REVIEW A RTICILE
`
`Compendium of Excipients for Parenteral Formulations
`
`MICHAEL F. POWELL, TUE NGUYEN‘, and LISA BALOIAN
`
`Phomtocrurfca! Research and Development, Gerternrech, Inc. South San Frrmctlsco. CaJt_Tomt'o
`
`Overview
`
`formulation
`The selection of eitcipients in parenteral
`design is oltcn both rational and empirical. It is rational in
`the sense that certain types of cscipients are added to alter
`the formulation properties: it bulTers of appropriate pKa are
`added to control hydrogen ion concentration at a desired pH.
`ii} tonicitiers are added for hiocompatibility. iii) surfactants
`are added wlten necessary to prevent aggregation, adsorp-
`tion to surfaces. or increase solubility, iv) atntioxidants are
`included to prevent unwanted oxidation of the drug. and so
`on. The inclusion of various classes of forntulation 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. On the other hand. however. the selection of the
`
`e.tat.'t citcipieiu used is far from rational; it is empirical in the
`tirst order. satisfying only one question. “Has it been used
`previously in it similar parenteral formulation?“
`Many prototype forntulutions have been terminated be-
`cause one or more of tltc selected cxcipients was not found
`in a previously approved parenteral product. In fact. there
`have been it handful ol‘ eseipients with striking favorable
`properties. such as trehaiose with its ability to confer solid
`state stabilization of several types of proteins. or EDTA and
`its antioxidants by metal
`ion ehelation. 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
`
`dilemnta—whic|1 excipicnts are truly available for use
`(based on what has been used previously). and wlticlt are
`not‘? For example. PEG 400 has been added to several
`parenteral formulations. but What about PEG 1200, or PEG
`4004)’! And at what concentrations. and by what route?
`Sodium citrate is an excellent buffer for many formulations
`at 5 mild, but is too painful in most instances for subcutane-
`ous use at 50 mM. lliglt concctttrations of propylene glycol
`may he used in it slow intravenous infusion. but would
`produce unwanted hcmoiysis and pain it‘ given by subcutane-
`ous or intrnrnusculnr Injection.
`it is often the case that the
`"sale level" of an cxeipicnt may depend on the route of
`adntinistration. These. are only a few examples of factors
`which ntust be considered when designing a formulation;
`there are dozens more based on empirical
`infon-nation
`required for efficicnt formulation design. but thus far a
`
`compendium ltus not been publislted. This review was
`written to till this void.
`
`Herein are listed the cxcipients found in most of the
`approved and marketed parenteral fonnulations. given sys-
`tematically by escipient nantc. In this format it is easy to
`determine what concentrations were used the route of
`adtnirtistratiou.
`the main rationale for addition of that
`
`e-Jtcipient. the tll't.lg that was formulated. the rnanufacturer.
`brand name. etc. The i nforrnation 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 cxcipicnt concentration was often given in
`different units.
`including:
`rngfrrtL.
`rnDs. Molar. sodium
`equivalents. biological Units. Molal. weight percent. etc..
`and provided one of the greatest challenges in putting this
`eontpcndiunt together. We sought to list all the csclpicnts
`(where possible) in common units l'i.c.. mgi‘mL). 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 30 concenuauotts at 00001 M, 0.01% and
`l
`tng/‘tnL:
`fortunately.
`the average molecular weight
`is
`known for most cscipients. permitting a standardization of
`excipient concentrations]. This standardization of excipicnt
`concentrations is perhaps the greatest value of this compen-
`dium. but also represents one of the greatest sources of
`potential error. The recalculation of eitcipient concentra-
`tions. oftcn from scant or nondcscriptivc data, is not trivial
`and there may be an occasional discrepancy despite cross-
`checking with the original
`sources.’ Nevertheless.
`this
`compendium represents it comprehensive survey of paren~
`teral citcipients used today. and is a resource for the
`parenteral fortnultttion scientist.
`
`NOIB3
`
`in putting together this excipient compendium. there were
`it number of points that should be noted. so that the reader
`understands the limitations nrtd assumptions in some of the
`calculations.
`
`1} Concentnttinns are listed in weightfvolunteitv unless
`otherwise noted. in some cases values are listed in volume!
`
`volume‘3{n or the manufacturer did not specify what kind of
`percentage they were using it and in this Case it was assurnctl
`wciglttivolume '-at-.— t.
`2) Sterile water for injection is included W the excipient
`list when used in solution fomiulations: however. in most
`
`Received liehniary ltu. 15i'92l.J\ecepterl for publication June 1. 1998.
`‘Author to whom eorrespotidencc sltouid be addressed
`
`them to nguyett.tue@gene.conI for
`‘if di.scro1\ttnt‘it:s ttrc ittutttl. e-tnttjl
`correction to sulrsequent runtpettdiutns of this nature.
`
`23%
`
`PD'AJo-urnal of Pharmaceutical Science & Technology
`
`lnnoPharma Exhibit 1‘l05.0001
`
`

`

`
`
`cases the quantity or percentage 0|’ 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 eitcipients present in diluent (for
`cxatnple, when it lyophilizcd formulation is diluted with
`bacteriostatic water containing benzyl alcohol).
`In some
`cases, a diluent is supplied that contains several additional
`excipiettts and.
`in the case or provided diluent,
`these
`excipients are Listed in the excipient category and designated
`with at
`in addition to their usual cxcipicnt type {the D
`stand for present in diluent).
`4) If no L‘.)tCl[Jit:t1lS are listed. it means that no eitcipicnts
`were revealed by tlte manufacturer. In some cases. this is
`because there are no excipients in the fonnulation. but this
`should not be assumed.
`[11 some cases.
`there. may be
`eitcipieots 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 ntanufucturer.
`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
`t'ot'mu|ated as salts such that the salt name is listed in the
`
`drug name category {For example-. tnitoxantrone hydrochlo
`ride}. However.
`in the drug concentration category.
`tltc
`concentration of the active component is usually listed (for
`example. equivalent to 2 n1 yml. rnitoxantrorte free base). so
`as to have a correct concentration of the active drug form.
`6] When concentrations of cxcipients 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 itnations only. based on the available information. In
`no way should these ranges be assumed to encompass all
`possible dilution schemes or configttrations.
`‘ll Preservatives (such as hcnzyl 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 [(}~x%). This was to avoid making
`two or more records for essentially dte same product
`configuration.
`8) For drugs that are given as a salt form, the counter ion
`may not be listed as an cxcipiertt. To search for counter ions
`{like sodium or potassium] one may look 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 excipicnt
`section.
`
`9) If a pH value is listed for a lyophjlized product, in most
`cases. it is the pit of the drug after its initial reconstitution
`with diluent. not the pH at lyophilization.
