PTX0142-00001
`
`1
`
`CIP2061
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`CIPLA LTD. EXHIBIT 2039 PAGE 1
`
`

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`NOTEBOOK NO. 1/ Jt; r(
`ISSUED TO y.~{L~ ' !1c·";Z;
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`DEPARTMENT /!ocL e·f,._ /~\'L3"' L << '<~lf,/Ju ,_;r-
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`LABORATORY NOTEBOOK ERROR CODES
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`CE CALCULATION ERROR
`ER ENTRY ERROR
`GE GRAMMATICAL ERROR
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`LATE ENTRY
`RE ROUNDING ERROR
`SE SPELLING ERROR
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`
`SCIENTIFIC NOTEBOOK COMPANY
`2831 LAWRENCE A VENUE
`STEVENSVILLE, MICHIGAN 49127
`(800) 537-3028 - http:/lwww.snco.com
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03470949
`
`2
`
`CIPLA LTD. EXHIBIT 2039 PAGE 2
`
`

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`Table of Contents
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`INSTRUCTIONS
`
`1. The primary purpose of this notebook is to
`protect your and the Company's Patent(cid:173)
`Rights by keeping records of all original
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`Copyright Harold Gallop
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`Form 590
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`CIPLA LTD. EXHIBIT 2039 PAGE 3
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`Table of Contents
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`SCIENTIFIC NOTEBOOK CO.
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`SCIENTIFIC NOTEBOOK CO.
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`HIGHLY CONFIDENTIAL
`·SUBJECT TO STIPULATED PROTECTIVE ORDER
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`MEDA_APTX03470951
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`4
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`CIPLA LTD. EXHIBIT 2039 PAGE 4
`
`

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`Table of Contents
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`SCIENTIFIC NOTEBOOK CO.
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`·SUBJECT TO STIPULATED PROTECTIVE ORDER
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`CIPLA LTD. EXHIBIT 2039 PAGE 5
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`

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`~~~~~~~~~~~~~~~~~~==·=-=····==- ·······
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`Table of Contents
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`CIPLA LTD. EXHIBIT 2039 PAGE 6
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`CIPLA LTD. EXHIBIT 2039 PAGE 7
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`96
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`Project No.
`
`Book No.
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`TITLE lHt(~if*.-: ~e~11J~ ~ _dOM~;Jf'.;; __ ~_r:ro -rc.-LQ_':;-1.;-/u
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`Project No.
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`Phvsical Testtnq: Soma 700mg SR TatMta 11048·12 & U
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`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03470955
`
`8
`
`CIPLA LTD. EXHIBIT 2039 PAGE 8
`
`

`

`Project No.
`
`18
`
`-
`
`Physical Teatina: Soma 700mg SR Tabllla_,1)31..24. 26. & 21
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`kif-.:'
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`Project No.
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`~in Registration Batches- Decatur 03/2006
`
`8Mib # 03-33-03c
`OOM: 03/13/06
`Batch Size: 3300L
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`No· problems occurred during the making of this batch. This batch was made in the 940 gallon
`processing tank, samples were taken according to E-Req 1112 sampling record (see below), the
`batch was filtered through a Millipore 0.45 micron PVDF 20" ftlter (code# CVHL-72P-P3), and
`transferred into the 940 gallon holding tank.
`
`t o*lt+
`
`SAMPLING RECORD
`
`05-3'3'-0!:s
`03-H-o</s
`Batcl>Nambor. 03-l3'-D3c
`
`Bulk Solution
`
`E-hquisition 1112
`
`Followitlg
`Stopl8
`
`F'mo!Bulk
`Solution Prior
`to Packaging
`
`~-point of note is that during the filtration process it became clear that the filtration rate
`slowed considerably after approximately the !-hour mark. At this time, I began charting the
`(see pg.IOI), and will continue to do so for the three remaining batches, for
`
`~~OJ!. I~
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03470956
`
`9
`
`CIPLA LTD. EXHIBIT 2039 PAGE 9
`
`

