or antLoxidan~, ~uch as a b1qUl~it~ ~.g.
so~ium bi~ul~1te. Su~h epinephrlne solutlon~ provide improvad ~pinephrlna compo~itlons ~or ~s~ by surgeon~ a~
l~rtg~ting ~olutionq to m~int~ln hemo~ ls ~or extr~
aap~ular ca~a~ac~ ex~rac~on ~nd phaco~mul~ia~tlon. ~n co~tr~st wlth co~m~rciall~ ~Yallabl~ ~plnephrine in~ec-tion~ or ~olution~ h~vlng ~he conc~ntration of eplneph-~ina of l S l , OOO ~ 1 mg/m~), which solu~lon~ beçAuse o~ th~
pr~s~nc~ o~ sQdium bi~ul~ite t~erein a~ a pre~rv~tlve or ~ntixodxlant and ~cau~e o~ low pH (3.0-~.0~, must dilut~d prior to u~e ~o an ~pin~ph~ine content o~
l:~,OO~ (O.l mg/mL~ or to An Gpin~phr~n~ conc~n~rat~on o~
l:lO,ooO tO.l ~g/mL), th~ eplnephrino ~olutlon~ ~n accor~
dan~e with this invantion sinca ~uoh solutlon~ ar~ pre-~rv~lv~ or antlox1dAnt-~ree,..i.~. d~.~4t.!.contain a ~ulfita, quch a~ sodium b~ul~it~ c~n;Abo~:u~ed..directly, a~ a ~tr~ng~h o~ l:l,OOO tl mg~mL) or, lf de~lred, dilu~-~d ~or ophthal~ic us~. Moreov~r, 1~ d~ired, th~ c~mpo-s1~ion~ in accordanc~ wlth thi~ ln~nti on can b~ ad~u~t2d ~o d~ d pH, such ~ a p~ o~ 7.0 l or a~ a pH in thQ
~a~ge 2.~-~Ø Da~irabl~ p~cial epl~ephrln~ compo-~it~ons or solution~ ln accord~nce:with thl~ l~v~ntlon are m~int~i~ed, prior t~ u~e, in an airtight or ~eaLed a~pul~ or ~on~alner whereln ~h~ epinaph~ine 801ution ~ontaln~ there~n i~ malnt~in~d und~r a blan~t of an oxyq~n-~ree g~8 or a~mospha~e, ~uch ~ ~n ~xygen~Pr~
nitrGgan g218~
T~e ~ollowlnq are 3x~pIeD o~ compo~i~lons in accor-dance ~lth ~hl~ in~ntlon~
20~ L3 An ~pinephr~n~ solution ln ac~or~ance with thl~ lnvsntlon ~a~ prapared without Any ~ul git~ or ~ntloxidant or pre-tl~re ~gont ther~in and ampule~ or ~ontalne~ the~e-oP ~ale~ under a ni~rog~n at~no~phere. The golut1 on was mada i80tonl~ by th~ addltiorl o~ ~odl~ ~hlo~ido 60 ~ to pro~lde a sod~um chloride concen~ratlon ln ~ solut~ or o~ 9 mg~mL to ma.ke th~ solution i~tonic. Tha pH of th~
~olution wa~ al~o adju~d to a valu~ o~ 7 . O + 1 by ~che addi~ion of ~od~um ~i~rat~ and~or cltrl ~ . A suit-~bl~ ~uch aompo~i~lon per 1~l1 wou~d contain:
Epinephrine - 1. 0 mg Hydrochloxi~ a~id (12N) - o. 0005 sn$.
Sad~um chlorid~ g~o mg Sterile wat~ romalnder AmpUle8 0~ con~in~a o~ such solutions, a.g. 1, 5 and 10 mL the~e~, would ba ~ d and sa~led under el nit~os~n a,~mo6p~era .
.,. , Othe~ ep~ n~ph~ln~ ~olutior.~ in ac~rdanço wi~h thl~
lnv~nt:l~r) would ~hav~ the foll~wing~ compo~ltion per mL:
Epin~p~f n~ mg Hy~lroc}lloric ~cld (l~N) - O . 0005 mL
So~ium ~hlorlde ~ ~ . o mg Ster~l~ wat~r ~ m~ ~ nà~r Su~h ~olution~ would l~awi~e ~ filled in ~ g~ tigh~
~onta~nor under ~ nit2~0gen a~mosphe~a, t~ G pH o~ the ~olution haYlng be~n ad ju~t~d ~:o a p~l ln th~ ra~n~ 2 . 2-2~ 43 ..
