This document discusses dissolution testing apparatus and methods. It defines dissolution as the process by which a solid substance enters the solvent phase to form a solution. Several theories of drug dissolution are described, including the diffusion layer theory, Danckwert's model, and the interfacial barrier model. Six common apparatus are summarized: the basket, paddle, reciprocating cylinder, flow-through cell, paddle over disk, and cylinder methods. Procedures for each apparatus are provided. Common dissolution media and factors affecting media selection are also outlined. The document provides an overview of key concepts and equipment in dissolution testing.
Presentation about dissolution apparatus testing machine for tablet and new version which is manufactured by lab 8 "Industrial Pharmacy Course" faculty of pharmacy october 6 university.
we added new modification which is already applied and others not applied due to high cost but suggested.
and all modifications are approved from industrial pharmacy department O6U.
WHAT IS COMPRESSION ?
Compression means reduction of bulk volume of material as a result of the removal of gaseous phase (air) by applied pressure
WHAT IS CONSOLIDATION?
Consolidation is an increase in mechanical strength of material resulting from particle - particle interactions.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Presentation about dissolution apparatus testing machine for tablet and new version which is manufactured by lab 8 "Industrial Pharmacy Course" faculty of pharmacy october 6 university.
we added new modification which is already applied and others not applied due to high cost but suggested.
and all modifications are approved from industrial pharmacy department O6U.
WHAT IS COMPRESSION ?
Compression means reduction of bulk volume of material as a result of the removal of gaseous phase (air) by applied pressure
WHAT IS CONSOLIDATION?
Consolidation is an increase in mechanical strength of material resulting from particle - particle interactions.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
DISSOLUTION
Dissolution is a process in which solid substance solubilizes in a given solvent
DISSOLUTION TESTING
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. In-vitro test must predict the in-vivo behaviour
Factors in design of dissolution tests:
Factors relating to dissolution apparatus
Factors relation to dissolution fluid
Process parameters
Need of Dissolution Testing:
Development and optimisation of dosage forms
Batch to batch drug release uniformity
Quality, safety, efficacy and stability of the product
IVIV Correlation
Bioequivalence
Assessing pre and post approval changes
DISSOLUTION APPARATUS
Dissolution apparatus evolved to prepare a sample under controlled conditions thereby making the test repeatable.
Principle types of dissolution apparatus-
Close-compartment apparatus
Open-compartment apparatus
Dialysis systems
Ideal features of Dissolution Apparatus:
The fabrication, dimensions, and positioning of all components must be precisely specified and reproducible
Simple in design, easy to operate and useable
Sensitive
Nearly perfect sink conditions
Provide an easy means of introducing the dosage form into the dissolution medium
Provide minimum mechanical abrasion
Easy withdrawal of samples
Elimination of evaporation of solvent medium
DISSOLUTION METHODS
The Standard Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).
Official methods:
Rotating Basket
Rotating Paddle
Reciprocating Cylinder
Flow-Through Cell
Paddle Over Disc
Rotating Cylinder
Reciprocating Disc
Non-official methods:
Static Disc Method
Beaker Method
Flask Stirrer Method
Peristalsis Method
Rotating Bottle Method
Dialysis Method
Diffusion Cell Method
Dissolution Apparatus Types and their Applications
Problems associated with dissolution apparatus
USP Performance Verification Test (PVT):
The USP Performance Verification Test (PVT) assesses the suitable performance of apparatus used in dissolution testing.
Responsible for detecting problems associated with the dissolution apparatus that are found to be within mechanical tolerances.
REFERENCES
Dissolution, factors affecting drug dissolution, methods to evaluate dissolution, advantages and disadvantages, recent approaches--these are the topics covered in this presentation.
Introduction to Concepts of Similarity and Difference factors,
Importance of dissolution profile comparison,
Objective of dissolution profile comparison,
Method to compare dissolution profile , f1 & f2 Comparison
Presented By
N. Poojitha
Department of Pharmaceutics
SOLID DISPERSION
Definition: The technology is the science of dispersing one or more active ingredients in an inert matrix in the solid stage.
Need of solid dispersion:
Increases Oral bioavailability of a drug
Increased dissolution rate.
Enhanced release of drugs from ointment.
Improved the solubility & stability.
The concept of solid dispersion was originally proposed by Sekiguchi & obi.
