ON
`
`
`
`Mylan v. Janssen (IPR2020—00440) Ex. 1024 p. 001
`
`

`

`Ansel’s
`
`Pharmaceutical
`
`Dosage Forms and
`Drug Delivery Systems
`
`ElGHTH EDITION
`
`Loyd v. Allen, Jr” PhD
`Professor and Chair Emeritus
`Department of Meéicmal Chemistry and Phamaceutics
`College of Pharmacy
`University of Oklahoma
`Edator-in—Chieé
`intemabomlJoumal of Phamaceutical Compounding
`
`Nicholas G. Popovich, PhD
`Professoi' and Head
`Department of Pharmacy Administrator
`Co legs of Pharmaty
`Un varsity of Illinois at Chicago
`
`Howard c. Ansel, PhD
`Professor and Dean Emeritus
`Ca iege of Pharmacy
`The University of Geargia
`
`A lewwwglmggémNS
`A Mm Ilium t my
`V
`"
`PM
`. him. - i
`r
`-
`am": . MWm. WM;
`
`Mylan v. Janssen (IPR2020—00440) Ex. 1024 p. 002
`
`

`

`Drslyaer [Jung 5mm]!
`i‘mnpmitw. Flirt: (5mm mum. H!
`Prmm Dam Rtprmka‘lluns (mp,
`
`Lopyrigiu 0 2W: 1 Ippfinwu “fillimm L! W :lklm
`351 Wm (.me Street
`Baltimore. MD 21201
`
`530 Walnut Sine:
`Plailatlrlphia PA 11mm
`
`Ml righK mn‘cd. This basil is pram-red by cupfi'tmht. Na pm 02' this book may be rcproducfll in my
`:mm or by my means, including phulocqmng. or utilin-cl ll} nm' mlurmmion slang: ind Rlfltvll sys-
`u-m unlit-m m rium perms-gum from 1hr mpmghl mrncr.
`
`TE".- publisher is nu: :mmmsible us a mnlm exl product habilil}. urgligmce. L'll' ulhflwlse) im‘ any inim'y
`resulting from my malcml nmminul hm-m Thi§ publauuiim mmnim inlmmtian «111anqu general
`przmipies ml medium: can: Elm almuld no! ha- rmmrued as specific insimcxmns for individuul pllicms
`Manufacturers ptoduct infanmmm and package mums should he mfiewcd for wrrem inlurmulinn! in-
`cluding umzfaindicaunnx (lungs. and :asruamlons
`
`Puma! m illr 1 1mm} bluffs a] 4mm; 1.
`
`Library of (was Cmalaginglnal’ublir-im Bun
`
`Allen. Layd \
`Ansel} pharmacrmk'nl dosage: lcrma and drug “(livery systems i Loyd V Alix-n IL. Nicholas 5.
`Papa“ sci/L Howard C‘ “Mlxfllh rd
`p .rm.
`Ru Ld cl: Phamuceuxml (“Mgr forms Emil :lrux delncn ~stth J Howard (A Ansel. Loyd VI
`Mic-".13.. Mchnlat G. Popuvich. 71h $1.129?“
`-
`hwlucli-s bibliogupi’ucal :eftrmccs and Index.
`2583 iii-$174611 4
`l. ‘lizlef I‘hirmacuuticsl dosage {arms and drug
`1 Drugs , Dung: forms 2 Drug dc!“ tfl‘ warms.
`[Murry aplcmq ll Mun-".11“ Sultan“;
`ll: mm". “mun! I'M 1'43)- IV. AmlJlownrd L, 19!)-
`l’lumm cum-ell dumge fun-ax and drug drlixer) iyswms. V Tails
`um \i- 1_nssugeh1rn;s 2 llrugliclucn Systems. Q\ 783' .Hl‘lnlflo'll
`R5200 A5? 3004
`M ‘5 . l—dcl).
`
`20040+8276
`
`Thr publhllm law-v mack mm (flow In new flu: mmright hold”! you bummed martial. 1! thin have mad-
`\‘crtmth in'e'rlmlks'cl (my Ilm hiil hr piruml m Ilmln' (Hy rim-sun} m mngrmems at Ih: fin! uppwmnltv
`
`1:; puxclmc addlssuml mpws nl (Ilia. him, mil our custumm sen m- écparlmem at (903) 638-3030 or
`in: min». in {301) 82+7590r lnlcrnazimu: cuss-mus should all {301) 714-1324"
`
`llup:lim~w.LWW.cm Lippincan Willlums 8|:
`Visit Lipflnmrl Williams 6- Wilkimz an lin- Imcmu;
`Wllkms guslamer sen-inc repEeM'nlam rs an avmlahlr from S'k‘ am In (3:08 pm. FST.
`
`05600706309
`12315678910
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1024 p. 003
`
`

