This document discusses in-vitro dissolution testing and drug release. It defines dissolution as the process where a solid substance is solubilized in a liquid solvent. Dissolution is the rate determining step for drug absorption if the drug is highly soluble. The document then covers various theories of dissolution, types of in-vitro dissolution testing models and apparatuses, and factors that can affect drug dissolution and release such as drug properties, formulation components, and test conditions.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Dissolution, factors affecting drug dissolution, methods to evaluate dissolution, advantages and disadvantages, recent approaches--these are the topics covered in this presentation.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Dissolution, factors affecting drug dissolution, methods to evaluate dissolution, advantages and disadvantages, recent approaches--these are the topics covered in this presentation.
Biopharmaceutic considerations in drug product design and In Vitro Drug Produ...PRAJAKTASAWANT33
Introduction, biopharmaceutic factors affecting drug bioavailability, rate–limiting steps in drug absorption, physicochemical nature of the drug formulation factors affecting drug product performance
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
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.
drug execipent compatibilty studies is of prime importance for the better formulation of the new drug and also for reducing cost by verfication of the data at the earlier atage.
this presentation will give the brief explanation of the goal, importance, dteps involve to studi the drug execient compatibility studies with different examples suitable accordiingly.
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..
Biopharmaceutic considerations in drug product design and In Vitro Drug Produ...PRAJAKTASAWANT33
Introduction, biopharmaceutic factors affecting drug bioavailability, rate–limiting steps in drug absorption, physicochemical nature of the drug formulation factors affecting drug product performance
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
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.
drug execipent compatibilty studies is of prime importance for the better formulation of the new drug and also for reducing cost by verfication of the data at the earlier atage.
this presentation will give the brief explanation of the goal, importance, dteps involve to studi the drug execient compatibility studies with different examples suitable accordiingly.
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 apparatus, invivo-invitro corelation, factor affecting,BCS classification ..
Complete dissolution topic in this slide & easy way to write..
Cheak it now and give feedback
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 present document provide the information about Methods of extraction of drugs from the biological matrix (protein precipitation method, liquid extraction)
In this experiment I have provided the complete information regarding limit test for sulphate and also preparation of 0.1 N sulphuric acid and barium sulphate reagent for your better understanding.
complete details for performing limit test for chlorides its is very helpful for the B.pharmacy 1 year students for both analysis as well as inoganic chemistry.
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dissolution and drug release.pptx
1. IN-Vitro DISSOLUTION TESTING &
DRUG RELEASE
Prepared by
Dr. Anumalagundam Srikanth
Dept. of .Pharmaceutical analysis
2. DISSOLUTION
A process in which a solid substance is solubilized in a given solvent i.e.,
mass transfer from solid surface to liquid phase. (i.e., from solid to liquid)
(or)
It is a process by which drug released from solid dosage form and
immediately goes into molecular solution.
It is a Rate Determining Step
If the drug is hydrophilic with high aqueous solubility then dissolution is
rapid and rate determining step in the absorption of such drugs is rate of
permeation through the bio membrane.
Absorption of such drugs is said to be permeation rate limited or Tran’s
membrane rate limited.
3. Dissolution process of solid dosage Forms :
TABLETS OR
CAPSULES
GRANULES OR
AGGREGATES
FINE PARTICLES
DRUG IN SOLUTION
(IN-VITRO OR IN-VIVO)
DRUG IN
BLOOD,OTHER
FLUIDS,AND
TISSUES
DISINTEGRATION
DISAGGREGATION
DISSOLUTION
ABSORPTION
IN-VIVO
4. Theories of Dissolution
1. Diffusion Layer Model/ Film theory
2. Danckwerts’s Model/ Penetration or Surface Renewal Theory
3. Interfacial Barrier Model/ Double Barrier Theory
5. Diffusion Layer Model/ Film theory
• Solution of the solid to form a thin layer at the solid/liq. interface is called Stagnant film or Diffusion layer
which is with saturated drug.
• This step is Rapid Soluble solute form diffuses from the stagnant layer to the bulk of the solution. This
step is slower and rate-determining step in drug dissolution.
• This rate of dissolution if the process is diffusion controlled and invovles no chemical reaction.
• It can be explained by Noyes – Whitney Equation .
dC/dt = k(Cs-Cb)
where dC/dt = dissolution rate of drug
Cs = conc. Of drug in stagnant layer
Cb= conc. Of drug in bulk of the solution at time t.
k = dissolution rate constant. (First order)
6. Danckwert’s Model
• This model suggest that turbulence in dissolution medium exists at the solid/liquid
interface.
• As a result, agitated fluid consisting of macroscopic mass of eddies or packets reach the
interface in random fashion due to eddy currents, absorb the solute by diffusion and
carry it to bulk of the solution.
