This document discusses different types of dissolution test apparatus and their design considerations for testing controlled release tablets. It describes the four official dissolution apparatus: 1) rotating basket, 2) paddle, 3) reciprocating cylinder, and 4) flow-through cell. For each apparatus, it provides details on its components, advantages, disadvantages and uses for quality control, research and development, and different dosage forms. The document emphasizes that the choice of apparatus depends on the intended use and factors like dissolution medium and process parameters must be considered in test design.
Dissolution as one of the most important aspects of Pharmaceutical dosage form showing the correlation between the in-vitro & in-vivo availability. Importance of dissolution, comparison with Disintegration, Sampling point, acceptance criteria as per Pharmacopoeias.
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.
Dissolution as one of the most important aspects of Pharmaceutical dosage form showing the correlation between the in-vitro & in-vivo availability. Importance of dissolution, comparison with Disintegration, Sampling point, acceptance criteria as per Pharmacopoeias.
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.
Basic Approach to Dissolution Method Development – Challenges and Regulatory ...Dr. Harshal Pawar
This presentation explains the theoretical as well as practical aspects of dissolution. It provides a systematic and scientific path for development of dissolution method for a new pharmaceutical product.
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.
Basic Approach to Dissolution Method Development – Challenges and Regulatory ...Dr. Harshal Pawar
This presentation explains the theoretical as well as practical aspects of dissolution. It provides a systematic and scientific path for development of dissolution method for a new pharmaceutical product.
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.
RIPER (Ragavendra Institute of Pharmaceutical Education and Research) was established by a group of Pharmacy Teachers in the year 2002 under Raghavendra Educational and Rural Development Society (Reg.No.198/2001). It is the premier educational institute in Andhra Pradesh, well recognized throughout India and dedicated to pharmacy education. All academic programmes are as per norms and approved by AICTE, PCI, JNTUA, UGC under section 12b and 2f and State board of Technical Education and Training (SBTET), Govt. of Andhra Pradesh. It is affiliated to Jawaharlal Nehru Technological University Anantapur (JNTUA), Anantapuramu, Andhra Pradesh.
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Institute with higher number of university gold medals under JNTUA
Private Institute with stronger alumni at NIPER and other reputed universities.
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Best intellectual capital award by Faculty branding awards 2014.
Best placements for PG students.
First institute to start Ph.D. programme under JNTUA.
First institute to start M. Pharm (PA & QA).
Recognized institute to conduct EAMCET, GROUP II, III, IV (AP Government).
Recognized institute for syllabus revision workshop for JNTUA.
The role of dissolution in the demonstration of bioequivalenceinemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
Here is all information about Invitro dissolution of drug by various Apparatus as per USP. It includes 7 Official and 3 Unofficial methods.in official method maintain condition in apparatus same as gastric fluid Example.Temperture, PH , Rpm( like Peristaltic movement ), Dissolution media.
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
MEETING DISSOLUTION REQUIREMENTS PROBLEMS OF VARIABLE CONTROL IN DISSOLUTION ...MukeshKumarBhagat
The dissolution profile data from the pivotal clinical batches and primary (registration) stability batches should be used for the setting of the dissolution acceptance criteria of your product (ie, specification-sampling time point and specification value).
Introduction to Dissolution equipment's, Calibration of dissolution apparatus, Dissolution procedure development and validation, Dissolution method development for generic drug products.
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Umesh bhandari
1. PRESENTED BY
MR. BHANDARI UMESH M.
SSDJ COLLEGE OF PHARMACY
CHANDWAD
DISSOLUTION TEST APPARATUS
& DESIGN FOR CONTROLED
RELEASE TABLET
2. WHICH TYPE OF DISSOLUTION APPARATUS ?
Depends on intention
1. Quality control
• examining batch homogeneity
• examining batch to batch conformity
• examining stability
2. Research & Development
• examining drug release behavior of preformulations
• in vitro simulation of the gastrointestinal passage
3. IVIVC 2
3. Factors must be considered in design of dissolution
tests:
1.Factors relating the dissolution apparatus
2.Factors relating to the dissolution fluid
3.Process parameter
e.g. method of introducing dosage form, sampling
techniques, changing dissolution fluid etc.
4. DOSAGE FORMS TO BE TESTED
controlled release dosage forms
• powders, granules / beads, tablets, capsules
4
Controlled release dosage forms:
apparatus 1 or 2 using different media for QC
apparatus 3 or 4 for R&D purposes
10. Apparatus 2 (Paddle)
The assembly is same as apparatus 1 except that a paddle
formed from a blade & a shaft is used as stirring element.
The metallic blade & shaft comprise a single entity that may
be coated with a suitable inert coating.
11. APPARATUS 2 - PADDLE
Useful for
• tablets
• capsules
• beads
• delayed release / enteric
coated dosage forms
Standard volume
• 900/1000 ml
11
12. APPARATUS 2 - PADDLE
Advantages
• easy to use
• robust
• pH change possible
• can be easily automated
which is important for
routine investigations
12
13. APPARATUS 2 - PADDLE
Disadvantages
• pH/media change is often difficult
• hydrodynamics are complex, they vary with site of the dosage
form in the vessel (sticking,floating) and therefore may
significantly affect drug dissolution
• sinkers for floating dosage forms
13
14. SINKER TYPES
JP/ USP / Ph. Eur.
5.3 Sinker
„a small loose piece of nonreactive material such as
not more than a few turns of wire helix may be attached
to dosage units that would otherwise float …“
„…. other validated sinker devices may be used“ 14
17. Apparatus : (reciprocating cylinder)
The assembly consist:
1.Set of cylindrical, flat bottomed glass vessels
2.Set of reciprocating cylinders
3.Stainless steel fittings
4.Polyproylene screens
5.Motor & drive assembly
18. APPARATUS 3 – RECIPROCATING CYLINDER
Useful for
• tablets
• beads
• controlled release formulations
Standard volume
• 200-250 ml per station
18
19. APPARATUS 3 – RECIPROCATING CYLINDER
Advantages
• easy to change the pH
• pH-profiles
• hydrodynamics can be
directly influenced by
varying the dip rate
Disadvantages
• small volume (max. 250 ml)
• little experience
• limited data
19
21. Apparatus : (Flow through cell )
The assembly consist of
Reservoir & pump for dissolution medium
A flow through cell
A water bath
The flow through cell is transparent & inert mounted vertically
with filters.
Standard cell diameters are 12 & 22.6 mm.
The bottom cone usually filled with glass beads of 1 mm
diameter.
Tablet holder used for positioning special dosage form e.g.
inlay tablets.
23. APPARATUS 4 – FLOW-THROUGH CELL
Advantages
• easy to change media pH
• pH-profile possible
• different modes
a) open system
b) closed system
Disadvantages
• Deaeration necessary
• high volumes of media
• labor intensive
23
24. CELL TYPES
24
Tablets 12 mm Tablets 22,6 mm Powders / Granules Implants Suppositories /
Soft gelatine capsules
26. REFERENCES
The Theory And Practice of Industrial pharmacy by
LEON LACHMAN,HERBERT A. LIBERMAN,
JOSEPH L. KANIG, Third edition.
Physical pharmacy And Pharmaceutical sciences by
MARTIN’S, Fifth Edition.
The Science And Practice of Pharmacy by
REMINGTON , 21 st Edition.
