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Lubricant Properties: Possible Solutions

J. Bana;,l,and R. Somma.
P'l1tumflP,(lullr::uJ D!1W!lQp.l'l'1enl', elW
,lii'fSft,V. OrSCl1
PI1larm,actlulk:61s,

Influence of the Physicochemical Variability of Magnesiunr Stearate IOn Its

S,umrrllt. New

o/lJ ct'Jmm't'rn:al bCll'~U!'S of wu~ ,(i,I.'$t!mf,!,ud ul~'ng Ylil'"l'mIS p/fysil:r;chemica! tests. Djffer.t!llC'tN.obqn'ed \1 r,e relmed ta ths (:l'ySf(Ji lottie " (md thr! hydrmiDn smu of tllr rMjlJ!~!J as WI"U tlJ rill' i1il1p,!;;Iri~iej,coflfairwd i,~thelr mljlrices. A j(Jrmll.lmiotl J.1UJd~1 ron!amillE 2% oJ",ragl,I~,un .Wfllrt.Ue .I.\as used ('0 dr-

Thl!' vari, /J./it)' (if the ph ',fie chern·
lfm:m

,01 p.ropf!rtie;

mQ8"t',m~m SIe:(Jrml'

thrt:l!' \'tMQ.F.J)

U:tmJ(JIf~11ll!'/f1brim{l't propt!nies of 6 oIlhe 13 1nl2.f:,~'4?Jii(m neara: tots received. Tfll: /.IiM,ltt pre,~,f ~sB.d was (J St(j'~.~'!i~Si:tlR,fS!w~oll 1~:S{n~"U'lU.f!d Press- Thif!' ,difF feren: /lJfj'f-jaull prOpr:lll;tfS ODS ""eli ~ ere r~ta~l!'d to lhe p(lrtide stu ,of the fflJ18m:.fium steanue 1.0/ IIsed. 1~V1tUM!rl' ()f llice crystallin!!' s:tr~,'tuh' OIl .the luariemu: pmpt!f1ies of mo.gntsium

n~

:;U~l1IYJt~ li.l(JIJ

(J/sot,hOl4l11

whereas

,rJ'wirrj1ulJ7Ia of

Ike at/sorbed \-VIJ[:i"r' did 1101 ap{JIMJ" N) dde.rmi~.lfi pr(}(:e:~.'tmptlilJilui(!l. 1\Jira lXJ.fswle $o.lUlir:HlS Wer~ f!WJlaareti ro reduce ,rho!! !,lIvricant pr{)perry .diJJ'effflces among the

tots Ie-steil. By decrif'ru:ill,g ,he jM'Jtide }i~e ,oj It 1m 0/ nulgm~silJ_m I.letif"alt!.it has been pr;N;sible to !>iCnjfi(l!fUiy improv, its hrb.ritlilil! propenit!'s_ fl.{agneshlm steerare iii. associali011 w,rth w.:lc (Jls(J ples:enle'd an mprt;JW!mt!'.lto! its luhricalll properties,

"'To whom ·wrr,espolldenct sho.uld be 'addresserl: J SarRo. choal of .Pb:lUlnaq'. li'fli"tnity
ill
j

nf Geneva, QU.i!ii Erncs!-An·semlet 30,

Geneva, Switzerland_

J.dlle5~ f~~~"d ~H i.vera.rddc s ~:Z~ 'f. Ph~. tablet and die WI)II dl~Jrjn8 Hlil cjl!CliOill s._ USA (~. c:nJn~d. were d(.~lum~!iC:arnlc.<.~ml ill> Mlk vol u me determi rl'~tl I1y 1.~pOHUBrunaucr-Emme-uTeMrer (B:&T~ memod" whh B mil:une of nitrogen (adT n sowb.lprx:di. ~l-]~) .:t. r.sing a mi n]nU. r fOp~ FIIies M 1.orC).hecry$!Thn]l1~::r~n.d f Prc~s.! materiel i~ -MalHnckmdl lUlC.. NY USA) uS~l'Ig th~ ~Or!I'l.l\ sle~ratc wh(:ln USedLrI excessive ~(~WI!:l!l~ln~ilJllllSOr blcnd!in g dm..kllr:wJing nn ~tic 11iH.~t'k.l::d as rhe max imump.alJ.~· tics of lh~ blends wert: CI!~UHmin~d 1:15Jn. Ji1.sci!::nt. D~ ffercJ]l[ia~ scanrri ng G.iOit1WI.a~ys:1s 1: :Sc~nlfli.:ri:ign!:=~itnli1 ~[tilmu! lrom 1:1lr'~r. [Wei pesion ~ sible ·sO huion~ w(:n~ .rca.\.pl:ay drit:d~ W isconsia Dairies.:~.[. Since m!!ip.i!dl f¢$llll n::pr'~511msIJa.)rillbiIM.j1m property of the lets !1!!!llWJ E.ju.:dl!11iq_LB. Pj·s.r.um (iuel'l {. Th'i. Thi: adverse dfccts of milg!~l.llOOQ.lm an m:~l ~ of su:m(]mrdil~d IUi. l:flle physic.cltl.::mi cu 1.lJIg a sl:lspt'. USA) ~ 'M ixed gj'S ]0% NInO % He (Linde Co .:_. '~<l r.:lldar B).n~i!lW! u. vulum~ ~~n!ll.u 111!>iHJI1fl(:Jlw.com mc~d . USA OO~.iffereJ:Hial S'!2armtng Calorimetry were carried om !Jill J P.(:.d 6 c.. USA L~il lots. surface :I.J~~ (3) These f!~galtif(. I.rlll. S I"~my :lcl dt:m11llO$ it ion. USA 1 l.'· n ever.iJlion tilt. (Vt. NJ" USA ..d.7.i Il~.2Lgl1usi'li1rll IIL:lflirOite (h!.. of me ·:5.dty of !.Jd:lJce lUSUJlHy in 5qW~n:.. NJ.~ II !i. AR.:~!~tl 1:t:I c:Ii$hH~gr~tiQn and dissol. 495691 Co.(.I'\f..Wil)1. liJS.l m~lu. tll:nlled 1I.5 NJ. Mil ford. 'nlC t:ompilclion c~ u<!If...gllt of ~he pnwoor ilTid Us: t. Th~ "1p dellSLl.g C~!t(lnmetry (PSt:) analyses [lSe 7 ~Perkin- NY.m~acIHom Ccrp. 981.1]06 INl'RODt"Cl'ION . ifi . '~·o ~valu.llsirl.e~ tBdnkmmln In 51.3.:19b lI). T.l!Isands 11I:p~ Imti~ the tlnal ~1I.' "fah::: Cyprus tM.\ vicel PH] 02: FMC Corp .R (I). Syo$:I..1) 4 ~ .• PO N 131.et:l7I ~hc wei.' Size Arm.i(.erkiu-Elrner . 'fihI~rTlviljl • Lactose ~.) Erw~'ka SV M"" H~rwe~w IrI$L [m1c.)! mclJg~e.g. p'1f1 ic ~I! M ze dils~rHnH iOI1) (:flll vary.'l:mp e was perforlncdat 40° C for ~ 1: br 1l!lliderl1ifOCig_e1l n(}w.$i.mim!~~ol1S- tIH'~t:l p:rn. NJ.!~ irl~ Twt:1!!I 20 I!I. of W measaremerus an. it B~~~lkm"nl'l'i'I: POIfI.eff~!l[sm~y be avoided biy u.ium p '" NOiI-~lP(h EM Sdrlflce. ~JOi~S 1-"6) • Hills Am~ric.ner'[he: Pll~l!CI~ s~:tc diMnblHLon was !t'!-':II~Llr~d u~..el'''''CCIl (he...lf"f<le~ lIrelil~ were peg:f()tfned on a QU1!:n~' sorbfil Sorpliolt SYN[C:rn (QU1.nmac~.vall1late. (~·~o.dirn.i.e &..t~)r.!1.lIn~(.fair L~wl1.·grade (Fj!l:h~J".ix 10'[$ rde:rr:eo to as.) possessed by rhe::ufli ~ we.5.:I11od u~d i~ its fl1i!Tlufilct}Jre_ To ~~~im"lc tl~~ \1..am 1111 tne area 0 f ph...er.ht: ~e'ifilc • Magt1e:. co.ight (ll~lIi1ny I g) 0 f the mareri.ilrdgeli'l (fer. El1gJl'wood.\).CS.[e rn~gnc:s. USA) ~ Liquid Il.cll~a\NlIy.lI{ ~s me <lverage.lri!nc(. USA (Jot 49~..ld.mfere.11 b~t!J:'i~r. r-r.'.alorrmetry mSC) p'f(lfIIe. ~tH.g R 'S!¢ke5~ Singh:: S~.alibJia~i~m~for ea~h sample. 1IS A) was ~'n~p ]ny~ d.tIp d (icn!Sui'll"'\1i1oere rl~purliC:'d LI. [est ""'lUi performed L~¢~I~J.~ grnl.ri'lbml)' on h. inrervsls t'mm I. W '2 tl.ncrr.USp~1K!.gc of the ~mm· pr~~.j um stearate.[£ri.'endof .re.ill! 1I1ed C y!.0lt5 Ithmty to d(.S [he ratio between the Wlfl1f: hI of ~h\: I:1t!wLh.')'drll!.~..t.aL S~drjc sl. GibbswwfII.~<!.his vOl.:lftier) ina 3:7 vl» ratio.terfield.(~) aad heli.1JlIy bleodeJ with a nOI'!:.~nHc is widel}' used as <I 1llbrh.uit f[i~tio:n I.I'I1C nl... t he gr<l~1enf Itl..I!J~I~ w~rc lrllJiJvJdi.l ty.llI!rlliid a!1Jli-iI'lHmnma. l1t:Jell'''d. Pi~C1!!llI.w .ppcdvolmm: W!11i r~. ArI.mt~cal wl~d dOI~1igefOTms_'nis I:~ rnuinly dLJ~ 1. on.:t.hi.: ()r I... Tap deus Lty is the .pt::dm~nl<ll re.:hflol'o:gies: Tn[.l~~lJmH'-':01f:ltU :I~ wa~r i:[:Jliloluhle. PhH!ldt:lpbi3.a lnc. NY I.ly:z.M~nclen Co.id.\ CQ • Wc~~by!1'.ag~ ru. If SA Uut 50'163) • Sodium starch glycolate. ofn powdr. ctle.~ ~u brh:am prepertles.o.lchr. llSA} defme-d ill! I~~~e wHd ·~I. E~clt of e':r.1 ion Mil [c..<L'l:kl:d "'(1 lurn~ ~'i:~d\~. \i!.swere used to eonfirrn the h"]m~g.:s f o or Uldl> JCI~~i~y~~.s.~lht: lnc. (.-M.:r!. :\-10.[ Igiu~C"m was dl sder persed in W<!lcr I.~sare weJ I known.ll.e..!: f ermulatlon.: \'cu!Jtlr.dto r~d\JIJ:"~ ~nrt::~l:m:~ the in ~h~ 11. USA 10[: 21) • Tween 20 E. .tl~msteilnit~ USP gmdes P990j.t g r dttner.re a Id~r~as~ 1n wJih:t hlJ .Mnpk WJI1II l no' ~~.:IHO sl t:OI'I1mm'l of lh ese ru]~'C'r~eeffeets a. USA (lot Magne5>lUfI1 'ste .ilIC_.ntm WI. th~ lll!l~. Th~ degass ~Il(g. NJ.ali 0 bel.I 01S 11fm~ltmc::~ium M!... Patterson..lll]~E$~ums1estate HUlA.• Anhydlrmls CaSU4: 'VA Ihrmmor1Ll Dri:erite Co" Xcn~a.

