REVIEW A RTICLE
`
`Compendium of Excipients for Parenteral Formulations
`
`MICHAEL F. POWELL, TUE NGUYEN‘, and LISA BALOIAN
`
`Pharmaceutical Research and Development, Generator-h. Inc. South San Francisco. CaJrYomt'u
`
`Overview
`
`formulation
`The selection of cttcipicnts in parenteral
`design is alien both rational and empirical. It is rational in
`the sense that certain types of escipiems are added to alter
`the {emulation properties: i] bullets of appropriate pKa are
`added to control hydrogen ion concentration at a desired pH.
`ii} tonieifiers are added for bioeompatibility. iii) surfactants
`are added when necessary to prevent aggregation, adsorp-
`tion to surfaces. or increase solubility. iv) antioxidants are
`included to prevent unwanted oxidation of the drug. and so
`on. The inclusion of various classes of formulation compo~
`items. and the concentration used is often quite rational. in
`that their behavior and properties are known. and they are
`added to prevent specific problems that would arise in their
`absence. 0n the other hand. however. the selection of the
`
`exact escipient used is far from rat ional; it is empirical in the
`first order. satisfying only one question. “Has it been used
`previously in a similar parenteral fonnulation?“
`Many prototype formulations have been laminated be-
`cause one or more of the selected cxcipients was not found
`in a previously approved parenteral product. in fact. there
`have been a handful of excipients with striking favorable
`properties. such as trehalose with its ability to confer solid
`state stabilization of several types of proteins. or EDTA and
`its antioxidants by metal
`ion chelation. These excipient
`compounds. and many others. have not been used widely.
`largely because of concerns with unknown toxicity. contin-
`ued production supply. or cost.
`ThUs.
`the formulation scientist
`
`is often faced with a
`
`dilemma—which escipients are truly available for use
`(based on what has been used previously). and which are
`not? For esatitple. PEG 400 has been added to several
`parenteral formulations. but what about PEG 1200, or PEG
`4000'? And at what concentrations. and by what route?
`Sodium cilrntc is an excellent buffer for many formulations
`at 5 mM. but is too painful in most instances for subcutane-
`ous use at 50 mM. lligh concentrations of propylene glycol
`may be used in a slow intravenous infusion. but would
`produce unwanted hemolysis and pain it' given by subcutane-
`ous or intramuscular Injection.
`It is often the case that lhe
`"safe level" of an cxcipient may depend on the route of
`administration. These are only a few examples of factors
`which must be considered when designing a formulation;
`there are dozens more based on empirical
`information
`required for efficient [emulation design. but thus far 3
`
`compendium has not been published. This review was
`written to fill this void.
`
`Herein are listed the cxcipients found in most of the
`approved and marketed parenteral fonnulations. given sys—
`tematically by escipient name. in this tumor it is easy to
`determine what concentrations were used the route of
`administration.
`the main ratiode for addition of that
`
`excipient. the drug that was formulated. the manufacturer.
`brand name. etc. The information found in this table comes
`from several sources. including package inserts. the Physi-
`cian's Desk Reference [PDR '97], as well as personal
`correspondence from the companies supplying the products.
`The published excipient concentration was often given in
`different units.
`including: mgiml..
`rnDs. Molar. sodium
`equivalents. biological Units. Molal. weight percent. etc.
`and provided one of the greatest challenges in putting this
`compendium together. We sought to list all the escipients
`{where pDSSiblc) in common units lie. mgimL). so that a
`rapid comparison of the different formulations could be
`made at a glance. {This is not easy to do. for example. when
`comparing Tween 20 concentrations at 0.0001 M, 0.01% and
`l
`tng/‘tnL;
`fortunately.
`the average molecular weight
`ts
`ltnowu for most cscipients. permitting a standardization of
`excipiem concentrations]. This standardization of excipient
`concentrations is perhaps the greatest value of this compen-
`dium. but also represents one of the greatest sources of
`potential error. The recalculation of escipicnt concealm-
`tions. often from scant or nondescriptivc data. is not trivial
`and there may be an occasional discrepancy despite cross-
`checking with the original
`sources.1 Nevertheless.
`this
`compendium represents a comprehensive survey of paren~
`teral excipicnts used today. and is a resource for the
`parenteral formulation scientist.
`
`NO‘BS
`
`[n putting together this escipient compendium. there were
`a number of points that should be noted. so that the reader
`understands the limitations nod assumptions in some of the
`calculations.
`
`1} Concentrations are listed in weightfvolurne‘ii—r unless
`otherwise tinted. in some cases values are. listed in volutnei
`
`volume% or the manufacturer did not specify what kind of
`percentage they were using (and in this case it was assumed
`weightlvolumc ii.- i.
`2) Sterile water for injection is included in the excipienl
`list when used in solution fomiulations; however. in most
`
`Received l‘ehnntry in. 1998. Accepted for imhlicationlunc l. 1998.
`'Aulhor to whom corrcsptmdcucc should be addressed.
`
`Ilium to nguyeu.tue@genc.coul for
`'ll' discrtnutneies are found. e-tnujl
`correction to subsequent eoutpeudiutna of this nature.
`
`23%
`
`PD‘AJournal oi Pharmaceutical Science & Technology
`
`
`
`lnnoPharma Exhibit 1105.0001
`
`

`

`
`
`cases the quantity or percentage of water in the formulation
`was not indicated by the manufacturer or identified only as
`(1.5. We have kept the same conventions here.
`3'] Excipients listed are present in the drug formulation
`itself. and do not include crtcipients present in diluent (for
`citatnplc. when a tyophiltaed formulation is diluted with
`bacteriostatic water containing benzyl alcohol).
`In some
`cases, a diluent is supplied that contains several additional
`excipiertts and.
`in the ease or provided diluent,
`these
`excipients are listed in the excipient category and designated
`with a
`in addition to their usual excipicnt type {the D
`stand for present in diluent).
`4) If no ertcipients are listed. it means that no excipicnts
`were revealed by the manufacturer. in some cases. this is
`because there are no excipients in the formulation. but this
`should not he assumed.
`in some cases,
`there- ntay be
`excipients present but the manufacturer has not disclosed
`them to us. largeiy for proprietary reasons. Specific follow-
`up about these drugs should be referred to the manufacturer.
`it The given drug concentration is usually the concentra-
`tion of the compound listed in the drug name category.
`unless identified as otherwise. For example. many drugs are
`formulated as salts such that the salt name is listed in die
`
`drug name category {for example. rnitoxanlrone hydrochld
`ride}. However,
`in the drug concentration category.
`the
`concentration of the active component is usually listed (for
`example. equivalent to 2 mglml. mitoxantrone free base). so
`as to have a correct concentration of the active drug form.