`

`Project No.
`
`00
`
`:rom Page ....... ...£...:. i
`
`Batch # 03-33-04s
`DOM: 03/14/06
`Batch Size: 330L
`
`During the compounding of this batch, specifically steps # 8 through 11, it was observed that the
`250 gallon processing tank began to shake (as it is equipped with shock-absorbing technology to
`counteract the force of the moving liquid inside) at a speed that caused the batch to " roll" or
`slosh around the inside of the tank, thus causing a loss of any true vortex. Without baffles to aid
`in the breaking up of the active and excipients, it was determined that the mixing speeds should
`be adjusted upwards until a suitable vortex could be obtained again.
`
`Once this was done, no further problems arose in the manufacturing of the batch.
`
`Samples were taken according to E-Req 1112 sampling record. The batch was filtered through a
`Millipore 0.45 micron PVDF 20" filter (code# CVHL-72P-P3), and transferred into a 375 gallon
`holding tank.
`
`These new (greater) mixing speeds will be used for the two remaining 330L batches as well.
`
`Batch # 03-33-0Ss
`DOM: 03/15/06
`
`No problems occurred during the making of this batch. This batch was made in the 250 gallon
`processing tank, samples were taken according to E-Req 1112 sampling record, the batch was
`filtered through a Millipore 0.45 micron PVDF 20" filter (code # CVHL-72P-P3), and
`transferred into a 375 gallon holding tank.
`
`Batch # 03-33p-03s
`DOM: 03/16/06
`
`No problems occurred during the making of this batch. This batch was made in the 250 gallon
`processing tank, samples were taken according to E-Req 1113 sampling record (see below), the
`batch was filtered through a Millipore 0.45 micron PVDF 20" filter (code# CVHL-72P-P3), and
`transferred into a smaller holding tank.
`
`AlTACIIMKNTD
`
`SAMPLING UCORD
`
`,i~11\0b
`
`lbteh NUDI.ber:
`
`03-.33p-03s
`
`PROCESSING I Top of holding
`FioaJBulk
`tank
`Solution
`
`•~•ro~~~
`
`11 wei ht :kg)
`n/a
`3136
`14
`14
`12
`12
`12
`12
`12
`10
`12
`10
`10
`10
`10
`8
`8
`8
`10
`6
`10
`8
`2
`0
`
`nne
`14:18
`15:20
`15:21
`15:22
`15:23
`15:24
`15:25
`15:26
`15:27
`15:28
`15:29
`15:30
`15:31
`15:32
`15:33
`15:34
`15:35
`15:38
`15:37
`15:38
`15:39
`15:40
`15:41
`15:42
`
`Batch#
`DofM:
`
`03-3~3c
`311312006
`
`Batch Weicht "kal
`3350
`214
`200
`186
`174
`162
`150
`138
`126
`116
`104
`94
`84
`74
`84
`56
`48
`40
`30
`24
`14
`6
`4
`4
`
`03-33-04&
`3/14/2006
`
`I Batch Weicht fk•
`335
`323
`313
`308
`302
`
`Tme
`13:10:00
`13:10:30
`13:11:00
`13:11:30
`13:12:00
`13:12:30
`13:13:00
`13:13:30
`
`13:14:00 I
`
`13:14:30
`13:15:00 I
`13:15:30 I
`13:16:00 I
`13:16:30 I
`13:17:00 I
`13:17:30 I
`13:18:00 I
`
`I 27
`
`n/a
`12
`10
`5
`8
`15
`22
`25
`
`27
`27
`28
`28
`28
`28
`29
`18
`
`213
`186
`159
`131
`103
`75
`47
`18
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`Project No.
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`101
`
`03-33~5s
`311512006
`
`0
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`after qs
`after sampling
`after filter purge
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`. • ..•. -l-.-l
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`Batch Wei ht kal II weight kg)
`335
`nla
`328
`7
`308
`20
`270
`38
`46
`~-
`46
`45
`45
`45
`4'
`
`afterqs
`
`Batch#
`DafM:
`
`Time
`
`12:35:00
`12:35:30
`12:36:00
`·-----
`
`I 12:39:oo
`i2'39'30
`1:40:00
`
`Batch#
`DofM:
`
`Time
`
`12:42:00
`12:42:30
`12:43:00
`12:43:30
`12:44:00
`12:44:30
`12:45:00
`12:45:30
`12:49:000
`12:49:30
`12:50:00
`
`0
`
`2
`
`03-33JH)38
`311612006
`
`Batch Weioht (kal
`336
`306
`292
`248
`203
`158
`114
`71
`37
`34
`3
`3
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`11 weioht kol
`n/a
`29
`14
`44
`45
`45
`44
`43
`34
`3
`31
`0
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`after qs
`after filter purge
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`MEDA_APTX03470957
`
`10
`
`CIPLA LTD. EXHIBIT 2039 PAGE 10
`
`

