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. Cairfirmt'u
`
`Overview
`
`formulation
`The selection of escipients in parenteral
`design is alien both rational and empirical. It is rational in
`the sense that certain types of cttcipiertis are added to alter
`the {emulation properties: i] bullets of appropriate pKa are
`added to control hydrogen ion concentration at a desired pH.
`ii} tonicifiers 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
`nents. 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 excipient used is far from rat icon]; 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 terminated 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 escipiertts 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 encipients are truly available for use
`(based on what has been used previously). and which are
`not? For example. 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 mild. but is too painful in most instances for subcutane-
`ous use at 50 mM. lligh concentrations of propylene glycol
`may be used it] 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
`adnunisttauon. 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 formulations. given sys—
`tematically by excipient name. In this fomtat it is easy to
`determine what concentrations were used the route of
`administration.
`the main rationale for addition of that
`
`excipienl. 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 excipicnt concentration was often given in
`different units.
`including:
`rngiml..
`tnDs. 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 DDSSlbIC) 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
`known for most escipients. permitting a standardization of
`excipiem concentrations]. This standardization of excipient
`concentrations is perhaps the greatest value of this compen-
`dium. but aim represents one of the greatest sources of
`potential error. The recalculation of excipicnt 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 excipient 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 weightfvolurrte% unless
`otherwise tinted. in some cases values are. listed in volutnei
`
`volume‘iln 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 fomtulations; however. in most
`
`Received l‘ehnntry in. 1908. Accepted for imhlicationlunc l. 1998.
`'Aulhor to whom corresptmdeucc should be addressed
`
`Ihem to ngttyeunueldv'gcnecoul for
`'ll' discrmutnries are found. e-tnail
`correction to suinequettt eoutpettdiuuts of this nature.
`
`23%
`
`PD‘AJournal of 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
`q.s. We have kept the same conventions here.
`3'] Excipients listed are present in the drug formulation
`itself. and do not include citeipients present in diluent (for
`example. when a lyophiliaed formulation is- diluted with
`bacteriostatic water containing benzyl alcohol).
`In some
`cases, a diluent is supplied that contains several additional
`excipients and.
`in the ease or provided diluent,
`these
`excipients are Listed in the excipient category and designated
`with a “D“ in addition to their usual excipicnt type {the D
`stand for present in diluent).
`4) If no exeipients are listed. it means that no eitcipicnts
`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 may be
`excipieots present but the manufacturer has not disclosed
`them to us. largely for proprietary reasons. Specific follow-
`up about these drugs should be. referred to the manufacturer.
`2'” 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 t_ for example. rnitoxanlrone hydrochlo
`ride}.
`l-iowever,
`in the drug concentration category.
`the
`concentration of the active component is usually listed (for
`example. equivalent to 2 mglml. mitoitantrone free base). so
`as to have a correct concentration of the active drug form.
`a] When concentrations of excipients and drugs are 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.
`7i 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 e-xcipient. To search for counter ions
`{like sodium or potassium] orle 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 lyophillzed product, in most
`9)
`cases, it is the pl] 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 usual ty 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 lists 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) Finally. 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
`nguyen.tue@gene.com for correction.
`
`Acknowledgments
`
`This compendium would not have been possible without
`the diligent work of Mitianne Chin. She compiled much of
`the data, engineered the database. and contacted 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 Name-
`pl] when Administration
`Cont.
`Exclplent
`Slot-ago
`Con ulnar
`Form
`applicable
`Route
`“AWN
`——..__.._—._.________.._.__..________—-—————__.________
`mullidnao vial
`paravortebtal
`amoral-tit
`Sanpin
`High Chemical
`Solution
`purl-rum. pitcher
`Company
`nlanl olafillala
`I'mvidos Rose's
`tooommndod daily
`Intake of osmlial
`Old Tubarwlin
`
`on - 7.0
`
`W - intravenoua
`
`5.4% NophMminr "
`
`MD Laboralotioa
`In.
`
`Solution
`
`Blair container;
`
`1' .0
`
`ID - intradotmfl
`
`Mundin. 01¢ Tina Test
`
`(gnarl: Laboratories
`
`Solution
`
`d'tiponllle
`
`acacia (gum cubic)
`
`"LO
`
`ID - inundonull
`
`tuberculin. purified (FPO) Tin: Tut
`protein derivative
`
`Leda-l: Laboratorioa
`
`Salullon
`
`multiple-gunning;
`
`Boot-Ito
`
`will:
`
`”all“!
`
`IOEGcadd
`
`aortic acid
`
`nu-Ilr. mid
`
`aoelic acid
`
`acetic maid
`
`loolil: laid
`
`Imitac‘td
`
`0.0 59
`
`4 .0
`
`IN — inmwm
`
`mutral
`
`5C . nthcuraneous
`
`nouttal
`
`SC - momma:
`
`0.435
`
`W - inn-Ivorian
`
`filgtaatirn
`[recombinant
`methiomi human
`Lento (a) human
`inaulia zinc
`suspension
`Lento {L} Purified
`Park Insulin Zinc
`Suspension. USP
`filodrine
`hydrochloride
`
`Neupogotl ID
`
`Artisan. Inc.
`
`Solution
`
`sing): don rial
`
`Novolin an L
`
`Nuvo Narnia]:
`Phatruuulinla
`
`Suapcnaion
`
`Lento {L} Purified Pork
`Insulin Zinc Stupension.
`
`Nova Nordlxk
`Phanmmtical:
`
`Suspension
`
`Wrap-r
`
`Mira USAJnc.
`
`Soluliort
`
`vials
`
`villa
`
`vial
`
`SC -mm leuptolide acd‘mn
`
`Lupron Injoclion
`
`TAP
`Photmacotuimla
`
`IM - intramuscular
`
`minimum-salmon Caloimar Iii lujeclion;
`Svotlietic
`
`Rhona-Pool“:
`Rom
`
`IV . intravenous
`
`albumin (human). Mburnimt GUI!