`10) The concentration values given for excipicnts and
`active drug product in lyophilized products are usually those
`present at the initial rcconstitution step. and are not necessar-
`ily thc concentrations present at delivery {often further
`dilution occurs). This applies to solution formulations as
`well. Further, excipicnt 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 tltc manufacturer provided
`the total volume after mixing. this final volume was used for
`calculations.
`
`12) For drugs requiring rcconstitutionfdilutittn, 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
`sortie 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. Many
`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 c-mail them to
`nguye.n.tue@gene.com for correction.
`
`Acknowledgments
`
`This contpendium would not have been possible without
`the diligent work of Miliannc Chin. She compiled much of
`the data, engineered the database. and contacted dozens of
`different companies to ensure that the listings are up to date.
`
`Vol. 52. No. 5 I September-Ootober1998
`
`239
`
`lnnoPharma Exhibit 11050002
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Dosage
`Manufacturer
`Brand Name
`Drug Name
`pl] when Administration
`Cone.
`Eaclplent
`Storage
`Con ulnar
`Form
`applicable
`llama
`'/EWIV
`.jj.
`mllllidnlt: mi
`paravurlebnl
`sarrazania
`Sarapin
`High Cbemital
`Solution
`pun-tum. Pitcher
`Company
`nlant tratiltata
`?rnt-tides Rosa‘:
`teeomrmndad daily
`intake of esaznlill
`Old Tubarctllitn
`
`6.0 - In
`
`W - intrswenaua
`
`5.4% Nephrarniue "
`
`BALD l.l.bUl'l|.Dfl'l¢I§
`Inc.
`
`Solution
`
`31-“! container;
`
`1' .0
`
`ID v inlradertnfl
`
`TU-buwlin. Old. Tina Tr.-at
`
`Lzdzrla Lahontotiea
`
`Solution
`
`disposable
`
`acacia (gum atabin)
`
`1.0
`
`ID ~ imadenual
`
`tuberculin. purified (FPO) Tl-I1: ‘Inst
`protein derivative
`
`Ledarle Lahumlnrina
`
`solution
`
`ll'lUllI"pl.¢-_punGlI.L.':-
`
`Ecol-Ila
`
`Ifltlle
`
`Mflflllfi
`
`Ioelicacld
`
`auatiu acid
`
`at:.t.-I1: acid
`
`acetic acid
`
`acetic acid
`
`acelin acid
`
`mil: acid
`
`0-0 59
`
`4-0
`
`IV’ — inmlwrwuti
`
`naulral
`
`5C - nlhcutaneuus
`
`neutral
`
`SC - stthctalazteaua
`
`0.435
`
`W — int:-avctinua
`
`filgmiirn
`[recombinant
`methimwi human
`LING‘ (R) humor:
`inaulia zinc
`suit:-enai-on
`Lento {L} Purified
`Pail: Imulin Zine
`Suapensiuu. USP
`filodrine
`hrdiachlofide
`
`Ncupogett D
`
`Amati, Inc.
`
`Solution
`
`single diam ti-1:1.
`
`Nuvulin ll! L
`
`Nam Nomiak
`Phartuaaaulinla
`
`Suspension
`
`Lenu: {L} Purified Pork
`Insulin Zinc Suspension.
`
`Nova Nnrdisk
`Pharrttamticalt
`
`Suspension
`
`Yulaplr
`
`Aatra USA,Int:.
`
`Solution
`
`vials
`
`vial;
`
`vill
`
`St.‘ - attlamtanenua
`
`leuptolide actrmi»
`
`Lupron Injection
`
`TAP
`Pharmaceminala
`
`IM - intramuamiar
`
`t:aleiItmin—5aIrnnn Calcimar Iii lnjcctinn:
`Svutlictic
`
`Rhona-Pmlanc
`Rom
`
`IV v intravenous
`
`albumin {human}, Aibuminnt GU15
`35%
`
`6.9 2 0.5
`
`IV - inlnttanaul
`
`albumin [human]
`5%
`
`Albuminnt II}-S
`
`A.i-rntttn
`Pharmaceutical
`
`.l\.I'a'l¢)1l.f
`Fharmaueutiual
`
`Solution
`
`Sulttllott
`
`Suluiiuri
`
`nmltidoaa fill
`
`vial:
`
`villa
`
`Sulution
`
`baltlvs
`
`3.5 — 5.5
`
`l\«‘ - lnlnvattulta
`
`vincristina sulfate. Onaovin in
`USP
`
`Eli Lilly -at Company
`
`Solution
`
`flumucnil
`
`Rntnaziann W
`
`Rutalt: Labotatottas
`
`Snlulion
`
`vials
`
`vials
`
`0.0I
`
`‘-1.0
`
`IV — ll1ll'I\'E!‘Dll5
`
`acutiu lcid
`
`(2.5 (wtw)
`
`SC‘ - aul:-cutantwtas
`
`aoaemlin acetate
`implant
`
`?nIade:: ED
`
`acetic acid.
`
`0.45
`
`3.0 - 4.5
`
`W - Lult-avai-tutu
`
`rnttootaritrune
`hydwaltlnrida
`
`Nuvammnc
`
`Zanrcz
`Pltarn-iaceutitnls
`
`lmniunntt
`Corpfltlllfln
`
`Solid Implant
`
`disposable
`
`Solutitin
`
`rrutltidose triali
`
`aoatln Icld
`
`acfli: Istd
`
`lull": acid
`
`acetic acid
`
`2.5 ~ 11.5
`
`[M - tnltamuacular
`
`ottytootn
`
`Dxytn-oin Injection
`
`Wyathvayaral
`
`Suiuliun
`
`slnriia cartridge
`
`IM — itatramsucular
`
`prumezhazine
`htrdrochlutida
`
`Pltanergan Injlclinn
`larnnultsl
`
`Wyelh-Ayenl
`
`ficilttliun
`
`arupuls
`
`[M -itttt'atn1asculu
`
`-5. 3
`
`IM - intramusctllax
`
`pmmclhnzitu
`hydmcltlofldc
`
`nnaaligmina
`mnthylaulraia
`
`Fhauatgan Ittjectian
`
`Wyeth-Ajftnl
`
`Sultarion
`
`smile caruidga
`
`Piosligrnita lnjutahie
`
`ICN Fhantmautticala
`
`Solution
`
`multidase trial
`
`acetic acid
`
`0.225
`
`[M - iaitnnuamalai
`
`calcitcnin-salmon Miacalein G3
`
`Sandor
`Pltamaacauliunla
`
`solution
`
`Vial
`
`aitaw.-. acid
`
`Acetic acid
`
`5.: - 7.2
`
`It»! - iulrlmusculu
`
`4 0
`
`W - inlxlvenuns
`
`tatanua immune
`glubulin (human)
`Itxirnarllv Incl
`mcuronium
`brurnlde
`
`Hyper-Tel is
`
`Bayer
`Corporation-Bitalugi
`
`solution
`
`prefilicd
`
`Eemmon ""' ltlicsaliun
`
`Drganun
`
`Solution
`
`Illultldnaz via]
`
`Au-lit: acid lampul]
`
`[M - inttamuautilar
`
`leupmlide nectar:
`
`Luptutt Depnl 'l'.S
`
`acetic acid [glacial]
`
`0.2
`
`-1.2 -_ 0 .1
`
`IV v lntravanmia
`
`oclreclide Icnlale
`lnjntzlion
`
`Santlmtatin at
`
`TAP
`Pharmaacutiaala.