Increasing the dissolution, absorption & therapeutic efficacy of drugs in dosage forms.
Increasing solubility in water.
Improving the oral absorption and bioavailability of BCS Class II drugs.
It includes Introductory part about what is Dissolution...then Mechanism of Dissolution is elaborated...Theories of Dissolution also given..It also includes Factors affecting Dissolution profile..Along with References given below for easily searching..
Dissolution is a process in which a solid substance solubilizes in a given solvent.
Method for dissolution are-
1. Beaker methods
2. Open flow through compartment system
3.Dialysis concept
DISSOLUTION
Dissolution is a process in which solid substance solubilizes in a given solvent
DISSOLUTION TESTING
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. In-vitro test must predict the in-vivo behaviour
Factors in design of dissolution tests:
Factors relating to dissolution apparatus
Factors relation to dissolution fluid
Process parameters
Need of Dissolution Testing:
Development and optimisation of dosage forms
Batch to batch drug release uniformity
Quality, safety, efficacy and stability of the product
IVIV Correlation
Bioequivalence
Assessing pre and post approval changes
DISSOLUTION APPARATUS
Dissolution apparatus evolved to prepare a sample under controlled conditions thereby making the test repeatable.
Principle types of dissolution apparatus-
Close-compartment apparatus
Open-compartment apparatus
Dialysis systems
Ideal features of Dissolution Apparatus:
The fabrication, dimensions, and positioning of all components must be precisely specified and reproducible
Simple in design, easy to operate and useable
Sensitive
Nearly perfect sink conditions
Provide an easy means of introducing the dosage form into the dissolution medium
Provide minimum mechanical abrasion
Easy withdrawal of samples
Elimination of evaporation of solvent medium
DISSOLUTION METHODS
The Standard Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).
Official methods:
Rotating Basket
Rotating Paddle
Reciprocating Cylinder
Flow-Through Cell
Paddle Over Disc
Rotating Cylinder
Reciprocating Disc
Non-official methods:
Static Disc Method
Beaker Method
Flask Stirrer Method
Peristalsis Method
Rotating Bottle Method
Dialysis Method
Diffusion Cell Method
Dissolution Apparatus Types and their Applications
Problems associated with dissolution apparatus
USP Performance Verification Test (PVT):
The USP Performance Verification Test (PVT) assesses the suitable performance of apparatus used in dissolution testing.
Responsible for detecting problems associated with the dissolution apparatus that are found to be within mechanical tolerances.
REFERENCES
Dissolution, factors affecting drug dissolution, methods to evaluate dissolution, advantages and disadvantages, recent approaches--these are the topics covered in this presentation.
Introduction to Concepts of Similarity and Difference factors,
Importance of dissolution profile comparison,
Objective of dissolution profile comparison,
Method to compare dissolution profile , f1 & f2 Comparison
Presented By
N. Poojitha
Department of Pharmaceutics
SOLID DISPERSION
Definition: The technology is the science of dispersing one or more active ingredients in an inert matrix in the solid stage.
Need of solid dispersion:
Increases Oral bioavailability of a drug
Increased dissolution rate.
Enhanced release of drugs from ointment.
Improved the solubility & stability.
The concept of solid dispersion was originally proposed by Sekiguchi & obi.
Increasing the dissolution, absorption & therapeutic efficacy of drugs in dosage forms.
Increasing solubility in water.
Improving the oral absorption and bioavailability of BCS Class II drugs.
It includes Introductory part about what is Dissolution...then Mechanism of Dissolution is elaborated...Theories of Dissolution also given..It also includes Factors affecting Dissolution profile..Along with References given below for easily searching..
Dissolution is a process in which a solid substance solubilizes in a given solvent.
Method for dissolution are-
1. Beaker methods
2. Open flow through compartment system
3.Dialysis concept
The objective of in vitro dissolution testing is to evaluate the variables that effect the rate and extent of release of a drug substance from the finished dosage form, and in turn, the in vivo performance of the drug product.
Thin-layer chromatography (TLC) is a chromatography technique used to separate non-volatile mixtures. Thin-layer chromatography is performed on a sheet of glass, plastic, or aluminium foil, which is coated with a thin layer of adsorbent material, usually silica gel, aluminium oxide (alumina), or cellulose.