`a] When concentrations of excipients and drugs an: listed
`as a range it
`implies that
`these values could only be
`approximated. Frequently. a range is given because the
`product is available in a variety of storage containers, or
`having several dilution schemes. The ranges given are
`approx irnations only. based on the available information. In
`no way should these ranges be assumed to encompass all
`possible dilution schemes or configurations.
`7t Preservatives tsuch as betray] alcohol) that are present
`only in one configuration of a drug (for example in the
`multiple-dose product, but not
`in the single-use product]
`may be listed as a range [04%). This was to avoid making
`twu or more records for essentially the same product
`configuration.
`8) For drugs that are given as a salt form, the counter ion
`may not be listed as an excipient. To search for counter ions
`{like sodium or potassium] one may loolt in the drug name
`fields [where the entire salt
`is often listed} or in the
`
`comments section {where the quantity of the counter ion per
`gram of drug is often provided) as well as in the excipient
`section.
`
`if a pH value is listed for a lyophilized product, in most
`9)
`cases, it is the pit of the drug after its initial reconstitution
`with diluent. not the pH at lyophiliaation.
`10) The concentration values given for excipiean and
`active drug product in lyophilized products are usually those
`present at the initial reconstitution step. and are not necessar-
`ily the concentrations present at delivery {often further
`dilution occurs). This applies to solution formulations as
`well. Further, excipient concentrations may not
`take into
`account additive effects from the diluent (for example, a
`drug containing sodium chloride and reconstituted with
`0.9% Sodium Chloride usually iists the concentration of
`sodium chloride present in the undiluted state}.
`ll) When the excipient concentration is calculated for a
`lyophilized product, it is usually done by dividing the weight
`of the material by the volume of liquid added. Note that this
`does not take into account the additive volume of mixing
`that occurs. so such values are to be considered only
`approximations. In cases where the manufacturer provided
`the total volume after mixing. this final volume was used for
`calculations.
`
`12) For drugs requiring reconstitutionldilution, in most
`cases a diluent recommended by the manufacturer is identi—
`fied. in cases where multiple compatible diluents are pos-
`sible. or when dilution schemes are complicated, one will
`see the note “Consult FDR for appropriate dilution." In
`some cases, often when the recommended diluent is pro—
`vided. the manufacturer would not reveal the identity of the
`diluent for proprietary reasons.
`13) Finaliy. most of the entries herein have been sent to
`the manufacturer for their correction and final notes. Matty
`manufacturers participated in checking the data: others did
`not. We want
`to make this compendium as correct as
`possible, and so if errors are found. please e—mail them to
`ngnyen.tue@gene.com for correction.
`
`Acknowledgments
`
`This compendium would not have been possible without
`the diligent work of Mitiannc Chin. Site compiled much of
`the data, engineered the database. and cotttath-d doaens of
`different companies to ensure that the listings are up to date.
`
`Vol. 52. ND. 5 I September-October 1998
`
`239
`
`lnnoPharma Exhibit 1105.0002
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Bongo
`Manufacturer
`Brand Name
`Drug Nama-
`pl] when Administration
`Cont.
`Exclplent
`S[01'le
`Con ulnar
`Form
`applicable
`Route
`“A.er
`——..__.._—._.________.._.__..________—-—————__.________
`mulridoaa vial
`paravortobnl
`swam-tit
`Sanpin
`High Chemical
`Solution
`purl-tum. pitcher
`Company
`nlanl distillala
`i'rovidas Rose's
`recommndod daily
`intake of annual
`Old Tubarwliu
`
`an - 7.0
`
`W - intravenoua
`
`5.4% Nook-minim "
`
`MD Labial-atoms
`In.
`
`Solution
`
`BL“! container;
`
`1' .0
`
`ID v inlradonnfl
`
`Mundin. 01¢ Tina Teal
`
`[zoom Laboratories
`
`Solution
`
`disposable
`
`acacia (gum ail-shin)
`
`"LO
`
`ID - inundonual
`
`tuberculin. purified (FPO) Tin: Tut
`protein derivative
`
`Leda-l: Laboratoriua
`
`Salullon
`
`multiple-gunman
`
`Ecol-Ito
`
`mm:
`
`morale
`
`Mficadd
`
`aortic acid
`
`not-Iii: mid
`
`aoelic acid
`
`aortic maid
`
`lull: laid
`
`mtitacid
`
`0.0 59
`
`4 .0
`
`IN — inmwm
`
`mulral
`
`5C v subcutaneous
`
`neutral
`
`SC - Manama:
`
`0.435
`
`W - inva
`
`filgtaaiirn
`[recombinant
`methiumi human
`Lama (a) human
`inaulia zinc
`suspension
`Lem {L} Purified
`Park Insulin Zinc
`Suaponaiou. USP
`filodrine
`hydrochloride
`
`Neupogon :9
`
`Mason. Inc.
`
`Solution
`
`sing): door rial
`
`Novolin an L
`
`Nam: Nero-is]:
`Pharmuulinla
`
`Suapcnaion
`
`Lento {L} Purified Pork
`Inmlin Zinc Stupension.
`
`Nova Nordlxk
`Pharrmmtical:
`
`Suspension
`
`Wrap-r
`
`Mira USAJt-ic.
`
`Sulolion
`
`vials
`
`villa
`
`vial
`
`SC v strontium
`
`let-prolific ammo
`
`Lupron lnjoolion
`
`TAP
`Pharmminfia
`
`1M - intramuscular
`
`minimum-salmon Calcimar Iii lujeclion;
`Svutneric
`
`Rhona-Pool“:
`Rom
`
`IV v intravenous
`
`albumin (human). Mbumimr GUI!
`35%
`
`6.9 2 0.5
`
`N ~ inmvm:
`
`albumin [human]
`5%
`
`Albmninnr 0'5
`
`Armour
`Pharmtuutiul
`
`Ara-rm
`Pirannaueutiuul
`
`Solution
`
`Sululion
`
`Solution
`
`nulltidoao fill
`
`viola
`
`vials
`
`Solution
`
`boltlos
`
`3.5 — 5.5
`
`IV ~ Intravenous
`
`rincrisune suliuo. Ontovin do
`USP
`
`Eli Lilly it Company
`
`Solution
`
`IV ~ intravenous
`
`flummnll
`
`Romlzionn m
`
`Roch: Laboratotlra
`
`Eululion
`
`vials
`
`vials
`
`
`
`0.0I
`
`"1.0
`
`acufio lcid
`
`(2.5 (wrw)
`
`SC- Mallow!
`
`gem-elm mute
`implant
`
`malaria: 9D
`
`acetic acid.
`
`0.45
`
`3.0 - 4.5
`
`W - lulravenous
`
`mirootantrone
`hydronhlorido
`
`Nurantmnc
`
`Zoom
`Phamamfllioll!