`
`Sat-idea.
`Fhltmaneulicala
`
`Lyuphilizcd
`
`siaiglv dim ml.‘
`
`Sulutim-1
`
`ampuls
`
`240
`
`FDA Journal at Pharmaceutical Science a Technology
`
`lnnoPharma Exhibit 11050003
`
`

`

`
`
`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`£‘"|’1'|‘||
`
`"°"* "*4 *0‘
`
`'°'““ """' NF
`
`'"'“"‘ "°“i|||-m
`
`'“"'“' ‘WM
`
`'°°““" indium
`
`(Inna.
`%WN
`
`pi! when Adtulnlalrutlon
`appllcnbla
`Raul:
`us: - lutuxnuiculad‘
`
`Drug Name
`
`Brand Nam:
`
`Mnnutlcnlrtf
`
`tenprouaa mm:
`
`lmrun ucpomnl
`
`TAP
`Phumuuticals
`
`Danae
`I?m-In
`Lvarhiliml
`
`Slflfflze
`Cautnlilcr
`siunle -Me via:
`
`1 D : I: 3
`
`JM — inklnnucullt
`
`oaylucm
`
`Symmwm 0
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`
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`
`Ilfifllil
`
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`
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`
`(IA
`
`40 - 5.0
`
`in! -inu-unmzulnr
`
`pentnocinu Items Talwu: lluacuon
`ftlrfllditi noodle!
`
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`
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`
`cantidxl nude
`
`40 . 5.9
`
`IM - Lunnmscullr
`
`pmuza-nae mum l‘aJIr'uI lmecuou
`Imultldou villi
`
`Scaofi Wnfllm-3'
`
`5°'==5°!I
`
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`
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`
`pm¢_g|ng
`lurdronllluride
`
`Nmnuin
`
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`
`Soluliun
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`an-lpnls
`
`nuoluna sodium
`
`5 I1‘:
`
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`
`gm: mmlmia
`
`Iulnclim
`hydmchlafidc
`
`Puulnclinu llydmclnlunflc Slllufi Winihmp
`15:‘. Soluuan
`
`Salmon
`
`unpuu
`
`‘''''"1*‘
`
`"WNW
`
`'1b""'““
`
`was .
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`
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`
`9.25
`
`<lU.0
`
`mo . 1.:
`
`IV - inlnvennua
`
`anlillumnbln Ill
`thmlnnl
`
`"nuamlsm In on
`
`Bayer
`I'.'nrpumian‘Hinloui
`
`Lronhilir-=6
`
`I-'==x|° 40" ‘N!
`
`5.3 . 7.!
`
`IV . um-Ivgnnus
`
`u-poerin alrn
`
`Prnmt
`
`Orlhn Binleuh. Inc.
`
`salutiau
`
`single ulna: ml
`
`lM 'il'lfl’I.l'«II1sI'.lIJJtl'
`
`Inlnvu 0 lhbaa Vmemn Cons-snughs
`Llboruiau Inc.
`
`Pmcw-dniod
`
`single dose um
`
`“huh thmlfli
`
`51 ll!
`
`IV‘-iumvuwus
`
`Biuclllo W
`
`“mm” (“W”)
`
`=0 '
`
`6.3 t 0-!
`
`I\-'—|nl.I'a\r¢mu.|.
`
`ltuauna Cllotmlln Clutlmgntnlnsm
`Inlnunom
`(lm'na|IIl|'(]'N'I
`
`Jumnut
`Pluwnnoeutioll
`
`B-Inner He!-ilk‘-IN
`1’-'9|'P°¢||l°B
`
`Lyaplnlizad
`
`niuglmtlnue
`
`Ll"°?h“-53"’ mil’ "3' 59'5"
`
`9-04" 0
`
`W iulnvcuusu
`
`Kognnn ii
`
`L3'||P||'I|-3195
`
`liflflfi 50'‘ "113
`
`rlhi-=1 vim
`ptcpumd {rum
`smin
`
`Mllihemophilic
`Fmor
`iusorublnml
`
`“mm “W”?
`
`“W9 ("N-Illilll
`
`sl a
`
`N - Lnlnvennua
`
`mum“ fl‘'''”‘'‘''}
`
`“ 4'1 0
`
`IV — ultra-vauuu
`
`ulmllin {hunuru
`
`n 0963
`I‘: M
`
`IM - Lntrlnnalculn
`
`"bum" ""’“‘"‘3
`
`5-0
`
`IV v LlIlra\'L'|wus
`
`'“’"-"W (Wm!
`
`ca 25
`
`may 2 0.3
`
`nr . u'r'(taw:nnus
`
`'n"""h" tmmifli
`
`0-IE
`
`6 I 1 0.3.
`
`[V - Lntrnvatuu:
`
`nlbmmn [mum].
`
`I o
`
`Ml 1» in
`
`N. uatrmmua
`
`“hm” u'‘'''''“”
`
`1 9 - 3-0
`
`W - ininvqmu
`
`anllheuuophilla
`facllw
`lreznubulafll
`
`aauuauaupluu:
`my (1-lm-mm
`
`uulihnmoglkiua
`{sum
`lmaamhuunnll
`boluleauln Iaaun
`13-99 A
`
`Ilmkinlu For
`injection
`
`npoulin all’:
`tmsnmbinlnl
`human
`
`apoolin nlrn
`lrocomhhuni
`human
`
`immune globulin
`N (human)
`prinmilv lga
`monoclonal
`unlhody puriliud
`human
`
`Balm
`L‘-olpnruma-Bictag:
`
`Koala an?