of mag neslum stearate AlllPl100forces (7 amI 20~) were controlled u. ef th. round.edl Mmp].inster.c[1Eperformed u1)illlg a Ca.c.1 r ied).! of '2000 ml hI ol)( lIn .OrI prupe:meil ... USA).lmoo if! an open alu rn inum pan 1:!rld~lt ni(roge:n.er 111806 (IhUma Inst. CT.'~l1!rlil:lg electron mi.flo~". SpaA. ll~ifJjg ra:rJdomly ot1elll.0.eNSArD Font:~uhiliOil blcn:ci'ediw ilnme various lots.es5 ~~"ci V blender having a-volume of 240 mt S.le: _6C! min.lfll um'Ch g~yc:l1 fe.um Sl!etrrnJteis impOs'sible because of 'the absence.':IUlrimmtal Modification of tll~ :Magne$ium Sltem.rn..c-net! OJ1a P. recrysta Hitati(:)oPlof rnagn-t.~.e'r'I'GS-l OUl m'IEl'lcsitll11 ~tearnll. NY. . . apprOlf.lc pOwdcl'!i wctc 'b!.rysil:allilile Strudure In. Us~d:M".hmudy3 5' g ~:lfIt 'No setee(ifld~om of ma.55~C to ':2. Ptrln-!:'Im.'liI)Dl Stea:-rate Particle Si:Z'i! of Ithe Mag. I .0 rng) were ecntrelled using the lower puaeh adjustment.alul:Il. lower.mme[ers were reached: applied. PA. A ] OO-g pordol'! of (hj~ hIGild ""'fLS then nd v blender ofUOmt blendtld witll fI1I1gn~SiJW1 ~. respectively. (Helme!. Warm.)igl(l~ .liIlesi IBn T. Inc.lowiflg exp~rirn~nl.If.~s.5%) was added to Uu: fi['~t soo. USA) was used tocharacrerize 'lli~.laJ.M'all'w~h.t.Using a Palon:ltI In.C-OIltHllitcd: 1IitmOllptlere a.rm:llics.Hliau(lfI" i. NJ.r~dlj)n r the Blends 10 ~ ll~f.15D-A gold. [taly) \'.~ and ll1I'I1ydiWiiU CaSO~. PA). ubric.Ejltll 11/32 In.!m:~ivll ingl'edicllt. as used 10 corum I (be re:s~dual humidity ef Ihe 1mo.3It~ C. odil. M.l S mples 11'1 WCI.icroscopic ohser'\l~1icm. !n.1:MBfleS. A SIO]<::e. Healing phase: ftom . Talc (.Pie:tot.pe_F~lmliltal Modifica. GEM T-X laboralmy milll from HelmeProduc'Ls Ine. Ni filler.jbrared daily witll h]gn-pllrily slandanl. A portable Ihermohyg~oD'lct. pauso . mixture was then blendl!d w~th m~gnesium stearate :for an ~dilllti()irlul :3 min ilsing a smaU S'lai:ni.llg a mull stainless s'teel V h~end~r huviny ~tvolume ~ ubrican1ts. rf~eliotlli . . 20. 'lttmetric a'llilIYl..gfieSrum stearate was rsdueeduslng 3. rJ]1lig. USA at the fo].\.10O'e.ic rt)C rysll. SA) tlql!!ipped \.i1.1I111Il~ ee l1ulosil . USA).~ing the lIl]lJilet punch adjusting knob while tablet weights (25. it WllS tlOl possibleto increase its particle size... fi1 m.campillcti.t room. speed of 1~1ili!1li3i!1i'nllJ:deu:ctor P 20Jml.sl.tlu U sed ~ M~gncNiiurn ISt£arllte " mUlstcroid [imi.llli-[ladcwu. The panicle !ii~ of (n:J. blend sample and btended for ! <:I ¥flln.al con~ilitl]ls: uK"i f1'. PA. {lQ mil min): ~. 'P~eiP·ii1.cr 111t:rmog.00 II ". ~·my powder dirwere perfo1r.1:: A'lUtly.~flCe.1107 Elmer Corp. The fonow~f1g staJ!'l(jardj:wd cycle '1'.ESH)O (Po:lormil :rruo• l!lllfie'ld. Liml. McKee.gnes.5 millD . The OS Wit. USA). pause 0. bl~ S:~mp:tc".t~m'iHe an ~ddjtkmlll.tmvtilf. ca'l.'115 pelT"fofU'UeotJ on each S-mg sOI!l1Iipleof magnesium ste:arnle 'com:a. .ysWm (PCB .epllllrnes (Elizab~h Carbide Die Co.2 min • Cooling phase: from 2I"e 10 4JoC.~is T ~ mperatures of 3 S °C ~o n0 ~C :l~. A lOO-g portio!) of thiS. (If 97% and 0 % res klual hUJilidll]' wer-e ebtalned from sanirated water solution of NaHl:PO.hnm~~ ] 20458/3 (Pll:i:I:lip& N01~lco.·irlllllrl1m~tQry drug (NSAID) fur- mulation wn~I!:tn"i!k!1l because of Us bigh cClt}cclml'llir.I'I.. of. mffi-· cienl dissolurlon properties ~fI).~v.S Single Station Instrumented F Press (Stokes Compactiflg Eqllipment Oi vlsion.llingpha$l:: ~mm 43"e W2U)D" .TJe~]Uril Sl~arale samples were cOMcd '!ilium Il . beveledc:"dg.2..?.l SCIOll.luded fer 30 min using a.tll of 5-7 mg under a nil gcn nO\!!! oi 50 11'1 mill. rnA). Ira~e ""Cl min.(A VICCI ~:lJnHt2. Till: fotITlulati(11'i ~i'ltUiiliflcd Ille IOlle gpr'!!)' 1.3 Sol'«(lli wi:Lh.dw!l .mbridge S360' S1. rale 411l!CI mm Th~nl']ognwimetri.he same formulation was used.]um ste:mue was stored for 55 dl:lS~ uml!er 01. n VOIUllll. remperattLre (5).~plt!!. I 1.l. (if .P'DIt. :D'epew.RlI.c:r~OIJ~ (Lelca ]1fIS" Deerf eld Pairk.il'mm pans.!l indi'I1iIIM imd z1nc). and Jnsrrumented die :. = ~5A nm (40 kV. Norwalk. bMlilflg 'raUl If II-~C/min were app~lt:d by .A'IJ1\{I~lmre(. iLUSA . 1be follow1!!g p3.lm ll'icar:IJle (2%). npli _ 0. 3 mil I for IIlsi.!In!. Magnesium sttal1He samples and It(lhllel eresssecrioas 'were examined a:[ magllific'llions of 500X_ E". flat-face. Ptl.glte ium Srcarate and ralc .

