BOOK
`TITLE
`
`(cont. from page.
`
`NO: 11118
`fr~tJtt~ fi/k frN
`~'{i:.F
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`. __ .. ., ..
`r
`.
`~~ ?·:1.-'f)r
`
`PAGE
`NO: 77
`PROJECT#___..J~~~~)~~,__~~~
`
`Experimental:
`
`Equipment:
`Mettler AX 205 DR Analytical Balance, Asset No. 515840, Rm. C128 (referred to as Balance 1)
`Mettler PG 5002 Balance, Asset No. 101265, Rm. C128 (referred to as Balance 2)
`Orion 520A+ pH Meter, Asset No. A2220, Rm. Cl28
`Coming Hot Plate Stirrer, Rm. C128
`Millipore 0.22 µm Filter Unit (1000 mL and 150 mL)
`Laminaire Laminar Flow Hood, Asset No. 13324-00, Rm. B-132
`Conner Center Clean Suite Rm. C143
`
`Formulations:
`FID
`Batch
`04-37157
`107047
`107337
`04-37158
`107339
`04-37159
`107340
`04-37160
`107343
`04-37238
`
`Description
`TRA VAT AN BAC Free, 0.004%
`TRA VAT AN BAC Free, 0.004%-no Zinc Chloride
`TRA VAT AN BAC Free, 0.004%-no Boric Acid
`TRA VAT AN BAC Free, 0.004%-no Sorbitol or Propylene Glycol
`TRA VAT AN BAC Free, 0.004%-no Boric Acid - lOX Zinc Chloride
`
`Compounding Procedures: (see attached batch records with adjunctive data)
`
`A
`
`Batch 04-37157 TRA VAT AN BAC Free, 0.004%
`
`FID 107047
`1tt;1-~..-0l(
`1. Tare weighed a clean glass bottle with a stir bar. (Balance 2)
`'»Hfe W
`2. Added about SO % of batch water.
`3. Weighed and added the batch quantity of the following excipients to the~: boric acid,
`sorbitol, 0.1 % zinc chloride stock solution. Stirred the solution to dissolve these ingredients.
`(Balance 2)
`4. Adde~:~atch quantity of AL-6221 0.2%/25% HC0-40/37.5% Propylene Glycol Stock Solution
`ot \~and QSed to 95% of batch weight with purified water. (Balance 2)
`to the
`to"furx 'fh\ solution. Measured the pH .
`5. Stirre
`Initial pH= Lf-0 ~
`6. Adjusted pH if necessary.
`Amount of lN HCL added= to11~
`Amount of lN NaOH added=/~. t.f,..L
`
`;s 1-""'f
`
`7. QSed to 100% of batch weight. (Balance 2) Final pH= ~.o)7
`.
`.
`If> /-J...-0 lf
`
`• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
`
`!
`
`··!·"
`
`....... i
`
`.. ................ .. ········~···.! . ···············-··-0· ......... , .......... _,,,,_,,, ....... l. ___ ,,. .......... _i_,, ..
`
`Entered By: d:.U
`
`Date
`7-rf-o'f
`
`ALCON 2008
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`

`

`• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`BOOK ---""'-N'""""'O'-'-: =--11"-""1-=->18
`11-uvfl~ BJl-c free 0 .00~%
`TITLE
`I
`
`NO: 78
`PAGE
`PROJECT# 1')5/11
`
`~~~----~~~~-
`
`B.
`
`····~·
`JI~ 1;;
`
`)
`
`Batch 04-3 7158 TRA VAT AN BAC Free, 0.004%-no Zinc Chloride
`
`FID 107337
`fr) 7-~-ti•(
`1.
`Tare weighed a clean glass bottle with a stir bar. (Balance 2)
`4i>Kf-t dJ. 7' J."'
`Ad~ed about S-0 % of batch water. .
`2 .
`.
`. .
`3.
`Weighed and added the batch quantity of the followmg exc1p1ents to the~: boric acid and
`sorbitol. Stirred the solution to dissolve these ingredients. (Balance 2)
`4. Added t%ftPltch quantity of AL-6221 0.2%/25% HC0-40/37.5% Propylene Glycol Stock Solution
`to the~-~~ QSed to 95% of batch weight with purified water. (Balance 2)
`5. Stirred Af'~~ the solution. Measured the pH.
`.
`Initial pH= L(.O~
`6. Adjusted pH if necessary.
`Amount of IN HCL added= N/'1
`Amount of IN NaOH added= ~ .O,..l
`
`I{
`
`7. QSed to 100% of batch weight. (Balance 2) Final pH= {;.Of)
`
`C.
`
`Batch 04-37159 TRA VATAN BAC Free, 0.004%-no Boric Acid
`
`h
`7. QSed to 100% of batch weig t.
`
`(B 1
`a ance
`
`FID 107339
`~ 7-J--<J"f
`ftt; .,..,.~
`J. Tare weighed a clean glass bottle with a stir bar. (Balance 2)
`2. Added about 50 % of batch water.
