Formula Code

Parameter

Time (month)

0

1

2

3

 

F1

Appearance pH Drug content (%)

Clear 5.4(0.11) 98.9(0.)22

NC 5.07(0.25) 95.9(0.14)

NC 5.01(0.22) 95.88(0.39)

NC 5.00(0.11) 95.12(0.99)

 

F2

Appearance pH Drug content (%)

Clear 5.1(0.55) 99.5(0.6)

NC 5.45(0.55) 97.23(0.22)

NC 6.38(0.2) 97.78(0.95)

NC 6.38(0.19) 96.55(0.99)

 

F3

Appearance pH Drug content (%)

Clear 5.8(0.33) 97.99(0.39)

NC 4.94(75) 96.28(0.69)

NC 4.29(0.22) 97.22(0.99)

NC 4.3(0.44) 96.88(1)

 

F4

Appearance pH Drug content (%)

Clear 4.86(0.26) 100.62(0.66)

NC 4.55(0.6) 98.99(0.25)

NC 4.55(0.25) 96.55(0.89)

NC 4.48(0.15) 96.2(1.5)

 

F5

Appearance pH Drug content (%)

Clear 5.46(0.23) 110.66(0.21)

NC 5.67(0.1) 101.45(0.44)

NC 6.2(0.6) 100.669(1)

NC 6.15(0.23) 99.99(0.95)

 

F6

Appearance pH Drug content (%)

Clear 5.28(0.65) 109.23(0.22)

NC 5.37(0.22) 107.13(0.64)

NC 6.41(0.5) 100.93(0.99)

NC 6.41(0.22) 100.55(1)

 

F7

Appearance pH Drug content (%)

Clear 5.99(0.49) 99.98(0.22)

NC 5.66(0.11) 96.626(0.21)

NC 5.78(0.25) 96.626(1)

NC 5.55(0.5) 96.18(0.92)

 

F8

Appearance pH Drug content (%)

Clear 5.51(0.99) 97.23(0.69)

NC 4.77(0.66) 96.4(0.22)

NC 4.22(0.45) 95.22(0.99)

NC 4.3(0.21) 95.21(1.5)

 

F9

Appearance pH Drug content (%)

Clear 3.38(0.22) 99.96(0.36)

Brittle 5.00(0.55) 98.19(0.22)

Brittle 5.00(0.55) 98.5(0.25)

Brittle 4.88(0.23) 97.66(0.95)

 

F10

Appearance pH Drug content (%)

Clear 3.58(0.22) 111.9(0.26)

Brittle 6.34(0.65) 103.5(0.66)

Brittle 6.34(0.1) 100.92(1)

Brittle 6.00(0.1) 99.98(1)

 

F11

Appearance pH Drug content (%)

Clear 5.65(0.36) 99.7(0.59)

Brittle 6.53(0.25) 97.972(0.22)

Brittle 6.58(0.9) 97.19(0.99)

Brittle 6.2(0.44) 96.99(0.89)

 

F12

Appearance pH Drug content (%)

Clear 4.6(0.12) 99.99(0.56)

Sticky 5.06(0.5) 98.04(1)

Sticky 6.43(0.12) 96.28(0.99)

Sticky 6.3(0.5) 96.12(0.99)

 

F13

Appearance pH Drug content (%)

Clear 4.02(0.33) 128.21(0.98)

Sticky 4.12(0.33) 110.05(1.5)

Sticky 4.11(0.39) 99.55(1)

Sticky 4.11(0.66) 99.10(0.96)

 

F14

Appearance pH Drug content (%)

Clear 4.98(0.22) 109.98(0.96)

Precipitation 5.33(0.12) 102.45(0.96)

Precipitation 5.28(0.42) 99.25(1.5)

Precipitation 5.25(0.12) 98.66(1)

 

F15

Appearance pH Drug content (%)

Clear 5.89(0.21) 119.99(0.99)

melt - -

- - -

- - -

F16

Appearance pH Drug content (%)

Clear 5.82(0.45) 100.99(0.99)

melt - -

- - -

- - -

 

F17

Appearance pH Drug content (%)

Clear 5.81(0.23) 99.98(0.89)

melt - -

- - -

- - -

 

F18

Appearance pH Drug content (%)

Clear 5.3(0.44) 120.96(0.5)

melt - -

- - -

- - -

 

F19

Appearance pH Drug content (%)

Clear 5.82(0.43) 98.36(0.56)

melt - -

- - -

- - -

Table 3: Stability of Timolol maleate ocular inserts (NC: Referred to no change in appearance).