Official methods of dissolution testing

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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

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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

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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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