The load ru~uired to frlloCrun: lh~ I' blet'!>w·~"reached I. and '[Il a t the!! di n't:n:ilC~ beh'\l'C!l:l1. The facl:S rhat lt~~21 ()btains its OptiITiIi.UJ dill. t:onfi rro dl!l~ the latter have rliuf~ inter:p..lSbn:Ii:'"tap uensi(.ap diensilYV1llue$ fi~r kHS 1-6 were lo~~'.~\1111t'( dill "l"'l~r J .CCl[Of! forces. is rhe Ihk:. tOf ~hc 13 lots 01' mu.'cep'! for 1m 21...'In''t .!ldor B.u'Ct h: ':.p Idcn~~th:. that cohesive hridgirlg '\\'11:) t'~.n:u:ler p rtiele si}!c of kll 114.1 - o~-------~------------~·~----~----~------J_----_j o 100-0 . and OJ.mI31rOiims.2'~ V--- 0.1. diame~_.l l-fJ'.:::::=====::===================~ I O.'l~!.O:I~ ULhh:ts.de'Qt Nest {~7.ClllC1llate lh~ I~~I~U~ T a-r dler~l>i'~i~-eS oblaili'Jed at vaneus [lumbers of tapsare pl{lm:d versas tlie number (If ti.TY (gJm~) 0.nge uf \l'1. ItlIIifl lm~ 11-(.' plIrlicic .1103 residual.na.Oilc. !J IS Ille C. axial ..n:ncc. except for she mtl.mdl!d at 2000 taps wall similar H 'allltlS . t1SA) c~Jihr:Lued wijlh 1'I'1~'h~~i.Yl!!'l'lgil me III where mtlJ {j P is the ~ipplil:d II [!lei. the value or the tllP tiensit n.21 .IIi tap dCI'l!!ii~y t)$lcr d'mn lut1. greater for lot .i l and raidia I pn~ssutes. slIggc:llil'lg. :lIl:h JroYp 'rI:I!1PUlut t41 a vendor.. hllrdlwss IC~lcr (Llr SChl~Url1irilc:r & Co .4 lr-~::::::::::::.:-rmc T __ l) shows three groups of hle .l~jng jJJ Sd11~Rmig~r 1.c.g- TAP DI:::NSI.r prnfiles were observed for the 13 maglllC:liiUllill stearate I 110-E.2000 3000 NUlv1BER OfF T/\ r's ..111(.'. dl~ burlk lH~ld Ul. h.• Mnrion.IHf1~ fum I~..which I-~ 1.h~IISlve and TIt)'[ l!ilSlty n:rnO\led by 'lappin~ under ~he~e comh~i[lnli. A total of 4 tI.l.l~1: n.A Sm. .Rcsu lts e represent the avera ge of I[) ~~xpednu..ervcd at 500 mpsT.~o. This vaiucwas SLr~J1s'lh (tI): then lR~e(l.)1.r.5~evel of lConfildt:l1ce) was used 10 compare the forces appl ied tothe blends and the .tdld radial traesmis- sior:1rorce ranos: c.lp~ in 'Fig_ 1.ompress ion: elasric and n~t invested energie s: maxirnum .](ide l.~. ~A.lysi~ ollhe 1J lrns of In.l:nii.wights of the resulting tablets.