`
`lmmunnx
`Comoralion
`
`Solid ltnplanl
`
`disposable
`
`Solution
`
`millions: viali
`
`will: add
`
`mi: acid
`
`and: acid
`
`acetic acid
`
`2.5 ~ 11.5
`
`[M A Intramuacular
`
`oxylooin
`
`nytnoa'n Injection
`
`Wyovayuril
`
`Solullor!
`
`smile cartridge
`
`FM -irnnmm1flat
`
`ptomethazin:
`hydrochloride
`
`Phrnugan Injaciim
`tamnulsl
`
`Wyelh-Ayenl
`
`fiolulion
`
`ampuls
`
`[M dammitsz
`
`-5. 9
`
`1M - intramuscular
`
`promolhlzine
`hydrochloride
`
`amallsmina
`mothylnull'ala
`
`Fhooamn Injection
`
`Wyeth-Ayml
`
`Solution
`
`smile natuidgv
`
`Prouisrnin Injullble
`
`ICN Pmmicala
`
`Salulion
`
`mum-dose vial
`
`acetic acid
`
`0.225
`
`[M - intramuscular
`
`oalcitcnin-nlrnon Miaulcin o
`
`Sandoz
`Phlrrmceutiulll
`
`solution
`
`vial
`
`can: acid
`
`with: acid
`
`5.: - 7.2
`
`1M - intrunuscutu
`
`4 0
`
`IV - intravenous
`
`Iolanua immune
`globulin (human)
`ufimrflv he
`roe-urori‘inm
`bromidtl
`
`Hyper-Tel is
`
`Bayer
`Corporation-Biologi
`
`Solution
`
`profilicd
`
`Bowman "‘" Injection
`
`Drynon
`
`Solution
`
`multloou m1
`
`atolls acid lampul]
`
`[M - inT-Elmusuuilr
`
`lfllpmlide ammo
`
`Lupion Depot 1.5
`
`acetic acid [glaulll]
`
`0.:
`
`4.2 o. 0 .I
`
`IV v lnlrawnoua
`
`octroctide acetate
`lnjouiion
`
`Sandmtatin a:
`
`TAP
`Pharmaceutical}.
`
`Sat-idol
`Pharmaoeuticala
`
`LyupI-t‘ilizod
`
`singli- dou VIDI.‘
`
`Solution
`
`ampuls
`
`240
`
`FDA Journal of Pharmaceutical Science a Technology
`
`lnnoPharma Exhibit 1105.0003
`
`

`

`
`
`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Storage
`993329
`MInI-lflfllll'tf
`Brand Nam-I
`Drug Name
`13!! when Admlnlm-ulon
`(Inna.
`“"91"”
`Cantatas!
`-—-—-—-—.__...__.______———_—_————-——-——-—-———-——
`ssww appllcnblo
`Rom
`I’mi
`siuglc lime via:
`IM - immacqu
`Lyaphiliml
`
`lawman: «ml:
`
`lnpmn beam-M
`
`TAP
`rhumuuticxls
`
`m ""1 m
`
`mm m NF
`
`1 O z 0 3
`
`1M - inhuman;qu
`
`mflmn
`
`Symonnm 0
`
`Sande!
`
`501%”
`
`W‘ “dim
`
`mm Iodimn
`
`“"9” Indium
`
`a I
`
`0 2
`
`0.4
`
`w - 5.0
`
`m vinuumbcum
`
`penumcinl Imm mm lnmuon
`(“mm medlel
`
`sum: thmv
`
`Sol-man
`
`m - 5.!)
`
`IM -W “alum 1am" I‘d-via macaw
`unmade-Ia will}
`
`Soaofi Wank»:-
`
`50'35’”
`
`mm; mm,“
`
`mom“
`hrdrmhluride
`
`14mm!"
`
`Suwfi Wis-trump
`
`Soluliun
`
`'“hl‘. iodium
`
`5 ll:
`
`l J - 5 I)
`
`51ml mmuic
`
`Ielmlim
`hydrochloride
`
`Mined»! llydmclllunn: Slnufi Winihmp
`15". Sofiuuun
`
`Sollflinn
`
`1m . 1.5
`
`sv- inmvemu:
`
`mimmnbin Ill Mmhm m a
`{m}
`
`Buyer
`t'nrpumian‘fiinloui
`
`unwind
`
`5.8 - 7.2
`
`w . Lumenm
`
`upoerin am
`
`Pram!
`
`Drum Hialeah. Inc.
`
`Salmon
`
`summon vial-
`
`Imps]:
`
`mpuu
`
`single do" main
`
`sinsls ulna: ml
`
`will: use bonito
`
`«made
`
`“mm
`
`Ilhuvrun
`
`dburnln
`
`mm .
`|
`|
`
`I
`
`on
`
`«tum
`
`1M «mm-mm
`
`M (hm-n1:
`
`s: as
`
`numme
`
`mm“ mm")
`
`m l
`
`6.3 t 0‘
`
`IV—mu'avzm
`
`“his: vim
`W [m
`3min
`
`halihenwphilic
`Fmor
`(:munmfl
`
`Imam Globulln
`tumultuous
`thmnlll'flWl
`
`Inlnvll a Rubia lem Connlufl:
`Llhl'lli“ [I16-
`
`mum. m
`
`turnout
`imam-untied
`
`Prawn-dried
`
`I'msle do” vul
`
`Lmh‘uim
`
`singled“:
`
`(Jung-mam
`
`Eisner Balm
`CflI'PWIll-OB
`
`I.de
`
`Min {him-n;
`
`(HM-I a
`
`[v
`
`imam
`
`Kali-n- l1
`
`Bayer
`L'OIPDFIIW-Bifllagg
`
`WWW-3195
`
`
`
`I
`|
`
`mania (mm sl 0
`
`IV - mum
`
`antlkuop‘nillc
`(“m
`“th!
`
`aafibemwhlll:
`in" [mm
`
`“m MAI}
`
`u 4-L o
`
`W - mm nulih‘mojlkillc
`{mm
`{fa-manhunt}
`
`Km. em!
`
`flaunt: “l
`
`“M‘MMMJ
`
`can“
`n M
`
`IM . mum-cm:
`
`balulmum lulu:
`I”: A
`
`Bola: a
`
`3m:
`Cumming—Rimes:
`
`l-ynphilim'
`
`mm
`Flume-alum
`
`340193553"
`
`Mien-m In:
`
`Lrnohrilim
`
`hing]: do“ harm
`
`single dose
`
`Imp-alt
`
`vial
`
`[Illa]: dun ml
`
`multidmu vinl
`
`Ilmkinlu rm
`infection
`
`npmlin alr-
`(Inmmbinlnl
`111mm
`
`apoolin aln
`lruomhhun:
`human
`
`Abboklnne
`
`Mabel: mammal
`
`Lmhflimfi
`
`Bpoggn 0
`
`Muslin, In:
`
`Sniution
`
`Epogm a: mutual-nu-
`
`Mme". Inn.
