Dissolution methods (Official and Non-Official).pptx

DISSOLUTION
METHODS
Name: Mr. Shubham S. Fatak
Class: 1st Year M Pharm
Sem: II
Roll no: 02
Guided by: Dr. D. M. Shinkar
(Associate Professor MSG COPER)

Needof DISSOLUTIONTESTING
Development and optimization of dosage form.
Batch to batch drug release uniformity.
Quality, safety, efficacy, & stability of the product.
IVIVC Correlation
Bioequivalence
Assessing pre and post approval changes.
Preformulation studies

IDEALFEATURESOF DISSOLUTIONAPPARATUS
•The apparatus must be simple and easy.
•The apparatus must be sensitive enough to
reveal process variations.
•The apparatus should permit a uniform and
non-turbulent liquid agitation.
•The apparatus should provide minimum
mechanical abrasion to the dosage form.

IDEALFEATURESOF DISSOLUTIONAPPARATUS
•Medium must be maintained at a fixed
temperature.
•Nearly perfect sink condition should be
maintained.
•Samples should be easily withdrawn without
interrupting the flow of the liquid.
•The apparatus should be capable of evaluating
disintegrating, dense or floating tablets, or
capsules, and finely powdered drugs

DISSOLUTION
Dissolution is a process of mass transfer of solid into the solvent. It is a multiple process involving
heterogeneous swinging reaction/interaction between the phases of solute- solute, solute-
solvent and solvent-solvent interface.
Dissolution Methods:
Two methods:
Official methods Non official method
Rotating basket method
Paddle method
Reciprocating cylinder method
Flow-through method
Paddle over disk method
Rotating cylinder method
Reciprocating Holder method
Percutaneous absorption technique
Rotating Bottle Method for sustain release formulation.
Beaker Method

OFFICIALMETHODS (ASPER USP)
It was first discovered by PERNAROWSKI. It is basically closed
compartment, beaker type comprising of a cylindrical vessel
with apparatus hemispherical bottom of 1 litre capacity
partially immersed in a water bath to maintain the temperature
at 37°C.
A basket made of 40 mesh to hold the dosage form is located
centrally in the vessel.
The tablet is placed in a dry basket.
Apparatus- 1 BASKET Vessel
Evaporation
cover
Shaft

Useful for:
 Tablets
Capsules
Suppositories
Delayed/enteric coated dosage forms
Floating dosage forms
Agitation:
Stainless steel 316
Usual speed: 50 to 100 rpm
Advantages:
Limited area, capsules are placed in a basket- float, used for
non-official test such as suppositories & microencapsulated
particles.
Disadvantages:
Clogged, light particles float.
Vessel
Evaporation
cover
Shaft

The assembly is same as that for apparatus 1 except that the
rotating basket is replaced with a paddle which acts as a
stirrer.
 This method was first discovered by levy & Hayes.
The dosage form is allowed to sink to the bottom of the
vessel.
SINKERS are used to recommended to prevent floating of
the capsules and other floatable forms.
The tablet is allowed to sink to the bottom of the vessel prior
to the rotation of the paddle, if the tablet floats, a wire or glass
helix is used.
Apparatus- 2 PADDLE

Useful for:
Tablets
Capsules
Agitation:
Rotating stirrer
Usual speed: 25 to 75 rpm
Standard volume: 900/1000 ml
Advantages:
Easy to use
Paddle method produces greater turbulence compared to basket
method.
Disadvantages:
Some tablets and capsules tend to float. Hence sinkers have to be used.
Orientation of paddle is very important, else result vary.
pH/media often change is difficult

The apparatus consists of a set of cylindrical flat - bottomed
glass vessel equipped with glass reciprocating cylinders.
stainless steel fittings and screens that are made of suitable
non adsorbing and nonreactive material(poly propylene).
motor and drive assembly to reciprocate the cylinders
vertically inside the vessel.
Apparatus- 3 Reciprocating cylinder
300 ml
Vessel

The vessels are partially immersed in a suitable water bath of
any convenient size that permits holding the temperature at 37°c
± 0.5°c during the test.
The dosage unit is placed in reciprocating cylinder & the
cylinder is allowed to move in upward and downward direction
constantly.
Release of drug into solvent within the cylinder vessel.
Apparatus- 3 Reciprocating cylinder
300 ml
Vessel

Useful for:
Tablets,
Controlled release
Extended release Bead-type formulations.
Standard volume: 200-250 ml.
Advantages:
1) Design is technically easy
2) Medium can be changed easily by removing the dosage unit(inner
cylinder) and placing it in another medium.
3) Easily automated.
Disadvantages:
1) Small volume (max. 250 ml).
2) Little experience.
300 ml
Vessel

The assembly consists of a reservoir
and a pump for the dissolution medium.
A water bath that maintains the
dissolution medium at 37°c ± 0.5°c.
The pump forces the Dissolution
Medium upwards flow through the cell
holding the test sample.
Large Volume of media is required.
Apparatus- 4 FLOW THROUGHCELL

 Useful for:
Low solubility drugs.
Implants.
Powder granules.
Capsules.
 Advantages:
1. Easy to change the pH.
2. Feasibility of using large volume of
dissolution fluid.
3. Easy to maintaining Sink conditions.
 Disadvantages:
1. clogging of filter creates difficulties.
2. High volumes of media.