`

`Project No.
`
`Book No.
`
`J2
`
`rom Pag!!
`
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`
`LIQUID
`'- vuv~~~'-~ .. u L~~LL'.a~' ~"''-"' ._.'"'<'-'&&...0'
`
`Re: Codeine placebo ofTussi-Organidin NR for analytical testing.
`theoretical SG = 1.125
`L
`2.000
`BATCH SIZE:
`
`#
`I
`
`In2redient
`Guaifenesin USP
`
`Code#
`4055
`
`Lot#
`{X;c()DOZ3!»
`
`~ ·~-~
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`F
`
`#·
`
`mg
`per
`SmL
`100.0
`
`..
`
`-" ............
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`grams
`per
`batch
`(t!l
`40.00
`
`~- ... --·
`1044-102P
`actual
`grams
`per
`batch
`(g)
`
`'/(J.D/4
`
`z.oo7
`2.00
`o./ilJ/o
`0.80
`/.fs'IS
`1.84
`200.00 Zr:fJ. 2.
`tk» 5
`863.50
`'\a).O
`400.00
`D.'/Ot.
`0.40
`7Jf7,7
`7.48
`
`2249.4 g
`
`Sodium Benzoate NF
`3
`Saccharin Sodium USP
`4
`Citric Acid Anhydrous USP
`5
`Propylene Glycol USP
`6
`7 Glycerin USP
`Sorbitol Solution 70% USP
`8
`9 Dye: FD&C Red #40
`Flavor: Raspberry
`10
`II Water, purified
`
`0168
`7260
`1134
`6257
`5100
`8135
`3073
`3425
`8542
`TOTAL:
`Theoretical specific gravity is 1.125 based on Processing Batch Record
`Batch produced in Room #133
`Manufacturing Procedure:
`
`2L Z508
`5.0
`rmYni99't
`2.0
`nllffmtz.'JZ
`4.6
`O"bo5o):l
`500.0
`IYtYJGJttK
`2160.0
`<XAX01230
`1000.0
`a:tl?col.6 oz.
`1.0
`(}C()<XNJ 2'/ I(.
`18.7
`Q.S. (to make 2249.4.,;)
`
`1.
`
`In a stainless steel beaker (FINAL CONTAINER~ g tare), add approximately 600g of
`Purified water.
`2. With mixing, add the Red #40 (./)to the beaker and mix until unifonn.
`3. Lower the mixing speed and slowly add the Propylene Glycol (J) and mix until uniform.
`4. Raise the mixing speed again to obtain a sufficient vortex and add the Guaifenesin (./},mixing until
`5 "''" .
`the solution is complete.
`t.-Jixing Time:
`5. Lower the mixing speed and add the Glycerin (.{)and Sorbitol Solution (J). Mix until uniform.
`Mixing Time: S "'."' ·
`6. Raise the mixing speed and slowly add the following, mixing after each until the solution is complete:
`Sodium Benzoate (J)
`Saccharin Sodium")
`Citric Acid (J)
`Raspberry Flavor(/)
`7. Adjust the batch weight to 2249.4g with Purifi water.
`Before adjustment:
`Afte
`d'ustment:
`Gross:~
`Gross:--'"""=-
`12'1· f>
`Tare:
`Tare:
`Net: ~ Net: _
`1
`g to bring final net weight to 2249.4g
`
`8.
`
`M. · ixing Time:~, Final pH: __ (date____), Final Viscosity: __ _ (date__)
`Viscosity Testing- spi~ # .....J 60 RPM for l minute@ 25"C)
`
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`fus~0KGJ17JtbiiJ IJI( [!QUI.!>
`
`Project No.
`
`Book No.
`
`Theoretical specific gravity is 1.125 based on Processing Batch Record
`Batch produced in Room #133
`
`Manufacturing Procedure:
`
`I.
`
`In a stainless steel beaker (FINAL CONTAINER~ g tare), add approximately 600g of
`Purified water.
`2. With mixing, add the Red #40 (./)to the beaker and mix until uniform.
`3. Lower the mixing speed and slowly add the Propylene Glycol ( J) and mix until uniform.
`4. Raise the mixing speed again to obtain a sufficient vortex and add the Guaifenesin (/),mixing until
`the solution is complete.
`~ixing Time:
`~ .. ; •.
`5. Lower the mixing speed and add the Glycerin (,f) and Sorbitol Solution (J). Mix until uniform.
`Mixing Time:
`10 •" • ·
`6. Raise the mixing speed and slowlY. add the following, mixing after each until the solution is complete:
`Sodium Benzoate <h
`Saccharin Sodium (J)
`Citric Acid <J)
`Raspberry Flavor (J)
`7. Adjust the batch weight to 2249.4g with Purified water.
`Before adjustment:
`After Adjustment:
`Gross: 27/!.fl. ~
`Gross:~
`. Tare: ~ Tare: ~
`2-2. '19. i
`ZIZZ.O
`Net:
`Net:
`1 Z 7.1
`Amount of water needed
`g to bring final net weight to 2249.4g
`8. Mix for I 0 minutes or until uniform.
`Mixing Time:~ Final pH: .!1:.di_ (date .,),,),~ \, Final Viscosity: ~(date~
`VisrosityTesting-spindle #..£, 60 RPM for 1 m~25"C)
`
`~q+~oSI~
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`-
`
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`
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`··•
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`······---;
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`6~
`
`11
`
`CIPLA LTD. EXHIBIT 2039 PAGE 11
`
`