`
`ikllule W
`
`arm
`L‘nrpumiua~Riologi
`
`l-srnvhilited
`
`urinal! do-I home
`
`Muww
`Illnamuuuuul
`
`Lyuphilixed
`
`single time
`
`Balm ll
`
`Mlcrgan In:
`
`Lynphrilizzd
`
`amp-uli
`
`Abhoinnue
`
`olbboli I-I|:N=I’l!¢|’I#|
`
`I-l’°Fh-353°‘
`
`"'1
`
`spam 0
`
`human, In:
`
`Solution
`
`-finale dun ml
`
`Ep-om.-rs is mullidnne
`
`Amgul, Inc.
`
`Solulion
`
`rnultidmu visl
`
`nnmm ow
`
`Annuu:
`Phlmnmnlical
`
`Lynphllizcd
`
`sinus dam vim
`
`Mnaontm-F -0 halo:
`VIII: (2 Pmuutzod
`
`Amour
`Pknrmawfliul
`
`Lyupbiiind
`
`sins}: ah» will
`
`"°"“"" "“""'°l
`
`i 15
`
`sc - nbunmoua
`
`mlcrfalou has-tb Immm 0
`
`Bonus Lahnrllmies
`
`l-yup!-ilized
`
`-use use vial
`
`“hm” "'"""“"
`
`'
`
`'3
`
`W — lnluvunus
`
`qrzoulqalmrsrus
`immune globulin
`intravenous
`
`l':y1oG-nu C
`
`ModI|nnr.|u:.ln:.
`
`smile: hand
`
`single dam I-LI}
`
`“Mm °"“""'|
`
`'35
`
`SC - nab-nmnaotu
`
`I
`"’*‘“"“" "flimrr
`
`II 5
`
`IM - ummmm
`
`poliovuu nicotine Poliuux 0
`inacrivuad. Int: J
`l.\-la.I:nn-ryl, 1390 1'
`lmecruon III:-Ia. norm» on
`recomhiaanl
`
`Cnunnuuu
`L41:-nmorim. in:
`
`fiugstnsiun
`
`unpwlu
`
`Each: Lu:-onmu-.u
`
`Salutmn
`
`ma
`
`241
`VOL 52. No. 5 : saptamnar--october 1993
`
`
`|nnoPharma Exhibit 11050004
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Exclplcnl
`Cone.
`9|! when Administration
`Drug Name
`Brand Name
`Manulncturar
`Dong:
`Slang;
`%\W\v‘
`applicable
`Route
`Form
`Contain"
`
`albumin (human)
`:1 161'
`IM — inlramuucudar
`interferon alfa-Zn. Roman owl {powder}
`Rnaho Lnlaoraloriu
`Powder falorilel vial
`l‘fl:D1'Ilbi|lIflI
`
`nlbumin {human}
`
`albumin (human)
`
`0 l
`
`0.1
`
`{L I mlrulouionll
`
`mmrfoton all‘:-Eb,
`rzcombinlnt
`
`lnuon A
`
`IM - inlm-nu.scuI.nr
`
`interferon am-2b.
`recomhinnnl
`
`lnuon A {solution}
`
`albumin flttllllnnl
`
`0.6
`
`IV - inlmrounun
`
`oninlrapllse
`
`gnomes
`
`Illaumin flmmoo)
`
`DA - as
`
`IV ~ lnlnw.-nous
`
`albumin human USP
`
`1 ll
`
`W intravenous
`
`amtiliemopl-lllic
`liclor {human}
`{Factor VIII. Alli‘!
`ulglunoraxo
`injection
`
`Hun1aro~l"“
`
`Cerzdaanm
`
`alcohol
`
`30.5 (vim)
`
`1.0 — 4.0
`
`IV"-inrrovonous
`
`Elo-,-Iosidl
`
`\«":FI:sid
`
`6.3 (um.-j
`
`IV - lnuavonoos
`
`10.0
`
`6.8 — 3.1
`
`[M -iruraarrusculat
`
`lioihyronine
`sodium lnjeonou
`ITS]
`digoxin
`
`Tiinsul
`
`lznoxin
`
`Schorin:
`Comoralinn
`
`Sohnring
`Cotpomion
`
`Robe:-is
`Flmnnooulioul
`
`arlnaur
`Phlnnaccutionl
`
`Eknzyirio
`Cbrpnrllinn
`
`Bristol-Myom
`5quibo—Dnoo1og:p
`
`Srn:illIK1i.no Eeechnm
`Fhmnucauliools
`
`Powder
`
`vial
`
`Solofion
`
`vial:
`
`Lyuphilized
`
`vinl
`
`L3:-uphi1!7.od
`
`!l.ll],|.I.' dos: ml
`
`Solution
`
`glass bi‘.-‘lilo
`
`Solution
`
`Inulllple dose
`
`Soluliocn
`
`amlmvglass ml;
`
`Gloxwwullonmr
`
`Solution
`
`lu'.n'p||l
`
`alcohol
`
`Llouhol
`
`nloohol
`
`nloohol
`
`I.loo|1u1
`
`6.! {WV}
`
`3.6 t 0.4
`
`IM -inlmnusculu
`
`dilwdroerauumlno D.H.FL $5 0
`mos)-Ina:
`
`Sandal
`
`Solution
`
`nurpuln
`
`10.0
`
`IDJJ
`
`-9.5
`
`[M — inlumlucular
`
`penlolurhilll
`so-Ilium injoelion
`
`Nzmlmtalsodil-1m
`solution
`
`Abbott LIbora|ou'oa
`
`Solulion
`
`unpul
`
`15.1! - 1.1
`
`[M - i.nIran1u.u~ul.n
`
`digoxin
`
`Lanoxin tlligcuinl
`lnieution
`
`{Hum Wolloouio
`
`Solution
`
`ampul-
`
`slorl-vials
`
`alcohol
`
`alcohol
`
`lD.0
`
`In n
`
`|1.0
`
`IV — intravenous
`
`plmnrtoin Indium Dllanlill
`injection, USP
`
`PIrko—Davls
`
`Solution
`
`lM~iulrm-n1.1n:ul.|r
`
`h‘.lcl'flIIc
`lromozhimint
`
`Tendal
`
`Synlol Laboratories
`
`Solulion
`
`Tube: cartridge
`
`alcohol (P11. I-Iohr]
`
`32.9 two;
`
`N - i.-nuvmnu:
`
`alcohol (USP)
`
`0.61 mu)
`
`4.0 1 0.3
`
`W! - inoanmsculu
`
`oyolosporine
`concamme for
`inioolilm USP
`oxylocin
`
`Srmdlmmuno 0
`
`Synloclnon II
`
`alcohol {USP}
`
`6.1 [vrvfihl
`
`3.6 : D.-I
`
`In-I -inuxmuaoullu
`
`Ilphl
`
`alumimun
`
`1 .0
`
`sf! 1'.’