S . o wl t~ sodium hydroxid* and/or hydrochlorlc aci~ .
Anoth~r example o~ ~n eplnephrin~ compo3ition in accor-dan~ wlt~ thi~ lnventlon wo~ld contaln, par m~.
Epin~phrlne - l. O m~
~yd~ochloric a~id (12N) - O. 0005 sn~
Wat~r - remainder Such solut~ons ~ould 1~XQWiS~ b~ ~illed in a g~ tight or airtigh~ contslner or ampule undor a ni~rog~n a~cmosphere, th~ pH h~ving ~e~n ad~u~ted to ~ ~alue ln tt~e rang~ 2 . O^
5 . O by ~he addition o~ ~oc~ um hydroxld~ and~or ~ydro-chlori~ ~ld.
~ 3 will b~ apparent to tho~ killed ln th~ art ln th~ llght of ~ or~go~ng di~ ;:losure, many modirlc~-tlon~ sration~ and eub~t~ tu~cion~ a~e po~6i~1~ in the prhctlce of hi~ ventlon witho~t dep~rting ~rom t~o ~pi~it ~r 5COp~! thor~o~
-:
.
,, , ~
., ;
Pl~XRINE
Thi~ lnvRntlon r~ t~ epipneph~ine ~ompo~ltlon~
o~ ~olu~lon~ ~or ophth~lmlc purpo~. For example, the intr~camQxal us~ o~ ~pinephrine, dlluted o~ u~dilut~d, in th~ tnte~lor chamber ~a~ beon recomman~d ~or the control o~ interior Yeg~n~ ~ie~ding o~ lnad~quat~ pupillary dlla~tion ln rou~in~ round pupll cataract extrnctlon and ph~coamul~PIca~n. How~r, ~h~re ~re hazard~ in~ol~a~
in the U$2 0~ in~rAo~ular ep~naphrlne #olutlon~ ln ~t~-r~ct ~urger~. ~or ~xampl~, aee the work r~portad in the pap~ by ~. O. ~chwartz et al ent~tled "Hazards o~ ~ntra-ocular Irri~a~lng Solution~ '~n~ P~Q~h~ c~taract S~r~e~y", publl~hed ln Curr~nt::co~ t~ _~n _ ~a~act Surqary, ~leG~ed Proceedin~ o~ th~_5th Bl~nnlal ~ata-, S~. ~ouis, Mo., ~. V~ Mosby Co.
(19~5), pp. 26~-~76, ~horeln lt is r~por~ed that commer-cial ~pinephrin~ in a 1:1,000 concent~tion wa3 cl3~rly d~ma~ing t~ corne~l ~ndothellum. ;Accordlng ~ ~hi~
~rti~l~ lt wa~ ~oun~ that sodlum bi~ul ite p~ese~vative u~ed in con~n~ra~on~ pre~en~ in oo~m~rcial epinbph~in~
~olutlons dama~d th~ c~rn~l en~othellum. Such da~age, how~r, co~l:d ~ pr~van~ed ir commerclal e~in~ph~ne i~
dlluted at least ~vo ti~.~s, i.e. a conoHntrat~on no~ ~o exceed 1:5,000. Fur~h~r, ac~ording ~o this ar~icl~, a relati~ely no~mal endothalial truct~r~ c~n b~ o~served:
~ ~ on ~anni~g and t~an6m~s~ion microscopy ~hen th~ n~
i~ ~XpOs~d ~o dilute eplnephrlne or 1:1,000 conc~n~r~-tlon o~ ~plnephrlne wi~hout a p~e~rvative which, ~ccord ing to tha 4rticle, d~onstrateo ths ~fect o~ diluting th~ pre~erYati~e~ ra~her tha~ d~lut~nq ~he epln~phrlne it~
.
, .
:
~%~43 - -2~
Commercially a~a~lable ~pinephrlne in~eo~lon solu-tiosl~ O~ 000 t l mg~m~) ar~ ~vallA~le ~O~ ophthalm~c purposes ~ut, ~9 ln~ic~d, mU8~ 4e ~lluted tQ 1:5~000 (0.2 mq~L) .or l:lO,OOo (0. ~. mg/mL) due eo the low pH o~
~uch ~p~n~ph~n~ lnj~c~ion solution~ ~3.0-4.0) and ~he pre~an~e the~e~n o~ sodium blsul~lte. The concentratlon o~ s~dium ~lsul~lt~ ~0.5-2.0 ~/m~ comm~roial ~pl-nephrin~ ~olu~lon~ h~l been ~ound to ~ toxic ~o the oorn~l endoth~lium and at a p~ o~ 4.0 has produced corn~al ~de~a ln the cornea O~ al~lno r~b~lt~.