`

`Project No.
`
`1)4
`
`Project No.
`
`Batch#
`DOM:
`
`Time
`14:18
`15:20
`15:21
`
`03-33-03c
`3/1312006
`
`I
`
`200
`
`I
`
`3150
`
`I
`
`14
`
`I
`
`N
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`03-33-05s
`3/15/2006
`
`224
`178
`
`1'
`157
`
`1··
`
`.• . •
`.• (
`--a8
`I
`46 T~
`
`DOM:
`
`Time
`
`12:35:00
`12:35:30
`12:36:00
`12:36:30 I
`12:37:oo I
`12::
`1l
`
`: 1~
`·-r~
`
`Batch#
`DOM:
`
`Time
`
`12:42:00
`12:42:30
`12:43:00
`12:43:30
`12:44:00
`12:44:30
`12:45:00
`12:45:30
`12:49:00
`12:49:30
`12:50:00
`
`. 401"~-
`
`03-33p-03s
`3/16/2006
`
`Batch Wei ht (kg)
`335
`306
`292
`248
`203
`158
`114
`71
`37
`34
`3
`3
`
`Amount Filtered (k )
`n/a
`nla
`43
`87
`132
`177
`221
`264
`298
`301
`332
`332
`
`tJ. weight (kg) Rate (kg/min)
`n/a
`n/a
`~'
`n/a
`29
`14
`43.0
`44
`58.0
`89.0
`45
`45
`90.0
`89.0
`44
`87.0
`43
`34
`77.0
`3.
`37.0
`31
`34.0
`31,(!
`0
`
`15:29 I
`
`15:27
`15:28
`
`15:30
`15:31
`15:32
`15:33
`15:34
`
`I
`I
`
`I
`I
`I
`I
`
`I
`
`12e ~ 3224
`I
`11s
`3234
`104
`3246
`94
`3256
`'266
`84
`:,,
`3276
`74
`64
`3266
`se
`3294
`
`I
`I
`I
`I
`
`I 12
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`I
`I
`
`1
`I
`I
`
`12
`10
`
`10
`•n
`10
`10
`8
`
`I
`I
`
`1
`I
`I
`
`I 12.0 I
`
`14.0
`14.0
`12.1
`12.i
`12.1
`12.1
`12.1
`10.0
`
`10.0
`•n n
`1o.o
`10.0
`8.1
`
`~ .
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`bi• . •. ·•"%"'"'~'
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`Q;Q •.
`
`15:40
`15:41
`15:42
`
`4
`4
`
`03-33-045
`3/14/2006
`
`Time
`13:10:00
`13:10:30
`13:11:00
`13:11:30
`13:12:00
`13:12:30
`13:13:00
`13:13:30
`13:14:00
`13:14:30
`13:15:00
`13:15:30
`13:16:00
`13:16:30
`13:17:00
`
`Batch Weight
`335
`323
`313
`308
`302
`287
`265
`240
`213
`186
`159
`131
`103
`75
`47
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03470959
`
`12
`
`CIPLA LTD. EXHIBIT 2039 PAGE 12
`
`

`

`Project No.
`
`)6
`
`100.0
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`i.L
`
`40.0
`
`30.0
`
`20.0
`
`10.0
`
`0.0
`
`0
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03470960
`
`13
`
`CIPLA LTD. EXHIBIT 2039 PAGE 13
`
`

`

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`20.0
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`10.0
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`0.0
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`500
`
`1000
`
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`2500
`2000
`Amount Filtered (kg)
`
`"""'
`
`3500
`
`E1112: Post Manufacturing Observations Report.
`
`Authors: John D'Aconti & Kalidas Kale
`
`Date: March 24, 2006
`
`3300L Batch
`
`In the week of March 13th four batches of Astelin lmproved taste were manufactured.
`One full scale, 3300 liter size registration batch (Batch Number 03-33-03C), two 330 liter · --~--+- -~ ··•·-··'-· · ~ · ···· l---1
`size batches (batch numbers 03-33-048 and 03-33-058) and one 330 liter size placebo
`batch (batch number 03-33P-038) were manufactured.
`
`The 3300 liter size batch was prepared in the 940 gallon capacity processing tank.
`During the filtration of this batch after one hour, the filtration rate was considerably
`decreased. At this point 3136 kg of material was filtered. From this time onward
`filtration rate as a function of time was measured. The filtration rate at this point was
`only 14liters per minute; it decreased to 8 liters per minute at the end of the filtration,
`when all liquid was filtered. The total batch was filtered within one hour and twenty four
`
`The filter used was Durapore Cartridge .filter without prefilter 20 inch, 0.45 micron from
`Millipore Corporation. The filtration area of this filter was 1.38 m2• To maintain the
`good filtration rate throughout the filtration step, there are two options, either use same
`size filter with a prefilter or use 30 inch cartridge with larger filtration area 2.07 m2•
`These options will be evaluated during the next manufacture of 3300 liter size batches.
`
`330 liter size batches
`Batch# 03-33-048
`These batches were processed in the 250 gallon capacity processing tanks. It was
`observed that at the time of addition of Azelastine HCl (step 8) the liquid was sloshing
`around the processing tank at the stirrer speed of 120 (+-20) rpm. To create a vortex for
`proper mixing conditions, the stirrer speed was increased to 200 rpm. In step 9 the proper -+-+--+--+- ..i. .... +--1
`In step 10 the stirrer speed was 175 rpm. In step 11 it
`vortex was achieved at 175 rpm.
`was 125 rpm. Total batch was filtered without slowdown of the filtration rate.
`
`Batch# 03-33-058 and Batch# 03-33P-038
`The stirrer speed was maintained at the same rate as used in the manufacture of batch#
`03-33-048. These two batches were filtered without slowdown of the filtration rate.
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03470961
`
`Date
`
`/
`
`o3jz.11ol
`
`Verified by:
`__..A51-vL 13~
`
`14
`
`CIPLA LTD. EXHIBIT 2039 PAGE 14
`
`

`

`Project No.
`
`Project No.
`
`Product: Astelin® Nasal Spray
`
`pg. ~o
`
`J\,.c;; LAU U~:U'-iJI LU IIUU.\.<U J.HY'-';,u,sauuu<u « VllUWUniVU v.J-..JJ• n1 • ru~ ~,.,... ~ ~ • u• •
`
`Ingredient
`
`Code
`II
`
`Lolli
`
`o/ewlv
`
`II)
`
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`Azelastine HCl
`
`HPMC 2910, USP
`
`Sorbitol Solution, USP, 70%
`
`Sucralose, NF
`
`Edetate Disodium, USP
`
`Sodium Citrate, USP, Dihydrate
`
`Benzalkonium Chloride, NF, 50% Soln.
`
`Water, Purified or Deionized
`
`1105
`
`2202
`
`tWOOOZD'/1 0.100"/o
`3340 oooooouzz 0.100"/o
`8135 UJaXX>IZ30
`0'/()1 3
`0.150%
`7474
`1349 ~2~5" 0.050%
`ZC-130</
`0734
`0.068%
`(CI304
`
`6.446%
`
`0.025%
`QSto
`100%
`
`Actual
`Theo.
`grams
`grams per
`per batch batch
`2 0/f
`2.000
`2. 002
`2.000
`128.920 JZ3.9
`5.008
`3.000
`o.SCZ
`/.3b8
`0.500 o.soz
`
`0.500
`
`1.360
`
`QSto
`2030.0g
`
`Manufacturing Procedure
`I. To a suitably sized container (tare weight 72£, .7 g), obtain 740g of deionized water. Begin mixing and
`heatto 80°C (175"1'). Record the temperature. While mixing. Slow(v add the HPMC (/)to the vortex ofthe
`mixing water.
`Mix for 20 minutes or until the mixture is Jump-free. Record the mixing time. Do NOT let the mixture cool to
`:tO"' i~ ·
`below 60"C (140°F) while mixing.
`Temp: ...$Q__oc
`Mixing Time:
`
`2. Add approx. IOOOg of deionized water. Cool to 320C (90°1'}. Record the temperature.
`Temp:~ oc
`
`3. Add the Azelastine HCl (./),mixing until completely dissolved. Record the mixing time and temperature.
`Temp.: _2/,_ OC Mixing Time:~
`4. Add the followin)l ingredients, one at a time, to the mixture: sucralose (/), sorbitol solution (./), EDTA (./),
`sodium citrate ( (). Mix after each until solution is clear and record the overall mixing time.
`Mixing Time: 2..0 "'' K
`5. Add the Benzalkonium Chloride(./) to the batch and mix for 10 minutes. Mixing Time: 10 "'i 1'1 •
`6.
`
`•
`
`Gross: £-tl tv. v g
`1ZIQ .1 g
`14£ • 1 g
`Tare:
`Tare:
`I 91/(,. 3 g
`;!()3Q. 0 g
`Net:
`Net:
`Amount of Water dded: 3).7 g to bring final net weight to 2030.0g.
`Mixing Time: bQ"' I~ Temperature at end of mixing: ~ "C Description: C/x~ V~
`Zl. ~•• ""{•1{0\
`I
`7. Filter finished product through a O~m Millipere Stainless Steel High Pressure Filter Holder. l.J77i.E fOA-/11
`Filter Info: l..JfMD/4; 0 · 22.tu• ~ 'VMf/'f250 L.Pr*i!<JIIN 2.913 c:l
`Discard the frrst 50mL to IOOmL and retain the rest of the proefuct for testing and packaging.
`
`8.
`
`tecorded by:
`
`I. To a suitably sized container (tare weight 1Z4 • 9
`g), obtain 740g of deionized water. Begin mixing and
`beat to 80"C (175"F). Record the temperature. While mixing, Slowly add the HPMC 1,/) to the vortex of the
`mixing water.
`Mix for 20 minutes or until the mixture is lump-free. Record the mixing time. Do NOT let the mixture cool to
`Temp: _1l__oc Mixing Time: ZO .,.; " ·
`below 60°C (140'F) while mixing.
`2. Add approx. IOOOg of deionized water. Cool to 32°C (90"F). Record the temperature.
`Temp:£_°C
`
`4. Add the following ingredients, one at a time, to the mixture: sucralose (:/),sorbitol solution(./}, EDTA (I},
`sodium citrate (.I). Mix after each until solution is clear and record the overall mixing time.
`Mixing Time: 20 .,;~ .
`5. Add the Benzalkonium Chloride (./)to the batch and mix for I 0 minutes. Mixing Time:~
`6. Adjust batch weight to (2028.0g) with deionized water. Mix for 30 minutes or until uniform.
`Before adjustment:
`After adiustmeot:
`Gross: ZhZ3.0 g
`Gross: Z.76Z.9 g
`7Zit. 9 g
`7~\.2 g
`Tare:
`Tare:
`I 8?»· I g
`zozg.O g
`Net:
`Net:
`Amount of Water dded: !Z9. 9 g to bring final net weightto 2028.0g.
`Mixing Time: .)0.., ;d Temperature at end of mixing:~ "C Description.: Cr..eitf. S" O:M (
`f'OI}-M
`ZZ ,;.b 11{01{o6 I)!;,..,_ I<·KME
`7. Filter finished product through a O.llijJm Millipore Stamless Steel High Pressure Filter Holder.
`Filter info: /<tU1Pt1/C.<-bo¢410tE O. Z2n., GVwfl'/2-<;;o
`Discard the first 50mL to IOOmL and retain the rest of the product for testing and packaging. t., rlf /!MtJ.l9130
`I. ' Measure the pH, viscosity, and specific gravity (viscosity testing- spindle #2, 60rpm for I minute at 25"C).
`(date c<t/t•/D¥ ).Finalviscosity:
`!>·OrfS (date otjl•l&" ).
`FinalpH: 6.Z.7
`(elat~ [p;t .. -----------=-B 1,.,el natct ~ 1 J35&'sample ====-e;]
`4pc:cilieGra 1
`
`1
`
`. ~--
`'
`
`MEDA_APTX03470962
`
`15
`
`CIPLA LTD. EXHIBIT 2039 PAGE 15
`
`

`

`Project No.
`
`Project No.
`
`Book No.
`
`Adjustment of Osmolarity of Sorbitol Solution
`Azelastine Hydrochloride Eye Drops 0.05% Lot 02306A, 250 liter batch made at
`Cardinal. Date 04/04/2006
`
`Amount of Sorbitol Solution Required for the batch =
`Amount of Sorbitol Solution Added in the batch
`Difference
`
`16666.5g
`16000.5g
`666.5g/250 liter
`666.5g/253.75 kg
`2.6266g/kg
`0.0026266g/g
`
`CD
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`
`1-+---i->~~
`
`Measur. eOsmolarity.
`
`~ .. · ... · ... '.:\.~ n .. ~ ·ll
`<J ? ·~~-·~I(]i I~~
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`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03470963
`
`16
`
`CIPLA LTD. EXHIBIT 2039 PAGE 16
`
`

`

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`---
`
`HIGHLY CONFIDENTIAL
`-SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`17
`
`CIPLA LTD. EXHIBIT 2039 PAGE 17
`
`

`

`
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`PTX0142-00018
`PTX0142-00018
`CIPLA LTD. EXHIBIT 2039 PAGE 18
`
`18
`
`CIPLA LTD. EXHIBIT 2039 PAGE 18
`
`
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`PTX0142-00019
`PTX0142-00019
`CIPLA LTD. EXHIBIT 2039 PAGE 19
`
`19
`
`CIPLA LTD. EXHIBIT 2039 PAGE 19
`
`
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`
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`
`
`

`

`Project No.
`
`......... ·-·-·~·-·"·'~"
`
`Targetwt. mg) Tabkttl Wei~_(g} Thickneaa mm Hardne:aa SCU
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`CIPLA LTD. EXHIBIT 2039 PAGE 23
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