Use the paddle and vessel assembly from Apparatus 2 with the
addition of a stainless steel disk assembly designed for holding the
transdermal system is placed at the bottom of the vessel.
The disk assembly holds the transdermal system flat and is
positioned such that the release surface is parallel with the bottom of
the paddle blade. The vessel may be covered during the test to
minimize evaporation.
Advantages:
Less expensive
Standard equipment (available with the manufacture)i.e. apparatus
can be modified and utilized apparatus 5.
Used for:
Transdermal patches, Ointments, Emulsion, Floaters.
Apparatus- 5 paddleover disk

Use the vessel assembly from Apparatus 1 except to replace
the basket and shaft with a stainless steel cylinder stirring
element.
 The temperature is maintained at 32°C ± 0.5°C.
The dosage unit is placed on the cylinder at the beginning of
each test.
Place the cylinder in the apparatus, and immediately rotate at
the rate specified in the individual monograph.
Apparatus- 6 ROTATINGCYLINDER

 Design:
Vessel - In place of basket cylinder is used.
Shaft- stainless steel 316.
Sample-mounted to cuprophan (inner porous cellulosic material) an
entire system adheres to cylinder.
Dosage unit is placed in cylinder and release from side out .
Used for transdermal patches.
Adv: apparatus 1.
Dis-Adv: large volume of medium is required. Drugs gets diluted and
causes difficulties in analysis of drug.

The samples are placed on disc-shaped holders using inert
porous cellulosic support which reciprocates vertically by means
of a drive inside a glass container containing dissolution medium.
The test is carried out at 32°C and reciprocating frequency of 30
cycles/min.
Apparatus 7 is applied to transdermal patches and solid oral
dosage forms.
Used for the drug release from osmotic pumps and extended
release tablets.
Adv: This method is for selecting the volume of the medium and
for maximising the drug conc.that is suitable for drug analysis. It
can be automated.
Dis-Adv: Invesment on dissolution apparatus is high, because the
design is totally different from std. equipment already available in
the industry.
Apparatus- 7 RECIPROCATING HOLDER

UNOFFICIALMETHODS
Percutaneous absorption is related to the absorption across the
skin. Percutaneous absorption methods are currently used to study
transfer kinetics through membranes.
These are useful in testing membrane characteristics and
studying absorption through skin.
These are generally use for patches, the patches generally
mounted in same position as the simulated skin membrane and
serves as the donor side of the system.
Some of the tech. that are used in percutaneous absorption
measurement includes side-by-side, the Franz cell, and flow
through cell design.
PERCUTENOUS ABSORPTIONTECHNIQUE

UNOFFICIALMETHODS
This is probably the oldest method used for sustained release
dosage forms.
The system consists of 12 small bottle attached to a horizontal
shaft that rotates at a slow rate of 6-50 rpm.
The whole assembly is placed in a constant water bath.
Each bottle consists of 60 ml of dissolution fluid that is decant
through a 40-mesh screen after each sampling period and is
replaced by fresh fluid.
ROTATINGBOTTLEMETHOD

UNOFFICIALMETHODS
Reported by Levy and Hayes (1960).
Dissolution medium, 250 ml of 0.1 N HCL at 37 degree placed in
400 ml beaker.
Agigation by three blade polyethylene stirrer, 5cm diameter and
rotate at 60 rpm.
Stirrer immersed to depth of 2.7 cm.
Tablet are placed in beaker and test is carried out.
Sample is removed and assayed for the content.
Beakermethod
370C

The USP Performance verification test (PVT) assesses the suitable performance of
apparatus used in dissolution testing.
Responsible for detecting problem associated with dissolution apparatus .
USPPERFORMANCE VERIFICATIONTEST

reference
1. https://www.usp.org/sites/default/files/usp/document/harmonization/qen-
method/stage_ 6 monograph 25 feb 2011.pdf
2. Biopharmaceutics and pharmacokinetics- D. M. Brahmankar-Pg. No.272-276
3. http://www.collegeofpharmacy.com/callearningcentre/demonstrationCALPa
ckages/DissolutionDemo/1Introduction/page-7.html
4. https://labecx.com/apparatus/ Animation images https://www.presentermedia.com/
5. Lachman/liberman’s the theory and practice of industrial pharmacy, fourth edition 2013.
Page no. 182-213.

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