PMID- 31692384
OWN - NLM
STAT- MEDLINE
DCOM- 20200413
LR  - 20200413
IS  - 1520-5762 (Electronic)
IS  - 0363-9045 (Linking)
VI  - 45
IP  - 12
DP  - 2019 Dec
TI  - Optimization of gliclazide loaded alginate-gelatin beads employing central 
      composite design.
PG  - 1959-1972
LID - 10.1080/03639045.2019.1689992 [doi]
AB  - Objective: The aim of this study was to optimize the formulation of 
      alginate-gelatin (AL-GL) beads containing gliclazide (GLZ) employing design of 
      experiments (DOE).Significance: DOE enabled identification of the interaction 
      between the studied factors, deep understanding of GLZ release pattern and 
      acceleration of the optimization process.Methods: A three-factor, three-level 
      face centered design was employed. The effects of GLZ content (GLZ%, X(1)), 
      polymer ratio (AL:GL ratio, X(2)), crosslinker concentration (glutaraldehyde, 
      GA%, X(3)), and their interaction on incorporation efficiency (IE) and release 
      rate were studied. The optimized formulation was prepared using numerical 
      optimization and evaluated by DSC, FT-IR, SEM and release rate studies.Results: 
      Increasing GA% (X(3)) decreased IE (Y(1)) with the highest magnitude of effect 
      among the studied factors. On the other hand, increasing alginate content in 
      AL:GL ratio (X(2)) increased IE (Y(1)). The amount of GLZ released Q(0.5h), 
      Q(2h)(pH 1.2) and Q(4h)(pH 7.4) decreased by increasing GLZ% (X(1)) and AL:GL 
      ratio (X(2)). Both drug content and AL:GL ratio appeared to affect water 
      penetration into the gel matrix and drug release. Generally, there was a direct 
      relationship between GA% (X(3)) and GLZ release in pH 1.2 (Q(0.5h) and Q(2h)). 
      However, in pH 7.4 (Q(4h)), increasing GA% decreased GLZ release. In addition, 
      increasing GA% caused deviation from zero-order release model. The actual 
      responses of the optimized formulation were in close agreement with the predicted 
      ones.Conclusion: The selected factors and their levels studied in the 
      optimization design were useful for tailoring the anticipated formulation 
      characteristics and GLZ release pattern.
FAU - Elsayed, Ebtesam W
AU  - Elsayed EW
AUID- ORCID: 0000-0001-7991-8858
AD  - Medicinal and Pharmaceutical Chemistry Department, Pharmaceutical and Drug 
      Industries Research Division, National Research Centre, Giza, Egypt.
FAU - El-Ashmawy, Ahmed A
AU  - El-Ashmawy AA
AUID- ORCID: 0000-0001-7442-6133
AD  - Medicinal and Pharmaceutical Chemistry Department, Pharmaceutical and Drug 
      Industries Research Division, National Research Centre, Giza, Egypt.
FAU - Mursi, Nadia M
AU  - Mursi NM
AD  - Department of Pharmaceutics, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
FAU - Emara, Laila H
AU  - Emara LH
AUID- ORCID: 0000-0001-6166-2102
AD  - Medicinal and Pharmaceutical Chemistry Department, Pharmaceutical and Drug 
      Industries Research Division, National Research Centre, Giza, Egypt.
LA  - eng
PT  - Journal Article
DEP - 20191114
PL  - England
TA  - Drug Dev Ind Pharm
JT  - Drug development and industrial pharmacy
JID - 7802620
RN  - 0 (Alginates)
RN  - 0 (Cross-Linking Reagents)
RN  - 0 (Drug Carriers)
RN  - 9000-70-8 (Gelatin)
RN  - G4PX8C4HKV (Gliclazide)
SB  - IM
MH  - Alginates/chemistry
MH  - Calorimetry, Differential Scanning
MH  - Chemistry, Pharmaceutical/*methods
MH  - Cross-Linking Reagents/chemistry
MH  - Drug Carriers/*chemistry
MH  - Drug Liberation
MH  - Gelatin/chemistry
MH  - Gliclazide/administration & dosage/*pharmacokinetics
MH  - Hydrogen-Ion Concentration
MH  - Models, Chemical
MH  - Particle Size
MH  - Research Design
MH  - Solubility
MH  - Spectroscopy, Fourier Transform Infrared
OTO - NOTNLM
OT  - Design of experiment
OT  - Fourier transform infrared
OT  - differential scanning calorimetry
OT  - glutaraldehyde
OT  - multiparticulate delivery systems
OT  - natural biodegradable polymer
OT  - response surface methodology
OT  - scanning electron microscope
EDAT- 2019/11/07 06:00
MHDA- 2020/04/14 06:00
CRDT- 2019/11/07 06:00
PHST- 2019/11/07 06:00 [pubmed]
PHST- 2020/04/14 06:00 [medline]
PHST- 2019/11/07 06:00 [entrez]
AID - 10.1080/03639045.2019.1689992 [doi]
PST - ppublish
SO  - Drug Dev Ind Pharm. 2019 Dec;45(12):1959-1972. doi: 
      10.1080/03639045.2019.1689992. Epub 2019 Nov 14.