`35%
`
`6.9 2 0.5
`
`N ~ inmvm:
`
`albumin [human]
`5%
`
`Albmninnt 05
`
`Armour
`Pharmaceutical
`
`Ara-rm
`Phannnoeuriuul
`
`Solution
`
`Solulion
`
`Solution
`
`nmlridoao fill
`
`viola
`
`vim
`
`Solution
`
`bottles
`
`3.5 — 5.5
`
`IV ~ Intravenous
`
`rincrisline sulluo. Onnovin do
`USP
`
`Eli Lilly at Company
`
`Solution
`
`IV ~ intravenous
`
`flummnll
`
`Romlzionn m
`
`Roch: Laboratotira
`
`Enlulion
`
`vials
`
`vials
`
`
`
`0.0I
`
`"1.0
`
`acarin lcitl
`
`(2.5 (wtw)
`
`SC- Minnow!
`
`moi-elm mute
`implant
`
`70km 9D
`
`acetic acid.
`
`0.45
`
`3.0 - 4.5
`
`W - lull-averted:
`
`mitootantrone
`hydronlilnrido
`
`Nurantronc
`
`Zoom
`Phannacoulioals
`
`lmmunox
`Comoralion
`
`Solid Implant
`
`disposable
`
`Solution
`
`mullldote viali
`
`mun Icld
`
`mi: acid
`
`mi: and
`
`acetic acid
`
`2.5 ~ 11.5
`
`[M . Inltamuacular
`
`oxylooin
`
`nytnoa'n Injection
`
`Wyavayuril
`
`Solution
`
`slorila cartridge
`
`FM - imamttmflar
`
`ptomethnzin:
`hydrochloride
`
`Phrnugan Injlcl'mn
`Iamnulsl
`
`Wyelh-Ayenl
`
`fiolulion
`
`ampuls
`
`[M durum ptomolhlzine
`hydrochloride
`
`-5. 9
`
`1M - intramuscular
`
`nm‘llsmina
`mothylnull'ala
`
`Fhonnmn Injection
`
`Wyeth-Ayml
`
`Solution
`
`smile natuidgr
`
`Piouisrnin Injullble
`
`ICN Phanttuaulicala
`
`Solulion
`
`mum-dose vial
`
`acetic acid
`
`0.225
`
`[M - inmmumtlar
`
`calcitcnin-Ialrnon Miauloin on
`
`Sanduz
`Pharmaceutical:
`
`solution
`
`vial
`
`tram: acid
`
`moo aoid
`
`5.: - 7.2
`
`1M - intmnuscntu
`
`4 0
`
`IV - intravenous
`
`Iolanua immune
`globulin (hum)
`urinmflv he
`mourm‘inm
`bromide
`
`Hyper-Tel is
`
`Bayer
`Corporation-Biologi
`
`Solution
`
`prefilicd
`
`Bowman "‘" Injoclion
`
`Drynon
`
`Solution
`
`multldou m1
`
`{Mlle acid lampul]
`
`[M - intramuscular
`
`leuprolide acetate
`
`Lupion Depot 1.5
`
`acetic acid [glacial]
`
`0.:
`
`4.2 ._ 0 .I
`
`IV . Intravenous:
`
`octrecude nubile
`injouiion
`
`Sandmtatin o:
`
`TAP
`Pharmaceutical}.
`
`Sande:
`Pharmaoeoticala
`
`Lyuph‘tliznd
`
`singlv do“ vwl.‘
`
`Solution
`
`ampuls
`
`240
`
`PDA 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’m-i
`siuglc lime via:
`IN! - intrumuculfl
`Lyaphiliml
`
`lcslprwd'fl «ml:
`
`lnpmn beam-M
`
`TAP
`rhumuuticxls
`
`m ""1 ”I‘
`
`““5 m NF
`
`1 O z 0 3
`
`1M - inkmucuhl
`
`mflmn
`
`Symonnm 0
`
`Sande!
`
`501“”
`
`W‘ “dim
`
`mm Iodimn
`
`““9“ Indium
`
`a I
`
`0 2
`
`0.4
`
`w - 5.0
`
`m vinuumbcum
`
`pmumcinl Imm mm Immune
`(“mm medlel
`
`sum: thmv
`
`Sol-man
`
`m - 5.!)
`
`IM -W “alum 1am" I‘d-via macaw
`unmade-Ia will}
`
`Soaofi Wan-law
`
`50'3“”
`
`mm! mm,“
`
`mot-Ila:
`hrdrmhluride
`
`14mm!"
`
`Suwfi Wis-mung
`
`Soluliun
`
`“““l‘. ”dim
`
`5 In
`
`I J - 5 I)
`
`gain.“ mlhuic
`
`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
`
`mandamus:
`
`“'HIM
`
`Ilhuvrun
`
`dburnln
`
`Mas .
`|
`|
`
`I
`
`Ins
`
`«tum
`
`1M «mm-mm
`
`M (hm-n1:
`
`s: as
`
`W—imnvanaus
`
`mm“ mm")
`
`m l
`
`6.3 t 0‘
`
`IV—mu'avzm
`
`“his: vim
`W [m
`3min
`
`halihenwphilic
`Fmor
`(:munmll
`
`Imam Globulln
`tumultuous
`thmnlll'flWl
`
`Inlnvll a Rubia lem Connlufl:
`Llhl'lli“ [I16-
`
`mum. m
`
`Jumu:
`imam-untied
`
`Prawn-dried
`
`I'msle do” vul
`
`Lmh‘uim
`
`singled“:
`
`(Juan-MOSH)
`
`Eisner Balm
`CflI'PWIll-OB
`
`{.de
`
`Min {him-n;
`
`(HM-I a
`
`[v
`
`imam
`
`Kali-n- l1
`
`Bayer
`L'OIPDFIIW-Bifllagg
`
`WWW-3195
`
`
`
`mania (mm sl 0
`
`IV - mum
`
`antlkuop‘nillc
`Tum
`“th!