~ cord~r,qly, lt is ~n ob~ect o~ t~ls lnventlon to p~o~de epin~ph~lne solutions or eplnephrin~ ln~Qct~ons whic~ can b~ ~a~Qly employed ln ophthalmlc p~oa~dura~, suc~ ~ ln cataxact extractions.
It 18 another objact o~ ~i9 lnvention to provld~
epln~phrine solu~ions whi~h do no~ cau~ corn4al damag0 or a~ toxic to the corneal endothQlium~
~ yet ~noth~r objectlon o~ thl~ inven~lon to provld~ ~Able epinephrine injRc~lon~ or ~plnephrine -solu~on~ &ult~la for ophthalmic u~e.
H~w the~ ~nd oth~ ob~e~ts of ~hi~ l~v~n~ion ~r~
~chieved ~ill b~o~e apparen~ in ~he llght o~ th~ accom-p~ny~hg di~clo~ur~ In ~t l~a~ one embodlm~n~ ~ th~
p~a:~tlce~ oP ~ lnv~ntio~ at l~ast one o~ th~ ~oregolng o~j~c~s w~ll b~ achie~ad.
~ plne~h~lne lnj~ct~on~ or epinephrin~ ~olut~ons, p~rticularly ~uit~bl~ ~or opht~al~i~ u~e, cuch as ln ca~a~ac~ operatlons, hav2 be~n pr~pared whlc~ ar~ r~se o~
, 2~ 3 . ~
a pres~rv~tl~ or antLoxidan~, ~uch as a b1qUl~it~ ~.g.
so~ium bi~ul~1te. Su~h epinephrlne solutlon~ provide improvad ~pinephrlna compo~itlons ~or ~s~ by surgeon~ a~
l~rtg~ting ~olutionq to m~int~ln hemo~ ls ~or extr~
aap~ular ca~a~ac~ ex~rac~on ~nd phaco~mul~ia~tlon. ~n co~tr~st wlth co~m~rciall~ ~Yallabl~ ~plnephrine in~ec-tion~ or ~olution~ h~vlng ~he conc~ntration of eplneph-~ina of l S l , OOO ~ 1 mg/m~), which solu~lon~ beçAuse o~ th~
pr~s~nc~ o~ sQdium bi~ul~ite t~erein a~ a pre~rv~tlve or ~ntixodxlant and ~cau~e o~ low pH (3.0-~.0~, must dilut~d prior to u~e ~o an ~pin~ph~ine content o~
l:~,OO~ (O.l mg/mL~ or to An Gpin~phr~n~ conc~n~rat~on o~
l:lO,ooO tO.l ~g/mL), th~ eplnephrino ~olutlon~ ~n accor~
dan~e with this invantion sinca ~uoh solutlon~ ar~ pre-~rv~lv~ or antlox1dAnt-~ree,..i.~. d~.~4t.!.contain a ~ulfita, quch a~ sodium b~ul~it~ c~n;Abo~:u~ed..directly, a~ a ~tr~ng~h o~ l:l,OOO tl mg~mL) or, lf de~lred, dilu~-~d ~or ophthal~ic us~. Moreov~r, 1~ d~ired, th~ c~mpo-s1~ion~ in accordanc~ wlth thi~ ln~nti on can b~ ad~u~t2d ~o d~ d pH, such ~ a p~ o~ 7.0 l or a~ a pH in thQ
~a~ge 2.~-~Ø Da~irabl~ p~cial epl~ephrln~ compo-~it~ons or solution~ ln accord~nce:with thl~ l~v~ntlon are m~int~i~ed, prior t~ u~e, in an airtight or ~eaLed a~pul~ or ~on~alner whereln ~h~ epinaph~ine 801ution ~ontaln~ there~n i~ malnt~in~d und~r a blan~t of an oxyq~n-~ree g~8 or a~mospha~e, ~uch ~ ~n ~xygen~Pr~
nitrGgan g218~
T~e ~ollowlnq are 3x~pIeD o~ compo~i~lons in accor-dance ~lth ~hl~ in~ntlon~
20~ L3 An ~pinephr~n~ solution ln ac~or~ance with thl~ lnvsntlon ~a~ prapared without Any ~ul git~ or ~ntloxidant or pre-tl~re ~gont ther~in and ampule~ or ~ontalne~ the~e-oP ~ale~ under a ni~rog~n at~no~phere. The golut1 on was mada i80tonl~ by th~ addltiorl o~ ~odl~ ~hlo~ido 60 ~ to pro~lde a sod~um chloride concen~ratlon ln ~ solut~ or o~ 9 mg~mL to ma.ke th~ solution i~tonic. Tha pH of th~
~olution wa~ al~o adju~d to a valu~ o~ 7 . O + 1 by ~che addi~ion of ~od~um ~i~rat~ and~or cltrl ~ . A suit-~bl~ ~uch aompo~i~lon per 1~l1 wou~d contain:
Epinephrine - 1. 0 mg Hydrochloxi~ a~id (12N) - o. 0005 sn$.
