This document summarizes a seminar on developments, modifications, and challenges in dissolution testing. The seminar covered topics such as the historical background of dissolution testing, apparatus used for different dosage forms, challenges including a lack of objectivity in experimental conditions and issues with in-vitro in-vivo correlations, and case studies of testing different dosage forms. The conclusion emphasized that dissolution testing continues to change and develop new methods as drug delivery systems evolve in order to properly assess product performance.

1. A seminar on
Development, Modification and
Challenges in Dissolution Testing
Presented by:
Miss Swati M. Aute
(M. Pharm. SEM-I )
Department of Pharmaceutics
Supervised by:
Dr. J. I. D’souza
Department of Pharmaceutics
Guided by :
Mr. D. A. Bhagwat
(Assistant Professor)
Department of Pharmaceutics
Tatyasaheb Kore College of Pharmacy,
Warananagar

2. Content
 Introduction
 Apparatus
 Historical background
 Challenges
 Case study
 Conclusion
 Reference
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3.  Dissolution is a process in which a solid substance solubilises
in a given solvent i.e. mass transfer from the solid surface to
the liquid phase.
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Dissolution

4. Sr. No. Types of dosage form Dissolution testing method
1. Solid dosage forms Basket, Paddle, Reciprocating
cylinder or flow through cell
2. Oral suspensions Paddle
3. Oral disintegrating
tablets
Paddle
4. Chewable tablets Basket
5. Transdermal patches Paddle over disk
6. Topical semisolids Franz diffusion cell
7. Suppositories Paddle, flow cell
8. Chewing gum Special apparatus
9. Powder & granules Flow through cell
10. Implants Modified flow through cell
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Apparatus used for different dosage forms

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Historical
Development

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9. Limitation of some commonly described practices in drug
dissolution testing
1) Failure of the performances evaluation of the apparatus or
product
2) In-vitro In-vivo correlation
3) Lack of objectivity in setting or selecting experimental
conditions
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Challenges in Dissolution testing

10.  Why calibration an issue for Dissolution testing
 Calibration with tablets.
 Environmental factor
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Failure of performances evaluation of
apparatus or product
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11. Calibration an issue for dissolution
testing
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12.  It is as predictive mathematical model describing the relationship
between an in-vitro property of dosage form (usually the rate or
extent of the drug dissolved or released) & a relevant in-vivo
responses
 IVIVC practices appear to have serious limitation
 Rather than saying the IVIVC, it is called as IVIVC seek a
matching
 The question would then be what is intended purpose of IVIVC
practices
 It is not essential IVIVC have to be repeated with every drug &
product
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In-vitro In-vivo correlation

13.  Temperature adjustment
 pH
 Rotating speed
 Dissolution medium
 Solubilising agent
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Lack of objectivity in setting or
selecting experimental conditions
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Modification of flow through cell
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15. Case studies
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16.  Use of enzymes in the dissolution testing of gelatin capsule
 Liquid filled capsules
 Dissolution of dietary supplement
 Performance tests for semisolid drug products
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Challenges in Different dosage forms

17. There has been remarkable progress in developing ways to assess
product performance and to assure that this performance is stable
over time. We have seen many changes in the field of dissolution,
and anticipate a future of continuing change. There is much to learn
and many interesting testing methodologies will be developed. As
new chemical entities and new drug delivery systems are developed,
we are challenged to develop new methods for in vitro drug release
determination.
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Conclusion

18.  Margareth R. C. Marques*, William Brown, Gabriel Giancaspro,
Natalia Davydova, Edith Chang, Jeanne Fringer, Walter Hauck, and
Anthony DeStefano Current research journal, Aug. 2006.
 Giancaspro, Natalia Davydova, Edith Chang, Jeanne Fringer, Walter
Hauck, and Anthony DeStefano al.Challenge in dissolution testing,
Aug. 2012.
 Margareth R. C. Marques*, William Brown, Gabriel Giancaspro,
Natalia Davydova, Edith Chang, Jeanne Fringer, Walter Hauck, and
Anthony DeStefano. vivan grey, May 2006
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References
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