PMID- 19165579
OWN - NLM
STAT- MEDLINE
DCOM- 20090803
LR  - 20211020
IS  - 1573-904X (Electronic)
IS  - 0724-8741 (Linking)
VI  - 26
IP  - 6
DP  - 2009 Jun
TI  - The science of USP 1 and 2 dissolution: present challenges and future relevance.
PG  - 1289-302
LID - 10.1007/s11095-008-9822-x [doi]
AB  - Since its inception, the dissolution test has come under increasing levels of 
      scrutiny regarding its relevance, especially to the correlation of results to 
      levels of drug in blood. The technique is discussed, limited to solid oral dosage 
      forms, beginning with the scientific origins of the dissolution test, followed by 
      a discussion of the roles of dissolution in product development, consistent batch 
      manufacture (QC release), and stability testing. The ultimate role of dissolution 
      testing, "to have the results correlated to in vivo results or in vivo in vitro 
      correlation," is reviewed. The recent debate on mechanical calibration versus 
      performance testing using USP calibrator tablets is presented, followed by a 
      discussion of variability and hydrodynamics of USP Apparatus 1 and Apparatus 2. 
      Finally, the future of dissolution testing is discussed in terms of new 
      initiatives in the industry such as quality by design (QbD), process analytical 
      technology (PAT), and design of experiments (DOE).
FAU - Gray, Vivian
AU  - Gray V
AD  - V. A. Gray Consulting, Inc., 9 Yorkridge Trail, Hockessin, DE 19707, USA. 
      vagray@rcn.com
FAU - Kelly, Gregg
AU  - Kelly G
FAU - Xia, Min
AU  - Xia M
FAU - Butler, Chris
AU  - Butler C
FAU - Thomas, Saji
AU  - Thomas S
FAU - Mayock, Stephen
AU  - Mayock S
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20090123
PL  - United States
TA  - Pharm Res
JT  - Pharmaceutical research
JID - 8406521
RN  - 0 (Tablets)
SB  - IM
MH  - Calibration
MH  - Chemistry, Pharmaceutical/*instrumentation/methods/trends
MH  - Quality Control
MH  - Solubility
MH  - Tablets/*chemistry
MH  - United States
RF  - 135
EDAT- 2009/01/24 09:00
MHDA- 2009/08/04 09:00
CRDT- 2009/01/24 09:00
PHST- 2008/09/04 00:00 [received]
PHST- 2008/12/24 00:00 [accepted]
PHST- 2009/01/24 09:00 [entrez]
PHST- 2009/01/24 09:00 [pubmed]
PHST- 2009/08/04 09:00 [medline]
AID - 10.1007/s11095-008-9822-x [doi]
PST - ppublish
SO  - Pharm Res. 2009 Jun;26(6):1289-302. doi: 10.1007/s11095-008-9822-x. Epub 2009 Jan 
      23.