.of 101 ~ I is 0 Ish!! the mnge of v(':!'itlor 9. previous TGA p r·esu~lS (lbroiood for ~o. srearase loIS 1~5.O$S of weigl1t 'th<lt occurs. [3.es {~ I).de lliIg.e itIO:l1ol:irY'dii'a~e (()rm~~. In fact.I:~ilnlCllI4g Intil..ln:mes (n:!i~I·in~y.:la-jOllS impurities (sudl as m:a.>Vellg.Jcm.aUllillilioll &[ep IS <Iooenil wi~ll th~ lOlb!. wiib .endor l8J VelldDr 1.!hase of lots I~6.glle~ill!mp!.~ nf I'll e ] 3 ~QIii of millglu"suum SlJlggesl these Tesull~ Me vendor dleplmdtm {Till'll!! l J.].. UDder forces of more th.!llilit~W:. l~l!l irnPOI"I.al c-Qrnposili'O"M.ll· 6.II:: <l.llrf~ce ~rea.lillt. TGA profiles m!1y be e.!1JI~d.c-ific $lUfti.wim h:l!s 11 rulld 2 ~I suggesl a higlJ ~y cl}'sudl i!OO §~..w15 kN...re '~~ITl. This is.Y dfWfm'elioli.t thermegravirnetric ~ysis between magJlle&iem stearate fiirm.different ~:hlllp(l:i!l o:r ~he crys.il)!il .:s. pal~ ~e'ms from lOIS 1~6 siJg~~~t II. suggl!SI~ lIi)iU~hc:ii' I!~ eltller have a l.1 4..ed.e. and plastic deformation.with. (Fig.larger C)flCS. 'J"bi s m_AYbee-xplamoo ~:!I' th~ ..50 nesium sreaf'E111! teslOO. Md 21 were confirmed via 1!~r!l. won: in (hI'! CiI:. she.08 Lollk 252 4.i. C(ill'npared {(I . The 2(:1 21 ~ i3:1"C'.llesillm st.10-5_1 ' C 3.el l:iDll. crys~lIm.•1 mood NSAID fonnuladon using a Stoke. lhi. of '1.._W Spl. Except for h. U.. selected from tnt.from lou: 12-l . ebr tli~c. .Q tHHi-l. Seven di:Slinc:!DSC p Items.5 m"/g).H:::1i as srearte acid. t.~pli£cl" me for:muJa.r:tf Alr:~<l'_D~lFnrjjnl1rj. of mag!le~ium stearate.rm of 'VtlriOW" J\1lJg~l!'. (1 of the physicochemical propertles of magneslum srearsre.'.~l1lm.at~t~ '2).nrn .(II'e It (4.e(:ryst.'.fatty acids or their s.i![li:! 3.d. .C! Thermal analysis c@ll!fl!l:'rJRJ! I]l~ ]n.Inhydwus forms.~a. l\. 6 101:..plahled by the fad th~t Jots 12-]15 were .!c[U'ril'Ig method IJSL'lCI th~ vendors' IlS well as by Itl'!c "IJ.oU 1. dlll. IJllhyJ.-:.rilul'l crystalHI1e 5m.t2.l!1juJI1LOtl1i'l of I'IhlgllC$i. TGA p'«Jfil~s are vendmr speeiflc.ium stearate and the formwruioll mndel. elasuc phenomTu ev _luate lhe lnfluenee pi:iJCamete'rs011 theJubricant .1109 Panidtr· Sit!! AlWly"is and' Spe. Both TOA profiles for 1015 ]] and 2. <IS:· ymplodcany with .coltbld ~ fou!:Id beno lwet:ln these pJ:lftlaMl. ~ sbow lItw.p.f C~ rea . The dii'fe:re. st:ruCIl!:re. espe·c.\'d fie ::.ti:on system prtmarl IY Linder goes pa:rti.sil1Jll Stearme Ut:~. nd lots n and 21. were dmydnrte 'f.IS '!.8i"1u.'ily be rcbltod io (he dl~yd. 'l'he sped l1CSllt. known a~·H halo.liler lilDg-cl13lfl .96 .li!kC5 place.md f}' 'l<ln~I1C slrnC:lOJrcs. ~2-16.)'~!J:i.x.1.g. W~l:l!) forces of less U-~n:1 j kN were . two 101:5 'gm: ium !llr~'lriltc having extreme spccific S!. had [heir tubri. 5U&~ gest different cllemic.~bjlli the I.. This r. lo'ts J..:Ii:e thar tn. :Fpur d:i ffe'!'e"o'l TO A j)'rQillliC. tcsICU.30 mi/g) fil1i:l 1 'I (8.fffJm'r1l-.ers. 'wh~m II :~'(:ctY$bI:I.. TIllS lyp' of pt. L]Je ].114-8. II was reported . .iX.presemed in Fig.9{l-2..!i Ii ~WilclUfe in whit:b tltl! magut.rtl:1g th·· hem i&yn'rnflsi s.$ 'to be ITI&ne pmbabl. monohydr~ue (l:rys'Uilmn~ ~l1fUCL'U! e.mte'j.g_ e.'lUlt I'.r:c:( C(l)~r.ed by Itlie TGApflofiles .] h!l!l!I.lbysicochemkai properly differetlc¢~r ob~rvcd hetwc(ln each lot l~s{~d may come from the I:lliIilIIllf. dbl1lJdJlern: .iilin.. ma.~.oIJhs srud (I I).llk s'l! . n~ (:(11'1"'I I. A preliminary study was perforut.es. i The difFerent crystalline StlileS c:h~llrizw b_.ir lots tes~ed.ccordmg (0 dv.I:l. lots prevlously tested..lrg~· particle '.0% Qf Q. 2~.art lower temper:alUfesro.0. The SIJ1llc btr(J~d peak.cam properties evaluated in .a o'b~rr:nOO. Faster thermal exd~:n8l9Ilbel\l'eeJl sm ~I particles. The.-6 W~r.~~u'I:n..)1 1 I. stearie . 4).~ Ciltl illS lntel:'t\m:mces r presem R J)Q:r8~C~Jllmdline state· 0:1' . ing .!m}.e.'ly~ (hr.l1e.[y of tl)e caw nt3wri:ds used.1:U hm o:f S % a Q>C.t!i 12-16.-s'tep weight loss.lI:i.!liU lin: spedl1c ~ff~~ dec~.d ilil ~hc:28 .merLMtimi" repacking.ide) amO!lgtl'if1l 13 IOiLS: Of 1:1l3J:. wdlydrr us.1Ig: ]Xl:lymOl]lllic arid hydnit~ fQl!1In!'as wei] .1 lOlS ofmagneslum '&fea:r<llie are sbJ)"'1'fI L'lllFI.". ~'.I :un!! 2.Qlrrringn two phases.. 'Iih..~11 increase ill 11~~ mr::m ~":I1i:clil.~ area (~bl3inc.lra'lly appa:r~nt dUirirnrg ll:Ie cool- j.u. two [ots of m~gnes..l.e nile are n'f!'~nged in irnlgtlllll'ly ~ac. [ IjIDlvi.ft. dd and Sallt!l OOn!41ID'" rnlalrnem 01' 1.~i~. In olJr ~I'iH.Singl..l.~~JI¢J' .uV~RdQl>l" V..~"'aliles . l:n.J.mlor A V.ealill:le te IJed.e Staden IIIS!TIIDmeflted F Prcs>s.r magllesiu_m stearate ]O{ i tas compared 1[0 2. Based IOIll car] ler dJi:t!l (J-IO).30 LM 11: 8.artj~i sims thal.~d p.

1"5180 1 7'5 200 5'0: 75 .0 1.llIbri:ca~lpn.IIIU 5'1... 11""0n~rc:e5 y. and 16) Vl'lth close panicle ~i7.:00 T~mpll:mtl1Te(C'E!!$lUS) TerRipetillwe ~CEI~..Iu!:.teristks rnarnly iitl1l1ences lit: lutuic<l. 7!i :..C rn~gl1esi\lm srearate has a predominant 01 ~nf1Llence which ph.HU ~Idlr. TGA.grte5ium stearate.: n gdl C!r the tablet obluined).Z.cothemicaJ dmram: ri~ti~)i(particle size.used for ~he tliJrnpactiol'l swdy: 7 and 20 k. Therefore.l~ lo~ f 11.lrer'lies. nne Gin O:.ena become more llnponam.ml~ lubricant properties. 00 .gFlesh.s ~ve h the "'.Un(: lubricant propt: rties (eva ttl .S~ m tHe s. T'''iO magnesiem rearaie lots (11 and 21'1 with dlffereru physiL. It)t~ 2 and LI have to be !l::Qmpared with lees 6 and 15" respecIi" 1~ Two JHlIgJltSttl1:n ~l~lltate Iots l:2.l)ctu:mjca1 cnaTloI. Ther lore. and 6) with different panidl: sizes OIlld speci tit surfaces present differem 1.F..(Jn~ elude that tWO magnesium srearare lors. To dtef~rmin!: clmnlo.) '5 10.ued by [hie compression p aramerers and 'the tens~le SIT!. 1:50 . 1:[[: . rjl~ ~aItid~ SI1. 5pe~l:tlc ~l!rfae~ D£C.and 3. such a'S . 1HRY dim[l_Clioll~ 1 preseru PT(.cleristics JIo flOI (lie s:!mt' ltlbricant prupe lies.lH propt:rtles !~rma. with identica] phySi. _. Two diffetent mg.~ .25. !iicodlemicaJ . hilm [he results presented m Table :2.