`
`N ~ inlnu-nusuula:
`
`ll-rl-irilrarnusoulnr
`
`aluminum
`
`£O.CI00l
`
`IV — inrravonoua
`
`aluminum
`
`50.014
`
`— ‘L-I
`
`JM-ullmnusculat
`
`alu.m'unu'n
`
`Ilmulxuun
`
`aluminum
`
`9.1.16
`
`$0.16
`
`$0.16
`
`IM - intramuscular
`
`L\o{ — luunnmsnullx
`
`IM - inrrnrnuooulnr
`
`Snndnz
`Phnrtuaoollaiclls
`
`Solution
`
`Amyul
`
`Smdoo
`
`Sandor.
`
`Roorlg
`
`sululion
`
`ompul
`
`Solution
`
`nmpuln
`
`Solution
`
`rnultidoaz vial
`
`dihydroergoumine D.l-LE. -I5 0 or Dyhdergol
`muylm
`ao
`inioolion. U59
`oxytnlncyulinc
`
`Terruuycin
`
`Diphlhcdu and
`Tomius Toxoidn
`ll'l.I5 Acolhllnr
`
`nntihetnophilic
`flclof (HurIIl1'I}
`
`Diphtheria it
`Tmnus Tonoids
`and Accllulu
`oumbinlnlion of
`ialinod tr.l.uiu: J’:
`diplnl:-eri:
`toxolda
`mined lclonua
`Ioxoid
`
`diphlhcm &
`tourlna lalolds at
`Pertussis Vaccine
`
`Mel-Irnunc
`
`Lcdorlo Labonloriu
`
`SuspensinrL(m mulfidose vial
`
`K:-ate G-HP
`
`Tripodinw
`
`Bayer
`Corporltion-Biulogi
`
`Lropihlllxed
`
`single dose nonu-
`
`Corinmghl
`Labomol-lea. Inc.
`
`solutionisuspc VIII-
`
`Teunun 5': Diphlharia
`To-mdds Ad.Io1‘bed {Mull
`
`Lodarla Laboratories:
`
`Suspension
`
`vial
`
`Tolanua Toxoid Adaurbo.-sl, Lldlrle Lnhonlofin
`aluminum
`
`Suaporuiou
`
`vial
`
`‘l'fl—1inmunol
`
`Loderlc Labosllurin
`
`Burl:-anaiornuft
`
`rooltirluso YISIS
`
`242
`
`PDA Journal of Phannaceutlcal Science E. Technology
`
`lnnoPharma Exhibit 11050005
`
`

`

`
`
`EXCIPIENTS F01-I PARENTERAL FORMULATIONS
`
`Eiicipicnl
`Cnnc.
`pf! where Adnilnlstl"-Ilinn
`Drug Name
`Brand Name
`Manufacturer
`Dosage
`Storage
`
`‘few.-“V
`appllnablu
`Rnutu
`Form
`Contalner
`
`aiuminnrn
`
`0.05
`
`IM — intramuscular
`
`nepalilis A vaccine Havnx (fllpllilis A
`Vaccine. {unrivaled}
`
`Srnilhxline Bccchanl
`Biolngicalh
`
`Suspension
`
`single dose vial
`
`|Ill.|T|i|!I|-I'D
`
`0.0-1 — LI 12
`
`IM - inuumuscuiar
`
`iilun-iinuna
`
`50.034
`
`W — ihll'-ifntlilitllfll
`
`a[IImiI1LlI'I'I
`
`:Iun'|.1'num
`
`alumumnn
`
`aluniinum
`
`aluminum
`
`alurrtinlml
`
`SLLIE
`
`50. I 1'
`
`I1 {J-1-S
`
`-4.1 US
`
`I105
`
`2.0
`
`IM - intramuscular
`
`IM — intramuscular
`
`[M v ininmuscullr
`
`IN! - inlrumuaaular
`
`IM - iniramusculnr
`
`[M — inmmimcumi
`
`iiluminum phusphnrn
`
`$0 2
`
`IM - il'I1I'al1'III.1i:1.I'm
`
`comhination nf
`pi.ui.l'u.-d Ielmiu at
`dinhthciiu
`combine:
`diphlhoiin &
`mums rnpmida
`cnmhinltion af
`refined dip|l|II:l'il
`J: lcllfllfl loxaids
`Diphxhuia an
`Teuinus Toxoisls
`nnd Ptnussis
`immmphilua I:
`conjugal: vaccine
`tmenillmcaccnl
`hepatitis E
`vaccine
`trzcumbinanti
`hcpklilia R
`vaccine
`frecombinnnll
`isuiolhiugiucasc
`
`inactivated CV5
`K.iulirI|;I'MDI"H
`rabies virus
`
`Diphthfliu .1 TCIUPLII
`'1‘i.u.uiu!.i & Paituuis
`
`Smitlsfiline Bee-nburn
`Pharrnateulicals
`
`Suspension
`
`vista
`
`Diphthuria ai Tetanus
`Toxoida 3: Pertussis
`
`Cnnnaught
`l.II'.-unlnrl-ea. Inc
`
`Tuflaid Liquifl
`
`vial
`
`Diphlhmia ii Telumx
`Toxuidn fiidsurbad.
`
`Luderlu Labunlolien
`
`Suspanlinrflafl
`
`vial
`
`'1'¢iriiniunc, (D'l'P-Hboria
`
`Ix.-dcrle I-flbflllfflliei
`
`Suspansioriiafi
`
`vlal
`
`Pcdvulllli
`
`Muck & Company
`
`Lyophilizcd
`
`oinglis dust: vials
`
`Rcoornbivnx HE
`
`Muck -Q Company‘
`
`Sllspensu-I1
`
`single don vinl
`
`Engi.-n.1vB
`
`Solganal
`
`Simili1Kline fltechml
`Pharraacnulicala
`
`Suspension
`
`single dim vial
`
`fichering
`l':n|'puraliun
`
`Suspeiisinn
`
`muliidnse via.‘
`
`Ration Vnminn Adsoihi.-:1
`
`Smilhifluic Beecharn
`Phalrnaeeuliuls
`
`Suspensiian
`
`vial
`
`uutiiin acid
`
`0.3
`
`In - inriainu.-aculan
`
`Illpniilii A vaccine HIVFLK (H!.‘pI'Lili§ A
`Vacciiu. Inaciiviiledi
`
`Sn1iu-iK.|iue Bnechiim
`Hialogicals
`
`Suspansion
`
`single dns: rial
`
`Imrnumn
`
`11.21‘!
