Poster No: A05

DEVELOPMENT AND EVALUATION OF SELF-MICROEMULSIFYING PELLET

FORMULATION OF POORLY WATER SOLUBLE GLICLAZIDE
Bhoomi Patel* , Niharika Pandey , Hetal Patel ,Sneha Patel
MALIBA PHARMACY COLLEGE , UKA TARSADIA UNIVERSITY , BARDOLI

INTRODUCTION METHOD OF PREPARATION

Gliclazide is a second generation hypoglycemic sulfonylurea which is Gliclazide and optimized liquid SMEDDS were mixed using a
useful in the treatment of non-insulin dependent diabetes mellitus magnetic stirrer until the solution was clear.
(NIDDM). Prior reports reveal that the drug shows good tolerability,
low incidence of hypoglycemia, and a low rate secondary failure.
Separately MCC was homogeneously mixed and pre-wetted with
STATEMENT OF PROBLEM distilled water.
▪Gliclazide exhibits slow GI absorption rate and inter-intra
individual variation of its bioavailability.
▪The slow absorption rate of drug originates from poor dissolution of The wetting was then completed by addition of liquid
drug from the formulation. gliclazide-SMEDDS leading to the formation of a wet mass.
AIM

To develop self micro emulsifying formulations of Gliclazide in liquid The wet mass then extruded through an extruder.
and pellets dosage forms.
PREFORMULATION STUDY
Solubility of Gliclazide Solubility of Gliclazide The extrudate was then spheronized on a frictional plate. The
(mg/ml) (mg/ml)
moist pellet was dried in an oven at 45 ± 2oC.
120 120
100 100
80
60 80 EVALUATION PARAMETERS OF OPTIMIZED SMEDDS
40 60 Solubility of
20 Solubility of
0 Gliclazide (mg/ml) 40 Gliclazide (mg/ml) EVALUATION PARAMETER RESULT
20
0
Poly dispersity index (PDI) 0.7
Tween 20 Tween 80
Avg. globule size (nm) 31.50
(a) (b)
Zeta potential (mV) 0.90
Solubility of Gliclazide Fig 1:(a) Gliclazide solubility in Assay (%)
(mg/ml) 100.9
oils
20
(b) Gliclazide solubility in pH 6.38
15
surfactant
10 Solubility of EVALUATION PARAMETERS OF SMEDDS LOADED
5
Gliclazide (mg/ml) (c) Gliclazide solubility in co-
PELLETS
0 surfactant
PEG PEG 400 PEG 600
(c) 1.Pellet size analysis
2. Micromeritics properties of pellets
PSEUDO TERNARY PHASE DIAGRAM 3. Friability 120
4. Angle of repose 100
Fig 2: Pseudo ternary phase 5. Assay
% Drug Release

80 Marketed
diagram showing 6. In-vitro drug release study 60
formulation
Gliclazide-
Microemulsion region Fig3 : % drug release of 40 SMEDSS pellet
containing surfactant:co- SMEDDS pellet and 20
surfactant ratio of 4:1 marketed formulation 0
5 10 15 20
Time (minutes)

FORMULATION OF SMEDDS CONCLUSION

Batch Oil(ml) Surfactant(ml) Co-surfactant
Concept of SMEDDS and S-SMEDDS has a strong potential to
M1 0.1 0.56 0.14 serve as a good platform for improvement of dissolution rate of
M2 0.15 0.44 0.11 gliclazide which may prove its bioavailability. The developed
M3 0.12 0.48 0.12 optimized formulation of gliclazide SMEDDS pellet can be a
M4 0.18 0.36 0.09
suitable approach for effective anti-diabetic therapy.
M5 0.05 0.29 0.14
M6 0.10 0.36 0.18 REFERENCE
M7 0.08 0.42 0.21
M8 0.06 0.29 0.14
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POSTER PRESENTED AT NATIONAL CONFERENCE ORGANIZED BY SUMANDEEP VIDHYALAYA, VADODARA ,2018