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2. DEFINITION
● Dissolution is the physicochemical process by which a solid sustance
enters the solvent phase to yield a solution.
● WHY DISSOLUTION STUDY:
● Estimation of amount of drug released per unit time.
● Batch to batch quality control.
● It is the rate limitimg factor for poorly soluble drugs.
● For product development.
3.
4. Therioes of drug dissolution
● Several theories to explain drug dissolution have been
proposed. Some of the important theories are:
● 1. Diffusion layer theory
● 2. Danckwert’s model / penetration or surface renewal
theory
● 3. Interfacial barrier model / Double- barrier or Limited
solvation theorymm
5. Diffusion layer model / Film theory
● Solutions of the solid to
form a thin film or layer at
the solid /liquid interface
called as stagnant film or
diffusion layer which is
saturated with the drug.
● Diffusion of the soluble
solute from the stagnant
layer to the bulk of the
solution. This step is the
rate determing step in drug
dissolution
6. ● When the process is Diffusion – controlled and involves no
chemical reaction it ws given by Noyes and Whitney
● dC / dt = k (Cs – Cb )
● It was based on Fick’s second law of diffusion. Nernst and
Brunner incorporated Fick’s first law of diffusion and modified
the Noyes-Whitney equation to
● dC / dt = DAKW/O ( Cs – Cb ) / Vh
7. Danckwert’s model
● Danckwert did not approve of the existance of a stagnant
layer and suggested that turbalence in the dissoluion
medium exists at the solid/liquid interface. As a result, the
agitated fluid consisting of macroscopic mass of eddies or
packets reach the solute by diffusion and carry it to the
bulk of the solution.
● Such solute containind packetsare continuously replaced
with new packets of fresh solvent due to which the drug
concentration at the sold/liquid interface never reaches Cs
and has a lower limiting value of Ci. Since the solvent
packets are exposed to new solid surface each time, the
theory is called as surface renewal theory..
9. Interfacial barrier model
• The rate determing step that control dissolution
is the mass transport.
• Solid- solution equlibrium is achieved at the
solid / liquid interface.
●
● G = Ki ( Cs – Cb )
● G = diffusion rate per unit area
● ki = effective interfacial transport constant
10. Dissolution media
● Common dissolution media used
● Purified water
● Dilution acid (0.9 N Hcl)
● Buffered aqueous solutions
● Simulated gastric fluid
● Simulated intestinal fluid
● Factors effecting selection of dissolution media:
● Dissolved gases
● Composition of dissolution media
● Ph of dissolution media
● Viscosity of dissolution media
● Surfacace
11.
12.
13. Apparatus 1-Basket apparatus:
● The assembly consists of the following:
● A covered vessel
● Transparent material
● A motor
● A metallic drive shaft
● A cylindrical basket the water bath permits the holding of temperature
inside the vessel at 37(+/-) 0.5 degrees centigrade
● The vessel is a cylindrical with hemispherical bottom.
14. ● The shaft is positioned so that
its axis is not more than 2mm at
any point from the vertical axis
of the vessel and rotates
smoothly.
● Use 40mm mesh cloth.
● A basket having gold coating
0.0001 inch thick may be used.
● The dosage unit is placed in a
dry basket at the beginning of
each test.
● He distance between the inside
bottom of the vessel and the
basket is maintained at 25+/-
2m.
15. Apparatus 2-Paddle apparatus
● A shaft is used as a stirring
element.
● The distance 25+/-mm between the
blade and the inside bottom of the
vessel.
● The paddle, blade and shaft may
be coated with a suitably inert
coating
● The dosage unit is allowed to sink
to the bottom of the vessel before
rotation of the blade.
● A small loose piece of nonreactive
maretial such as wire helix may be
attache to dosage units in order to
prevent floating.
16. ● Procedure :
● Place the stated volume of the
dissolution medium in the
vessel. Equilibrate the
dissolution medium to 37+/-
0.5degree centigrade.Place 1
tablet in the apparatus.
● Operate the apparatus .Within
the time interval, withdraw a
specimen from zone midway
between the surface of the
dissolution medium and the top
of the rotating basket, not less
than 1cm from the vessel wall.
● Replace equal volume of
dissolution medium at
37deg.cent.