`
`Soluiion
`
`"mm" WWII!)
`
`5.0
`
`w v mmvem
`
`“bu-"N" (W!
`
`(I 25
`
`0.9 g {13
`
`hr . mwm
`
`“Min (human!
`
`0.29
`
`6 t 1 {1.3.
`
`[V . Lnva
`
`mm (MW)
`
`‘ 0
`
`M5 t m
`
`[V1 Lnva
`
`MI" "mm-n1
`
`1 n - :.o
`
`W . mum
`
`immune globulin Chm-t Q-[V
`1V (hm)
`pdmuilv I'd
`mandan
`unhody [win-d
`Man
`
`Mums-M a mm: m
`VIII: (2 11mm“!
`Plan-mankind
`
`Am"!
`Phumml'acai
`
`Ll'flilmil'v‘d
`
`mg: day.- vim
`
`Lywhiiind
`
`mascara!
`
`“Min rhuan
`
`t 15
`
`5C —W Lama-on beta-lb MW 0
`
`Berk: Lamar-lode:
`
`LYON-iii!“
`
`"m mm“?!
`
`| D
`
`W - Inan
`
`gram-[airman
`I'IIHIIIIIII globulin
`immutaqu
`
`(Mm-m I:
`
`Minimal».
`
`5min: hm
`
`Ihflcmfllfl
`
`aw: data will
`
`Ill'ulna Oman-III
`
`I35
`
`“m I‘M-Int
`
`n 5
`
`SC A mum poliovuu vaccine Polimrn O
`imrivuad. In: I
`(Manual. Tyne 2
`lawman sun-h. norm on
`rmmhialnl
`
`IM - um:
`
`(“nun-nun
`[Ab-amorm. in:
`
`assassin-I
`
`mm
`
`Roch: me Samara
`
`vu!
`
`Vol. 52. No. 5 I September—October 1998
`
`
`241
`
`lnnoPharma Exhibit 1105.0004
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Exclplmr
`Cone.
`9|! when Administration
`Drug Name
`Brand Name
`Mannheim-or
`Dosage
`Slang;
`%\W\"
`applicable
`Roule-
`Farm
`Conrail-m.
`
`albumin (Man)
`:1 161'
`IM - intronuuculnr
`interferon alfaAZI. Roman WA {powder}
`Roche leonroriu
`Powder {alorile} vial
`recombinant
`
`Ilbomin {human}
`
`albumin (human)
`
`0 1
`
`0.1
`
`IL - lnlmlflifllfll
`
`utlm'foron alto-2b,
`racomblnln!
`
`Intron A
`
`IM - inlnnmuhr
`
`interrgmn urn-2b.
`rmmhinnnl
`
`lullon A {solution}
`
`domain (human)
`
`0.6
`
`IV - inlmvmm
`
`mintroplu:
`
`Emir-natal
`
`Ilhumin {hurnuol
`
`DA A as
`
`IV ‘ intravenous
`
`gloom]: humrtu USP
`
`1 ll
`
`W :nlrnvcuous
`
`unlihemopnllic
`{war {human}
`{Furor VIII. Mil"!
`Ilgluuomo
`injection
`
`HrnnanP‘“
`
`Candace
`
`iloohol
`
`30.5 wqu 3.0 - 4.0
`
`lV-inrruvonous
`
`Elupolido
`
`Val'osid
`
`6.3 (m)
`
`w ‘ intravenous
`
`10.0
`
`6.8 — u
`
`[M Ara:me
`
`Irornyrunine
`sodium lnjeonou
`ITS]
`digoxin
`
`Trinmt
`
`Lanoxtri
`
`Schema
`Camonlion
`
`Balloting
`Corporation
`
`Rohom
`Fhmmooulioul
`
`Armour
`Phlnnlcctllionl
`
`Gum
`Corpnrllinn
`
`Bristol-Myon
`Squibb—Dracula”
`
`Southth Brechnm
`Fhrmcauliools
`
`Powder
`
`via].
`
`Solnn‘on
`
`vim
`
`Lyuphilized
`
`trill
`
`Lynphillzed
`
`{tulle dos: ml
`
`Solution
`
`glass homo
`
`Solution
`
`mulllple dose
`
`Solution
`
`ambervglm m1,
`
`Glaxo-Wollwm
`
`Solution
`
`mpul
`
`alcohol
`
`Ilouhol
`
`“001101
`
`dunno}
`
`.tloohol
`
`6.! {WI}
`
`3.6 t “.4
`
`1M ~intmnuscum
`
`dihydroerautumino HELP; #5 O
`mosylue
`
`Sandor.
`
`Solution
`
`Iltl'pLIII
`
`10.0
`
`IOJJ
`
`-9.5
`
`[M - r'ntrmmular
`
`pentoharhdlll
`'10:“th injurion
`
`Nunlmtal Sodium
`solution
`
`Abbott uboralou'ua
`
`Solution
`
`mpul
`
`6.1! - 1.1
`
`[M - intramuscular
`
`digoxin
`
`Lanoxin Inigo-xiii}
`luieuliun
`
`{11m Wolloomo
`
`Solution
`
`ampul-
`
`Solution
`
`start-vials
`
`alcohol
`
`alcohol
`
`l0.0
`
`It! In
`
`I1.0
`
`IV — intravenous
`
`phonytoin sodium Dilanlin
`injectionY USP
`
`Parka-Davis
`
`lMdulrIr-nuuuur
`
`haterqu
`Iromolhamin:
`
`'l'oradal
`
`Symon Lnborllories
`
`Solution
`
`Tube: cull-loge
`
`alcohol (Pit. Huh!)
`
`32.9 (vrv:
`
`W - inhuman:
`
`almhnl (USP)
`
`0.01 [Wu]
`
`4.0 1 0.3
`
`[M A intramusculu
`
`cyolusporiue
`commune tor
`inioolim LISP
`onylocin
`
`Snndlmrnuno 0
`
`Sandra:
`Phonon-oatmeal;
`
`Solution
`
`Arlle
`
`Synloclrion 1|
`
`Sand“
`
`Solution
`
`mpul
`
`alauhol {USP}
`
`6.1 MW.)
`
`3.6 1 0.0
`
`ml -intrmmuln
`
`Ilphl
`
`aluminiun
`
`1 .0
`
`sf] 1?