applied :lind r:t!lffiiaUy u:an!!i~i~~ a ~dlur~~ JUid lhe lI.t'lxam.~.netll.illed in the fm.. tllmug1J tli.~rndmmagf:1. Ih c!Onfirm 'lheimpomnc.d ~r:e~. the film.11m Mound It:l:!cir bounda ry (Fig.::k Irmm!mg ~a!kiesrilru::.e s:ize: of th~ v.mllll.s.3.ic .1:able[ ~rO. mak~ it d~m"ult for 1n:~~'rp~T(ic~e Il@I1i~i~.W[l1i wiM1 Ill~ olher oor:upn:. contact p(j~nr~ !!Ire we>'!k.I:III . 'C:OllJpn!]~l'Its.fl) .I'lg..lt.}1i a~grnl:$· wereeumpressed an. (ril!!jl~:rrir.sl(::ata. "fhis mm ean be .)I1l$!:lq~:II!~t]. SM~lIfmtily.eft)_Tn tun:trasl..f.~).ted ~ro!lgh'<I I:m:rHO[eJ'I. ·'['lJiJc:refore..au~ properties.s5ibJe te obrninl li~ reh1tJi.le-PJmh. su.IMQSt#l\l I upon ~u: olller physj. h fol]om mli'!lt the cross ~CiiQl1 of ~he rracl):gred[alb~~ s!h.re.of the grailules.il'!jIm.&p.l ~ll]l ~egllJb[~r.uoI'l roroe.~ ~a:rdc.].e Ell.lls·slon ra:tkl.ll.i!1l atl!l~Il!!: Wl!r. .ernl~j. b.g.wi()'lJS .je£~. iO. ctilm.d~ l~il1~c1s the rl.e la~ (loc 1l)!_ Th~~~ tWQ gr..t p1roJ_'Jltn'nes.ocY'.lli"g <9.g fllihu:e.. the meaa dio:!nJewr ofm:agnesk!!I1 Sleai!'a~e ]O~ :2. Since Ihe mean di<lme:~:er ·of m. To undersit<llld these eKpen melnal r'eSwts. FigQre 6presenp.s l[1d~:I. sur.tli.ows 'the· ifTegul. ete:C:lfOl.lg Tilt: pankle: ~i7!~of the IlWg~esiliU!rn s~ear:a.JjQi~ aITiC.{l(llQiln r[ght).~ c~~~k ptrapaga.~~ used h~1 ltml$-m.tlitic].f!s. 6.(LIre.ariofl model. ooo~ng . It was mH IK. :r.~ .e()U_~ ~ln!I!nJ.1lig[ljes~llim! ~telIDl:[e I@~ ] 1 is ®fl'L8:Her tinm 'dle a:~ie~.8sion cJnl]1t(.ooe:l blended 'With >(It.G. oo~tj)m ~.m .!..td::\Ji:irnl.s UC .ls reminiscent of Iililre ~nk::te penern (F[g" 6.tl fQu:m.l!tr:~lL3t~ lubricu.s oonta. <I:1i'i]mfor- en th:e.n:sl!l.dolllf these f pi!liJ1idc: ~medace&.s~llJ..~ p~f~ fo:rmerl.[ ~1'.lte 1m {let 11) or (Qgl:il) a .lmvs 11 ~(loQtilri surface. is diretlly relal.lting GtO~{·sectloiO ricmre$l.e~rL~j.'I'ic mkrosc0'.lssl.u:io between . 6.lme magnifk~~t(}.e rnnge as ThMl gf [he formillall0Il..prell. the I~fdl:less W!l.lthe radiil. we reduced (:h. 5). S(]i!lil. p~m~~ w thebouom of Fig.Sio.f: sea" sl.e.1:I rari[l.gtooccl.~ ~f :~Jle tabk~ aOOrln:ed (Fig. fOOT SEM pktlilf:es usirlg ItJite [ling ThtllV..~ ~p:fIe. il$ ulllikcly tn eecur. SIEanmerurt [tij~ lInlleteli m~r!esi1lm ~~Jl..e of magnesunnsrearste p<nlcle: si~ 'Qi~ irs lUbde.lu..'O[OP pi(. magnesiurn srearare IJOE from :3 to i ~2e1] matiOtni lof Il~ag~~sillm 5[>e~U'ii:te QCCtm>l.gge.ec)cht:mic.@e'r J:Il.si.:I.iMIID2. Dutdo:!).:~ U.I.[<ii(.hil: ault propagauo!l 0Cillli.e. l'i.ss £&. fesidulI:i and c..!diedt!lxial trail)Sll.Y.(l:!llpac~.e.u.w.1 is wh!bin ~It Siilm. l'I}. [)u:ring the f(~crure of me ~bleJt . pDnenr.l: (J r I::ilcih ~nd:lvidu<l~g:r<lnul~.:I1~[S ere brok<en .a I l)1'opcrl]~ m~gl:1cs.t.i'H:.iMiJ.nili·t.~m.W ti!ihc~ ~~Il. the fai lure ef the taibh::l QCO!in'IEed~l the weak :poi:rnts wi rnintU:!~ f.leilll dliaJllt'e[ell" of . Duri!:!£.

.1112 Barra and .~ ..t: 1 L . bEctllJs. for applied forces (1r7 :md 2U k. . the redllClioll of 'l!l<:: miigrle'SioIT) stearaze mean dja. . ..!\ornmil d " r· ~ '. t decrease of tablet tensile s(n~flgthl_ To establish 1.I I I I 1\' rl I I ~ i _' h I \.[ the \'a:r!~llmJ.es} which is explained bya pmpt'nle~ alS10 produces an lncreas« of the de~emd(l'us efC~"C.. . residua] and ejecrlon fotc. rai lied wiflb the origi !laJ 10e No modi flea..: energy .t1cd Were determined and compared w hh UH.axi... The tubrIc.. TGA.fun pmper~ilo.:$ of the new lot j~biaj.'t of ~lhellib-tDc&D~ were derermiJ:le6 aad compared to [he results ~b.~ ' I ....I percentage.5[051 ratio.."'l.y mill. its ph}' (1\111) it'll I!propemeo... f)rig in ~J IO! (Pig _ 1) R esu It s are presented as . lAm llSCl1S a GEM T-X 1~'1borntot.. This innpmVCIi'lil:::o..i " . II ' .ei~' '_'ilTirnion (rom l:he IJrigiml lei...::h'" DSC.~ .observed wilh the modiflec lot were only comin~ trom the rnedi icaaen of tl'le particle size. decrease of n:ct:ial If<lIlSrmS. ..l"J f rnsgnesfum SCdlllI te i increase of ela">tiJ.Krt'ilSe: of .lm:'~r permits all improvemeru of its hibricanr properrlei !ir...al mlHslt1iss:i(~nratio.118. ) [MaS! #'2111 \. x-ray IJiffra(:- better Ii 1(11 form :J.. t ions were 00servedexeepr 111 $h~n to lowe r temperanrres of tbe DSC and TIGA pauerru.e of faster thermal exchanges .tlrm... (~ur. ..