`

`S E C T! 0 N Vi :
`
`Sterile Dosage Forms and Delivery Systems
`
`
`
`
`
`INJECTlGNS .......... l ...........m
`Parenteral names of
`Administration 1 .............444
`Intravenous We
`.4“
`mtmmuscular Rom
`. .447
`Subarunmw flour:
`. ‘448
`mn'adermal Rowe
`. .443
`Specialized Access . . .
`.4418
`Offklal Types of frijtcflons ........«a
`501mm and \Mxlclcsfor
`lnjectiens ...................450
`
`_ . . .452
`”mamas Vehicles
`Addnd Substanm ......
`. . . .457
`Methods of StarElation .........453
`Steam Stefilolmtinn ...........458
`90' Heat Sterilization .........459
`Starfiizatr‘pn by Filtration ......460
`GasSterih'zatlon ..............‘62
`SW23lion by Ionizing
`Radiation .................452
`Validation 0f Sterility ............463
`W"! W WEI"
`Testing ...................463
`The Samaria Preparation of
`hunters: Products ...........454
`hanging, ubellng, and Storage
`of lnhalons .................468
`Quallty Asurancn far Pharmacy-
`Fmpamd Sterile Prndum ......475
`Available Infections . . ‘ ..........476
`LDVOLUME PARENTEML’! ......47T
`hsulln Injection (ngularl ........483
`Human Insulin ....... . .........484
`“Sam insulin Salmlan ...........as
`
`insulin mm ............ 1 .....485
`lsophmn Insulin suspensien
`(MPH Insulin) ................“6
`Whine lmulin Susperxlon and
`insulin Inlecflm ..............4E6
`Humalog Mix ..................487
`Insulin Zinc Suspension .....
`Insulin Glargine ........ . ...... A8?
`Extended lman Zinc Suspensian . .488
`insulin Infusion humps ...........488
`LARGE-VOLUME PMENTEMLS ......4!9‘
`Maintenance Therapy . . a a . .. .....£90
`neplacemmt'fheapy M,
`Water Requimment .............491
`Hectmlytn Requirement
`Caloric Requirements . .
`Farentnra! Mutrltlen .
`Enteral Numtion ...............495
`lntrwenuus lnfusicn Devices ......436
`SPfCIAI. CONSlDERATa‘DNS
`ASSOCIATED WITH FARENTERAL
`THERAPY .....................497
`LaobAlike Proéucu .........
`Adsorpilnn of Drugs .............499
`Hmdllng and Disposal of
`Chemotherapeutic Agents for
`Cancur ......................500
`OTHER INJECTARE PRODUCTS:
`PELLst on lMPLANTs ...........5m
`Lwonnrgnmel Emplnm:
`iRRlGATlON AND DIALYSIS
`SOLUTiONS ...............501
`
`Irrigation Solutions .
`Diilysis Sohnicms ...............592
`
`
`
`’4‘!”..._V
`
`Mylan v. Janssen (IPR2020—00440) EX. 1024 p. 004
`
`