`
`N ~ intramuscular
`
`lMAtnIm-nusmllr
`
`uluminnm
`
`$0.000l
`
`IV — innovations
`
`aluminum
`
`50.014
`
`— H
`
`lM-mmmuscular
`
`alumimun
`
`Ilmnlwrn
`
`aluminum
`
`50.16
`
`$0.16
`
`$0.16
`
`in - intramuscular
`
`[M - tummqu
`
`IM - inn-muscular
`
`dihydrurgmlnfim Ill-1E. IIS 0 or Dyhdergol Slfldfl
`muylm:
`a
`iniooiion. U59
`mytnlncyulinu
`
`Terr-march
`
`Rood;
`
`Solution
`
`ll'l'lpuII
`
`Solution
`
`multidorz vml
`
`Diphthom and
`Tetanus Toxo‘tdr
`and Acolhrlnr
`
`Inlihetnophilic
`flclor (Human)
`
`Diphtheria a
`Tmnus Tmids
`and Acollulu
`cumhlnlnlion of
`relinod tat-rut: a
`diphtheria rancid:
`tanned lcllnui
`onoid
`
`diuhlhem &
`Imam Mold: 6:
`Formula Victim
`
`AceI‘Irnunc
`
`Lcdorla Lahorltoriu
`
`Suspensinrwm mulfidou: vial
`
`Knot: @HP
`
`Tripodin"
`
`Tear-urn a Diphlhon'a
`‘l’c-mids Adamo (AMI
`
`Tolam Toxuid Adaurlml,
`aluminum
`
`Bayer
`Comnrltion-Biulogi
`
`Lyophllmd
`
`single dnsa outm-
`
`Conmghl
`Laboratories. Inc.
`
`SululiouJSuspe ml
`
`Luanda Labor-alarm
`
`Suspension
`
`trill
`
`learle Lthonlorin
`
`Snapfluiiotl
`
`vial
`
`Til-Immune]
`
`thkl'lc Labanlurin
`
`Surpauaiunul‘t
`
`alumnus: \‘ISIS
`
`242
`
`FDA Journal of Phannaceutlcal Science Er Technology
`
`JA-
`
`lnnoPharma Exhibit 1105.0005
`
`

`

`
`
`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Excipicnl
`Cnnc.
`pf! where Adnilnlnraiinn
`Drug Name
`Brand Name
`Manufacturer
`Dosage
`Sloruge
`
`%WN
`appllcablu
`Rnutu
`Form
`Contalner
`
`:ILunionrn
`
`£1.05
`
`N - intramuscular
`
`napnlilis A vaccine Havrix (nguiiis A
`Vaccine. {motivated}
`
`SmilhKlioe Brechanl
`Biologicali
`
`Suspension
`
`single door.- vial
`
`Diphthnia a Tclmu:
`comhimiion of
`piuil'icd lellnLLn a 'J‘umidi J: Panuui:
`dinhthona
`combine:
`diphlhorin &
`minus inimida
`cnmhinli'ion of
`"fined diphlhma
`k lelll‘llfl onolds
`Diphxhuia a:
`Tet-nus Toxoids
`Ind Pumsis
`
`Diphthuria a Tclonus
`Toxoida 3: Pmuss'u
`
`Diphtheria o Talmux
`Toxnidli Admired.
`
`Terri-mum, (DTP-Khan)
`
`SmithKJine Bet-ohm
`Pharmaoeulicals
`
`Suspension
`
`Vista
`
`Cunning!“
`Lit-unmth 1:1:
`
`Timid Liun
`
`Vial
`
`Lndcrlo Labuniorien
`
`Suspensiontafi
`
`vial
`
`[Ruffle {abonrnries
`
`Suspensiorflafi
`
`vlal
`
`slurninum
`
`0.0-1 - u 12
`
`IM - intramuscuhr
`
`aluminum
`
`50.034
`
`W - intramuscular
`
`atuminurn
`
`:Iun-u'num
`
`alumimn
`
`Aluminum
`
`aluminum
`
`aluminum
`
`SUJB
`
`50. I 1"
`
`O 045
`
`“U US
`
`0.05
`
`2.0
`
`IM - intramuscular
`
`1M - inmmuscuiar
`
`[M v intramuscqu
`
`IN! - inlrumuaaular
`
`IN: - I'niramuscullr
`
`[M - inmmmumr
`
`aluminum phosphate
`
`50 2
`
`IM A imramuscniar
`
`hnmophilua b
`conjugal: vaccine
`(meninmmccnl
`hgpltilil E
`vaccine
`frecum hirian
`hepalilia R
`vacoine
`treacmbimnl}
`surolhiogiucasc
`
`innovated CV5
`Kiulinp'MDI'H
`rabies virus
`
`Pcdvulllli
`
`Morel: uh Company
`
`Lrophilizcd
`
`ainglc dos: vials
`
`Rammbivnx HE
`
`Muck .fi Company
`
`Suspension
`
`single don Vin]
`
`Engem-B
`
`Solganai
`
`SmilhKline Bmhnn
`Pharmcnulinala
`
`Suspension
`
`single arm will
`
`fichcring
`Corpuraliun
`
`Suspension
`
`mullidnse vra.‘
`
`Rubia \I'nmino Adsorheu
`
`SmiIhKluia Beecth
`Phalmaceuliuls
`
`Suspension
`
`vial
`
`amino aid
`
`0 3
`
`IM - inhmmular
`
`hcpniili'a A vaccine Hum (liepufilis A
`Vaccim. ImcliVIledl
`
`Sn‘iilhluiue Buchlm Suspansion
`Biologicals
`
`single dos: vial
`
`mama
`
`0.2!“
`
`W - inlravcnous
`
`ammonium meme
`
`1] 4
`
`-?.0
`
`WI - ion-amulet:
`
`'I’rionlnt
`
`sumac.-
`
`SmilhKlim Bauhaus
`Phan'mcciuicala
`
`Suhllion
`
`nrnhervglass viala
`
`Roche Lnbonmn'u
`
`Solulion
`
`ampula
`
`liorhyroninc
`sodium iru'golion
`{Til
`humcllnide
`
`ammonium hydmido
`
`SC subouinnaous
`
`panlngunlrin
`
`Popluvlon
`
`Wyth-Ayem
`
`Solution
`
`‘IIIPIIIEI
`
`anhydrous citric acid
`
`(ml 75
`
`N - 'mlravcnmii
`
`anhydlous aim: acid
`
`0.05
`
`6.3 - 1.2
`
`IM - intramuuum
`
`limhyron'tn:
`sodium injulicn
`[T3]
`digoxin
`
`Trlosm
`
`Lanwin
`
`SmilhKJLne Bmluam
`Pharmuuiieals
`
`Salulion
`
`amber-gill: via]:
`
`Glaxo-Wellcome
`
`Solution
`
`nmpul
`
`minimum nitric acid
`
`3.0 - 4.0
`
`N A inlravemus
`
`diclrhuinc
`
`MIC-Dome Sierilc
`
`Buyer
`ComonrionAFhuma
`
`Solid
`
`vials
`
`znhydmas citn': acid
`
`0.03
`
`5.8 - 12
`
`IM - inmmuscuilr
`
`drguxin
`
`kaolin {Digoxin}
`Iniroflon
`
`(31am Wdlnomo
`
`Solution
`
`Impuls
`
`anhydrous dun-rise
`
`n! S
`
`3.0 - 4.0
`
`N A intravenous
`
`labeinlul
`liydmchluridc
`
`Trandm Injgcuon fl:
`
`Glam Wellcorrle
`
`SoIUIion
`
`villa
`
`anhydmux dextrose
`
`6.5
`
`1.0 - 4.0
`
`IV - intravenous
`
`iabelnlnl HC!