`
`aafibemwhlll:
`in" {Human}
`
`“m MAI}
`
`u 4-L o
`
`“M‘MMMJ
`
`now
`n M
`
`W - mm ”limes-kill:
`{mm
`{fa-manhunt}
`bolulmmn lulu:
`I”: A
`
`IM . mum-cm:
`
`"mm“ WWII!)
`
`5.0
`
`w . mmvem
`
`“bu-"N" (W!
`
`(I 25
`
`0.9 g {13
`
`hr . mwm
`
`“Min (human!
`
`0.29
`
`6 t 1 {1.3.
`
`[V . anvmm
`
`mm (”ml
`
`‘ 0
`
`M5 t m
`
`[V1 mmvm
`
`MI" "mm-n1
`
`1 n - :.o
`
`W . mum
`
`Ilmkinlu rm
`iflffilinn
`
`npmlin alr-
`(Inmmbinlnl
`111mm
`
`apoolin aln
`Irocomhhunl
`human
`
`immune globulin
`1V (hm)
`prllnnilv I'd
`mnodnml
`unhody [win-d
`Man
`
`Km. em!
`
`flaunt: “l
`
`3m:
`Cumming—Rimes:
`
`l-yovhilim'
`
`m
`Flume-mum
`
`Hawaii“
`
`hing]: do“ harm
`
`single dose
`
`Bola: a
`
`Mien-m In:
`
`meium
`
`Abboklnne
`
`Mabel: mammal
`
`Lmhflimfi
`
`Bpoggn 0
`
`human, In:
`
`Sniution
`
`Epogm a: mutual-nu-
`
`Mme". Inn.
`
`Salmon
`
`Imp-alt
`
`vial
`
`[Illa]: dun val
`
`multidmu vinl
`
`film-t Q-[V
`
`Anna"!
`Phumml'acai
`
`Mums-M a mm: m
`VIII: (2 mm“! W
`
`Ll'flilmilt‘d
`
`5W9 day.- vim
`
`Lyuslhiiind
`
`mascara!
`
`“Min [human]
`
`t 15
`
`5C — mum»
`
`Lama-on beta-lb MW 0
`
`Berk: Lahnnlmifi
`
`LYON-iii!“
`
`“Mm mm“?!
`
`| D
`
`W - tummy
`
`gram-[airman
`I'IIHIIIIIII globulin
`intuumlu
`
`(mm-m I:
`
`Minimal».
`
`5min: hm
`
`Ihflcmfllfl
`
`aw: data will
`
`Ill'ulna Oman-III
`
`I35
`
`”m I‘M-Int
`
`n 5
`
`SC . mum poliovuu vaccine Polimrn O
`imrivuad. In: I
`lMahun-ryl. Tyne 2
`lawman sun-h. norm on
`rmmhialnl
`
`IM - um:
`
`(“nun-nun
`[Ab-0mm“. in:
`
`Sumsiun
`
`mm
`
`Roch: me Samara
`
`vu!
`
`Vol. 52. No. 5 I September—October 1998
`
`
`241
`
`lnnoPharma Exhibit 11050004
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Exclplmr
`Cone.
`9|! when Administration
`Drug Name
`Brand Name
`Manulncturar
`Dosage
`Slang;
`%\W\"
`applicable
`Roule-
`Form
`Conrail-m.
`
`olhumln (Man)
`:1 161'
`IM - intronuuculur
`interferon alfaAZI. Ruler-an will {powder}
`Roche leonroriu
`Powder {alorile} vial
`recombinant
`
`Ilbomin {human}
`
`albumin (human)
`
`0 1
`
`0.1
`
`IL - lnlmluionll
`
`interferon ills-2b,
`recombinant
`
`ll'lIIDll A
`
`IM - inlnnmular
`
`interferon urn-2b.
`recombinnnl
`
`lurroo A {solution}
`
`albumin (humour)
`
`0.6
`
`IV - inll'l‘fmlll
`
`mintroplu:
`
`Emir-natal
`
`Ilhumin {tunnel
`
`DA . as
`
`IV ‘ intravenous
`
`slhumin humrto USP
`
`1 ll
`
`W intravenous
`
`unlihemopn'tlic
`{color {human}
`{Furor VIII. All?!
`Ilgluuomo
`injection
`
`Hmnatovl’“
`
`Candace
`
`iloohol
`
`30.5 (NM)
`
`3.0 - 4.0
`
`lV-inrrovonous
`
`Elm-Inside
`
`Vai'osid
`
`6.3 (m)
`
`w . intravenous
`
`10.0
`
`6.8 — u
`
`[M -lul:arrmcular
`
`Irornyronine
`sodium lnjeonou
`ITS]
`oigoxin
`
`Trinmt
`
`Lanoxtri
`
`Schoflna
`Camonlion
`
`Sonatina
`Corporation
`
`Rohom
`moi-rammed
`
`Armour
`Phlnnacoutionl
`
`(Marylou
`Corporation
`
`Bristol-Myers
`Squibb—Dwell)”
`
`Snu’lhKlr'nc Brechnm
`Fhrmcauliools
`
`Powder
`
`via].
