PMID- 29098869
OWN - NLM
STAT- MEDLINE
DCOM- 20180201
LR  - 20180201
IS  - 1520-5762 (Electronic)
IS  - 0363-9045 (Linking)
VI  - 44
IP  - 3
DP  - 2018 Mar
TI  - A step forward towards the development of stable freeze-dried liposomes: a 
      quality by design approach (QbD).
PG  - 385-397
LID - 10.1080/03639045.2017.1395457 [doi]
AB  - This study highlights the advantages of using a Quality by Design (QbD) approach 
      in order to gain a more comprehensive understanding of the freeze-drying process 
      of pravastatin-loaded long-circulating liposomes (LCL-PRAV). Within the QbD 
      paradigm, the present study aimed to establish the design space for the 
      optimization of freeze-dried LCL-PRAV by means of Design of Experiment (DOE). The 
      encapsulated solute retention (ESR), the average particle size, and zeta 
      potential after freeze-drying, the residual moisture content, the macroscopic 
      cake appearance, the glass transition temperature (T(g)) of the freeze-dried 
      cake, and the primary drying time were defined as critical quality attributes 
      (CQAs) for the freeze-dried final product. Further on, the influence of 
      lyoprotectant type, freezing rate, shelf temperature during primary drying, and 
      the presence of an annealing step on the CQAs was investigated through a 21-run 
      D-optimal experimental design. Three-dimensional response surfaces were generated 
      to complete the statistical analysis and for a better understanding of the 
      influence of variables and their interactions on the responses. The developed 
      model was then used to build the design space for the freeze-dried liposomes, 
      within which the product quality was assured and the process variability was 
      minimized.
FAU - Sylvester, Bianca
AU  - Sylvester B
AD  - a Department of Pharmaceutical Technology and Biopharmaceutics , University of 
      Medicine and Pharmacy 'Iuliu Hatieganu' , Cluj-Napoca , Romania.
FAU - Porfire, Alina
AU  - Porfire A
AD  - a Department of Pharmaceutical Technology and Biopharmaceutics , University of 
      Medicine and Pharmacy 'Iuliu Hatieganu' , Cluj-Napoca , Romania.
FAU - Achim, Marcela
AU  - Achim M
AD  - a Department of Pharmaceutical Technology and Biopharmaceutics , University of 
      Medicine and Pharmacy 'Iuliu Hatieganu' , Cluj-Napoca , Romania.
FAU - Rus, Lucia
AU  - Rus L
AD  - b Department of Drug Analysis , University of Medicine and Pharmacy 'Iuliu 
      Hatieganu', Cluj-Napoca , Romania.
FAU - Tomuta, Ioan
AU  - Tomuta I
AUID- ORCID: 0000-0002-5094-008X
AD  - a Department of Pharmaceutical Technology and Biopharmaceutics , University of 
      Medicine and Pharmacy 'Iuliu Hatieganu' , Cluj-Napoca , Romania.
LA  - eng
PT  - Journal Article
DEP - 20171108
PL  - England
TA  - Drug Dev Ind Pharm
JT  - Drug development and industrial pharmacy
JID - 7802620
RN  - 0 (Liposomes)
RN  - 0 (Solutions)
RN  - KXO2KT9N0G (Pravastatin)
SB  - IM
MH  - Chemistry, Pharmaceutical/methods
MH  - Desiccation/methods
MH  - Freeze Drying/methods
MH  - Freezing
MH  - Liposomes/*chemistry
MH  - Particle Size
MH  - Pravastatin/chemistry
MH  - Solutions/chemistry
MH  - Transition Temperature
OTO - NOTNLM
OT  - DoE
OT  - Freeze-drying
OT  - QbD
OT  - design space
OT  - liposomes
OT  - optimization
OT  - response surface methodology
EDAT- 2017/11/04 06:00
MHDA- 2018/02/02 06:00
CRDT- 2017/11/04 06:00
PHST- 2017/11/04 06:00 [pubmed]
PHST- 2018/02/02 06:00 [medline]
PHST- 2017/11/04 06:00 [entrez]
AID - 10.1080/03639045.2017.1395457 [doi]
PST - ppublish
SO  - Drug Dev Ind Pharm. 2018 Mar;44(3):385-397. doi: 10.1080/03639045.2017.1395457. 
      Epub 2017 Nov 8.