The document discusses compendial methods of dissolution testing according to pharmacopoeia standards. It describes the need for dissolution testing to evaluate drug release from solid dosage forms and ensure bioavailability. The key compendial apparatuses discussed are the basket, paddle, flow-through cell, and dissolution testing methods for modified release forms. The document provides details on the components, operating conditions and applications of the various apparatuses specified in pharmacopoeias for testing common oral and other dosage forms.

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Compendial methods of dissolution testing
Under The Guidance Of:
Prof. R. Nagaraju
Institute of Pharmaceutical Technology
Sri Padmavathi Mahila Visvavidyalayam
( Women's University)
Tirupati Andhra Pradesh, India
u
Submitted By:
P.Reddyswetha
2018MPH40A025
M.Pharmacy
1st Year
(Pharmaceutics)

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Contents
 INTRODUCTION
 NEEDOF DISSOLUTION
 COMPENDIAL DISSOLUTIONMETHODOLOGY
 COMPENDIAL METHODS
 DISSOLUTIONAPPARATUS
 CONCLUSION
 REFERENCES

3. 3
Introduction

4. 4
Why we needto study dissolution in pharmaceutical sciences?

5. 5
Needof dissolutiontesting
• solid drugs absorbed only from the solution .
• Invitro test – estimate amount of drug released per unit
time.
• Invitro dissolution test most reliable, predictors of in vivo
performance.
• Dissolution –rate limiting factor.

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Compendial dissolution methodology
 Compendial : Reference to pharmacopoeia
 compendial dissolution means dissolution of dosage forms as
per USP/BP/IP/EP monographs which contain all the
specification and apparatus used for it.
The USP-NF provides several official methods for carrying out
dissolution tests of tablets,capsules and other special products
such as transdermal prepartions.
 Compendial dissolution apparatus are those described and are
generally use for oral dosage forms & suppositories ,transdermal
patches etc.,

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Official dissolution
Monographs

8. 8

9. 9

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Dosage form BP IP USP EP
Uncoated
tablet
(A)Basket Apparatus
(B)Paddle Apparatus
for (A) & (B) use
1000ml vessel,36.5-
37.7C,pH±5%,25±2mm
distance between lowest
point of vessel
and lowest point of
rotating element .
(c) flow Through Cell
Apparatus : 36.5◦- 37.5◦C
,Sampling at 45 mins or
as specified,
flowrate ± 5%
(A)Paddle
Apparatus
(B)Basket
Apparatus.
Conditions
same as BP
(A)Basket
Apparatus
(B)Paddle
Apparatus
Conditions used
for (A)&(B) are
same as in case
for BP
(A)Basket
Apparatus
(B)Paddle
Apparatus
Same conditions
for(A)&(B) are
same as in case
for BP
(C)flow Through
Apparatus :
specifically
intended for
Lipophillic solid
dosage forms
such as
Suppositories &
soft capsules.

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Coated
tablet
Basket andPaddleApparatus PaddleApparatus
andBasket Apparatus
Basket andPaddle
Apparatus
Basket andPaddle
Apparatus
E xtended
Release
........ .........
(A)Basket and
paddle Apparatus:
Time –Test time
points generally
expressed in
hours.specimens
withdrawn with a
tolerence of ± 2%
of the stated time
(B)Reciprocating
cylinder
(C)Flow through
cell:same condition
as in Basket and
paddle apparatus
.........
Rectal
and
vaginal
........ ...... ........
Same as solid
dosage form

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Dosage form BP IP USP EP
TRANSDERMAL (1)Disk assembly
method:With
addition of SSDA
inform of a net
with an aperture of
125µ.Rotate at 100
rpm/min.
(2)Rotating
cylinder method:
Replace paddle and
shaft. Rotate at
100rpm/min
.......
(1)PADDLE OVER
DISK:paddle
apparatus with SS
disk assembly
(SSDA) holding
patch at the bottom
vessel , temp
32±0.5◦C
(2)Cylinder
apparatus :similar
to basket
apparatus except
basket is replaced
by SS stirring
element &
maintain
temp.32±0.5◦C
(3) Reciprocating
holder: Temp
32±0.5◦C
applicable to
coated drug
Same as BP

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(3)Cell method:
Rotate at 100rpm
per min
Delivery system,
reciprocate at a
frequency of 30
cycles per min
with amplitude of
2 cm or as
specified in
monograph, time
as specified.
Delayed release
tablet ...... .........
basket and
paddle
apparatus: Time
as per individual
monographs.
after 2 hours
withdrawn
sample and carry
out test
.......