Sad~um chlorid~ g~o mg Sterile wat~ romalnder AmpUle8 0~ con~in~a o~ such solutions, a.g. 1, 5 and 10 mL the~e~, would ba ~ d and sa~led under el nit~os~n a,~mo6p~era .
.,. , Othe~ ep~ n~ph~ln~ ~olutior.~ in ac~rdanço wi~h thl~
lnv~nt:l~r) would ~hav~ the foll~wing~ compo~ltion per mL:
Epin~p~f n~ mg Hy~lroc}lloric ~cld (l~N) - O . 0005 mL
So~ium ~hlorlde ~ ~ . o mg Ster~l~ wat~r ~ m~ ~ nà~r Su~h ~olution~ would l~awi~e ~ filled in ~ g~ tigh~
~onta~nor under ~ nit2~0gen a~mosphe~a, t~ G pH o~ the ~olution haYlng be~n ad ju~t~d ~:o a p~l ln th~ ra~n~ 2 . 2-2~ 43 ..
S . o wl t~ sodium hydroxid* and/or hydrochlorlc aci~ .
Anoth~r example o~ ~n eplnephrin~ compo3ition in accor-dan~ wlt~ thi~ lnventlon wo~ld contaln, par m~.
Epin~phrlne - l. O m~
~yd~ochloric a~id (12N) - O. 0005 sn~
Wat~r - remainder Such solut~ons ~ould 1~XQWiS~ b~ ~illed in a g~ tight or airtigh~ contslner or ampule undor a ni~rog~n a~cmosphere, th~ pH h~ving ~e~n ad~u~ted to ~ ~alue ln tt~e rang~ 2 . O^
5 . O by ~he addition o~ ~oc~ um hydroxld~ and~or ~ydro-chlori~ ~ld.
~ 3 will b~ apparent to tho~ killed ln th~ art ln th~ llght of ~ or~go~ng di~ ;:losure, many modirlc~-tlon~ sration~ and eub~t~ tu~cion~ a~e po~6i~1~ in the prhctlce of hi~ ventlon witho~t dep~rting ~rom t~o ~pi~it ~r 5COp~! thor~o~
-:
.
,, , ~
., ;
Claims (15)
1. A aqueous sulfite or antioxidant-free epineph-rine solution suitable for ophthalmic use com-prising epinephrine, hydrochloric acid, sodium chloride and sterile or bacteriostatic water, the resulting solution having a pH of 7.0 ? 0.1 adjusted with sodium citrate and/or citric acid, the amount of sodium chloride present in said solution being adjusted so that said solution is substantially isotonic.
2. An airtight ampule or container containing a solution in accordance with Claim 1, said solu-tion being contained within said ampule or container under a blanket of oxygen-free nitro-gen gas.
3. A solution in accordance with Claim 1 wherein each mL of said solution contains epinephrine in the amount 1.0 mg, hydrochloric acid in the amount 0.0005 mL, sodium chloride in the amount about 9.0 mg, the remainder being water.
4. A aqueous sulfite or antioxidant free epineph-rine solution suitable for ophthalmic use com-prising epinephrine, hydrochloric acid, sodium chloride and sterile or bacteriostatic water, the pH of the resulting epinephrine solution being adjusted to 2.20-5.0 with sodium hydrox-ide and/or hydrochloric acid.
5. An airtight ampule or container containing a solution in accordance with Claim 4, said solu-tion being contained within said ampule or container under a blanket of oxygen-free nitro-gen gas.