`
`N - inlraw,-nous
`
`ammonium meme
`
`D.-1
`
`-'.?.D
`
`WI - iulflrnilscular
`
`'I':iuiiInt
`
`Bumexai
`
`Smilhiclinc Bocchan:
`Phamiacciuicala
`
`Sulillion
`
`arnliervglais vial:
`
`Roche Lnbonlltrici
`
`Snlulion
`
`ampuln
`
`Iiurnyrunin:
`sodium iruealiun
`{T31
`humclirlide
`
`unmonium hydzmidn
`
`SC subomnnauuoe
`
`pianlnginlrin
`
`I"v.-pnivlnn
`
`Wyclh-Ayers:
`
`Solution
`
`anlplllel
`
`ulhydruu citric acid
`
`0.0! TS
`
`N — inlravi.-nmis
`
`anhydlnus cinrin acid
`
`0.05
`
`6.2- - 1.2
`
`L'\-1-intraruu.n:1.1hI
`
`liouiyronine
`sodium irijaclian
`[T31
`iligolin
`
`Triusliir
`
`Lanuxin
`
`.‘im'iIhKJ!.ne Beocliam
`Phltrnacaulioals
`
`Saluiion
`
`amber-gm: vials
`
`Glaxo-Wellcome
`
`Solution
`
`In-ipul
`
`lnhydruus citric acid
`
`3.0 - 4,!)
`
`N - inlmrennus
`
`dacuhazine
`
`DTIC-Dom: Sietilc
`
`Buyer
`Corpumion-FhI.rma
`
`Solid
`
`vials
`
`znhydmus citric acid
`
`0.05
`
`5.8 - 12
`
`IM — inmimuscuinr
`
`diguxin
`
`Lanoitin [Diguxim
`Inil.-cilorl
`
`maxi: Wdlnomn
`
`snlution
`
`llnptuls
`
`anhydrous dextrrisc
`
`-1 5
`
`3.0 — -1.0
`
`N - intravenous
`
`lnbmlul
`llydmchlulidc
`
`Traiidine Injaunn -3'
`
`Glam wellcame
`
`Soluiion
`
`vinla
`
`anhydrous dextruse
`
`6.5
`
`1.0 — 4.6
`
`I\--' - intravenous
`
`iabelnlnl HC1
`
`Nsirniadync
`
`urilrydmun de:In:.'u:i:
`
`5.0
`
`[M - intramunzulzr
`
`buprenorphinc
`Fnrdmushloridc
`
`Huplcnfl
`
`Schcring
`Corporation
`
`Rankin £2 Colman
`Piianmueulicais
`
`Solulion
`
`muitidosc vial
`
`Soluiion
`
`glass snap-u-npuls
`
`a.|'I1'|)fd|'DItl aodmns
`
`is 0
`
`0.5 . 1[.o
`
`IV - inmivenuus
`
`argininn
`
`LEI‘: — 36.0
`
`-I 3
`
`T $
`
`1M - tnmmusculni
`
`ascorbic acid
`
`0.0-18 - Um”
`
`N - inlravrnous
`
`W.-rhoheziini
`Scidium tar
`inicctinn
`Jmrranam IO:
`irurzlion
`
`doxycyclinr
`hyclnta fur
`inieclion
`
`Brevitnl Sodium
`
`Eli Lilly 3: Company
`
`Ffttitvdlifll
`
`vi-115
`
`Axiclam fur Injeclinu
`
`Bris:cIJ-Myers
`Squibhvoncolugy
`
`Lyiipiiilizad
`
`vial!
`
`Vibiamycin lnlrnvenuus
`
`Rania
`
`Puwdar
`
`vial
`
`Vol. 52. No. 5 i‘ Sep1em|::ar—0ctober 1998
`
`
`243
`
`
`lnnoPharma Exhibit 11050006
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Storage
`Dosage
`Manufacturer
`Brand Name
`Drug Name
`pi! wlaa-re Admllll-slrnllon
`Corlc.
`Exclplenl
`
`
`
`
`FarmRantsapplicable°x.w.rv Containm-
`0.]
`ll»! —inlr1n1IueuLIr
`Solution
`uoothio acid
`irnipmninu
`Tufrlnil
`Clbafirnzvl
`Impulg
`hydrochlnrirle USP
`Corporation
`
`ucorbdu acid
`
`ascorbic mid
`
`I.l.::uttl'c aid
`
`Isnurhic acid
`
`0.2
`
`0.2
`
`0 1
`
`I.0
`
`1M - inlramusculatlsne
`
`chlmpmmazine
`hrdroclulnrinia
`
`"!‘hu«n:ino—ImpuIn
`
`Srrulnfiilna Beecham
`
`Solution
`
`arnpulu
`
`1.\{— i£|lll1!'l1J-|‘¢Illll[lO|!
`
`clllorpromuine
`hydronlllnride
`
`Thoruine
`
`$fl.'tl|ltKl.i!|Il Beochun
`
`Solulinn
`
`mullidou vial:
`
`3 J v 4 5
`
`various
`
`SC - subcwtanooua
`
`Maruine Hydrochloride
`bupivnclinc
`liydroclilnride -Ind Wltll Eflilifllflllfinc
`enineohrina
`Epiwrplltina
`
`Su$—pl1Iirna I9
`
`Snnufr Winthrop
`
`Solution
`
`single dose \-‘rat;
`
`Faro.-al
`Pllmnmceusicals Inc.
`
`Suspension
`
`arnpul
`
`ucmbjr: n:.l.d U5?
`
`I1. I.
`
`I'M v I'1IIrIInII:r.ular
`
`rhlalhylpnrlzlne
`rnnlotc USP
`
`Tnrnun Q
`
`Roxane
`Laboratarias. Inc.
`
`Solution
`
`mm]
`
`uparagine
`
`[vs — intnvasiall
`
`banznljrunium
`
`0.03
`
`6.8 — 1.!
`
`ID — inlradennal
`
`bennneamonin acid
`
`3.25 — 3.65 W - intravenous
`
`TICEGI BEG
`
`In atlv.-nualad livr
`culmtn pl!Pl.|’-I.l.lOrl
`OIBCG vaccine
`balnrnclhuonu:
`sodium phosphate
`.£ heumelhamna
`mauurium hetylale Trnniiurn
`
`Cclemona Sllluipln
`Susoonniur:
`
`Organon
`
`Freer»-dried
`
`lrnpulos
`
`sobering
`Curpomion
`
`Suspension
`
`nlullidnse vul
`
`Glaxo Welloome
`
`Solution
`
`airlgle use vial
`
`bnnzathonium
`
`0.0 — oo|-
`
`5.0 - 15.0
`
`IN! - ll|lr.lllllI3I:I.I.lI.r
`
`diglhenhydrzmina
`hydmahlutlda
`
`Ilcnadryl
`
`Parka Davis
`
`solulinn
`
`ampulas
`
`butumhoniurn
`
`0.0 - um
`
`IM - unlramuscuiar
`
`bulnrphanol
`Immu
`
`Slndnl Bl Injeulinn
`
`ApoIh¢ounJ‘BristoI-
`Myers Squibb
`
`Solution
`
`vial
`
`hanzyi alcohol
`
`In-.-nzyl alcohol
`
`1.0
`
`0.9
`
`3.0 v 4.0
`
`W-intravenous
`
`Eloposide
`
`WPI.-.sid
`
`5.0 v 15
`
`lJ|-I-intramuscular
`
`Dalalonc DP. 3‘
`
`Bfislol-Mym
`Squibb-Oncology
`
`Fates!