`
`Solnn‘on
`
`\‘illl
`
`Lyophilized
`
`Viol
`
`Lyophillzed
`
`ilngle dos: mt
`
`Solution
`
`glass homo
`
`Solution
`
`mulllple dose
`
`Solution
`
`ambervglm m1:
`
`Glaxo-Wollwm
`
`Solution
`
`mpru
`
`alcohol
`
`Ilonhol
`
`Ilcohol
`
`nacho}
`
`.tlcohol
`
`6.! {WI}
`
`3.6 t “.4
`
`1M ~intmouscum
`
`dihydroerautumlno HELP; #5 O
`mosylue
`
`Sandor.
`
`Solution
`
`Impull
`
`10.0
`
`Io_u
`
`-9.5
`
`[M - inummular
`
`pentohaihilll
`radium injection
`
`Rommel Sodium
`solution
`
`Abbott uboraiou'ua
`
`Solution
`
`mpul
`
`til! - 1.1
`
`[M - intramuscular
`
`digoxin
`
`Lanexin Inigo-11o}
`luieuliun
`
`{11m Wollcomo
`
`Solution
`
`ampul-
`
`Solution
`
`start-vials
`
`alcohol
`
`alcohol
`
`Lon
`
`It! In
`
`ILO
`
`IV — intravenous
`
`phonytoin sodium Dilanlin
`IinjectiorlY USP
`
`Parka-Davis
`
`lMdulrar-nuuuur
`
`tutorials:
`Iromolhamine
`
`'l'oradal
`
`Symon Lnborllories
`
`Solution
`
`Tube: cam-loge
`
`alcohol (Flt. Huh!)
`
`32.9 (vrv:
`
`W - inhuman:
`
`alcohol (USP)
`
`0.51 [viii]
`
`4.0 1 0.3
`
`[M . intramusculu
`
`oyoluspcrioe
`emulate tor
`inioolim LISP
`onylocin
`
`Snndlmrnuno 0
`
`Synloclrion 1|
`
`alcohol {USP}
`
`6.1 MW.)
`
`3.6 1 DJ
`
`1M -intrmmuln
`
`Ilphl
`
`aluminum
`
`1 .0
`
`5"] l?
`
`N ~ intramuscular
`
`lMAtnIm-nusmllr
`
`uluminm
`
`$0.000l
`
`IV — intravenous
`
`aluminum
`
`50.014
`
`— H
`
`lM-mmrouscular
`
`alumimun
`
`Ilmnleurn
`
`aluminum
`
`9.1.16
`
`$0.16
`
`$0.16
`
`m - intramuscular
`
`[M - roman!!!
`
`IM - inn-muscular
`
`Sudan:
`Pharmaceuticals
`
`Solution
`
`31:1le
`
`Sundae
`
`Sandor.
`
`Rood;
`
`Solution
`
`mpul
`
`Solution
`
`llTlpuII
`
`Solution
`
`multidoro vml
`
`dihydrurgmlmino Ill-1E. IIS 0 or Dyhdergol
`muylm:
`a
`iniooiion. U59
`mytnlncyulino
`
`Terr-march
`
`Diphthom and
`Tetanus Toxo‘tdr
`and Acolhrlnr
`
`Inlihetnophilic
`flclor (Human)
`
`Diphtheria a.
`Tmnus Tm‘ids
`and Acollulu
`cumb'mnnlion of
`refined tot-rut: a
`diphtheria tension
`refined lcllnui
`onoid
`
`diphlhem &
`Imam Mold: 6:
`Ferluui: Victim
`
`Amidlmunc
`
`Lcdorla Labmroriu
`
`Suspensinrwm mulfidou: vial
`
`Koala @HP
`
`Tripodin"
`
`Tear-tun a Diphlhoria
`‘l’c-mids Adamo (Artur
`
`Tolam Toxuid Adaurlml,
`aluminum
`
`Bayer
`Comerltion-Biulogi
`
`Lyophllmd
`
`single dose outm-
`
`Coomghl
`Laboratories. Inc.
`
`SolutiooJSuspe ml
`
`Luanda Laboratories
`
`Suspension
`
`trill
`
`learle Lthonlorin
`
`Snapfluiiotl
`
`vial
`
`Til-Immune]
`
`thkl'lc Labanlurin
`
`Eunwoaionul‘t moltirloso \‘ISIS
`
`242
`
`FDA Journal of Pharmaceutical Science Er Technology
`
`_.A-
`
`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
`
`:Imninnrn
`
`£1.05
`
`N - intramuscular
`
`hepalilis A vaccine Havrix (nguiiis A
`Vaccine. [naclivarcdl
`
`SmilhKl'ine Bacchanl
`Biologicala
`
`Suspension
`
`single dam.- vial
`
`Diphthnia a Tclmu:
`cornhimtion nf
`puil'icd lellnLLn & Tumidi J: Pmum:
`dinhthcna
`combine:
`diphlhorin &
`minus rnxoida
`cnmbinuion af
`"fined diphlhma
`a: mum maids
`Diphxhum a:
`Tet-nus Tomlin
`Ind Pumsis
`
`Diphthuria a Tetanus
`Toxoida 3: Pmuss'u
`
`Diphtheria in Tallinn:
`Toxuidlr Admired.
`
`Terri-mum, (DTP-Khan)
`
`SmithKJine MPH“?!
`Pharmuulicals
`
`Suspensmn
`
`Vista
`
`Cnnnlught
`Lihunlnrlea. 1:1:
`
`timid Liquid
`
`Vial
`
`Lndcrlu Labunlorien
`
`Suspanainntaf:
`
`vial
`
`lgderle Mbonrnries
`
`Suspensiorflafi
`
`vlal
`
`slurnimm
`
`0.0-1 - u 12
`
`IM - intramuscuinr
`
`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 - inmmmular
`
`[M v intramuscular
`
`IN! - ink-museum
`
`IN: - I'nIram-Isculnr
`
`[M - inmmmumr
`
`aluminum phusphura
`
`$0 2
`
`IM A imramuscnéar
`
`hnmophilua b
`conjugal: vaccine
`(meninmmccnl
`hgpnt'ili: E
`vaccine
`frecum bimnt}
`hepalilia R
`vacnine
`treacmbimnl}
`surolhiogiucasc
`
`imcuvnted CV5
`Kiulinp'MDI'H
`rabies virus
`
`Pcdvulllli
`
`Muck R. Company
`
`Lroiahilizcd
`
`ainglc dnsa vials
`
`Rammbivnx HE
`
`Merck & Company
`
`Suspension
`
`single don Vin]
`
`Engem-B
`
`Solganal
`
`SmilhKline Bmhnn
`Pharmcnulinala
`
`Suspensiun
`
`single arm will
`
`fichcring
`Corpuraliun
`
`Suspension
`
`mullidnse vra.‘
`
`Rabin Vaccine Adsorhed
`
`SmiIhKluia Bantam Suspensinn
`Phalmaceuliuls
`
`vial
`
`unfair: aid
`
`0 3
`
`IM - inhammulan
`
`hcan'in'a A vaccine Hum (liepufilis A
`Vaccim. ImcliVIledl
`
`Smilhluiue Buchlm Suspansion
`Hialegicals
`
`single dns: vial
`
`mom
`
`“.2!“
`
`W - lnlravcnous
`
`ammonium meme
`
`1] 4
`
`-?.0
`
`WI - iumamscula:
`
`'I’riunlnt
`
`alumna:
`
`SmilhKlim Bauhaus
`Phan’mrxiflicala
`
`Suhllion
`
`nrnhervglass viala
`
`Roche Lnbonmrm
`
`Sululion
`
`ampula
`
`liurhyruninc
`sodium iru'eflliun
`{T31
`humcllnide
`
`ammonium hydmidu
`
`SC suboumnauus
`
`panlngunlrin
`
`Ptpluvlnn
`
`Wyth-Ayem
`
`Solution
`
`ampulu
`
`anhydrous citric acid
`
`(ml 75
`
`N - 'mlrau'nmii
`
`anhydlnus aim: acid
`
`0.05
`
`6.3 - 1.2
`
`IM - intramuuulu
`
`limhyron'tn:
`sodium injulicn
`[T3]
`digoxin
`
`Trlusm
`
`Lanwin
`
`SmilhKJLne Bmluam
`Pharmaceuticals
`
`Salulion
`
`amber-gill: Vials
`
`Glaxo-Wellcome
`
`Solution
`
`nrnpul
`
`lawman: nitric acid
`
`3.0 - 4.0
`
`N A inlravemus
`
`dicuhuinc
`
`MIC-Dome Srerilc
`
`Buyer
`CorpummnAFhuma
`
`Solid
`
`vials
`
`znhydmas citric acid
`
`0.03
`
`5.8 - 12
`
`IM -inrran1uscuilr
`
`diguxin
`
`kaolin {Diguxin}
`Iniraflon
`
`61am Wdlnomn
`
`Solution
`
`lmpuls
`
`anhydrous dun-rise
`
`n! S
`
`3.0 - 4.0
`
`N A intravenous
`
`labeinlul
`hydmchluridc
`
`Trandm Injgcunn fl:
`
`Glam Wellcnrrle
`
`Solulion
`
`villa
`
`anhydmux demure
`
`6.5
`
`1.0 - 4.0
`
`IV - intravenous
`
`labelnlnl HC!
`
`Nurmudyn:
`
`unkydmun dextrose U;
`
`[M A intramunzulm
`
`buprenorph‘mc
`hydmuhloridc
`
`Buprcnm:
`
`Schcring
`Corpotaritln
`
`Rankin a: Cuiman
`Pharmauulicfls
`
`Solulion
`
`multidual! vial
`
`Solulion
`
`51m snap-Impala
`
`anhydruiia sodium
`
`is o
`
`0.5 - 1m
`
`IV - inmvenuus
`
`argininn
`
`LEF- — 36.“
`
`4 3
`
`T 5
`
`1M - intramuscular
`
`ascorbic acid.
`
`0.043 - U.AIS
`
`IV - intravrm
`
`Merhohexim
`Sudiurn {or
`irritation
`aztmnlm [or
`inrirzlion
`
`doxycyclinr
`hyclnta fur
`in'reclion
`
`Brev'ml Sodium
`
`Eli Lilly St Company
`
`Fmabdrietl
`
`vim
`
`Axnclam [or Injecliuu
`
`BristAMyar:
`SqurbvaHchugy
`
`Lyiapiu'lized
`
`vials
`
`Vibrarnycirl lnlrnvenuus
`
`Rania
`
`l’uwdlt
`
`vial
`
`Vol. 52. No. 5 f September—October 1998
`
`
`lnnoPharma Exhibit 1105.0006
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Storage
`Dosage
`Manufacturer
`Brand Name
`Drug Name
`pH whorl: Administration
`Cone.
`Exclplenl
`Contain"
`Form
`applicable
`Route
`‘AWW
`'—_—""—_——_—_—'—"—'—‘—"———_—"——-——.
`0.]
`IM - inlmnlueuhr
`Solution
`Impala
`ascorbic acid
`imiplminu
`Turmoil
`Cibafitnn'l
`hydrochloride USP
`Corporation
`
`ascorbic acid
`
`ascorbic acid
`
`uwrbic acid
`
`Islam-hi: acid
`
`0.2
`
`0.!
`
`0 1
`
`H)
`
`1M - inlramuaculvlm chlmpmmazine
`hydrochloride
`
`"l‘hmuinovmwulo
`
`Srnllhfii'lne Beech-II
`
`Solution
`
`umpulu
`
`lM— inhamusculu [loo
`
`chlorpmmuioe
`hydrochloride
`
`Thorm'ne
`
`StrtilllKli’M Benchun
`
`Solution
`
`mullidou vial.