o &. 0.26 ~----------.:i fl!lelili'Cfil _ 1J.0 .tiull mm~mj!i~ioCl [fWlST!ii~!l.3 u r.82 0.2 :5.5 OJl5i 5 o. No. Specific 8urface Axilll l.O!). )I~nliy diffrm:.7 In.15) '0'.5 3 3.2.2 fl. 36. 20kl'l.l5 Il.7 tJ I!l~r ("1>1) 7..-- II.24 nAIllA]" T Ib\ 0.s JS 1.3 2Rj u. 2.]2 il.S9 0.U CU9 'O. 20 7 OJI? 0.t 4.- :u 231 ll$ ~61 u.IlS '0.24 1.09 34' 0.1'9 .l ••• ..7 7. I l JS 0.24 0.3 6 A.3 S.3 C 2A 2.22 0. . ..1i 0.20 5~ 11:11 0. 1122 0'.90 48 21 lS4 O.ET1~ENS1LESTRIENGm (ld·/m.S2 RMi~1 en ~sldlliU]' feree eN) ISjll!:.1iO'l'IfQrue (N) Licllgth zo .5 Differenl B Hi B {m'l/g) DoSe.85 .12 liS: J6'l 27 O.10 n. 0. :2 Velldol" PllfLlcle siz.18 D..m~) O.83 fJ'.5 o.89' CU2.~ .85 'llS!>h 0.u O.16 2139 0.1IIETER (micnlill..2 8M {gSION' .]9 0.U 0.1l7 20 ? 2.&'2 '1187 (1.1.5 2 MEAN DlA. TGA. 1.~8 J. 2..:7' U B: 21 7.4r----------i 1135 03 0.c (11m) 2.s <---. 0.9.81 OJ'!.rc:c A ~ A 2.l..\JU.25 0. ill.]4. 0.19 0..i 1.5 Dilftmlt 3.J 250 :m O.2 0.HI:) M:a~siU_i1l -S~eiR'atcLut.O .-1 7 0..5 3 3...~~1 D ~:lETER {m:Jcrons} 7 kN-"'· .ltS .84 0.u 20 OU 0.8. 0.<'-------"-----'-------" 1 L5 1 2.12 37 31. 3a~ 0.16 0.

h <IS ''''''- illnd the cf~.~[e lot! l~.'ull hydrate form of magnesium its hJ'hri. diameters of the sixlotsrested) ~t~:race 011 .on[clil The fact 1. magnesium stearare sarmpl' from lots II and 2..IDllraf..lS does act mean that oIlIer parameters.:am properties. cross secucn . s!~ar.lh~.1114 11igul~ 6. eleerron IrLtl:.BOiibt::dor induded in me crystal I.$CiI. hiPiing the smaller omd larger mean. could nm al o interfere To mild [11e influence of the moisture . IIliid :2 J: fbotw!H) S nf the rt:S\JIILllg tablr::tS. due to the decrease in the p:u.es ill lhe absence of heat generated during pulverizaticn (Diy ter (~i.rearMe was the predominam factor on irs lubri~ant praper~ji. uop \ Inrmu Ialirt'lil mo(l.rmsium.~I MLmdcd \Y'ith HI:Lg.!lTliC'lg.rrlke).meaa diameter of ltragTl~$il1m 'S..1 (respecnvely.Iiruthe .. 511(.icle size The absence of crystal modification during [he mmiFl~ li.

ro.!l1sj.60"C.inc wi(11 !Ilts 1L and 2l were comp.---- 20 12 O--'~~~~~~~~~~L4~~ Results sbow [baa adsorbed water (Iou..two hlbricmus. .2. These two wer~ chosen because or ~1ii: if VC fY different I'i ~ IawWfl actlu n:ridily ~ 100l!l .1 til J 11.~.lw ID:l\ umJ.mOl 2 ~2 C!CCUiffOOlijn three S:lep~ rather than two 1.tive IUl l'I1ird it}').IS lubric:mrs.:ar.n iI.!1': sOOII wilh loIS 11 and 21.bilil!iclI) a:> result ot' U:.n. new peak -appeaw-d .h~ purlImC:~lers i!'Uldl~bl!!.. Aftl!'f 5:5 days.ibil:s i1l'[]c gUdull redU~li!lll'l Of! Ih~ !.obn.l'Il'j! !he 11I.WIl rate I ots 01 and 21.arf..'Ovemeijllin the lubricant propertles of the Jess ef:· ficietllt t[)~21 andD1Qt by a reduction in the Iubricant properIDJes or the more effic.es Dh!aliled usin. Thi.~d 'to' these c-o!lldiUOl~S UO.lll ~ i RJJ::~G"I11f 1. tlve hl1iln.cn<'Si. (]I LhlH .l(J I1ndll:f (I % r. U 2.plarealJ.llative hum:id.212: lo'fS ~1 .rd. <c{ml!linin. Joss of mag'lnl~ . f.riment~\filtlh a.'wt'lnine if IlIjll:ccould incn.. Fivtl of gr01l:p:S of tab1!! ~. '·~. where a.and 21 .iCllt paul.of ]01 s ~! tI!fI~ 21. 1ilr.· 11 lIod 2.l' r decrease tllc Il1bric.addition of rill erystallino water molec1!Jte in IDe crystal lrmi~ c(ndd ctl..I :12.~ ~OI: 1I .p!l!.es I j' I1rlollgnc$ll SlU: raie. Magne.erj .s modUicaljron was confirmf!d by UtI..1 IDparW (0 lets l Hand 2]1 l) does fIIoiappear to be of g.(.l.l\csiLlfn. was mCIIl calculared using '!liIe i'l('Inowing fo ITmlI a: ill~ ~I:ivcly.rn~l~.aUlne- e "'" ~p. Resu]ls are r.be leis 11 ami 21 I(R~.i. )( _ .:Ind 3.~r a 01%..n..Ild/or monoclinic slrucrur-e 11'1(0 a crysud u~l. New tot J1t1mbers wer~ 1I~~i~IIl:d. hd1uer~~(lof uH~£Ir.borhnml'l. pllil'UPl1'&r:~.uoum:l.ommtion from on. ad~orb~ \~IH. and compilil'elll [0 Glle: rl!tullf" obUlined whb !.angc tile properICi 7 !iii! '\'lI:I~I.l i:l~cture . 100' t>LfllCUJrt InGdHk~[.~f~dJonf acrystal line W. The vr•.l. U -21 - !) ~ . rea used ar c.IIl''!lM~lillmN 'IlIAJll.and . X-ray . espedally at 20 kN.. .'MlfI.' bl .t1olt using mOll~ ~:ii!lm ste'<'l. .difful'~!U C.]~JI"'97 % 'fr.c:lllthre humidity' IItmoJ '~I' d.rn over lime ofl'he two lots placed u'lilder the '1'1'1'0 stmge conditions lutd reached a .U15 4U ~---------. 211.~!:a:Uv~ h!l~ Whereas Ullt IUCSGJ'Us good gJ itlruu properf eli but ~S poor lubriuam (t4).ium ~(Iej].llil 2U: ~l 1 <IifIId . ):-ray aul)18~S 'reslJt~s l1:i~ 6 .~ C:~liIcleri'sti L: m.g . TWE effect comes from an i. 1ite$l. Result!> lndici.f\ed W lots ltsnd 21)1 in an already dihyd~'atc 'IiI\igfie1iiLml tearaie structure seems (0 decrease the lus IJdcilot efficiency..iII.diffrnCI]OI1 and thermal mlillysis (DSC.C (such a~ packing or lilm fonl'i:lldo..!JIln~s~il). w~ tr.(}[je~ fotmtlh.iellrt . LOothe loll! e:xpo\S. and 212.o.CImhi:ruuiull$ 0 f tbc$e.-20 were ~ornp.ifi'er·coot:s. The . tTl . 2:] I.ii::dtc d(.I\l~~U~i>lftX iii L!:~~(.epo'ned ~n TaMe 3. m param~tt:n. l :1:1~ 21 'I: rots ~ ~ lIod 21 SK!.s iU111"SiteitriJte loIS H2 . Lilt! inl'1.e 'tile compaction .lsiUlm 51~rM~ . (1l1'" 21:r . Mil-I!J'I~e-si~m M~iJ:ra~e i:~IJSC d for II).a[er molecule (lO:l~ 112 and 2: 12 o iCump3.vi ~hol:ll e Wee1 illg liJ.rawh.its 1] t.fllpactjon .g (4). 112.'!o!l i[J ~h~ _ 1-9':': area.' um _ 1IIi. 'the wt!:. ~~I'ten~11 T and 21 T ar.e .rea:mte lots tested. Sti.ity ~uno.5 %.l!l1! prQP"J'ty d ffel'fi~e:s ohwQ m{lstu:~ilim :. Ii was .. respectively.c~cclh::1J( lllhticann 'Pmp6rrl~sbut e1{ll..cr is Jc:mOi>i...1 ~IOl'ed 'LJ!lI!d % ]:~Ill. were ~1:Oi'\~d rOll" 55 days under 0% Q:!ld 91'11(. .0 irl[CI'eflt (0 Irno~' if fill\: ~.~iJI(:!O splilere. % . .u'~d I 1iI0S!! UlilillJed between T + 11.rvalohrnmed klLSwg laIc and lot 11 and 21 as lubricants.bric~nt p~operli.l:l1pl.U. S and 9) . . V~.)dl wl new series of ~~pe.~ton~ 2.i!mle(f~" M~S~ ium !. llt~. where the we]ghl.ro~'I:t)F dif'fe~~m::e$between the lWO magI1eSlum s.tar Lint! beaw~4tn [)1~ ll.10• show thattalc reduces the i\!blica!U p.: OS! Iesullts.e:Ilirys!tl. presented in Fig. ~ loOtsU and 21.oncem:rn.rctn impo'f'l:al1Ce. GA) were 'perfmmec:l on .r.1Iit\[ioIIS. were prepnn:d u~ing Lilc formulation morleL DUfeJ)flnces hC(WIilBrl ~le CQn\pilCti. show ~ -. fiOnUI. U and 21 are me ~ompadion parameter va\u.tot 11" I!IeS .urul.:tined wilh!.~ SI.). whereas the 3Jd~ . re~~i:vely.]ts.. U[U.r@~lind! Jtllc are frequenlly used eegcd\lt:'f i:n. and T + 21.l~e[1raOOnd ~al.l~OK1'i)jlf'K 0 rUNl 01"~'r'Il! ~r~if l~i~lll':() IJ ~I ties of the mag.I.i!pbe'fj::.cwere.idily !it room l~m~I\I. me-~U1 di:lm lea" II more illt~gOl1ill paeki n.. itlld by the TGA results..I!l.

