Dissolution Test: Edited By: CJ L. Acoba, RPH, Pharmd
Dissolution Test: Edited By: CJ L. Acoba, RPH, Pharmd
Dissolution Test: Edited By: CJ L. Acoba, RPH, Pharmd
Quality Control
– Examining batch homogeneity (uniform composition)
– Examining batch to batch conformity (same action)
– Examining stability (no change in quality)
Research & Development
– Examining drug release behavior of preformulations
– In vitro simulation of the GI passage
FACTORS AFFECTING THE
RELIABILITY OF THE TEST
1. Proper alignment of the dissolution apparatus
2. Proper conditions during dissolution test
– Temperature (37° C +/- 0.5)
– Agitation speed
– Sampling (sampling zone, timing, filtration, dilution)
– Vibration (plane area, stable, drive chain & belts should be free of tension & dirt,
external vibration)
– Dissolution medium (pH, surface tension & viscosity of dissolution medium)
0.9 mL read
900 mL
100mg 1 mL
100 mL
1L Water read
Standard
500mg:900mL::0.5mg:X
Dilute Dilute
X= 0.9 mL 100mL 100mL
DISSOLUTION OF ASPIRIN TABLET
2.99 grams
37 deg C
1.66 mL
pH 4.50
Water 1000mL
4.5 mL read
900 mL
100 mL