Standard volume:
900/1000ml
Advantages:
1. easy to use
2. ph change possible
Disadvantages:
1. floating dosage forms require
sinker.
2. positioning of tablet.
17. Apparatus 3- Reciprocating cylinder
● The vessel is immersed in water
bath holding temperature at 37+/-
0.5 deg.cent.
● Standard volume: 200-
250ml/station
● Advantages:
● Easy to change the ph profile.
● Disavantage:
● Small volume[max. 250Ml]
● Limited data.
18. Procedure
● Place the stated volume of the
dissolution medium in each
vessel.
● Equilibrate the dissolution
medium to 37+/- 0.5deg.cent.
● Place 1 dosage- form unit in
each of the six reciprocating
cylinders.
● Operate the apparatus.
● During the upward and
downward stroke, the
reciprocating cylinder moves
through a total distance of 9.9 to
10.1 cm.
● Within the time interval
specified withdraw a portion of
the solution under test from a
zone midway between the
surface of the dissolution
medium and the bottom of each
vessel.
● Perform the analysis as directed
in the individual monograph.
19. Apparatus 4 – Flow through cell
• The assembly consists of a reservoir
and a pump for the dissolution
medium, a flow- through cell, a water
bath.
• The pump forces the dissolution
medium upwards through the flow –
through cell.
• The pump has a delivery rang
between 240 and 960ml per hour,
with standard flow rates of 4, 8 and
16ml per minute
Advantages
• Easy to change ph media
• Ph profile possible
20. Disadvantages
• High volumes of media
• Labor intensive
Procedure
• Place the glass beads into the
cell specified in the
monograph.
• Place 1 dosage form unit on
top of the beads.
• Assemble the filter head and
fix the parts together by means
of a suitable clamping device.
• Introduce by the pump the
dissolution medium warmed to
37 +/- 0.5 degree through the
bottom of the cell.
• Collect the eluate by fractions
at each of the times stated.
• Perform the analysis as
directed in the individual
monograph.
• Uses
• Low solubility drugs
• Micro particulates
• Implants
• Suppositories.
21. Apparatus 5- Paddle over disk
• The paddle and vessel
assembly from apparatus 2
with the addition of stainless
steel disk assembly.
Standard volume; 900 ml
Disadvantage
disk assembly restricts the patch
size
22. Procedure:
• Place the stated volume of
dissolution medium in the
vessel assemble the apparatus
without the disk assembly and
equlibrate the medium to 32
+/- 0.5 degree cent.
• Apply the transdermal system
disk assembly.
• The system may be attached to
the disk by a suitable adhesive
• Place the disk assembly flat at
the bottom of the vessel with
the release surface facing up
• and parallel to the paddle blade
and surface of the dissolution
medium.
• Operate the apparatus
• At each sampling time interval,
withdraw a sample from a zone
midway between the surface of
the dissolution medium and the
top of the blade, not less than 1
cm from the vessel wall.
• Perform the analysis on each
sampled aliquot as directed in
the monograph.
23. Apparatus 6 - Cylinder
• The dosage unit is placed on
the cylinder at the beginning of
each test.
• The distance between the
inside bottom of the vessel and
the cylinder is maintained at
25+/- 2 mm during the test.
• Procedure
Place the stated volume of the
dissolution medium in the vessel.
equilibrate the dissolution
medium to 32+/- 0.5 degree cent.
24. • Prepare the test system prior to
test as follows
• Remove the protective liner
from the system and place the
adhesive side on a piece of
cuprophan.
• Cuprophan covered side down,
on a clean surface, and apply a
suitable adhesive to the
exposed cuprophan borders.
• Dry for 1 min. press the
cuprophan covering to remove
trapped air bubbles.
• Place the cylinder in the
apparatus and immediately
rotate at the rate specified.
• Within the time interval
specified, withdraw a quantity
of dissolution medium for
analysis from a zone midway
between the surface of the
dissolution medium and the top
of the rotating cylinder, not
less than 1 cm from the vessel.
25. Apparatus 7- Reciprocating holder
• The assembly consists of a set of volumetrically calibrated or tared
solution containers.
• A motor and drive assembly to reciprocate the system vertically.
• A set of suitable sample holder.
• The solution containers are partially immersed in a suitable water
bath, inside the temperature of the container at 32+/- 0.5 degree cent.