PMID- 28831818
OWN - NLM
STAT- MEDLINE
DCOM- 20180111
LR  - 20220331
IS  - 1520-5762 (Electronic)
IS  - 0363-9045 (Linking)
VI  - 44
IP  - 1
DP  - 2018 Jan
TI  - Clinical pharmacokinetic study for the effect of glimepiride matrix tablets 
      developed by quality by design concept.
PG  - 66-81
LID - 10.1080/03639045.2017.1371740 [doi]
AB  - OBJECTIVE: Implementation of a new pharmaceutical technique to improve aqueous 
      solubility and thus dissolution, enhancement of drug permeation, and finally 
      formulation of a controlled release tablet loaded with glimepiride (GLMP). 
      SIGNIFICANCE: Improve GLMP bioavailability and pharmacokinetics in type II 
      diabetic patients. METHODS: Different polymers were used to enhance aqueous GLMP 
      solubility of which a saturated polymeric drug solution was prepared and 
      physically adsorbed onto silica. An experimental design was employed to optimize 
      the formulation parameters affecting the preparation of GLMP matrix tablets. A 
      compatibility study was conducted to study components interactions. Scanning 
      electron microscope (SEM) was performed before and after the tablets were placed 
      in the dissolution medium. An in vivo study in human volunteers was performed 
      with the optimized GLMP tablets, which were compared to pure and marketed drug 
      products. RESULTS: Enhancement of GLMP aqueous solubility, using the polymeric 
      drug solution technique, by more than 6-7 times when compared with the binary 
      system. All the studied formulation factors significantly affected the studied 
      variables. No significant interaction was detected among components. SEM 
      illustrated the surface and inner tablet structure, and confirmed the drug 
      release which was attributed to diffusion mechanism. The volunteer group 
      administered the optimized GLMP tablet exhibited higher drug plasma concentration 
      (147.4 ng/mL), longer time to reach maximum plasma concentration (4 h) and longer 
      t(1/2) (7.236 h) compared to other groups. CONCLUSIONS: Matrix tablet loaded with 
      a physically modified drug form could represent a key solution for drugs with 
      inconsistent dissolution and absorption profiles.
FAU - Ahmed, Tarek A
AU  - Ahmed TA
AD  - a Department of Pharmaceutics, Faculty of Pharmacy , King Abdulaziz University , 
      Jeddah , Kingdom of Saudi Arabia.
AD  - b Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , 
      Al-Azhar University , Cairo , Egypt.
FAU - Suhail, Mohammad A A
AU  - Suhail MAA
AD  - a Department of Pharmaceutics, Faculty of Pharmacy , King Abdulaziz University , 
      Jeddah , Kingdom of Saudi Arabia.
FAU - Hosny, Khaled M
AU  - Hosny KM
AD  - a Department of Pharmaceutics, Faculty of Pharmacy , King Abdulaziz University , 
      Jeddah , Kingdom of Saudi Arabia.
AD  - c Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , Beni 
      Suef University , Beni Suef , Egypt.
FAU - Abd-Allah, Fathy I
AU  - Abd-Allah FI
AD  - b Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , 
      Al-Azhar University , Cairo , Egypt.
LA  - eng
PT  - Journal Article
DEP - 20170911
PL  - England
TA  - Drug Dev Ind Pharm
JT  - Drug development and industrial pharmacy
JID - 7802620
RN  - 0 (Polymers)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (Tablets)
RN  - 6KY687524K (glimepiride)
SB  - IM
MH  - Biological Availability
MH  - Chemistry, Pharmaceutical/*methods
MH  - Polymers/*chemistry
MH  - Solubility
MH  - Sulfonylurea Compounds/chemistry/*pharmacokinetics
MH  - Tablets
OTO - NOTNLM
OT  - Glimepiride
OT  - clinical study
OT  - matrix tablet
OT  - nano-sized silica
OT  - quality by design
EDAT- 2017/08/24 06:00
MHDA- 2018/01/13 06:00
CRDT- 2017/08/24 06:00
PHST- 2017/08/24 06:00 [pubmed]
PHST- 2018/01/13 06:00 [medline]
PHST- 2017/08/24 06:00 [entrez]
AID - 10.1080/03639045.2017.1371740 [doi]
PST - ppublish
SO  - Drug Dev Ind Pharm. 2018 Jan;44(1):66-81. doi: 10.1080/03639045.2017.1371740. 
      Epub 2017 Sep 11.