`Pharmaceuticals
`
`Solution
`
`mulliple dose
`
`Suspennion
`
`vials
`
`Suspension
`
`vial:
`
`banzyl nloahol
`
`n 9
`
`5 0 - 1.0
`
`IM—inlramus::ulu
`
`Deaumelhasom:
`Acalala
`Suspension
`Conisone Aware
`
`Cs:-none acelau:
`
`March a: Company
`
`henzyl alcohol
`
`benzyl alcohol
`
`benzyl alcohol
`
`0.‘)
`
`0 9
`
`0.9
`
`5.0 - 7.5
`
`lM—intrIn1I.I.5¢1IlI1'
`
`dnxlmnthuunn
`ICBIIIC
`
`Deoldrnn-1.:I\
`
`Mm}. -k Company
`
`Suaponsion
`
`viii:
`
`6.0 - 8.0
`
`M11 - inmsanicuhr
`
`Prudnlsulone
`Tehullln
`
`Hydtllra T. B. A.
`
`Mernk st Cmnpany
`
`Suspunaion
`
`vials
`
`5.0 - 1.0
`
`IAR v inlraartieular
`
`Hy-draconiaonc
`meme
`
`llydrocnuunu Acelal-e
`
`Merck & Company
`
`Suarpanaiola
`
`villa
`
`bennyl Ilnohnl
`
`0.89-0.9.1
`
`J 5 - 10
`
`[M - intrmmsouhr
`
`Melhylpminisulu Depo-Mndrnl
`nu mule
`
`The Upjohn
`Company
`
`Susplnaion
`
`single dose Till
`
`benzyl alcohol
`
`0.90
`
`bcnxyl llcohol
`
`0. 90
`
`-6.0
`
`~6.0
`
`IM — inlrarnnsculnr
`
`Immalnulone
`dinoelalo
`
`Juinocorl For1¢(P‘]
`
`Fujisawa
`
`Miptuniaed
`
`vial
`
`IL - lwaleaional
`
`manncinolane
`|§il¢t|a|i‘.'
`
`Arialonau
`
`Fujluwa USA. Inc.
`
`Minrnoizzd
`
`vial
`
`benzyl alcohol
`
`0.90
`
`4.5 - 5.5
`
`IL - inlniesioml
`
`banzyl alcohol
`
`1.02
`
`I‘-‘ - inzravamus
`
`Iriamninnlone
`h:xaI:e1ooida
`|u.I1'.HIn:lon
`amiadamne Hal
`
`Amrcupan Suspenaion S
`|I1fi|l|l.'|l
`
`Fujinwa USA. the.
`
`suspension
`
`vial
`
`Coidarmia Intravenous
`tcordaxoru: NI
`
`Wycih-Man:
`
`sululion
`
`an-ipuls
`
`benzyl alcohol
`
`bcnzyl alcohol
`
`0.9
`
`1.11
`
`IV — intravenous
`
`Enalaprtlat
`
`Vasmec HI.
`
`Metal 4% Cornpuny
`
`Solution
`
`vial
`
`~10
`
`IV - intravenous
`
`ruidazalarn
`hynfmchlotlou
`
`Vmnd
`
`I-l¢:lTrnan - Lllloclae
`Inc
`
`Solution
`
`vials
`
`244
`
`PDAJourna| of Pharrnaceutical Science 8. Technology
`
`|nnoPharma Exhibit 1105.000?
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`Eu-lplonl
`Cone.
`pl! when Admlabtraunu
`Drug Nam
`Ilnnd Nun:
`Msmllamnnr
`Donut
`Storage
`
`%\WV
`appllcabla
`Runs:
`Farm
`Canullur
`0.‘!
`1M - inlrinnlscnlu
`Soilalifln
`mu,lu',dn|o um.
`
`bcnayl ulwlanl
`
`hydmxyzim
`hydmclnlomln
`
`Vim:-1|
`
`ltoerig
`
`hurl alwhnl
`
`heufl Iltuhnl
`
`army! ulmhol
`
`bomnrl cloolml
`
`I1-emu‘! Ifaohol
`
`bunnrl tlouhui
`
`nanzyl mulqol
`
`bmzyl Ilmh-ol
`
`Imlryl Ilfltlhfll
`
`I) 3
`
`; 0
`
`0 0
`
`I 1'
`
`J 0
`
`1
`
`III
`
`1.0
`
`D.'3
`
`L5
`
`1| - 6.5
`
`Ill — l gold sotlium
`Ihinuulnn
`
`Mtfihmiu
`
`Man 1 Cumguur
`
`Solution:
`
`augnll.
`
`1.5 - an
`
`[M - imummuhr
`
`uliluicln sulfur. Nlisollayr-In l.1I_|-mum
`U51‘
`
`schmu liloclum
`Comontioa
`
`Solution
`
`vials
`
`H - 30
`
`IV - lnuzuunnus
`
`dmmnimn
`chloride
`
`fin-unis
`
`Glue Wallmnu
`
`Solution
`
`mlllidane ria-I
`
`N -imrauusculu
`
`hulnparidal
`decuocn
`
`HIIJ01 Deunnn: $0 and
`I00
`
`M:.‘1Taa'1
`Phlrnnouflinl
`
`Snlulloa {in
`
`utapuls
`
`-5 9
`
`W~ inn-nvenaua
`
`tanipuidu
`
`Vuunu lrdnclton
`Cmloonuilu WM-26'!
`
`Bn|!ol~.\vfyu-5
`SqI.Iihh«0non!axy
`
`Soludnn
`
`nmpldqn
`
`40.11
`
`[V ~ intravenous
`
`nilnalhnprlrn and
`auI.|‘amtLbaJ:Izo|v
`
`llama !.V. lnllallon
`
`mun Wallcumo
`
`snlmiuu
`
`rnullklole vi-L15
`
`IM ~ inlrurmacular
`
`lomepum
`
`Almn
`
`Wynn:-Aynn:
`
`Solufiml
`
`smile clrrrldgo
`
`--L!