`

`Cation mph-use:
`
`H—rcstn A? \i‘ i x- i H10»:
`M—rcsin + H‘ + X“ + 11:“ (pure)
`Anion exchange:
`Resin-NH: + H” + K * ”((1.4
`Resin-NH, ' HX 1- “:0 (puns)
`“am- purified in this manner. refined w 1:.
`.lmtinentitzcd ctr deim’tzcd water, may be used
`in any pharmaccutlul preparatinn or 12mm!»
`mm railing {or distiilrd water.
`
`Reverse Osmosis
`
`lien-m: osmosis is me oi the pmwm Menu!
`Iv! in th: industry as cross-flu“ tar tangential
`fiat») mrmbmne filtration (3) In {hm pranks. a
`liti’Hsunzfli sttcum of warm is guard par-Iiiri m
`. w .nncr std: (if a filter membrane mu. A pm—
`[i-z't at the [zed water, or infirm-ml mtmmlcs the‘
`trumhz'aue m filtratc, while the banana of the
`mm aunt’s tangentially airing the mtmbmne
`to cut the system without being Niel-3:1. Tin- ii!-
`ie :(I [10:1th :5 railed the pennant: bwmsr it
`has [x‘rmemt‘d the mcmhram: Th: water that
`has wsscd through the 9mm is called lib:
`cum-cmrmr became it contains the: comm
`mum! contaminants rejected by (ht mm:-
`iam 1e. Vt imam in mmusts. the flow thraugh .t
`mriyermnbk membrane ls {mm a less um-
`
`Chaptqr 13 - Solutions
`
`rammed solution to a mute concentnmd 5qu-
`tiou, the flow in thts ermflow 53mm: 15 {mm a
`mare com-annual to n [:58 concentrated salu-
`tinn: thus th: mm mm usnmk. Depending
`an that: part am, cmsvfiow film- membranes
`can remove particlcs ckfincd in thc mm u! m:—
`crofiitratiun (or L2 pg, $5., bacteria): ultmm-
`tram»: (OBI—0.! pg, cg“ nuns); mnmfiltmnon
`mam-o 01 “3‘ ex.“ urgxmc cuntjmtmds in the
`Itmkcular wring!“ mug; of mama); and up
`verse millm‘iifi (particle: mafia than 0.001 ugit
`[inverse mum mmtwes virtual!) alt viruws.
`bacteria. pymgens. and urgumr tunic-rules and
`90 “199% Hi inns l3?
`
`Emigration ofSolutions
`Mm! pharmamutimi salutuxns are unutumteai
`“3th 501mm Thu: 1h: auteurusni wiun- in be
`dmuit‘ed In usual“); WM! balm»: thv tap-M" cf
`tin: wium uf miwm Olliplflym'dl ‘i‘ltc urmgliu
`It! phartrmm‘utical preparations am usually ex-
`pressed m tmm oi pawn: sucngziz. although
`fur wry dilute [tn-pantHunt"h uxpt’esmnns «1| m:
`liu stnmglh may ht used. The-4c exprcx-tiusb
`mu rxampks are strum-1 m MN: I 3.1‘»
`The svtnbnl “b med mziwui quaiificauon ms
`mm “fix wk: or wlwt means pmccm wright m
`mlnmt for wittfims or suspenwimts ufsnlids u:
`liquids: pug-em qughi ‘tr volume in: soiutxum
`(1‘33an in lzqutrk: pact-n: mautm‘ m \"nEurm-
`
`Efren"; wiume in volume
`
`St WV
`
`TfiiE 13.4 COMMON METHODS OF EXPRESSING THE STRENGTHS OF
` PHARMMEUTICAL PREPARATIONS
`EA - I
`Ainmmo 7
`
`{figment
`_E_¥PR£58§ON
`My» vat-gm in volume
`9‘: Mv
`Gramsufcnnstituanl in 100 anf pmparatkm
`(2.9.. 1% w~ : t acoustitumtin 100 mi prong-anon)
`Mmmws ofmnstitwnt In too mt of preparation
`mg.
`1% m t mi. constituent in ma mt. preparation)
`Gram a! ounstitucm In I60 9 cf pmpawtibn (a 9.,
`m WM - i g constituent in too 9 preparation)
`idiliti nangthmeight in
`Grams at zomriituem in mind milliliters of magnum»:
`(n1. moon m - t gconstituent: in man ml preparation)
`“Id-w
`Millliitmatconstitumttn mimic»:of newsman ($9..
`-:-—- WV
`“In:Eret‘gfljwolm in
`monom - 1 mi constituent In tomml preparation)
`”lune
`Gramsofwrtuem inMadnumbuofgran-mo! preparation
`—:~ WM
`“Extreisgthath in
`0mg“ mam WM « 1 gmtitmnt tn 1mm 9 preparation)
`fight
`
`—__._._,A__;._.* __ _ __ “WML__~
`,
`
`hum Might in might
`
`rs wm
`
`a— wlv
`
`Mylan v. Janssen (IPR2020—00440) Ex. 1024 p. 005
`
`

