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. Author manuscript; available in PMC: 2022 May 31.
Published in final edited form as: AAPS PharmSciTech. 2022 Apr 19;23(5):113. doi: 10.1208/s12249-022-02256-2

Table I.

Compositions of the Dissolution Media (3, 4, 18, 19)

Composition (mM) PBS pH 7.4 Original SGF pH 1.2 Original FaSGF pH 1.6 Original FeSGF pH 5.0 Original SIF pH 6.8 Original/concentrateda FaSIF pH 6.5 Original/concentrateda FeSIF pH 5.8 Original/concentrateda
Sodium chloride 137 34.3 34.2 237 - 68.6/ 137 126/ 251
Potassium chloride 2.70 - - - - - -
Sodium hydroxide - - - - qs to pH qs to pH qs to pH
Potassium dihydrogen phosphate 1.80 - - - 49.9/ 99.9 - -
Disodium hydrogen phosphate 10.0 - - - - - -
Hydrochloric acid - qs to pH qs to pH qs to pH - - -
Acetic acid - - - 17.1 - - -
Sodium acetate - - - 29.8 - - -
Whole milk - - - 1:1b - - -
Pepsin - 0.092 0.0029 - - - -
TRIS maleate - - - - - 2/ 4 50/ 100
Calcium chloride - - - - - 1.87/ 3.74 5/ 10
Sodium taurocholate - - 0.08 - - 3/ 6 10/ 20
Lecithin - - 0.02 - - 0.75/ 1.5 2/ 4
Tween-80 3.82 - - - - - -

TRIS tris-hydroxymethyl aminomethane, PBS phosphate buffer saline, SGF simulated gastric fluid, FaSGF fasted state simulated gastric fluid, FeSGF fed state simulated gastric fluid, SIF simulated intestinal fluid, FaSIF fasted state simulated intestinal fluid, FeSIF fed state simulated intestinal fluid

a

Concentrated SIF, FaSIF, and FeSIF media were added after completion of the first step at 30 min to adjust the media for the second step in two-step biorelevant dissolution

b

Sodium chloride, acetic acid, and sodium acetate were dissolved in 1 L distilled water and mixed with whole milk at a 1:1 ratio to get final FeSGF