`
`3 J . 4 5
`
`various
`
`SC - ammo»
`
`Marvin: Hydmohloride
`bupivaclinc
`hydrochloride and with Emunhfim
`aninwhrino
`Epinephrine
`
`Sus—phtina I9
`
`Smofi Winthrop
`
`Snlulion
`
`single dose vial:
`
`Fnroal
`Phummulinlx Inc.
`
`Suspension
`
`unpul
`
`ambit: and US?
`
`I). l
`
`I'M - inounlmlar
`
`lhlglhylporlzino Term Gr
`mam: USP
`
`Roxane
`Lobomuriu. Inc.
`
`Solution
`
`maul
`
`upuagine
`
`[VS - iotnvasiul
`
`benzalkunium
`
`0.0:
`
`6.8 — 7.!
`
`ID — inkadonull
`
`banana-Moi: acid
`
`3.25 — 3.65
`
`IV - intravenous
`
`'IICEG: ECG
`
`In annulled liv:
`culture prowl-mu
`ofBCG vaccine
`Calm-i: thllpln
`balnrnelhuonc
`sodium phosphate Susoomion
`.i hummus
`mauudum haylale Tram'um
`
`Organon
`
`Frau-dried
`
`ampulu
`
`Sol-wring
`Curpomlon
`
`Suspension
`
`mullidnie ml
`
`Glaxo Walloon“
`
`Solution
`
`ainflo m vial.
`
`bnmethonium
`
`0.0 - 00I‘
`
`5.0 . 60
`
`IM - lnlramusuulu
`
`diphonhydrsmina may]
`hydrochllxido
`
`Parka Dlvls
`
`Solulinn
`
`ampuln
`
`butmelhoniorn
`
`0.0 - 0.0l
`
`IM - :nlramuscular
`
`bulorplunol
`Immo
`
`Sladol m Injeullon
`
`ApolhoounJBristDI-
`Myers Squibb
`
`Solulloo
`
`vial
`
`hanzyi alcohol
`
`hcnzyl alcohol
`
`1.0
`
`0.9
`
`3.0 . 4.0
`
`lV-lnlrlvenou:
`
`Eloposide
`
`VoPcsld
`
`5.0 . 1".5
`
`Ill-intramuscular
`
`Dllalon: DP. 3‘
`
`Bfislol—Mym
`Squibb-Oncology
`
`Fore.“
`Phumawolicals
`
`Solulion
`
`mullipl: dim
`
`Suspennion
`
`vialt
`
`March a: Company
`
`Suspension
`
`vial:
`
`buzyl nloohol
`
`n 9
`
`5 0 . 10
`
`IM-inmmusnflu
`
`Deumelhamm
`Acml:
`Suspension
`Conisone Aware Conan: menu:
`
`her-12y] alcohol
`
`bowl aimhal
`
`boozyl alcohol
`
`0.9
`
`0 9
`
`0.9
`
`5.0 - 7.5
`
`lM—inlramuscullr
`
`durmcthmnn
`“fill:
`
`monorail-LA
`
`Maul. ll Company
`
`Suaponsion
`
`vial:
`
`6.0 - 8.0
`
`mil - inmanicuhr
`
`Pudnirolooe
`Tallulah
`
`Hyddlra T. 1A.
`
`Moral: a: Company
`
`Suupunaian
`
`vials
`
`5.0 - 1.0
`
`IAR . inn-auricular
`
`Hydmconiaonc
`acelale
`
`llydroeouuno Acclale
`
`Morel: a Company
`
`Suspanalou
`
`villa
`
`bowl IloohoI
`
`0.39-0.91
`
`J 5 - 10
`
`[M - intramuscular
`
`Methylpradnimlu Depo-Mndrnl
`a: mule
`
`The Upjolm
`Company
`
`Summit-n
`
`single dose V111
`
`boozyl alcohol
`
`0.90
`
`bowl lloohol
`
`0. 90
`
`-6.0
`
`~60
`
`IM - inlrarmscular
`
`Ir'nmalnu'lono
`diloGlllfl
`
`Minoan Fun: (P1
`
`Fujlsawa
`
`Minonized
`
`vial
`
`IL - [mansion-l
`
`Idamciuolane
`Giacomo.-
`
`Mimosa”
`
`Fujluwa USA. Inc.
`
`Minonizcd
`
`vial
`
`bonzyl alcohol
`
`0.90
`
`4.5 - 6.5
`
`IL - inmieaioml
`
`boozy! alcohol
`
`1.02
`
`IV - inirawmus
`
`Iriamnlnolono
`hzxmmida
`rum-mini:
`amiodamne Hal
`
`minus-an Slovenian S
`mflml
`
`Fujinwa USA. 01:.
`
`Suspension
`
`vial
`
`Colour.” Intravenous
`(mam: NI
`
`“lulu-Mam
`
`Solution
`
`ampul:
`
`howl alcohol
`
`benzyl alcohol
`
`0.9
`
`1.0
`
`IV - intravenous
`
`Enalaprllar
`
`“some HI.
`
`Merck -& Comm?
`
`Solution
`
`vial
`
`~10
`
`[V - inlnvuucm
`
`midnzalam
`hydrothlorloo
`
`Vmod
`
`[-lol‘rrnan - IARoche
`Inc
`
`Solution
`
`vials
`
`244
`
`PDAJournal of Pharmaceutical Science 0 Technology
`
`lnnoPharma Exhibit 1105.000?
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`sulphur
`Cone.
`pl! when Aomlabrrarlnu
`Drug Norm
`Brand Nun:
`Monulutunr
`Donut
`Storage
`
`
`%WN
`applicahla
`Rouse
`Form
`CoorIIo-r
`59ml uloohnl
`0.0
`N - mun
`hydroxyzim
`Vlmrll
`Rom.