`

`346
`
`Section VI - Liquid Dosage Forms
`
`for mum of liquids in liquids: Ind might in
`wright ltvr mixtures nil solids mil semisolids
`Sam: chemical agents in a givtn wlitnt ic-
`quire an extend“! time: {at dissoh-ing. To hat.“
`in dmlutinn. a platinum may employ am:
`a! several techniques. filth as applying limit.
`naming slit- particle stat: ml the solutr. using a
`wlubiltzmg tgent. ur subjecting, the 'ngrtdi-
`cats in vigorous agitaiimt Must disminal
`agents are mm: snlublc 3t clmmi tempt“-
`turzs than iii t‘mm temperature or hrlum 1m
`muse an antlmlm-mic martian hctwccn the
`solute and lllri: mlvent muss the warm: ul ihc
`but [0 enhance diasnlullflfl llowwrt, cla‘alcd
`ttmpzmums cannot be maintained lnr phat»
`mututlcalSJntl tilt net ell'cct album is simply
`an interns: in the rate of militias: filth/f! than
`an incrcim- in solubility, An incrcaml mic K
`sttisfncwry m the pharmacist. brcaust "mm
`Hilarious an: mmluntm‘l anyway and tie not
`«quite a tuna-minim“ oi whit: almwc the
`mrrmtl tummy ol' the solvent at mum icmpct-
`attire, Phillmflllslb are reluctlnl iii 1w heat: in
`itcilitate mlution. and when thcy (in. the y are
`artful not in excted {ht minimally required
`tammrature. in: many mediciml agents are dc»
`strayed at clawed iempvmures. and the JILL
`mung: of rapid solution may be cumpicteli
`oflm by drug detrr'tnmlmnl if volatile salutes
`aw.a it! he diswlvecl or if the salient ii \‘tllllill‘
`{as a: ulmlml}. the heat would rummage {lit
`loss nl" these agent: it: ill: titmmplzt're and
`must therein” be “aided: Phamut'h-tt 4n.-
`mm that an Lain chemical agents. particularly
`micium isnltsu undergo cxmltérmtc minim". a<
`they distal“: and give off hm“ Fm fillt‘l‘l man--
`rink; the us: of heat wuuid actually dismtimge
`the formation (ll ll sulutmn The heat pharma-
`mum! example of tin-i type cl chxmiml ls culr
`cium hydroxide, which is used in the ptcpar:
`lion of Caltium Hydmmdr l‘uptcztl Solutian.
`USP. Calcium hydmxttle is soluble in mitt-t an
`the extent of HG mg per 106 ml nisuiutmn .11
`IS'C (about 77‘?) and 170 mg per 100 mi. of
`solution all 151 (about *5”). Obviously Ll‘lL‘
`icmpunturc at which the solutimt is [Irritated
`or stored can mutt tlir mncmtmtian it! the m:
`suluni salulim.
`hi addition at m instant! ul raising the tem-
`penture at the solvent to increase the me ofsa-
`
`
`
`561M! 13.1 Migrant»? nfilmaccatlctt mixing we s,
`(Come-s; 0' sum «9 Lawmmefii
`
`J
`
`luunu, a phazttaatcist may choose to decrease the
`particle size of thc salute Thlfi may he augm—
`plislted ht- comminuticm {grinding a solid to a
`lim- «We of subdivision) with a mortar and pes-
`tle utt .t small Mall' 01: imhmml micmnizet an
`a large waltz ll»: reduced partials size increast‘s
`ah: surface are: vi the suluia. If the powdet is
`placed in it suitable vessel (tag , a linker. grud-
`uaied cylinder. at battle) Milt a portion of “if
`solvent and is stirred at shaken. as suited to the
`“autumn: the flit‘ 0! solution may hit lantabuli
`by 1hr i. mttinuul circulntmn of fresh solvent to
`the thug}; surfm: mt] the mnstam mum-.1} a!
`tint-ii formed sultuiust [mm ill: drug‘s surface]
`Minn salutimts am prepared by simpli- mix-
`ing a! [lit- salutes with the wit-ism On an m‘
`i'lttstnnl scale. solutions are prepared in large
`inning vessels with parts [or ittt-chaniml -t'tt-
`ten-H451. llil When hut isdcsirrdr thermo—
`sutittlly cammliutl utlxing tanks may: he med.
`
`Oral Solutions and
`Preparations for Oral
`Solution
`WM solutions intended for oral xdmimsm'
`tion contain minimum; and colorants m mill"
`1h: mtdiution more aim-Clive: and palatablcv
`When “ceded they “my also tannin klabllg‘
`H“ in mnintmn the chmtiul and physicaf 5W
`hiluynl the medicinal :gt-nis and pick?“ ml?"
`in warm the grmmlt nf mmmurgnmsms in
`501mm“. The lbrmulminn pharmacist mu?“
`wan of thermal interactions btlwcfll the V”
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1024 p. 006
`
`