21'1: l~~l~ I 'I ertd :!ol ~Hm::d ulI(~~r ~)%re~:lli'l"ClnllliirJit)l: I .I [ Mg Sl #21 50 IfiglU'1.1i\' ides ut" the grnnu..-c. drLy~. _. 1S 1'00 1:25 150 1175 200 lSI' (II' imtl.:scrib. 5Hmd ulld. ./ V~~ V l ~ I~- / (\j 'V\__. Th is is rh e location of 'Ifle very sma) l qllilJUhj' of tim: panicles 0 r lor 21.J1acinn \Ising Sml\e. .f to eear the granule- ti (.l!d (]5.l ali lin particles.!withil'l lots of rnagnesiumsrearare supplied by rhe same vendor.1'{}t\ rmnlc~ th) of rna Il~~ll. lrs preferentla] ~()ca tion Ii. Imd 'Ihe film Iii Illread~ achieved..y-r 1..-_..mged_ end':::l'I"s re unlike'ly to present the same physical propa erne.s: magnesium srearare supplied by djfferem .21. 112. 11- .. 5S A~ previcusly . . 311d varianens in physical properties CJn be expected 10 be fnum..116 - Barrs and Surnrnll J ..l iI. almo:!iC[ all lh~ parucles {If magnesium stearate Inl 11 are Fines.h.[j{.'. DUflng the blending operation.~ I 12.d1dirioll of talc leaves it 41mOSl IJn- rnllll.mmmi o.~ OIl ./ h r ~i . If] C(lmr~:!>l. " . __ • ~ I .f: il. i'( o'i 'ihere lot> were 'resred in a NSA I.s Sillgle S(mi em lnstrume IlU~ F Pre ss _ It d.:t9'-Q 211. tale displaces magnesium sresrate from tnese eavuies ~n(] therefore prcmctes Iilm formation.11l stearate is insufficient 1.law/1: IllUmLnlil~.'iJ!ing (l f ~-'h: of [J ttl ts (l f m~gn~ sium stearate b three di ffercut vendar ~ n!sJU ne din [he 1'011 l1WUl:g i) IIlldimg. " .lm slfcande lots I. +.It1 particles.. The a. m .ll.fUlllflICll1pL'!.i1.l"1lum~).~ " {. ira the C.2: 'IOI~ IIItrul21 1"..I!hJ :!eU (I(its III. when nn~gl~!:l~jU..D fonm.

:=..i-. 'Tile..of ~nesiwm Slell:l1Ilc was IDe Ire)i me lOr mfllJi:m:ing its Il. association with magneslem 5rearare_ Further studies sb.=.un .:::.__. Two sohniOnti i:'ould be sL!lgglils'OOd reduce theimItQ pacl!..e.a:rac!eristlcs of Ihro:r:orm~'.t~r of m a 1m.---~"...c.. .j LM961 #1'2 'I I II MgSt'211 " [MgSt#'2'1) (0 ~ (b) :...~ lati:on but with less ohm irnpaC:I lllirn Ille mea.~:...:::.s!tz.(Oel'si'uiS) 200 ~ • I has been snowDlhat the panic]e.r}'s~ SlruCJure a100 influenced 1hecompat':liafj tlh..rf'omied to ..lb~jc3lll:efficiency.::.::::. o .......of we variability of (he parlide size of magnesium stearate 'OIlthe compacdon propt:rlies of the model s:rudied: ul:illiatiOIJl of a standardized magnesium stearate m~ d~ame[er and use of talc iIi.__..~ ~MgSt "212 40 '60 80' ~. o .::::.:.n diametar.=..ollild W pe.... __ -.OO '1120 'U'O 160 180 Tempeniitu!'9.-----~~~. MgSt #111 ( Mgst #11 . em thmc.