`Solution
`waldo» ml-
`hydraulic“:
`
`hurl alcohol
`
`hem Ilmohol
`
`hm! alcohol
`
`homl oloollol
`
`Maul Iloohol
`
`bum! doom-l:
`
`mml Ila-moi
`
`my] glean-0|
`
`booty} Ila-ho]
`
`0 3
`
`:
`
`(I
`
`a 0
`
`! 1'
`
`J (I
`
`l a
`
`Ln
`
`0.9
`
`LS
`
`1| - 6.5
`
`IN - immoral"
`
`gold sodium
`min-ulna
`
`Mmhmior
`
`m I Cong-Iv
`
`Solution:
`
`sum
`
`1.5 - M!
`
`[M - imam-molar
`
`uliluidw sulfur. Nmmym lmfllwo
`USP
`
`khan“ 3mm Solution
`Commie:
`
`vim
`
`H - )0
`
`IV - loom-um
`
`mam
`chloride
`
`Sum-m
`
`film Waflmo-
`
`Soluiion
`
`mlu‘m rial-I
`
`1M -imramoom
`
`hlnpariool
`doom“!
`
`Hilda! Dec-ml: so and
`loll
`
`Howell
`Phlrnloufliul
`
`Solufioo {in
`
`wool:
`
`-S 0
`
`W~ luminous
`
`tanlporldu
`
`Err-rowan
`Vanna [rimhon
`(‘mnmlo Will-26] WHOM“;
`
`Solution
`
`munda-
`
`49.11
`
`[V ~ inmvonoul
`
`Hirnalhnprlrn and Wu LV. lumen
`aull‘amrthoxlzolo
`
`mun Walk-om
`
`snlnliuu
`
`mulch» m
`
`IM ~ inlrurmamla:
`
`lonrcpnm
`
`AIIUIII
`
`Wyeth-Arum
`
`Solution
`
`smile curl-logo
`
`«U
`
`~10
`
`IMvhm-lumwhr
`
`mothonlmeprmna lwllpmmt
`u w.
`hrdmhlood: all
`
`Immune:
`Corpomlon
`
`Solution
`
`vials
`
`[M -W ohlordiamxlde
`hydranhloride
`
`Ulm'nrw tluoclohlo [1M1
`
`Room Pmlmu. Inc.
`
`Cmullim
`
`who:m
`
`Bowl. “90th
`
`0.945
`
`I'M 413W Insomnia
`hydrochloride
`
`leoelo mule autumn
`
`The ijolm
`Camp“?
`
`Solarium
`
`vials
`
`bowl llmhul
`
`0.9
`
`SC - Mm mlfi lulu.
`
`Luplm Monika
`
`TAP
`911mm.
`
`Solution
`
`mfllfldnu vill-
`
`
`
`bowl almhol
`
`boml alcohol.
`
`I
`
`5
`
`2.“
`
`WI :1th
`
`0-?!
`
`howl alcohol
`
`my] uoollui
`
`hm! alcohol
`
`I 0
`
`I 3'
`
`[.3
`
`n l t I13
`
`burnl doubt-l
`
`0.9
`
`SI)- 10
`
`N - intravenous
`
`Epogonl . mill-dour
`
`Mom In:
`
`mum Duma-
`
`mmmm-
`My“; Squib
`
`epoch]: I‘fl
`{mammal
`III-Iota
`[M . imam “when-tin:
`document
`minnow
`[M — mm Hm helm: Elam Wham-l-
`Em.
`”you Swim
`Injection
`Ill-imam phyumuliom MWIM
`{m Kl]
`
`Solution
`
`omllioou v'nl
`
`Solullolr
`
`tingle don
`
`Solmion
`
`vial:
`
`my! alcohol
`
`fl.“
`
`ICN - Ema-mm!
`
`llpmlldfl
`
`Cumin-I Sunk M:
`
`The Upjohn
`CW“?
`
`From-filed
`
`Vin!
`
`lam! alcohol
`
`howl ole-oh!
`
`mm alcohol
`
`0 ll
`
`2.15
`
`I."
`
`4.!
`
`N — imam Wait acid Main: Mullen, 'L'S!‘ Mum
`Carper-lion
`
`Solmioo
`
`vial
`
`IN - inn-am
`
`populism»:
`"link":
`
`Aalll'lmull
`
`Form
`
`salmon
`
`lupus:
`
`-? 0
`
`EM don-wok:
`
`humurm'do
`
`Ham 0
`
`Rocha Luau-min
`
`Solution
`
`ampul:
`
`hound Ilwhnl
`
`mas
`
`IM . inflammullr
`
`clindamycin
`phorphllt
`
`(moon-I l‘hmpllm 3mm: Tho Upjohn
`Sululion
`(tumour)!
`
`Soiulion
`
`vills
`
`IM —in1rarrmouliu
`
`Ill-2mm
`
`Vallum Momma
`
`Rocha Fromm
`
`Solution
`
`animus
`
`lM - inn-ammo!" (an:
`
`ohlorpromnine
`hydrochloride
`
`Tlmrw'nu
`
`.‘lmlllrxllnu Euchlln
`
`Soiulion
`
`moltidoaa viola
`
`EM — Immoral:
`
`proehlorporuiu
`In tho «Nylon
`
`Complain:
`
`ammo. Bmhuo
`Phammllimh
`
`Solution
`
`vial:
`
`Muck-3W norm“
`
`mu
`
`|
`245
`Vol. 52. No. 5 I September—October 1998
`___—————-—_————r—-——-——=—————'__—W_'
`
`lnnoPharma Exhibit 1105.0008
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Sign“
`Dang:
`Mlnuhelunr
`Bnml Nun!