`~.itf/~~
`3. Weighed and added the batch quantity of the following excipients to the~: sorbitol and
`0.1 % zinc chloride stock solution. Stirred the solution to dissolve these ingredients. (Balance 2)
`4. Added~tch quantity of AL-6221 0.2o/d25% HC0-40/37.5% Propylono Glyool Stook Solution
`to the
`t an9, QSed to 95% of batch weight with purified water. (Balance 2)
`5. Stirre 1 o Jx1fi'J solution. Measured the pH .
`Initial pH = S. C, H'
`6. Adjusted pH if necessary .
`Amount of IN HCL added= Nf/4
`Amount of lN NaOH added= /fl/~
`2) Fl.nal pH = S· 9 ?'?
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`• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
`
`Verified By :
`I~
`~~~
`
`Entered By:
`
`Date
`7-ff-Ol(
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`BOOK
`TITLE
`
`i
`
`)
`
`NO: 11118
`11lJ.Vt-1 ~ &Ac Ff'('e
`-
`ft9
`.
`. f,/
`(cont. from p~~;. 7 f
`
`0. 0 0 l( %
`
`PAGE
`PROJECT #
`
`NO: 80
`;l..~p/f
`
`)
`
`• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
`
`D.
`
`Batch 04-3 7 I 60 TRA VAT AN BAC Free, 0.004%-no Sorbitol or Propylene
`Glycol
`
`FID I 07340
`~ 7~g'tl'{
`1. Tare weighed a clean glass beaker with a stir bar. (Balance 2)
`2. Removed the stir bar. Weighed and added the batch quantity ofHC0-40 directly in the beaker.
`(Balance I)
`3. Added about '}O % of batch quantity of purified water.
`4. Stirred for at least I 5 minutes until HC0-40 is dissolved .
`5 . Weighed and added the batch quantity of the following excipients to the beaker: boric acid and
`O. I% zinc chloride stock solution. Stirred the s·olution to dissolve these ingredients. (Balance 1)
`6. Weighed the batch quantity of AL-06221 using a spatula. (Balance 1)
`The spatula was placed in the bottle with the end containing AL-0622 I immersed in the solution.
`7. QSed to 95% of batch weight with purified water. (Balance 2)
`8. Covered the opening with parafilm to minimize evaporation. Stirred overnight to dissolve the AL-
`06221.
`Stirring Start time and date: 4: ISprn 7-fj-Olf eNJ of~ ff-s 7-'l-O<f
`tr~ )·1--0'f Stirring Stop time and date:
`~ '. 3L?a!!ll 7-C(-O'f
`9. Measured the pH. Initial pH= Lf. 11(,,
`10. Adjusted pH ifnecessary .
`Amount of IN H CL added = "'(14
`Amount of IN NaOH added= o.of:?7
`
`I I. QSed to 100% of batch weight with purified water. (Balance 2)
`
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`~ 7Q:p)J"(
`
`(cont. on page . ~"/
`
`,icM> h~~~,,,,.;~~'~'
`
`''' ''~~-&~~~M~<h0M•--·~~.-~~h~,,~,~
`
`Date
`7-r?-oi
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`BOOK _ _ __,N,_,_O~: 1~1~1 ~18
`
`PAGE _ _ ~N~0~:~8~1 __
`
`E .
`
`FID I07343
`
`tr< )-1 l --o'{
`
`Batch 04-37328 TRAVATAN BAC Free, 0.004%-no Boric Acid- lOX Zinc
`Chloride
`
`l. Tare weighed a clean glass beaker with a stir bar. (Balance 2)
`2. Removed the stir bar. Weighed and added the batch quantity ofHC0-40 directly in the beaker.
`(Balance 2)
`3. Added about ~ % of batch quantity of purified water.
`4. Stirred for at least 15 minutes until HC0-40 is dissolved.
`5. Weighed and added the batch quantity of the following excipients to the beaker: sorbitol,
`propylene glycol, and zinc chloride. Stirred the solution to dissolve these ingredients. (Balance 1)
`6. Weighed the batch quantity of AL-06221 using a spatula. (Balance 1)
`The spatula was placed in the bottle with the end containing AL-0622 I immersed in the solution .
`7. QSed to 95% of batch weight with purified water. (Balance 2)
`8. Covered the opening with parafilm to minimize evaporation. Stirred overnight to dissolve the AL-
`06221 .
`,-;;,,,J of rJa.y 7- 1~·01.f
`Stirring Start time and date: :;;lODen. ?-/J..·ol./
`l\t; 7- 1~1"/Stirring Stop time and date: r/: 3De..,,, 2- 13--ol(
`9. Measured the pH. Initial pH= {p.)~~
`10. Adjusted pH if necessary.
`Amount of IN HCL added= 0·077
`Amount of IN NaOH added= ¥VIA
`
`I l. QSed to 100% of batch weight with purified water. (Balance 2)
`
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`Date
`Date
`~~
`7-ff-O'{
`?J!P6111ft
`
`Entered By:
`
`t
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`BOOK
`TITLE
`
`PAGE
`PROJECT #
`
`NO: 82
`J.').S711
`
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