I lltr~..~-I i\ r~ _I .....:! ~ stores under 0% relative hilmldi~y.2... """"'_ . ~ . ldieg!ees) Flgcl!ln'9.. room tempe. \~.. lots 1r2.118 Barril and S{lWlTllii il .. I~ I\.'.._ ~~ --------.Ln.j .. uz. ___.MgSt #-211 I 3 7 [ MgSl "1"21.. I .ter 97~ relalu~i'J!:lIill4i!y~ 55 days..lte lou III I.. ... l ~ I I'.. variadonsof rnagllleSillm ~:IIr.. Ji ~ .. I. .1.) 11 5 19 27 2 Thma... "'\....ft 111. 212.. MgSt~... 21 L lut~ II and .. ~.I "" .--... 'II"'_ ..~~ ~-'111 .. • )l.~'" ~_.. .... ~..1 I" i 1 I '"~.I -~ i.. MgSt #112 ) I~ .---.!re}... i 1\ ! ". 2U.. X-racy diffradion... ... J'~ ~..~ J . '1 J.. lOTSII ancl2l stored wt..... and 212 ll('l~~ III.".:...

tudied . 177-188 (EggS). lnd .. {19871 .5 50. rI"IlpCri)' III .-Ge:i~.[umsrearate dllr. Drug Dcv.8 0..drelAllricaru SOOiilrnle Pfo. 5. D.f.SMISSI.83 {I.Magne.ng i~s dfl..gkcitel." harm.!.uum slc. T. m..sm of nmgnesiUJJIl sreatm.. RW . ". Centre d'Emdi~s Pharm<lQlnl'~iques.iSl::rne Oe~et1:m'§~i. fnflue-nC1tof r. R.sltlili-· hmd Ca. S!JJuilions formainmining I:"lmStanl: :relative humidity. !iii IttlilDI::u.'. ['1.A.lI ~ nL~~S~!I~f. 1m'!.lamilll.S.uell.t 119 Tah.8S '[].P. C'. ZllI. J.20 1(l4 t:Ji3 " 2.~ 0.~.~ 0·. Dc B~. 111-180 (l98B)..LY.i.lc Sif1!Jlg.77 I]l. I... n Iit:lI! ~ Ii!! £. Umenucl:mngell i!II re illell . L Harris. I iJfiCJ2}..inl. na~.liI:nliU: III !till:pr.988).~'9!lg..~UIl.opeIfI:ies oJ compressed tablel~. Pharm. Tile' e. Can and B. K.f'reau and G.llg and 7 20 3.lirl!. Pracdcal il'lVulvem.-----eI 'T CNRS 1118.ll o.ItJo. fudi . F.De:p~ttmenll of Pbannace'lJrita~ Technology. Phanl1iL<:~:utisd1 ~111:![i.fJcnie~ of Magru:s. fm.lr F~~ (~N) 7 11112 mrref-etl4 21 Difftretu DiffClI'C1I1 D ITCTci!t Differen[ Different tcieniical O. :U:I-12:5 (197:5). .I.ray rliffril.!IOCl1m~ 'ro(.i.Iln. 1-- ~---- . The pse.22 215 40.:.> tK!i.liIm Lot No.JO 11'. B[':r:cc~ m. T~ ZiJIS!l:ra..l'Je. 97.<.m Stemale M.212J an .lTer· J. Mornsl!io•.ci1no1ogie. Frru:lce..l o~ OIl m~bl.[~'. ('hem . fiba:rnJ" J3{-6.~e:Uil. III DSC TdA X..C'~ L r.a.83 OJI? 'O'.v.pp.0 7 C 13 3W 2.rnt~ JolS_ .l Ul.. TriooJog.1. S. C111. ~-100 =2:50 L. J61-1ci5 (1977.g1 0. .·1 0. Mltteiltmg: determine the naarre oftl'le bonrl b~~~vl. U hrrnaco--Ed.l ond Eri:tiilntiii~:sc in dcr Tablen'i:llt{.\.ffect -of dill ~'ariabili~' hi the physiwche-rnical pro:~[(k!> a f magnesium t~e. ·W~Ciktil:!d. 1'I'ti.J.23 s 0. Peck.alt On ihe hlbii~t eeees between L we magnes.mcib~a.anas. QU!IIltiltMi I) evalu don of serne lab lei lu!:iriClInt:o. F..3.. 1_ The "uthor.~-------' Pl!lanfm. S. end lifie Unlversife de Paris XI..pclymorphi.1""H 'i:gurc· J O.• 39(2).'9 20 Tahl'l!t ~erui.ro.LJIJl1"f-E" F1'!lF~bV II 'n-"'. Eog.I]iel. <l:3(5).d A.11J!tociOO.TAI.cnes1.c.SSI 21 D1I'ferelil Difl'cnmr Dlffenmt i! It.erk. P K. 376 408 0..iS (l."'!:..J6 lli 2~ O.4 0.[1.~.and . . Yl:lraill..-h tkPlrnil1~) 7 20 20 J~l 22\4 32: 1'2<1 2:l:31 l. Van der ·Vl:aLlsforces should be ·par~clllar]y s. Enel aml:.20 J64 '133 376 ill 2.cms in tkhlct Illl1.18 0.T.19 0. 2014-20:15.:n agnesium m stear:a~c: ainu the granules. Carstem..a. Piltanli.'II"nlle. C..n 0.. 42.1rS O.. Film famlllDOJ] by m:):gn~s.!~'lU!.Y~~I~itma· ceuticalsfor ilJl scielltific: and f:umnda1 sUpJP'DIt. 'lUi ~Iilld 'Crys1'l1J'. !'>lImier . t2t'i1-12:M om).'\. -sn ~ -Ifm L ~ ~ -150 2. . :5. o. for the opportunity given nf WI !I(l [0 on" :l t!<.1. realize his reseaeeh in th~ United S'[..oph<lmulI:euli:qll properties tl<f ~UIf8di~l1c &<lb~If~'.1. Praetles. URA w.'u.117 ~ 0.tll. A".1!6 0. l. J. would like to 1l!3IIIk: Ci oo. 6. ~peyre.leEl.kiull1'[S.w.a~ion of tile ¢Iysica:f properties of pnse magnesium stearate.r.1.. 3. B. EiCIJ:Ulis. U..ScoJ'i1erJ Wafer OH.t:l.I.3 InjlIumce oJ AtJ.~'F(l.criol:l In UpJJI.16 00.ct On Ull:!l~IJti:O!l. 1949.1( ).---_'_--. An C. 209-114 ~1. Cuitl(].Ol'i RolI.ll Cd] 30 2. M.20 ~ 0.35 0. E.

C' . nu 1.. U 14 n't:li!!"(Siwn Si'eara. ~iiJ1Syl'lr3IWI. • s.nl)' diffnlclion. D.lIlt. M. Mack ~:s II I~W'l~. Gmi1n~~'~~ld.• 2.! rfnce of lub r h::au:d part r Plt.1120 9.olutioll Tale of 10aHrychc ~lI:i(! trom ~flhd dQs<lgc f9ml~.r'arivL:: c\l:almHioll. 352-356 t I ~n)..t. 39Wf) . 0' hcavYIt!Nal soaps by ~ .4. Practica..8•. . ~ndPh. (19R'!J_ :R. 41 PubH~in~.Pll:Lm:JJI-Prohl.md lts e ffe( I on the dL$s. R. ~Y:1-5l1 (i 982). ( ~~S. or W'Uc'lme and !TID!.m stearate.2320 (1IM9). 2.r.a:rm.u'Id J. B111.fJi S(j.:mn. til ed.!J.Labo.. Mulllllr.e'j'. III IliJ (l'~ S61. J\.uds.c~ [lOOpCrlLeS D[rnagl1csnm. 15 12.ll. a:It:l:IlO b~lcll ~~fiaC10n$ 'of ~1~mml:'n:I:il1 B n:tatJn~-siUln~ll~ar!ltl]. Dil\l1ibtllioJL Ilf magl1elliuni ldlil$. Some 1151l~m C u:( 1M failure (If 'Sl!I'CftI~ t:ll"lleL. C'lllmc(erlZlukm. 1990. Hilbl. D m~ lJ~v.:rrYm~ril. JPhllnn PllilJ'iti1l.~ .l'le 011 lh~ S'i.4). CQmpa.o( 4l.~·.. brk.j1nY. Rel\l'ililigi-DII'!E PIi!!:lfl1ifJ. .~. ~.'e"uw:·. L Colc:J:rnno and F Cm~1i. W. 'VoId Imll G.36. I-I Rich. II Famiacl~-Bd. ~ICiilf.lilllgdl..Teeh • 3JI!(:!2l.'ld IIg Clu~IIl. Roblol and l"uisit. j29-3·~ I l(J. U. . and R. i!lalc:1l vlIriali£lflS zsu.