Seminar On

In vitro dissolution testing models

Presented by
Mr. Prashant Gaikwad
Under Guidance of
Dr. A Srinatha
• The Usp-NF provides several official methods for
carrying out dissolution test.

• The selection of a particular method for a drug is

usually in the monograph for a particular drug product.
Apparatus Name Drug product

Apparatus 1 Rotating basket Tablets

Apparatus 2 Paddle Tablets, capsules,

suspension
Apparatus 3 Reciprocating Extended release
cylinder
Apparatus 4 Flow cell Low water soluble drug

Apparatus 5 Paddle over disk Transdermal

Apparatus 6 Cylinder Transdermal

Apparatus 7 Reciprocating disk Extended release

Rotating bottle Non-USP-NF Extended release (beads)

Diffusion cell Non-USP-NF Ointments, creams,

(Franz) Transdermal
Based on the absence or presence of sink
conditions dissolution apparatus are 3 types

1. Closed-compartment apparatus

2. Open- compartment apparatus

3. Dialysis apparatus
Factors must be considered in design of
dissolution tests:
1. Factors relating the dissolution apparatus

2. Factors relating to the dissolution fluid

3. Process parameter e.g. method of introducing dosage

form, sampling techniques, changing dissolution fluid
etc.
 Apparatus 1 (Rotating basket)
The assembly consist

1. A covered vessel
• Cylindrical, hemispherical bottom
• Diameter is 98-106 mm & normal capacity 1000 ml

2. Motor, metallic drive shaft

• Fabricated of stainless steel type

3. Cylindrical basket
• Gold coating 0.0001 inch (2.5 µm)
 Apparatus 2 (Paddle)

•The assembly is same

as apparatus 1 except
that a paddle formed
from a blade & a shaft
is used as stirring
element.

•The metallic blade &

shaft comprise a single
entity that may be
coated with a suitable
inert coating.
 Apparatus 3 (reciprocating cylinder)

The assembly consist:

1.Set of cylindrical, flat
bottomed glass vessels
2.Set of reciprocating
cylinders
3.Stainless steel
fittings (type 316 or
equivalent)
4.Polyproylene screens
5.Motor & drive
assembly
 Apparatus 4 (Flow through cell)
• The assembly consist of
– Reservoir & pump for dissolution medium
– A flow through cell
– A water bath
•The flow through cell is
transparent & inert
mounted vertically with
filters.
•Standard cell diameters
are 12 & 22.6 mm.
•The bottom cone
usually filled with glass
beads of 1 mm
diameter.
•Tablet holder used for
positioning special
dosage form e.g. inlay
tablets.
 Cell Types

Tablets 12 mm Tablets 22.6 mm Powders / Granules Implants Suppositories /

Soft gelatin capsules
Flow-Through Apparatus
 Apparatus 5 (Paddle over disk)
•The assembly consist
-Cylindrical vessel
-Motor drive shaft
-Paddle
-Stainless steel disk

•Disk- minimize “dead

volume” between disk
assembly & bottom of vessel

•Disk- holds the system flat &

release surface parallel with
the bottom of paddle blade.
 Apparatus 6 (Reciprocating cylinder)

• Use assembly from

apparatus 1
• Replace basket with
stainless steel cylinder
• Dosage unit placed on the
cylinder
 Apparatus 7 (Reciprocating disk)
• This apparatus consist
– Containers

– Set of disk shaped sample

holder
– Motor & drive assembly

• Reciprocate at frequency of

about 30 cycles/min.
 Rotating Bottle
• Used for controlled release beads

• Consist a rotating racks that holds sample in bottles

• Bottles are capped tightly & rotated in 37ºC water

bath.
• At various time, samples are collected from bottle,
decanted from 40 mesh screen & residues are
assayed.
 Diffusion cells
• Used for topical &
transdermal drug
products.

• Franz diffusion cell is

static diffusion system
used for
characterizing drug
permeation through
skin model.

• The source of skin

may be cadaver or
animal skin.
 Interpretation
• The amount of drug dissolved within a given time period (Q)
is expressed as a percentage label content.
Acceptance Table:
Stage Number Acceptance criteria
tested
S1 6 Each unit is NLT Q +5 %

S2 6 Average of 12 units (S1+S2) is equal to or

greater than Q, & no unit less than Q - 15%

S3 12 Average of 24 units (S1+S2+S3) is equal to

or greater than Q, NMT 2 units are less than
Q- 15% & no unit is less than Q- 25%
 References
• The United States Pharmacopeia, NF-18, Asian Edition, 1995,
Page no. 1791-1799
• Leon Shargel, Applied Biopharmaceutics & Pharmacokinetics,
5th Edition, 2005, Page no. 424-430
• Brahmankar & Jaiswal,Biopharmaceutics & Pharmacokinetics
A Treatise, Vallabh Prakashan, Page no. 291
• http://www.labplus.co.kr/tech/tech_note.asp?not_no=270

• http://www.pharmacopeia.cn/v29240/usp29nf24s0_c711h.html

• http://apps.who.int/phint/en/d/Jb/7.5.6.html

• http://www.pharmacopeia.cn/v29240/usp29nf24s0_c724h_view
all.html