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Compendial methods / official methods
Beaker methods
Open flow – through
compartment system
Dialysis concept

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Dissolution Apparatus:-
The dissolution apparatus are classified into 3 categories
based on the presence or absence of sink condition:-
Closed-compartment apparatus:-
Operated under non sink conditions.
Limited volume apparatus.
E.g. Beaker type apparatus such as the Rotating basket and
the Paddle apparatus.

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Open-compartment apparatus:-
 This is also known as continuous flow-
through.
 Operated by perfect sink condition.
 Dosage form is contained in a column.
Dialysis system:-
 Operated under sink condition.
 These are used for the poorly aqueous soluble
drugs.

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20. 20
Size 20 is more accepted to determine the rate of dissolution.
Used for Capsule, Delayed release, Beads.
Advantages:-
 Full pH change during the test
 Easily automated.
Disadvantages:-
 Basket screen is clogged with gummy
particles.
 Degassing is particularly important.
 Mesh gets corroded by HCl solution.

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USP Apparatus 2:-
o It is Paddle type of apparatus.
o Used for less soluble drugs.
Parts of paddle type apparatus:-
 The assembly is same as that of the basket type except the
rotating basket is replaced with a paddle.
 Used for Capsules, Tablets, Beads, Delayed release.
Advantages:-
Easy to use.
pH change is possible.

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Disadvantages:-
 pH media change is often difficult.
 Apparatus 2 is generally preferred for tablets.
 A sinker , such as a few turns of platinum wire, may be used to
prevent a capsule or tablet from floating.
 A sinker may also be used for film-coated tablets that stick to the
vessel walls or to help
position the tablet or capsule under the paddle .
 The sinker should not alter the dissolution characteristics of the
dosage form

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USP Apparatus 3:-
 It is a Reciprocating Cylindrical apparatus.
 This method is less suitable for precise dissolution testing
due to the amount of agitation and vibration involved.
The assembly consists of
 A set of cylindrical flat bottomed glass vessels.
 A set of glass reciprocating cylinders screens.
 Screens made up of non-absorbing or non-reactive
materials.
 Speed 5-35 rpm.

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Used for low soluble drugs, implants, suppositories,
micro particulates.
Advantages:-
• Easy to change pH media.
• pH-profile possible.
• Sink conditions.
Disadvantages:-
Deaeration is necessary.
High volume of media.

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USP 5 Apparatus:-
 This is the modification for apparatus 2 (Paddle over
disk Apparatus)
 Stainless steel disk are designed for holding of the
transdermal system at the bottom of the vessel.
 Samples are placed on the disk using an inert porous
cellulosic support which reciprocated vertically.
 Rotation speed 25-50rpm
 Temperature 32℃
 Volume 900ml
 Uses Transdermal patches, ointments.

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Advantages:-
 Easy to handle
 Sink conditions are maintained.
 Membrane effect is minimum.
Disadvantages:-
 Disk assembly restricts the
patch size.

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Disadvantages:-
o Investment is high.

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conclusion
 The ultimate objective of dissolution testing is to ensure adequate
& reproducible bioavailability , prescribed in the monographs of
IP/BP/USP/EP is to obtain about the drug release characteristics
under standardized conditions.
 compendial testing comprises all of the analytical testing required
to prove the identity, efficacy, & safety of drug products before they
are packaged/distributed .

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References
Brahmankar DM, Jaiswal SB, Biopharmaceutics and
Pharmacokinetics.
Applied Biopharmaceutics and pharmacokinetics 5th
edition Leon Shargel susanna wu-pong Andrew
 Subramanyam CVS , Biopharmaceutics and
Pharmacokinetics.
 www.google.com.

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