Dissolution Definition :

• Dissolution is a process in which a solid substance

solubilizes in a given solvent (Dissolution medium) i.e. mass
transfer from the solid surface to the liquid phase.
• It is the amount of drug substance that goes in solution per
unit time under standardized conditions of liquid /solid
interface, temperature and solvent composition.

14 May 2019
1
Factors affecting Drug dissolution
Factors relating to the physicochemical properties of drug
• Solubility
• Particle size and effective surface area of the drug
• Salt form of the drug

Factors relating to the dosage forms

• Manufacturing process
• Pharmaceutical excipients

14 May 2019
2
Overview of dissolution performance testing
• The dissolution apparatus consists of the following:
• An inert hemispheric vessel
• Dissolution solvent (medium)
• A rotating spindle which provides the
hydrodynamic flow of the solvent across
the surface of the dosage form.

Note: The dissolution apparatus must

maintain these three components in terms
of alignment, stability and isolation from
the environment.
14 May 2019
3
USP Apparatus 2 (Paddle)
Description:
USP apparatus 2 , a rotating blade fixed to the bottom of the
shaft at a height of 25mm from the inner bottom of the vessel.

The paddle apparatus consists of a metallic or suitable inert,

rigid blade and shaft.

The paddle is lowered into a 1L vessel and rotated at a specific

speed within media which is maintained at a specific
temperature.

14 May 2019
4
 Sampling procedure:
• Vessels must be securely held in place and ports in the covers
should be available for dosage form introduction and
sampling

14 May 2019
5
Contd…
• Glass vessels should be used.
• If product was sensitive to light, amber color vessels to be
used.
• Vessels should be free from scratches.

14 May 2019
6
Contd…
• Media temperature readings must be taken at every interval
of the sampling time point.

14 May 2019
7
Contd…
• Tablet introduction may be performed manually or
automatically.
Dosage forms may be introduced simultaneously or
sequentially but they must be introduced into non-rotating
media

14 May 2019
8
Contd…
• Sampling may be performed manually/auto with a
specialized cannula with pre filter fitted to a syringe.

14 May 2019
9
Contd…
• The samples to be withdrawn at a depth halfway between the
top of the paddle and the top of the medium and not less than
1cm from the wall of the vessel.

14 May 2019
10
 Contd…
• Individual disc filters (0.45 um PVDF) shall be used for
filtration of dissolution samples by discarding first 5mL of
sample liquid.

14 May 2019
11
Precautions:
• Suitable media degassing equipment(if applicable)
• Dedicated vessels and shafts for instrument.
• No turbulence’s during dissolution.
• Sufficient bench space for sample handling and analytical
measurement.

14 May 2019
12