`
`Nurmodyn:
`
`unhydwun dextrose
`
`{I}
`
`[M A intramunzulm
`
`buprenorph‘mc
`hirdmuhloridc
`
`Buprcnmr
`
`Schcring
`Corpotaritln
`
`Rankin & Coiman
`Pharmaueulicais
`
`Solulion
`
`multind vial
`
`Solulion
`
`51m snap-Impala
`
`anhydrous sodium
`
`6 o
`
`0.5 - 1m
`
`IV - inmvenuus
`
`arginino
`
`LEF- — 36.“
`
`4 3
`
`T 5
`
`1M - intramuscular
`
`ascorbic acid.
`
`0.043 - U.AIS
`
`IV - intrauan
`
`Morhohexiini
`Sodium {or
`irritation
`aluminum [or
`inrnolion
`
`doxycyclinr
`hyclnta for
`ill'reclion
`
`Brev'mi Sodium
`
`Eli Lilly St Company
`
`Frcczborietl
`
`vim
`
`Axle-lam [or Injecliuu
`
`BristAMyar:
`fiuibvaHcDIUgy
`
`Lyiapiu'lized
`
`vials
`
`Vibrarnyciri lnlrnvenuus
`
`Rania
`
`I’m-dai-
`
`vial
`
`Vol. 52. No. 5 i' September—October 1998
`
`
`innoPharma Exhibit 1105.0006
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Storage
`Dosage
`Manufacturer
`Brand Name
`Drug Name
`pH when Administration
`Cane.
`Exclplenl
`Contain"
`Farm
`applicable
`Route
`‘AWW
`___—_.._.—_—____—__._.—__.._—____._____h
`0.]
`IM - inlmnuaeullr
`Solution
`Impala
`ascorbic acid
`imiplminu
`Tufrlnil
`Cibcfirnn'l
`hydrochloride USP
`Camoralicn
`
`ascorbic acid
`
`ascorbic acid
`
`uwrbic acid
`
`Whit: acid
`
`0.2
`
`0.!
`
`0 1
`
`H)
`
`1M - inmmmulvlm chlmpmmazinc
`hydrochlarida
`
`"l‘hmuinovmwulc
`
`Srnllhfilinc Beecth
`
`Salution
`
`umpqu
`
`lM— whammqu [lee
`
`chlurpmmuiue
`hydroclllnride
`
`Thorm'ne
`
`StrtilllKliM Bacchun
`
`Scluu'nn
`
`mullidou vial.
`
`3 J v 4 5
`
`various
`
`SC - ammo»
`
`Mancini: Hydmuhlcride
`bupivaclinc
`hydrochlnridl and with Emunhfim
`anincohrind
`Epinephrine
`
`Sus—phtinc I9
`
`Smufi Winfl‘flup
`
`Sfilfllioll
`
`Single dose vial:
`
`Primal
`Phumaceulinlx Inc.
`
`Suspensinn
`
`unpul
`
`ambit: .1ch US?
`
`I). l
`
`I'M v inmmucular
`
`lhlclhylpcrlzinc Term Gr
`mam: USP
`
`Roxane
`Lchcmuriu. Inc.
`
`Solution
`
`maul
`
`upuagine
`
`[VS - intrinsic-l
`
`benzalkunium
`
`0.0:
`
`6.8 — 7.!
`
`ID — inkadennl'l
`
`banana-Mfume acid
`
`3.25 — 3.65
`
`IV - intravenous
`
`'IICEG! ECG
`
`In atlnnullad liv:
`culture preplnflol'l
`ofBCG vaccine
`Calm-i: thllpln
`balnrnelhuonc
`sadium phosphate Susnonnian
`.i hummus
`macunum haylale Tram'um
`
`Organon
`
`Frau-dried
`
`ampulu
`
`Sal-wring
`Curporallon
`
`Suspension
`
`mullidm ml
`
`Glam Wefloonu
`
`Snlulion
`
`ainflc m vial.
`
`banzethonium
`
`0.0 - 00I‘
`
`5.0 d 60
`
`IM - lnlramnsculu
`
`diphenhyduminc Mary]
`hydrachluride
`
`Parka Dim
`
`Solulinn
`
`ampuln
`
`butmelhoninrn
`
`0.0 - 0.0I
`
`lM - :nlramuscular
`
`bulnrpluncl
`Immc
`
`Sladol m Injcullnn
`
`ApolheounJBrlstnl-
`Myers Squibb
`
`Solution
`
`vial
`
`hmzyl alcohol
`
`hcnzyl alanth
`
`1.0
`
`0.9
`
`3.0 v 4.0
`
`IV-lnlrlvcnou:
`
`Eluposide
`
`VnPcsld
`
`5.0 v 1".5
`
`Ill-intramuscular
`
`Dllalon: DP. 3‘
`
`Bfislal—Mym
`Squibb-Oncology
`
`Fore.“
`Phumawulicals
`
`Solulion
`
`mullipl: dim
`
`Suspennion
`
`vinlt
`
`March a: Company
`
`Suspension
`
`vial:
`
`buzyl Ileana!
`
`n 9
`
`5 0 A 10
`
`IM-inmmusctflu
`
`Dcumelhamm
`Acml:
`Suspension
`Corlirone Aware Conan: menu:
`
`her-12y] alcohol
`
`benzyl aImhnl
`
`benzyl alcohol
`
`0.9
`
`0 9
`
`0.9
`
`5.0 - 7.5
`
`lM—intramusculu
`
`durnicthuum-
`“fill:
`
`Drama-Ln
`
`Merck In Company
`
`Suapunsion
`
`vial:
`
`6.0 - 80
`
`1A0. - lnmsanicuhr
`
`Pudnirulanc
`Tehullle
`
`Ilydollra T. 1A.