`Dru: Nam
`pl] when Admlnlnnllnu
`Conn
`Enlplmt
`Container
`Farm
`Ippllnblu
`Rants
`%WN
`————————-———-———————-—————-_——'_-fi
`0 I1
`1M Jamal-u
`Powder m vial:
`bowl almhnl
`cautious
`Funny! S
`inm
`Mil m
`iniwlioll. U5?
`
`hm! “and
`
`my! alcohol
`
`11.9
`
`[.0
`
`bum! W I D
`
`-a.!
`
`In « imam-m!
`
`momma:
`mu
`
`Nahum!- Scam
`lull-ell»:
`
`Imam
`flatworm
`
`Solution
`
`fill-D
`
`'IIIHI
`
`IV - hum lfimw Sam-n W Inlmu
`Mimi
`
`am mum.
`
`Salaam
`
`N - Ilium mum Ind
`mum-ms
`
`Sepia-I W WWI) mun Wm Solemn!
`
`611
`
`vial
`
`Til-I
`
`busy! Ibohnl
`
`u n . m}!
`
`TD . an
`
`[M- lmmnlu Wm: WSWI' PM Tho Uflohfl
`Mun mun
`Company
`
`PM
`
`AWM
`
`hurl llmhol
`
`OLD: mu
`
`1.0
`
`IV — lam-rm
`
`Indium ulna-qr: sum 8
`mm- Weller:
`
`Bum-SIM [as
`
`Satan“
`
`mu]
`
`benzyl llmhol
`
`D H
`
`N - ‘ualnnmscuhr
`
`ulflunpauzlm
`hymhlmldc
`
`Slduln:
`
`SmlIhKllm Hashim Solnilnn
`Phalnuaonums
`
`multiduu ml
`
`bonnyl llama
`
`1a {m}
`
`in ‘ m
`
`W» mmmm
`
`ulhanuluninu
`oluasc
`
`Ethnmllt- a luluallun
`
`50mm:
`Plum-alumni
`
`Saluliun
`
`ampules
`
`bowl Iluuhul
`
`10
`
`W durum
`
`gamdm’elin
`hydroahlul'ldu
`
`me
`
`WreIh-Ayml
`
`Ilwphtllznd
`
`slush 6m Saul:
`
`bum] Iltuhol
`
`all .n
`
`N - mmvmua
`
`hymn nudism
`
`Heparin Lock l'lunlt
`Salaam USP
`
`WyIIh—Mml
`
`Salmlnn
`
`Tm! 3m
`
`hurl limb-cl
`
`3! I)
`
`3.0 . 7!.
`
`IV - mm helm-in mum: Main Sodium human
`USP
`
`“Wells-Aye!“
`
`Sauna:
`
`Mu nails
`
`bony] maul
`
`LL94!
`
`5.0 - 1.:
`
`IV ~ hum helium! Mum HM Milan Noam The Upjob
`Comping
`
`Mule:
`
`vial
`
`any] all-om
`
`I n
`
`W - mun:
`
`min. cull-n:
`
`Eu till! a Comm Solullou
`
`mnlfldm ml
`
`llama 5m human
`491 ml!
`
`“WI limb-Bl NT"
`
`0-0
`
`l i - 5.0
`
`um“. alcohol NF
`
`0.9
`
`:.o - an
`
`W 41mm mm
`”Maud.
`mimic-n USP
`IM - mm lJywpynuluto. W Injulwlo
`US?
`
`Dayna lauutll
`
`A. ll m Sciatic: m «in:
`Cam
`
`A ll. Mu
`Col-splay
`
`Lwald
`
`mnllidun um
`
`hum Ilnnlml
`
`0.90
`
`4.! - 6.5 MR~WMM Imalmlnu:
`ammonium.-
`
`Arman»: snap-won
`20 alum]
`
`Fujmm
`
`Mammal!
`
`vim
`
`hazy! flannel (m n M
`
`3.25 - 3.65 W - inlnvnnmll
`
`“Imam buyulo Tim-hull
`
`Gm Walloon:
`
`Sululinn
`
`sink use will
`
`him] “cabal (In
`
`0.0
`
`0.9
`
`3.5 - 5.0
`
`N — inlay-em
`
`mllrlnlrlum
`uhludde
`
`Mlvumn lluullun
`
`ulna Wullwm
`
`Sulullnn
`
`single dose Null:
`
`bemyl olmhol t m an . 0.9
`
`IM durum-INN mm Lula 0
`
`“mm-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 {we
`
`0.0 - 09
`
`N - mm Sam
`
`Pauli bum
`
`Muck a Emu-y
`
`Salami:
`
`mam uh!
`
`balmy: nlwhl In M w
`
`3 I — 7?
`
`W - mum
`
`apuclln all:
`
`Pswm
`
`(Mm mama. Inc
`
`Sfllnllm
`
`single um: um
`
`ml “HON til.
`
`05 - 19'?
`
`T 0 - 50
`
`MM Ilium
`
`«anon:
`
`urn-am
`
`M -ulinnm:nlir
`
`mlylpfldmolo Sell-Hm Slain
`M Mum m
`mu. USP
`515mm panama name Mom a
`(Mull-d; In” I
`IHIWL ND. }
`typhoid “can.
`
`SC - mums
`
`Typhoid Vanilla U5!
`
`Ill! Uflahn
`Gamay
`
`Conn-ugh:
`MI. I:
`
`PM
`
`Acz-O-vill
`
`Swnnion
`
`ampules
`
`Wynn-6m
`
`Snaps-mm:
`
`with
`
`243
`
`.-
`
`FDA Journal ol Pharmaceutical Science & Technolugy
`-—1—
`
`lnnoPharma Exhibit 1105.0009
`
`

`

`EXCIPIENTS FOR