`

`Chapter 15 - Pamnterais
`
`EXAMPL£ 9
`
`Physical Pharmacy (unsuh' 15.1 mm.
`
`.
`
`Hm much sodwm chlonde is requimd to make the film pmsmptm isomnic?
`Rx Ephedrine su fate 2%
`Sterile wm-r. as
`30 mi.
`M. isotcn wth sodium chloride
`
`1. [30 rm) (0 009) =- 0370 g sodium (Norm is reamed if onty sodium (Norm .5 present fir the
`30 ml. of salmon
`2. (30 mi.) (0 021 * 3.6 g ephedrine sulfate is as be mesem.
`3
`ca 6 g) (0.23) . 0.38 g is he quanruzy of sodzur'f cHonde represented By {ha ephedrme sulfate
`4 Since 0.2799 sod-urr chionde is rimmed ficnly sodvumihlnnde l5 used andthe qudnmyc‘sodiurr
`chloride ihdt
`s emwalmt 19 0.6 9 5f ciphedme swim is 0338 9. mm 0.216 g - 0138 g -
`(1132 9 cf mum thlonde required rounder the 501mm WM
`5. Therefme. the safiumm raqui-‘es epfwdrlne suNate B 6 g, Mum chlmoe 0. 33? g, and sufficmm
`sterile water to make 36 mL
`
`inn.“ mously. as 1hr uiI mil muludu the me!-
`man"). macnmrculamn. 5mm: examples 0!
`ul'firul inlecuuns with oil as the which are
`pmmtexi in Tahlc 13 1
`
`Mdcd SUMRM$5
`Tim- !"il‘ pen-mus addition of suitable muhe
`slum“ to oiflcial premmions intruded far in-
`.ii'Cliun In “unease :Lahflnv or usefuinesa I:
`long As ll“: substances an: nut mmdhwd in my
`
`individual mmmgmplw. arr Inmnlws in the
`amounts. admmlstcred. .imi do ml interfere-
`mtil [he [Ix-mlwmic ul'hcacg ol du- prqumnun
`u: with sprcified ash“ 5 and u klfi. \«Lmy nl' th‘sc
`added subslnncts mr antibacterial presrnn-
`mus. huflrr‘
`sokubihzazs. auliuxulanu. and
`ulhcr adjuncts. Agenh cmplmx’d said} rm
`their mlurmg t‘lfu‘l .m- nmul; pmhtlnmd in
`parcmcrnl meuus
`lhe LS? I'fi'lnin“ that mm or Imm- Shir-LN?
`subsmm‘rs '9: uddcd [u pan-mam? products
`
`
`YABM; 3.35.1 SOME IMEETIOMS IN OIL
`
`W _ __ .
`._,
`77
`w 7
`_
`cu
`, __€¢Tl€i9_fl‘!,
`Di"Iflr‘mol
`Peanut
`Anfidotow arsenic. gem.
`and mercury poisoning
`Estrogen
`Estroge-
`Anti‘psychotic
`Anhmythk
`Progmin
`Fromm"
`Wrench
`Androgen and mmgm
`Andmgen
`
`Anamogen and Stfogen
`
`Comm-d
`5mm or (-5th
`Siam:-
`Sesame
`Castor
`Susana-or nunut
`Cottonseed
`Cuteonsud
`Sesame
`Sesame
`
`WI :vpiosme
`55":de "32"“
`Mmz-‘ne cleanest:
`“Whine manthalu
`. ”“mech cesium;-
`3:3 WNW 1‘ 0:1
`“"9 Winona!!!
`I
`”"9 rypionate and mradiol cypionue
`7We Pnamhate
`
`
`"W’mak ané estradial «lent:
`
`
`
`Mylan V. Janssen (IPR2020-00440) Ex. 1024 p. 007
`
`

