A seminar on
Development, Modification and
Challenges in Dissolution Testing
Presented by:
Miss Swati M. Aute
(M. Pharm. S...
Content
 Introduction
 Apparatus
 Historical background
 Challenges
 Case study
 Conclusion
 Reference
7/29/2013
2/...
 Dissolution is a process in which a solid substance solubilises
in a given solvent i.e. mass transfer from the solid sur...
Sr. No. Types of dosage form Dissolution testing method
1. Solid dosage forms Basket, Paddle, Reciprocating
cylinder or fl...
7/29/2013TKCP, Warananagar5/20
Historical
Development
7/29/20136/20 TKCP, Warananagar
7/29/20137/20 TKCP, Warananagar
7/29/2013TKCP, Warananagar8/20
Limitation of some commonly described practices in drug
dissolution testing
1) Failure of the performances evaluation of t...
 Why calibration an issue for Dissolution testing
 Calibration with tablets.
 Environmental factor
7/29/2013TKCP, Waran...
Calibration an issue for dissolution
testing
7/29/2013
11/20
TKCP, Warananagar
 It is as predictive mathematical model describing the relationship
between an in-vitro property of dosage form (usually ...
 Temperature adjustment
 pH
 Rotating speed
 Dissolution medium
 Solubilising agent
7/29/2013TKCP, Warananagar
Lack o...
7/29/2013TKCP, Warananagar
Modification of flow through cell
14/20
Case studies
7/29/2013
15/20
TKCP, Warananagar
 Use of enzymes in the dissolution testing of gelatin capsule
 Liquid filled capsules
 Dissolution of dietary supplemen...
There has been remarkable progress in developing ways to assess
product performance and to assure that this performance is...
 Margareth R. C. Marques*, William Brown, Gabriel Giancaspro,
Natalia Davydova, Edith Chang, Jeanne Fringer, Walter Hauck...
7/29/201319/20 TKCP, Warananagar
7/29/201320/20 TKCP, Warananagar
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challenges in dissolution,development in dissolution,modification in disso.

  1. 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. 2. Content  Introduction  Apparatus  Historical background  Challenges  Case study  Conclusion  Reference 7/29/2013 2/20 TKCP, Warananagar
  3. 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. 7/29/2013 3/20 TKCP, Warananagar Dissolution
  4. 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 7/29/20134/20 TKCP, Warananagar Apparatus used for different dosage forms
  5. 5. 7/29/2013TKCP, Warananagar5/20 Historical Development
  6. 6. 7/29/20136/20 TKCP, Warananagar
  7. 7. 7/29/20137/20 TKCP, Warananagar
  8. 8. 7/29/2013TKCP, Warananagar8/20
  9. 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 7/29/2013 9/19 TKCP, Warananagar Challenges in Dissolution testing
  10. 10.  Why calibration an issue for Dissolution testing  Calibration with tablets.  Environmental factor 7/29/2013TKCP, Warananagar Failure of performances evaluation of apparatus or product 10/20
  11. 11. Calibration an issue for dissolution testing 7/29/2013 11/20 TKCP, Warananagar
  12. 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 7/29/2013 12/20 TKCP, Warananagar In-vitro In-vivo correlation
  13. 13.  Temperature adjustment  pH  Rotating speed  Dissolution medium  Solubilising agent 7/29/2013TKCP, Warananagar Lack of objectivity in setting or selecting experimental conditions 13/20
  14. 14. 7/29/2013TKCP, Warananagar Modification of flow through cell 14/20
  15. 15. Case studies 7/29/2013 15/20 TKCP, Warananagar
  16. 16.  Use of enzymes in the dissolution testing of gelatin capsule  Liquid filled capsules  Dissolution of dietary supplement  Performance tests for semisolid drug products 7/29/2013 16/19 TKCP, Warananagar Challenges in Different dosage forms
  17. 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. 7/29/2013 17/20 TKCP, Warananagar Conclusion
  18. 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 7/29/2013 18/20 TKCP, Warananagar References TKCP, Warananagar
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