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Table 1 A side-by-side comparison of the experimental conditions for the three stability methods used herein

From: Non-isothermal stability by linear heating: a fast method for preformulation stability screening of drugs at the discovery and development interface

 

Non-Isothermal (LNISO) Stability

Abbreviated Isothermal Stability

Conventional Isothermal Stability

Drug Substance Concentration

40 ppm

40 ppm

40 ppm

Vehicle

80:20 (~30 mM Phosphate Buffer/Ethanol)

80:20 (~30 mM Phosphate Buffer/Ethanol)

80:20 (~30 mM Phosphate Buffer/Ethanol)

Target pH

Starting pH: 7.0, End pH: shifted by ≤ 0.2 pH-unit due to the temp. increase

7.0

7.0

Heating Type/Storage Temperatures

Linear Heating (50 – 95 °C)

Isothermal (50, 60, and 80 °C)

Isothermal (40, 50, 60, and 80 °C)

Target Time Points

0, 8, 32, 56, 80, 104, 120, 128, 144, 152, 168 h

0, 3, 7, 14 and 28 days

0, 3, 7, 14, 28, 42 and 56 days

Sample Storage Time

7 days

4 weeks

8 weeks

Total Number of Samples

11

13

25