`

`£5!
`
`Sectian W - smug Dosage Forms and Dallvgry Systems
`
`11w an: pulaggd m muluplcrdme comma-rs
`m pmvem 1hr gram-1h nl' micmummisms R‘-
`gmllcxs of d! methud nl sterilization em-
`ployed. unless udwrwist dimwd in “1: indi-
`udual mnnngzuph a: unless the initnwn‘s
`acme Ingredlznh m: themselves butlermstr
`tic 31w}: surnames are used m maximums
`that pram: the gmmh nl nr kill mi: margari-
`isms. Because may of the 1mm? presenmiw
`again are mm: m large amounts or Irrnating
`whim parcntmlk administered. ~p=cm§ cm
`mam he uncles-.11 in flu: sebacmm uf {he ap-
`pmprmc prey-Native gems, Far the influx»-
`mg pmfiervaiives. [he mdimxcd maximum llm-
`us pn'vml Inr us»: In a parrmemi product
`unlw. ulhcrvmr ail-cued: fm agents whinin-
`mg mercury and the cationic suffice-um:
`compounda 0 0H): {M 39%!“ like thumbw
`13ml. cmsnl‘ and phflml. 0.5%, fut sulfur dlax-
`1dr as an Immxulam a:
`fur rm equluicm
`.urmum ml the wllilc, insullut or membnsulfile
`of panwmlum m sodium. 112%
`la addition to the smniiimng :fim uf Iht
`nildnwa, 1hr an aaccmpnnymg an injecmhle
`produrl is frequemly mllmvd wuh an mrn
`gas. such in. mamgtzn. m submit the shimmy
`a1 Ilu- product by pmwmmg a chemical mu:
`Imn lmwecn oxygen and 1hr drug
`
`Methods of Sterflhafinn
`3112‘ mm mnlimmm as applmi m pharma-
`ceutiau': prtpammni. mum dmmcmu of all
`living, urgmnsms and that «fumes nr their mm-
`;alctt turmvil imm the prepammn l‘ive 3w-
`vral methods are wed m atth pharmacc-m»
`caE pnulucla.
`l. Slum
`2. Dry hm
`3. hhmmn
`.;
`(ms
`5
`imnzmgmdmuon
`(he mellmd 1: determined lJrgelv h} 111: n:-
`aun: uf Ihc preparauun and its ingredirms
`lhywvvfl. Icgardim a] the method used} 1hr
`mulling pmducl must pagfi :- m: [m sncnl‘m‘
`u pmuf of the cffccnvmm of 111: mellwd
`and a» mm a! sh: mummml and
`permnncl
`
`5mm Sterilization
`Steam szmlmtiun is canduclcé in an auma
`clnve and cmpluys mam undcr yam-sure I: is
`usually m: method of choice iftlw. producx can
`wilhsamdit (Fig. 15.3).
`Mos! phmmcemicai product» an: nth-ml}!
`filmed by heat. and cannot be heard safely :9
`the temperature tequirul for dry heat startlh
`zalmn (about
`lif—lTO‘C. or 302%; iB‘T‘.‘
`When Hummu- ls pmscul. hmcm m- cnngu
`lard and destroyed at a considcmbly kmer
`mmpemure 131m when mofsum is xhsem In
`lurk. bucuw'ml «115 will; a large percentage: ul‘
`water In gem-mil}- kilkd rather easily, Spur-a,
`which mnulm a rclnuvcly low percentagc a!
`water: we comparau‘vcly difficult 10 dram-y.
`{ht mgchanlsm ml micmlmd destrumun 1n
`mum but it. thought 10 hr hm dtruiumksu
`and umgulmun at some al the organist-11K rs-
`;mlial prolein. II is the Inn moisture. in the mi-
`cmhml cell than permits dmmctinn :1 leia‘
`:wtly low temperaturer Dmuh by dry lira! is
`Ll'umght m be by rich; dmlian cf the mmnhul
`cell followed he slew oxidation Mum: n x:
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