`
`Merck a: Company
`
`Suupcnaian
`
`vials
`
`5.0 - 1.0
`
`IAR v inn-auricular
`
`[lg-draconian:
`acelale
`
`llydroemunc Acclalc
`
`Merck a Cnmpnny
`
`Suspanaiou
`
`villa
`
`hem] IlnolmI
`
`0.39-0.91
`
`J 5 - 10
`
`[M - intramqu
`
`Methylprcdnimlu Depo-Mndrnl
`n: mule
`
`The [Jij
`Company
`
`Summit-n
`
`single dose V111
`
`benzyl alcohol
`
`0.90
`
`bowl Ileana]
`
`0. 90
`
`-a.o
`
`~60
`
`IM - inlrarmscular
`
`Iriamalnnlonc
`diloGlllfl
`
`Minnow Fun: (P1
`
`Fujlsawa
`
`Mintunized
`
`vial
`
`IL v [mansion-l
`
`Idamciuolane
`diletlalc
`
`Mimosa”
`
`Fujluwa USA. Inc.
`
`Micmniud
`
`vial
`
`benzyl alcohol
`
`0.90
`
`4.5 - 6.5
`
`IL - inlnleaioml
`
`bmyl alcohol
`
`1.02
`
`IV - inirawmus
`
`Iriamclnnlone
`hzxmmida
`“mansion
`amiadamne Hcl
`
`miman Supenaion S
`mflml
`
`Fujinwa USA. Inc.
`
`Suspension
`
`vial
`
`COMM Intravenous
`(mam: NI
`
`Wycih-Mrmr
`
`Solution
`
`ampul:
`
`012ml alonhcl
`
`benzyl alcohol
`
`0.9
`
`10
`
`IV - intravenous
`
`Enalaprflar
`
`Vacate: HI.
`
`Merck -& Comm?
`
`Solution
`
`vial
`
`~10
`
`[V - inlnvuum
`
`mic-ml“:
`hymchlcrldc
`
`Vmul
`
`[-lnl‘rrnan - ulnar
`Inc
`
`Solution
`
`vials
`
`244
`
`PDAJournal of Pharmaceutical Science 0 Technology
`
`lnnoPharma Exhibit 1105.000?
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`sulphur
`Cone.
`pl! when Admlabtraunu
`Drug Nam
`Brand Nun:
`Msnututunr
`Dunc
`Storage
`
`
`%WN
`applicahla
`Runs:
`Farm
`Catlin-r
`59ml ulwhnl
`0.0
`N - mun
`hydra).sz
`Vlmrll
`Rom.
`Saint-nu
`mum. ml-
`“Mona
`
`hurl alwhnl
`
`hem mum
`
`hazy! «who!
`
`homl “cabal
`
`mm Itaohul
`
`bum! doc-Junk
`
`mml flauhol
`
`my] glean-0|
`
`hm} Ila-ho]
`
`i) 3
`
`:
`
`(I
`
`a 0
`
`! 1'
`
`J (I
`
`1
`
`I)
`
`Ln
`
`0.9
`
`LS
`
`1| - 6.5
`
`IN - immanent"
`
`gold sodium
`min-ulna
`
`Mmhmiu
`
`Maul I Cong-Iv
`
`5mm
`
`am
`
`1.5 - M!
`
`[M dummy-11hr
`
`uliluidw sulfur. Nmmym Minn-11
`USP
`
`khan“ 35mm
`Commie:
`
`Solution
`
`vim
`
`H - )0
`
`IV - mums-n
`
`mam
`chloride
`
`Sum-m
`
`(Jim Waflmn-
`
`Minion
`
`mlu‘m rial-I
`
`1M -imrmm
`
`hlnparidal
`damn
`
`Hilda! Dec-ml: so and
`IOU
`
`Nth?!“
`Phlmoufliui
`
`Salmioa {in
`
`“was
`
`-S 0
`
`W~ him-Imus
`
`tanipmidu
`
`Buniol‘Mym
`Vanna Nathan
`Emma: Will-26] WHOM“;
`
`Solution
`
`3%
`
`49.11
`
`[V ~ huva
`
`Hilnalhnprirn and
`aull‘amtthaxlzoln
`
`5am“ LV. [mama
`
`mun Walk-mo
`
`snlnliuu
`
`nameler m
`
`IM ~ imamh:
`
`lonchum
`
`Almn
`
`Wynlh-Aylrll
`
`Solution
`
`smile cam-tugs
`
`«U
`
`~10
`
`IMvhm'lumlhr
`
`mothonlmeprmna [mfth
`u w.
`hrdmhlnfld: «If
`
`Immune:
`Carpenth
`
`Solution
`
`vials
`
`[M -W snowman:
`hymnhlnride
`
`Ulm'uw “unable [1M1
`
`Ranch: PM. In.
`
`Cmullim
`
`whatm
`
`lat-ml. mm
`
`0.945
`
`I'M 413W I'umnuyein
`hydrochloride
`
`Mikaela mule autumn
`
`The Union:
`(1an
`
`Sctulion
`
`visit
`
`bcnyl llmhul
`
`0.9
`
`SC - Mm mlfi luau Luplm Mamba
`
`Solution
`
`mfllfldnu vill-
`
`
`
`my! alcohol
`
`fl.“
`
`ICN - Ema-mm!
`
`Immudfl
`
`Cnuju'l Sunk M:
`
`TAP
`911mm.
`
`The Upjohn
`CW“?
`
`lam! “901ml
`
`WI dash!
`
`mzyl alcohol
`
`0 0
`
`2.15
`
`I."
`
`4.!
`
`N — imam
`
`amino-peak acid min: Malian, 'L'S!‘ Mum
`Carpet-lion
`
`IN - inn-am
`
`phywlligmm
`"link":
`
`Aafll'lmull
`
`Fatal
`
`salmon
`
`lupus:
`
`-? 0
`
`N am bun-Munich
`
`Ham 0
`
`Rncln Luau-min
`
`Solution
`
`unpuh
`
`marl Ilwhnl
`
`mas
`
`IM A inn-magnum
`
`clindamycin
`pumphllt
`
`Hmm anhm 3mm: Thu Upjohn
`Sululiun
`crummy
`
`Suiulion
`
`vills
`
`Flew Vin!
`
`Sulmiou
`
`vial
`
`Mandi almanl
`
`boml alcohol.
`
`I
`
`5
`
`2.“
`
`WI :1th
`
`0-?!
`
`WI alcohol
`
`my] unit-IE
`
`hm! Ilnolwl
`
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`
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`[.3
`
`n I t I13
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`banal mad
`
`0.9
`
`SI)- 10
`
`IM —in1rarrmcuiiu
`
`din:an
`
`Vallum Mac!on
`
`Rocha Fromm
`
`Solution
`
`animus
`
`lM - inlrainnnullr (an:
`
`uhlorplomnine
`hydlwhlnrida
`
`Tlmruinu
`
`animal". Euchlln
`
`Solulien
`
`multidnaa viola
`
`EM — [mm prnhlmpomiu
`u lb: «Nylon
`
`Complain:
`
`smuwno Emmi:
`Phammllimh
`
`Solution
`
`vial:
`
`N v inmvm
`
`Epoganl I mundane
`
`mum Duma-
`
`Mum In:
`
`Solution mm v'nl
`
`mmmm-
`mm Squib
`
`Solullon
`
`tingle don
`
`apnea]: III:
`{mammal
`III-mm
`[M ‘ imam {llama-tin:
`mm
`Iniulion
`[M — mm [lupime
`Em.
