Linking dissolution to disintegration in immediate release tablets using image analysis and a population balance modelling approach

Pharmaceutical Research

Volumn 29, Issue 1, 2012, Pages 198-208

  Wilson, David ^a   Wren, Stephen ^a   Reynolds, Gavin ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

Disintegration time; Dissolution; Population balancing

Indexed keywords

ARTICLE; COMPUTER MODEL; CONTROLLED STUDY; DRUG SOLUBILITY; IMAGE ANALYSIS; IN VITRO STUDY; MATHEMATICAL MODEL; MOLECULAR IMAGING; PARTICLE SIZE; PRIORITY JOURNAL; PROCESS DEVELOPMENT; TABLET DISINTEGRATION TIME; TABLET FORMULATION; TIMED DRUG RELEASE; CHEMICAL MODEL; CHEMISTRY; HARDNESS; IMAGE PROCESSING; METHODOLOGY; PHARMACEUTICS; SOLUBILITY; SOLUTION AND SOLUBILITY; TABLET;

EXCIPIENT;

EXCIPIENTS; HARDNESS; IMAGE PROCESSING, COMPUTER-ASSISTED; MODELS, CHEMICAL; PARTICLE SIZE; SOLUBILITY; SOLUTIONS; TABLETS; TECHNOLOGY, PHARMACEUTICAL;

EID: 84860596454     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-011-0535-1     Document Type: Article

References (17)

1. Tong C, D'Souza S, Parker J, Mirza T. Commentary on AAPS Workshop. Pharm Res. 2007;24:1603-7.
2. Azarmi S, Roa W, Löbenberg R. Current perspectives in dissolution testing of conventional and novel dosage forms. Int J Pharm. 2007;328:12-21. (Pubitemid 44827563)
3. Donauer N, Löbenberg R. A mini review of scientific and pharmacopeial requirements for the disintegration test. Int J Pharm. 2007;345:2-8. (Pubitemid 350087551)
4. Liu J, Stewart PJ. Deaggregation during the dissolution of benzodiazepines in interactive mixtures. J Pharm Sci. 1998;87:1632-8. (Pubitemid 28559654)
5. Stewart PJ, Zhao F. Understanding agglomeration of indomethacin during the dissolution of micronised indomethacin mixtures through dissolution and de-agglomeration modeling approaches. Eur J Pharm Biopharm. 2005;59:315-23. (Pubitemid 40127589)
6. Zhao F, Stewart PJ. De-agglomeration of micronized benzodiazepines in dissolution media measured by laser diffraction particle sizing. J Pharm Pharmacol. 2003;55:749-55. (Pubitemid 36752718)
7. Coutant CA, Skibic MJ, Doddridge GD, Kemp CA, Sperry DC. In Vitro Monitoring of Dissolution of an Immediate Release Tablet by Focused Beam Reflectance Measurement. Mol Pharmaceut. 2010;7:1508-15.
8. Tajarobi F, Abrahmsén-Alami S, Hansen M, Larsson A. The Impact of Dose and Solubility of Additives on the Release from HPMC Matrix Tablets-Identifying Critical Conditions. Pharm Res. 2009;26:1496-503.
9. Laitinen R, Lahtinen J, Silfsten P, Vartiainen E, Jarho P, Ketolainen J. An optical method for continuous monitoring of the dissolution rate of pharmaceutical powders. J Pharm Biomed Anal. 2010;52:181-9.
10. Chew JW, Chow PS, Tan RBH. Automated In-line Technique Using FBRM to Achieve Consistent Product Quality in Cooling Crystallization. Cryst Growth Des. 2007;7:1416.
11. Hermanto MW, Chow PS, Tan RBH. Implementation of Focused Beam Reflectance Measurement (FBRM) in Antisolvent Crystallization to Achieve Consistent Product Quality. Cryst Growth Des. 2010;10:3668-74.
12. Huang J, Kaul G, Utz J, Hernandez P, Wong V, Bradley D, et al. A PAT approach to improve process understanding of high shear wet granulation through in-line particle measurement using FBRM C35. J Pharm Sci. 2010;99:3205-12.
13. Ho R, Wilson DA, Heng JYY. Crystal Habits and the variation in surface energy heterogeneity. Cryst Growth Des. 2009;9:4907-11.
14. Sandler N, Wilson D. Prediction of granule packing and flow behavior based on particle size and shape analysis. J Pharm Sci. 2010;99:958-68.
15. USP 28 Physical Tests/ <701>Disintegration. United States Pharmacopeia.
16. Randolph AD, Larson MA. Theory of Particulate Processes. Burlington: Academic Press Inc; 1971.
17. Gelbard F, Seinfeld JH. Numerical solution of the dynamic equation for particulate systems. J Comp Phys. 1978;28:357-75.