Dissolution Test

Edited by: CJ L. Acoba, RPh, PharmD.

 DISSOLUTION
• A qualitative tool that can provide valuable information
about the biological availability of a drug as well as batch to
batch consistency
 IMPORTANCE OF DISSOLUTION TEST

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)

3. Proper validation of analytical method (accuracy or precision, sensitivity)

Dissolution Apparatus
SOTAX Hanson V8
Pharma Alliance Erweka
Campbell Electronic
 VESSEL

• Made of glass or other inert transparent material; cylindrical with

a hemispherical bottom
• The vessel is partially immersed in a suitable water bath.
• 1L capacity (ht. 160-210 mm; inside diameter 98-106 mm)
• 2L capacity (ht. 280-300mm; inside diameter 98-106 mm)
• 4L capacity (ht. 280-300 mm; inside diameter 145-155 mm)
Borosilicate Glass Plastic
USP: TYPES OF APPARATUS
• Apparatus 1 – Basket Apparatus
• Apparatus 2 – Paddle Apparatus
• Apparatus 3 – Reciprocating Cylinder
• Apparatus 4 – Flow-Through Cell
• Apparatus 5 – Paddle Over Disk
• Apparatus 6 – Rotating Cylinder
• Apparatus 7 - Reciprocating disk
 DISSOLUTION APPARATUS
Apparatus # Name Applications
1 Basket Caps, uncoated tabs, plain coated
tabs
2 Paddle Caps, uncoated tabs, plain coated
tabs
3 Reciprocating cylinder ER dosage forms

4 Flow-through cell ER dosage forms

5 Paddle over disk DR dosage forms, TDDS
6 Rotating Cylinder DR dosage forms, TDDS
7 Reciprocating disk DR dosage forms, TDDS
 RECIPROCATING
BASKET PADDLE CYLINDER RECIPROCATING DISK

FLOW THROUGH CELL PADDLE OVER DISK ROTATING CYLINDER

–Hard gelatin capsules
–Beads
–Floating dosage forms
 DISSOLUTION BASKETS
• The standard mesh size is 40 Mesh
(40 opening per linear inch of mesh)
• Correct handling of basket is
important to avoid physical damage 10 Mesh 20 Mesh 40 Mesh
Basket Basket Basket
and contamination
• A dented basket will also disrupt the
media flow around the basket
leading to erroneous results.

100 Mesh 150 Mesh Suppository

Basket Basket Basket
 Apparatus 1- Rotating basket
Dissolution Plain, Distilled water at 37 ±0.5°C
medium
Time 90 mins
Speed 100 rpm
Wavelength 272 nm (For Amoxicillin capsule)
USP NLT 80% -120 % of the labelled amount of
specifications Amoxicillin
– Immediate release oral solid dosage forms
– Tablets
– Capsules
– Beads
 APPARATUS 2 PADDLE

• The sample is introduced with the

paddle stationary
– If the tablet drops and the paddle is
rotating, there is a chance that it will
collide with the blade.
– The tablet will not fall to the bottom of
the vessel, but to one side.
 Sample

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

• Dissolution Media : 0.05M Acetate Buffer 900 mL; 37°C

• Apparatus : Apparatus 2 (Paddle)
• Speed : 50 rpm
• Time : 90 mins
• Wavelength : 265 nm
• Tolerance : Not less than 80%
 0.05 M Sodium Acetate

2.99 grams

37 deg C

1.66 mL

pH 4.50
Water 1000mL
 4.5 mL read
900 mL

100 mL

1L 0.05M Sodium 100mg:900mL::0.5mg:X

Acetate
X= 4.5 mL
UV-VIS Spectrophotometer
• A branch of spectrometry which embraces the measurement of the
absorption, by chemical species, of radiant energy of definite and narrow
wavelength.
Wavelength
UV 200-380 nm
VIS 380-780 nm
NEAR IR 780-3000 nm
MEDIUM IR 3.0-15 um
FAR IR 15-300 um
 Principle
• The sample absorbs a portion of the incident radiation; the
remainder is transmitted to a detector, where it is changed into
an electrical signal and displayed usually after amplification, on
a meter, chart recorder or some other type of readout device.
 Cuvette
It has a path length of 1 cm
Monochromator -
UV – silica or quartz
splits and diffracts
VIS – glass or plastic
light into several
beams travelling in
different directions

UV – hydrogen, deuterium Photodetector

changes the
VIS - tungsten radiation
transmitted into
current or voltage
 Computation

Aliquot - A portion of a total amount of a solution.

It is a method of measuring ingredients below the sensitivity of a scale
by proportional dilution with inactive ingredients.

Au- absorbance reading of the sample

As- absorbance reading of the reference standard
DF- dilution factor
 FORMULA
• mg/cap = Au/As x conc.of RS x DF x ave.wt cap
wt. of capsule in mg

• % labeled claim = actual amount obtained x 100

Labelled claim
 Preparation of the Paracetamol Reference
Std

The analyst weighed a standard equivalent to 100mg of

Paracetamol then dissolved into 100 mL dissolution media. An
aliquot portion of 1 mL was withdrawn from the first dilution, then
dilute it into 100 mL Volumetric Flask (second dilution).
The absorbance of the reference standard is 0.255
 Dissolution of Paracetamol 500 mg Tablet
• 10 Tablets of Paracetamol 500 mg Tablet were weighed and
computed the average weight (Ave: 0.6225 g)
• The analyst conducted a dissolution test in Paracetamol 500 mg
Tablet using the following parameters: Disso Media- Buffer 37°C,
900mL, Apparatus #1, Speed- 50 rpm, USP Specification 80%-110%
. The weight of the 6 tablets are as follows; 0.6215 g, 0.6296g,
0.6277g, 0.6301g, 0.6220g, 0.6229g respectively.
• After 90 mins, an aliquot portion equivalent to 0.5 mg was withdrawn
from each vessel. The aliquot portion was diluted into 50 mL of the
medium. The analyst read the absorbance of the six tablets at a
wavelength of 272 nm. The results are as follows; 0.196, 0.202,
0.197, 0.200, 0.198, 0.201 respectively.
1. What is the concentration of the reference std?
2. What is the average weight (mg) of the sample?
3. Compute the dilution factor.
4. Compute the Amount Obtained of each tablet?
5. Compute the % Labeled Claim of each tablet?
6. Disposition