6. A solution in accordance with Claim 4 wherein each mL of said solution contains epinephrine in the amount 1.0 mg, hydrochloric acid in the amount 0.0005 mL, sodium chloride in the amount about 9.0 mg, the remainder being water.
7. A sulfite or antioxidant free epinephrine solu-tion suitable for ophthalmic use comprising epinephrine, hydrochloric acid and sterile water, the resulting solution having a pH ad-justed to a value in the range 2.2-5.0 with sodium hydroxide and/or hydrochloric acid.
8. An airtight ampule or airtight container con-taining a solution in accordance with Claim 7, said solution being contained within said ampule or container under a blanket of oxygen- free nitrogen gas.
9. A solution in accordance with Claim 7 wherein each mL of said composition contains epinephrine in the amount 1.0 mg, hydrochloric acid in the amount 0.005 mL, the remainder being water.
10. In human cataract surgery wherein an epineph-rine-containing solution is applied to the eye, the improvement which comprises employing an epinephrine solution in accordance with Claim 1.
11. In human cataract surgery wherein an epineph-rine-containing solution is applied to the eye, the improvement which comprises employing an epinephrine solution in accordance with Claim 3.
12. In human cataract surgery wherein an epineph-rine-containing solution is applied to the eye, the improvement which comprises employing an epinephrine solution in accordance with Claim 4.
13. In human cataract surgery wherein an epineph-rine-containing solution is applied to the eye, the improvement which comprises employing an epinephrine solution in accordance with Claim 6.
14. In human cataract surgery wherein an epineph-rine-containing solution is applied to the eye, the improvement which comprises employing an epinephrine solution in accordance with Claim 7.
15. In human cataract surgery wherein an epineph-rine-containing solution is applied to the eye, the improvement which comprises employing an epinephrine solution in accordance with Claim 9.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US26906388A | 1988-11-09 | 1988-11-09 | |
| US269,063 | 1988-11-09 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2002643A1 true CA2002643A1 (en) | 1990-05-09 |
Family
ID=23025641
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2002643 Abandoned CA2002643A1 (en) | 1988-11-09 | 1989-11-09 | Antioxidant-free epinephrine solution for ophthalmic use |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2002643A1 (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2001833A1 (en) * | 2006-03-24 | 2008-12-17 | National Research Council of Canada | Anti-diabetic cataract compounds and their uses |
| US9283197B1 (en) * | 2014-08-15 | 2016-03-15 | Jugal K. Taneja | More potent and less toxic formulations of epinephrine and methods of medical use |
| US10004700B1 (en) * | 2017-05-16 | 2018-06-26 | Jugal K. Taneja | More potent and less toxic formulations of epinephrine and methods of medical use |
| US10285957B2 (en) | 2016-08-25 | 2019-05-14 | Imprimis Pharmaceuticals, Inc. | Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof |
| US10993921B2 (en) * | 2013-10-03 | 2021-05-04 | Harrow Ip, Llc | Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof |
| US11266611B2 (en) | 2017-05-16 | 2022-03-08 | Eton Pharmaceuticals, Inc. | More potent and less toxic formulations of epinephrine and methods of medical use |
-
1989
- 1989-11-09 CA CA 2002643 patent/CA2002643A1/en not_active Abandoned
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2001833A1 (en) * | 2006-03-24 | 2008-12-17 | National Research Council of Canada | Anti-diabetic cataract compounds and their uses |
| EP2001833A4 (en) * | 2006-03-24 | 2011-03-02 | Ca Nat Research Council | Anti-diabetic cataract compounds and their uses |
| US10993921B2 (en) * | 2013-10-03 | 2021-05-04 | Harrow Ip, Llc | Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof |
| US11045432B2 (en) | 2013-10-03 | 2021-06-29 | Harrow Ip, Llc | Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof |
| US9283197B1 (en) * | 2014-08-15 | 2016-03-15 | Jugal K. Taneja | More potent and less toxic formulations of epinephrine and methods of medical use |
| US10285957B2 (en) | 2016-08-25 | 2019-05-14 | Imprimis Pharmaceuticals, Inc. | Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof |
| US10004700B1 (en) * | 2017-05-16 | 2018-06-26 | Jugal K. Taneja | More potent and less toxic formulations of epinephrine and methods of medical use |
| US11266611B2 (en) | 2017-05-16 | 2022-03-08 | Eton Pharmaceuticals, Inc. | More potent and less toxic formulations of epinephrine and methods of medical use |
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