• Such solute containing packets are continuously replaced with new packets of fresh
solvent due to which drug conc. At S/L interface never reaches Cs and has lower limiting
value of Ci
• This theory is also called as Surface Renewal Theory.
7. Interfacial Barrier Model
• According to the interfacial barrier model: An intermediate concentration can exist at the interface as
result of solvation mechanism and function of solubility rather than diffusion. When considering the
dissolution of a crystal, each face of the crystal will have a different interfacial barrier such a concept is
given by the following equn.
G =Ki (cs - cb )
• where G= dissolution rate per unit area.
• Ki =effective interfacial transport constant.
• Cs = Concentration of drug in the stagnant layer
• Cb =Concentration of drug in the bulk of the solution at time t
In this theory, the diffusivity D may not be independent of saturation concentration cs.
Therefore the interfacial model can be extended to both diffusion layer model and Danckwerts model.
8. IN-VITRO DISSOLUTION TESTING
• Dissolution and drug release tests are in-vitro tests that measure the rate and extent of
dissolution or release of the drug substance from a drug product, usually aq.medium under
specified conditions.
• It is an important QC procedure for the drug product and linked to product performance in-vivo.
NEED FOR DISSOLUTION TESTING:
• Evaluation of bioavailability.
• Batch to batch drug release uniformity.
• Development of more efficacious and therapeutically optical dosage forms.
• Ensures quality and stability of the product.
• Product development, quality control, research and application.
9. IN-VITRO DISSOLUTION TESTING MODELS
Non-Sink methods
1) NATURAL CONVECTION NON SINK METHODS:
a) Klein solvmeter method
b) Nelson hanging pellet method
c) Levy static disk method
2) FORCED CONVECTION NON SINK METHODS:
a) Tumbling method
b) Levy or Beaker method
c) Rotating disk method
d) Particle size method
e) USP Rotating basket apparatus
f) USP Paddle apparatus
10. SINK METHODS
3) FORCED CONVECTION SINK DEVICES:
a) Wurster pollis adsorption method
b) Partition method
c) Dialysis method s
d) Rotating disk apparatus
4) CONTINOUS FLOW/FLOW THROUGH METHODS:
a) Pernarowski method
b) Langenbucher method
c) Baun and Walker
d) Tingstad and Reigelman
e) Modified column apparatus
f) Takenaka method
11. Conditions that May Affect Drug Dissolution and Release:
Drug and formulation related:
• Drug substance
• Particle size
• Polymorph
• Surface area
• Chemical stability in dissolution media
Formulation of drug product :
• Excipients (lubricants, suspending agents, etc)
12. • Conditions that May Affect Drug Dissolution and Release: methodology related
• Medium
• Volume
• pH
• Molarity
• Co-solvents, added enzymes/surfactants
• Temperature of medium
• Apparatus
Hydrodynamics
Agitation rate
Shape of dissolution vessel
Placement of tablet in vessel
Sinkers (for floating products and products th at stick to side of vessel)
14. Apparatus 1–7 refer to compendial dissolution apparatus in USP-NF (United
States Pharmacopeia)
15. Rotating basket (Apparatus 1)
In case of none-disintegrating dosage forms this apparatus is superior
to apparatus 2 since it constraints the dosage form in a steady state fluid
flow
It is inferior for testing dosage form s which contains gums due to
clogging of screen matrix
In the case of floating dosage forms this method performs well, but care
should be taken that excipients do not clog the basket mesh
16. Rotating Paddle (Apparatus 2)
This apparatus is identical to apparatus 1 except that the paddle is
substituted for the rotating basket
Frequently used for both disintegrating and non-disintegrating dosage
forms
17. Reciprocating cylinder (Apparatus 3)
One advantage of the reciprocating cylinder is that the gastrointestinal
tract conditions can be easily simulated, as it is easy to make time
dependent pH changes
This apparatus is most suitable for n on disintegrating (extended
release) or delayed release (enteric coated) dosage forms
18. Flow cell (Apparatus 4)
The advantage of flow through cell apparatus is the ability
to test drugs of very low aqueous solubility and t he ability
to change the pH conveniently during the test
20. Cylinder (Apparatus 6)
• The cylinder method for testing transdermal preparation is modified
from the basket method (Apparatus 1). In place of the basket, a
stainless steel cylinder is used to hold the sample.
21. Reciprocating Disk Method (Apparatus 7)
In the reciprocating disk method for testing transdermal
products, a motor drive assembly (Apparatus 7) is use d to
reciprocate the system vertically, and the samples a re placed
on disk-shaped holders using cupophan supports