PMID- 25563817
OWN - NLM
STAT- MEDLINE
DCOM- 20160415
LR  - 20181113
IS  - 1530-9932 (Electronic)
IS  - 1530-9932 (Linking)
VI  - 16
IP  - 4
DP  - 2015 Aug
TI  - Application of quality by design (QbD) approach to ultrasonic atomization spray 
      coating of drug-eluting stents.
PG  - 811-23
LID - 10.1208/s12249-014-0266-9 [doi]
AB  - The drug coating process for coated drug-eluting stents (DES) has been identified 
      as a key source of inter- and intra-batch variability in drug elution rates. 
      Quality-by-design (QbD) principles were applied to gain an understanding of the 
      ultrasonic spray coating process of DES. Statistically based design of 
      experiments (DOE) were used to understand the relationship between ultrasonic 
      atomization spray coating parameters and dependent variables such as coating mass 
      ratio, roughness, drug solid state composite microstructure, and elution 
      kinetics. Defect-free DES coatings composed of 70% 85:15 
      poly(DL-lactide-co-glycolide) and 30% everolimus were fabricated with a constant 
      coating mass. The drug elution profile was characterized by a mathematical model 
      describing biphasic release kinetics. Model coefficients were analyzed as a DOE 
      response. Changes in ultrasonic coating processing conditions resulted in 
      substantial changes in roughness and elution kinetics. Based on the outcome from 
      the DOE study, a design space was defined in terms of the critical coating 
      process parameters resulting in optimum coating roughness and drug elution. This 
      QbD methodology can be useful to enhance the quality of coated DES.
FAU - McDermott, Martin
AU  - McDermott M
AD  - Division of Biology, Chemistry and Materials Science, Office of Science and 
      Engineering Laboratories, Center for Devices and Radiological Health, Food and 
      Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, 
      USA, Martin.McDermott@fda.hhs.gov.
FAU - Chatterjee, Sharmista
AU  - Chatterjee S
FAU - Hu, Xiaoli
AU  - Hu X
FAU - Ash-Shakoor, Ariel
AU  - Ash-Shakoor A
FAU - Avery, Reginald
AU  - Avery R
FAU - Belyaeva, Anastasiya
AU  - Belyaeva A
FAU - Cruz, Celia
AU  - Cruz C
FAU - Hughes, Minerva
AU  - Hughes M
FAU - Leadbetter, Joanne
AU  - Leadbetter J
FAU - Merkle, Conrad
AU  - Merkle C
FAU - Moot, Taylor
AU  - Moot T
FAU - Parvinian, Sepideh
AU  - Parvinian S
FAU - Patwardhan, Dinesh
AU  - Patwardhan D
FAU - Saylor, David
AU  - Saylor D
FAU - Tang, Nancy
AU  - Tang N
FAU - Zhang, Tina
AU  - Zhang T
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150107
PL  - United States
TA  - AAPS PharmSciTech
JT  - AAPS PharmSciTech
JID - 100960111
RN  - 34346-01-5 (Polyglactin 910)
RN  - 9HW64Q8G6G (Everolimus)
SB  - IM
MH  - Chromatography, High Pressure Liquid
MH  - *Drug-Eluting Stents
MH  - Everolimus/chemistry/pharmacokinetics
MH  - Microscopy, Atomic Force
MH  - Microscopy, Electron, Scanning
MH  - Polyglactin 910
MH  - Surface Properties
MH  - *Ultrasonics
PMC - PMC4508304
EDAT- 2015/01/08 06:00
MHDA- 2016/04/16 06:00
PMCR- 2016/01/07
CRDT- 2015/01/08 06:00
PHST- 2014/08/26 00:00 [received]
PHST- 2014/12/08 00:00 [accepted]
PHST- 2015/01/08 06:00 [entrez]
PHST- 2015/01/08 06:00 [pubmed]
PHST- 2016/04/16 06:00 [medline]
PHST- 2016/01/07 00:00 [pmc-release]
AID - 266 [pii]
AID - 10.1208/s12249-014-0266-9 [doi]
PST - ppublish
SO  - AAPS PharmSciTech. 2015 Aug;16(4):811-23. doi: 10.1208/s12249-014-0266-9. Epub 
      2015 Jan 7.