`Injection
`phymdiom MWIM
`{m Kl]
`
`helm: Elam Wham-l-
`Mm Swim
`
`Solminn
`
`vial:
`
`IMAM-Main
`
`Muck-360':pr
`
`39ml:
`
`mu
`
`I
`245
`Vol. 52. No. 5 I September—October 1998
`___—————-—_————r—-——-——=—————'__—W_'
`
`innoPharma Exhibit 1105.0008
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Sign“
`Dang:
`Mlnuhelunr
`Bmd Nun!
`Dru: Nam
`all when Admlnlnnllnu
`Conn
`Enlplmt
`
`
`
`
`FarmRantsIppllnblu%WN ContainerM
`0 I1
`1M Jamal-u
`M m vial:
`haul almhnl
`cautious
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`Mil m
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`
`but?! “what
`
`my! alcohol
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`
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`
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`
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`
`momma:
`mu
`
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`lull-ell»:
`
`Imam
`flatworm
`
`Solution
`
`fill-D
`
`IV - Imam
`
`lfimw Sam-n W Inlmu
`Mimi
`
`am “Pullout
`
`Salaam
`
`bum! W I D
`
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`
`N - Ilium mum Ind
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`
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`
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`
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`
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`
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`Company
`
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`
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`hum llmhol
`
`OLD: mu
`
`1.0
`
`IV — lam-rm
`
`Indium ulna-qr: sum 8
`mm- Weller:
`
`Bum-SIM [as
`
`Satan“
`
`mm
`
`hem! llmhol
`
`D H
`
`N - ‘ualnnmscuhr
`
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`
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`
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`Phalnuaonums
`
`multiduu m]
`
`boumyl I.an
`
`1a {m}
`
`in ‘ m
`
`W» mmmm
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`oluasc
`
`Ethnmllt- a manual:
`
`50mm:
`Plum-alumni
`
`Saluliun
`
`ampules
`
`bowl Iluuhul
`
`10
`
`W datum
`
`gamdm’elin
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`me
`
`WreIh-Ayml
`
`Lymphth
`
`fiuglo 6m Saul:
`
`bum] Iltuhol.
`
`all .n
`
`N v mmvmua
`
`henna nudism
`
`"mun Lock l'lunlt
`Salaam USP
`
`WyIIh—Mml
`
`Salminn
`
`Tm! Shad
`
`hurl limb-cl
`
`3! I)
`
`3.0 v 7!.
`
`IV - mm hepu'in mum:
`
`“With! Sodium Wuhan
`USP
`
`“Frail-awn]
`
`Sauna:
`
`Tm: nails
`
`hasty] maul
`
`LL94!
`
`5.0 - 1.:
`
`IV ~ hum helium! Mum HM Milan Noam The Upjob
`Comping
`
`Mule:
`
`vial
`
`min cull-n:
`
`Eu till! a Comm Solullou
`
`mum ml
`
`any] um I n
`
`W - mun:
`
`flap-m: 5m human
`Jifi wlr
`
`“WI limb-Bl NT"
`
`0-0
`
`l i - 5.0
`
`um“. 1:09th NF
`
`0.9
`
`:.o - an
`
`W 41mm mm
`twain-Hand.
`mimic-n USP
`IM - mm lJywpynuluto. W Injulwlo
`US?
`
`Dayna health
`
`A. ll m Sciatic: m «in:
`Cam
`
`A ll. Mu
`Col-splay
`
`Lwald
`
`mullian um
`
`hum Ilvnnlml
`
`0.90
`
`4.! - 6.5 MR~WMM Imalmlnu:
`ammonia:
`
`Arman»: snap-won
`in alum]
`
`Fujmm
`
`Mammal!
`
`vim
`
`hazy! flannel (m n M
`
`3.3.5 - 3.65 W - inlnvmul
`
`“Imam buyqu Tim-hull
`
`Gm Walloon:
`
`Sululinn
`
`sink use will
`
`him} “cabal (In
`
`0.0
`
`0.9
`
`3.5 - 5.0
`
`N — inn-um
`
`mlmfium
`uhludde
`
`Mlucmn lluullun
`
`ulna Wullwm
`
`5u1|llinll
`
`single dose UNI
`
`bemyl olmhol t m an A 0.9
`
`IM durum-INN mm Lucia 0
`
`lingual-Mun].
`Putnam
`
`Solution
`
`tunnel)
`
`ham! dental {In
`
`0.0 ‘ ELIDI H - l!
`
`[V - lunmnnn
`
`mm
`
`Mum Wuhan
`
`Briml-Mym
`Squibb-owns!
`
`Solution
`
`mullidme vhll
`
`burl alcohol {In
`
`0.0 - 09
`
`N - mm Sam
`
`Pauli bum
`
`Muck at cm Salami:
`
`mam uh!
`
`balmy: nlwhl [m M w
`
`3 I — 7?
`
`W - mum
`
`apucu'n am
`
`Pswm
`
`(Mm mama. Inc
`
`Sfllnllm
`
`single um: um
`
`ml “HON til.
`
`05 - 19'?
`
`T 0 - 50
`
`MM Ilium
`
`«.000!
`
`urn-am
`
`M -ulinnm:nlir
`
`mlylpfldmolo Sell-Hm Slain
`M sodium m
`mu. USP
`515mm panama name Mom a
`(Inuit-lad; In” 1
`IHIWL ND. }
`typhoid 0mm Typhoid Vanilla U5!
`
`SC - mums
`
`m
`Gamay
`
`Conn-ugh:
`MI, I:
`
`PM
`
`Acz-O-vill
`
`Smnnion
`
`ampules
`
`Wynn-6m
`
`Snaps-mm:
`
`with
`
`243
`
`.-
`
`FDA Journal 0! Pharmaceutil Science & Technolugy
`-—1—
`
`InnoPharma Exhibit 1105.0009
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`hem-m
`Cone.
`pfl when Administration
`Drug Name
`Stand Nuns
`Manhattan:
`Dong:
`sung.
`
`“WW applicable
`Rom
`Farm
`Cnntnlmr
`
`11) -W qul pm: of
`0pm Ind 1m
`mm» a! lull-d
`
`NW Vflmiu A
`Paula: a:
`mural
`
`GM Victim US?
`
`Wyuhfiyml
`
`Sim