`
`~10
`
`IMvhm1m1.m:u.1.nr
`
`mozhorrunepnanne I-wnprunlt
`at um
`hrdrothlnndz an
`
`Immune:
`Corpomlon
`
`Solution
`
`rials
`
`[M - iulruuuuultr
`
`oltlutdilnpvsnde
`laydnonhlnride
`
`Ubtiuw tinsel-Able [IM1
`
`Emlyn Pmelmu. Inc.
`
`Cnrstlllinn
`
`unbar ulzpsia
`
`Hanuyl tlaolwl
`
`0.943
`
`I'M -lntnnnnaculu
`
`Iincnmyein
`Ilydrochlanridc
`
`Lluenela mule aohnlml
`
`Tb: Uyjohu
`Cmnplnir
`
`Solulinn
`
`vials
`
`bcntyl tluuhul
`
`0.9
`
`SC - mhmhnnu
`
`Iaupldldu mums
`
`Lupcm llaiunlina
`
`TAP
`Plmlanooutlclll.
`
`Solution
`
`mnlfldnw vlnl
`
`bauyl alcohol
`
`an
`
`ICN - iIlI|cI1r:'rnm.Il
`
`I.|,pmlIItl.f.I
`
`Cnvcqu-1 Sunk hunk:
`
`-6.!
`
`N — isunvmun
`
`nninoupcoit acid Main: nuuunn. 1:5!‘
`
`IM - inlnnumalu
`
`phywsligtnma
`nlicylan:
`
`Aaillinlull
`
`‘Illa K.-'p[nlnI
`Company
`
`Iuununn
`Cnrponuan
`
`Fotul
`
`Flute-¢'ued
`
`win!
`
`Sulmiou
`
`vial
`
`In-nlulion
`
`Impala
`
`-? 0
`
`EM—i
`
`bumclnnidu
`
`Human 0
`
`Ruth: Ldm-swim
`
`solution
`
`unpul:
`
`honauyl nlwhnl
`
`0.9-I5
`
`IM - inltnn-umular
`
`clindamycin
`phaaphnlt
`
`ltlnocm Pluuphuo an-mu: Thu Upjohn
`Sululiun
`(Eumpuui
`
`Sulunon
`
`vinls
`
`Inuyl nleohul
`
`bonxyl 1|:-ulna!
`
`bwzyl alcohol
`
`0 0
`
`2.0
`
`LI:
`
`basucyi nlmhnl
`
`helm:-I alcohol
`
`I
`
`5
`
`2.“
`
`hnzyl alcohol
`
`0-?!
`
`hluyl Ilullinl
`
`lmuyl unllui
`
`Inn}! alcohol
`
`I 0
`
`I 3'
`
`[.5
`
`IM —in1mrum:uIiur
`
`diuzupam
`
`Vlllllfll lujamblo
`
`Rocha Frochm
`
`Solution
`
`ampnls
`
`Dual - inlmnnscullr (am:
`
`uhlorplorruai-.in¢
`hydnchlnrida
`
`Tl1nru.I'nu
`
`-‘lmillukllnn Eucham
`
`Solulion
`
`mulridna-9 viola
`
`EM — Imnamnusmr
`
`pruehlnrporuine
`1: lb: aulltylm
`
`Cnmpnina
`
`Sn-nlrhlflhto Bemham
`Pharmnocllbc.-all
`
`Solution
`
`vial:
`
`n I t 0.5
`
`N - inlrav-mam
`
`[M - inlnnnscular
`
`Dr! — hmllunauntu
`
`npaelin :11’:
`{ |
`lluntn
`tllpheuutim
`dacannclt
`Inilclion
`fluphmuinc
`Elmllhuc
`Inicelion
`pliytnnuliem
`{vlumm KI)
`
`Epogonl I Imllnhnn
`
`Arngan l.|l‘—
`
`Solution
`
`mullidose vial
`
`Pmlixsu Duuumr
`
`Proltnin Ennlhm
`
`Apulhawuflrialoh
`Myan swifhb
`
`&p¢IJnw|vBmI.ul-
`Hyuu Sopihb
`
`Snlullon
`
`mule don
`
`SolIl.li|:n
`
`vial}
`
`Mumwhulm
`
`Murat-kcmapnny
`
`aquamu
`
`nnwls
`
`bcuylsleolsol
`
`0.9
`
`50-10
`
`1M—im'ums-chin
`
`Vol. 52. No. 5 I Septamber—{)c1oher199B
`
`245
`
`lnnoPharma Exhibit 11050008
`
`

`

`EXCIPIENTS FOR PARENTERAL FORMULATIONS
`
`stung»
`Dnuge
`Mlnufselurur
`Brunt Nam:
`Dru; Nam:
`all when Admlnlslrnllnu
`Cone.
`Enlplmt
`
`
`
`
`I-‘nrmRentsIppllcnblu%WJ'V Container
`D -1
`‘IN -iannnxmulu
`Fowder
`haul Ilmhnl
`cbnriounc
`Prvgnyi SI
`Olpnnu
`uI'III|$d-he vials
`gumdotlupin lb:
`iniiltlioll. U51’
`
`‘
`
`bray! Ikohul
`
`um-n nlmaol
`
`hurl alcohol
`
`11.9
`
`l.lJ
`
`I
`
`ll
`
`-5.!
`
`In ~ imzurlciul
`
`Iuafiunnuama
`wmn:
`
`Mlthnuulk Sandman
`[alumna
`
`Ilmluw.
`Carunruioa
`
`SUI-Illiflll
`
`-mu
`
`IV - latnwnuu
`
`-IIIUI
`
`N - Iunvulau
`
`|!i.I'n9l.bopri:I.I!I!
`wlfiuulhnuoic
`
`Imnilhnpnni Ind
`sulflnaclhuulznlc
`
`squn IV lnlmu
`
`mun fifnileaulc
`
`Snlntiol
`
`sepia: W anamunu
`
`Gino Ndleum
`
`Solulim!
`
`Ifill
`
`vial
`
`will
`
`bunt Ileohnl
`
`0 I1 . um
`
`1.0‘ 8.0
`
`|IM- i Esydromniwnu
`Mann macclulr
`
`Sal»-I'.‘4:flII5%GIi!I ‘Fault.-r Tho Uflahn
`Company
`
`Palvdu
`
`Act-O-Hill.
`
`huatyl alcohol
`
`I102 mu-j
`
`1.0
`
`N — mmvuums
`
`sodium lulmiuarl
`mtmu Iqfeclion
`
`Sulrulocol I
`
`Elluln-Sin: