Helsinn Healthcare Exhibit 2072
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
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`Page 1 of 9
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`132 Declaration of Daniele Bonadeo
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`U.S.S.N. 11/186,311
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`Page 2 of 9
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`7)
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`8)
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`All of our studies, regardless of the ‘Formulation parameter which was varied, show that
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`the stability of palonosetron generally improves as the concentration of palonosetron is
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`reduced, and that concentration is the most important determinant of product stability.
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`Table 1 contains the results of one of our stability studies, conducted in a phosphate~
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`buffered, saline solution at pH 7.4.
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`TABLE 1. Palonosetron HCI Concentration-Stability Study (pH 7.4, 40 °C)
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`Palonosetron HHCI Cone.
`% Palonosetron HClRemaining at
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`/ml, as free base)
` 2 weeks
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`5 weeks
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`M
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`S7
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`8 weeks
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`101
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`99
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`23
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`49
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`100 100
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`101
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`93
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`73
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`the stability of the molecule improves in this "formulation as its
`As can be seen,
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`concentration decreased, with greatest stability seen below 0.1 mg/ml. We made this
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`same observation in other studies, as discussed in greater detail below.
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`We also performed a pH—stabi1ity study to determine the best pH at which to formulate
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`the molecule. The study was conducted with 60 meg/ml palonosetron aqueous solutions,
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`buffered at pH 2.0, 5.0, 7.4 and 10.0. No ingredients were present other than the p.l—1
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`adjusting agent, pH buffer, and palonosetron. The results are reported in Table 2.
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`9)
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`10)
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`TABLE 2. Palonosetron BC] 80 °C pH-Stability Study
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`Carbonate
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`Not determinecl. 99.2%
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`remaining at 252 days
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`pH at Room
`Tem .
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`pH at Reaction
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`Tem .
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`Ph os a hate
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`Page 2 of 9
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`l32 Declaration OF Daniele Bonadeo
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`U.S.S.N. l l/186,311
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`Page 3 of9
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`14)
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` 3i
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`i i3
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`: EE:
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`TABLE 3. Formulation Optimization Study
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`ll)
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`13)
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`The results demonstrate that the molecule is extremely stable at a pH of 5.0, when
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`maintained at a low palonosetron concentration such 60 meg/ml, and that stabilizers and
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`the like are unnecessary to maintain that stability.
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`12) We also conducted additional studies to evaluate the impact of various excipients on
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`stability, and improve the stability even furtlier.
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`After settling on mannitol and a citrate buffer for the fonriulation for practical reasons,
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`we studied the effect of palonosetron and EDTA concentration on stability, maintaining
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`the pH constant at approximately 5.0, and keeping the same tonicifying agent (mannitoi)
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`and buffering agent (trisodium citrate). Stability was measured based on the percentage
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`of palonosetron that rernained undegracled at 1, 2, 3 and 6 months, under standard
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`conditions of accelerated stability testing (ie. 40 °C).
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`The results are reported below in Table 3.
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`Page 3 of 9
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`1.
`.5§
`Ei
`.4
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`fE *
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`11
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`132 Declaration of Daniele Bonadoo
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`U.S.S.N.11/186,311
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`Page 4 of 9
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`Degradation Products
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`(Total % Labe;i_Stren,g§_I1_)
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`Storage Time (rno.) at 40 C
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`0
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`1
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`0.30
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`Z
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`0.58
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`0.13
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`3
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`0.61
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`0.46
`0.40
`0__.32
`0.21
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`0.00
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`6
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`0.97
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`0.70
`1.92
`0.71
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`0.16
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`0.03
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`Rate
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`Const.
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`(4)
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`0.29
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`-0.61
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`Potency
`(% Label Strength)
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`Storage Time (010,) at 40C
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`2
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`99
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`103
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`1
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`103
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`106
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`0
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`10
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`10
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`99
`99
`10
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`“"3
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`101
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`106
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`6
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`100
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`104
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`Formulation (1)
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`EDTA
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`Conc.
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`Pal0.Conc.
`Buff
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`er
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`1
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`1
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`0.10‘"0'.01
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`0.13
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`0.02
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`0.02
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`0.37
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`0.22
`3.77
`1.73
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`0.23
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`0.20
`1.59
`0.61
`7.81
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`4.39
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`0.00
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`0.03
`1.49
`0.30
`2.52
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`1.45
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`0.75
`95
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`-0.59
`95
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`-0.15
`102
`100
`-0.29
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`99
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`99
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`90
`as
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`95
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`-0.27
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`0.35
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`-0.31
`-1.73
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`-0.55
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`-3.25
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`0.49
`0.24
`0.14
`0.07
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`0.09
`0.13
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`0.00
`0.07
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`0.17
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`0.00
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`0.21
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`0.15
`0.36
`0.03
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`0.00
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`0.08
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`0.07
`1.00
`0.37
`4.04
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`98
`100
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`97
`97
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`103
`103
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`1o1““‘1‘“01
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`100
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`100
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`99
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`97
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`93
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`91
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`99
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`102
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`99
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`90
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`97
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`93
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`99
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`98
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`103
`“"102
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`99
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`102
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`100
`99
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`99
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`11
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`-.075
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`-1.92
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`-2.41
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`4.66
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`-2.52
`-4.37
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`1.24
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`1.93
`3.10
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`2.86
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`2.05
`2.19
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`2.02
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`3.95
`3.56
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`4.19
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`4.29
`4.23
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`2.86
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`7.83
`8.14
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`7.10
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`7.55
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`13.37
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`100
`97
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`9‘)
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`93
`94
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`96
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`91
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`85
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`1.
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`."*5~‘!"‘
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`15)
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`Lots are sorted by Palonosetron HCI concentration, EDTA concentration and buffer concentration.
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`All lots contain mannitol as the tonicifying agent.
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`Palonosc-tron concentrations are in mg/mL free base equivalents.
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`Citrate buffer concentrations are millimolar. All formulations are pH 5.0.
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`Rate constants are calculated with degradation product concentrations in two significant digits.
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`One notable observation from these results is that the presence of EDTA improves
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`stability at
`low paionosetron concentrations, but actually decreases stability at high
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`palonosetron H.Cl concentrations.
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`2536648vl
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`Page 4 of 9
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`10
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`0
`0
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`99
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`0
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`0
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`0
`0
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`01
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`01
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`94
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`95
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`97
`99
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`97
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`97
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`99
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`102
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`100
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`91
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`96
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`.175
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`-1.50
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`-1.11
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`-1.58
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`-0.48
`-1.16
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`2.77
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`2.65
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`0.79
`2.72
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`1.22
`2.90
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`1.22
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`1.40
`2.25
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`4.04
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`1.07
`2.76
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`1.17
`5.56
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`1.34
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`0.36
`1.17
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`0.43
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`7.21
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`3.03
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`1 1
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`Page 4 of 9
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`I32 Declaration of Daniele Bonadeo
`
`
`U.S.S.N. "ll/186,311
`
`
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`?age 5 of9
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`16)
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`17)
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`I8)
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`higher
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`The fact that EDTA improves the stability of paionosetron at all is somewhat surprising,
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`given our earliest work with the molecule,
`in which palonosetron demonstrated
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`comparable stability at 5 °C as it did at 60-100 ‘’C.
`if the molecule were undergoing
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`auto-oxidation (the typical reason for adding a chelating agent), one would expect the
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`temperature to produce more radical
`initiators and a faster
`reaction and
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`degradation.
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`The fact that the chelating agent consistently improves the moleoule’s stability only at
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`lower concentrations is also an intriguing discovery.
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`Based on the results in Table 3, we prepared several graphs to inform our analysis,
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`including the response surface plot depicted below as Figure 1. This graph plots
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`degradation rate constant as a function of EDTA concentration and palonosetron I-iCl
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`concentration, holding the buffer strength constant at 20 mM. A lower degradation rate
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`constant indicates a more stable forrnulation.
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`skate
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`'i.&e§ea6a\.‘\onAt
`
`FIGURE 1
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`1.9)
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`As can be seen, the stability of palonosetron improved as its concentration was reduced
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`across the entire range of conditions studied. This same result can be seen when the
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`buffer strength is varied, as shown below in Table 4. These results are consistent with the
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`results reported above in Table ‘I , and reinforce our opinion that palonosetron
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`concentration is a critical ‘factor for the stability of palonosetron fonnulations.
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`132 Declaration 01° Daniele Bonadeo
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`U.S.S.N. 11/186,311
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`Page 6 of 9
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`TABLE 4
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`paiiorioisietron
`
`Cone. (mg/ml)
`
`_kg.4 _
`5
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`% Degradation
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`at 6 mo.
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`OJ
`7.55% (3 mo.)
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`EDTA Cone. W Citrate Cone.
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`(1331)/I)
`(%w/w)
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`10 W
`10
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`20)
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`We also prepared a contour plot of potency rate constant as a function of blrffer and
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`EDTA concentrations based on the data reported in Figure 3, at a low palonosetron
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`concentration (0.4 mg/ml). This plot is depicted below in Figure 2:
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`Buffer
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`21)
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`FIGURE 2
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`As can be seen ‘From this figure, at the low pel0noseti'on concentration depicted, there is a
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`region of no apparent degradation with EDTA from 0.025 to 0.075 % w/v and buffer
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`from 10 to 40 mM. This region is marked by the 59 symbol.
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`2536648v!
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`Page 6 of 9
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`132 Declaration of Daniele Bonadeo
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`U.S.S.N.1l./186,311
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`Page 7 of9
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`.____...
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`should be contrasted with the stability of the intravenous
`The foregoing results
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`formulation reported in example 13 of the Berger 5,202,333 patent (“Berger ‘333”).
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`The Berger
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`‘333 formulation vs. 0.05 mg/ml
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`eventually settled upon (10-100 mg/ml for the Berger
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`invention): and a lower pH (3.7 for the Berger
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`for the optimum formulation in the present
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`the optimum "formulation in the present invention).
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`‘333 formulation vs. 5.0 for
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`‘333 example 13
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`The following Table 5 compares the formulations described in Berger
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`4 of the current application, and their relative stability:
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`and example
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`TABLE 5
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`23)
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`24)
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`Bergéi77333 Example 13
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`Intravenous Formulation
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`l0-l0O rng*
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`Example 4 of Present
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`A lication
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`3.7
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`q.s. to ’H 5.0 e 0.5
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`0.5 mg
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`YES
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`If
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` Palonosetron
`Hydrochloride
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`H
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`Dextrose monohydrate
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`tonicifying agelit
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`Mannitol tonicifying aent
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`Citric acid monohyclrate
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`Sodium hydroxid.e**
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`—
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`Water For inaction
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`*Assuming compound of formula l in Example 13 is paionosetron
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`“Assumes ‘formulation requires pH increase
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`25)
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`This comparison shows, once again, that palonosetron concentration and
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`most significant impact on the stability of the formulation.
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`pH have the
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`2536648vl
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`Page 7 of 9
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`Page 7 of 9
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`132 Declaration of Daniele Bonadeo
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`U.S.S.N. 11/186,31 I
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`Page 8 Df9
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`26)
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`The formulations differ in terms of tonicifying agent, but 1 am unaware of any literature
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`that would suggest that changing the tonicifying agent from dextrose to mannitol in a
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`system such as this can have a bearing on the stability of the formulation. A study we
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`performed comparing mannitoi and saline, summarized below in table 6, supports this
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`TABLE 6. Chemical Stability Summary of Palonosetron HCI Injection Citrate
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`Formulations
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`opinion.
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`w
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`Formuiation (1) ‘
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`Potency
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`(“/0 Label Strength)
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`A
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`Degradation
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`Products (Total %
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`Label Stren th
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`3.10
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`Tonicifier
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`18635-DMl..~045—O5 Mannitol
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`18635—iDML—045-Qfl Mannitoi
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`1863 5-DMEL~O45—06 Mannitol
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`l863S—DML-045-08
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`1863§-DM.L~O45—0‘7
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`l8635~DML-045-09
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`Saline
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`1
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`Lot #
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`Buffer
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`40
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`80
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`W
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`At 0 mo. At 1 mo.
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`49 “C
`4,0 °C
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`96
`95
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`98
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`98
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`1.50
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`Palonosetron concentration is 10 mg/mL as free base equivalents. Lots do not contain
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`Citrate buffer concentrations are miliimolar. Ail ‘Formulations are pH 5.0.
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`2:
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`iii
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`27)
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`The formulations also differ in terms of the buffering mechanism (Berger ‘333 uses citric
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`acid as a buffering agent while Example 4 uses citric acid and sodium citrate). However,
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`the buffering agent is incorporated to maintain the solution at the prescribed pH, and
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`would not be expected to significantly influence the stability of the formulation except
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`through its pH maintenance capacity.
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`253664 8v]
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`Page 8 of 9
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`Page 8 of 9
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`vanx«F15W3-mwww-32w11kvvnW):<m«e\«‘wAvr‘«‘zQn\-:vn‘7r:>\:nrx;vxygw
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`i
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` 2
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`t,.
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`Ltl iN
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`132 Declaration ofDanieIe Bonadeo
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`U.S.S.N. ll/186,311
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`Page 9 of9
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`I declare that all sta.tements made herein of my own knowledge are true and that all statements
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`made on information and belief are believed to be true, further, that these statements were made
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`with the knowledge that willful false statements and the like so made are punishable by fine or
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`imprisonment, or both, under Section 1001 of Title 18 ofthe United States Code.
`I declare under
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`penalty of perjury that the foregoing is true and correct.
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`Dated: February 311%, 2009
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`Daniele Bonadeo
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`2536648»)!
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`Page 9 of 9
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`Page 9 of 9