PRESENTED BY

M.KINNERA (153H1R0046)
M.JANAKI RAM (153H1R0047)
M.RATNA BHAVANI (153H1R0048)

M.V.S.MANVITHA (153H1R0049)

N.SAI MONOHAR (153H1R0050)

N.LALITHAA SRI (153H1R0051)

UNDER THE SUPERVISION OF

CH.SIVA RAMESH M.Pharm.
Asso.professor
ACOP
Aim and objectives
Introduction
Selection of drug
Drug profile
Polymers used
Literature review
Method of preparation
Evaluation of Solid Dispersions
Results and discussion
Conclusion
References
To Design And Carry Out In Vitro Evaluation Solid
Dispersions Of Glimepiride For Dissolution Rate
Enhancement by using different hydrophilic polymers.
OBJECTIVES
 To formulate solid dispersions of Glimepiride using
hydrophilic carriers in different concentrations and to
determine their effect on solubility of drug.
To prepare physical mixtures & solid dispersions by solvent
evaporation method
To characterize & evaluate the prepared solid dispersions.
To carry out the in-vitro dissolution studies of prepared
solid dispersions.
Solubility is defined as the spontaneous interaction of two
or more substances to form a homogenous molecular
dispersion.
Poorly water-soluble drug with slow drug absorption leads
eventually to inadequate and variable bioavailability
A number of methodologies can be adapted to improve
solubilization of poor water soluble drug and further to
improve its bioavailability.
SOLID DISPERSION – METHODS OF PREPARATION:
•Melting method Solvent evaporation method
•Melting solvent method Melt extrusion methods
• Lyophilization techniques
Glimepiride has been selected as the test drug
 Glimepiride is a BCS Class II drug having low aqueous
solubility and high membrane permeability
 Bioavilability of the drug is low (25%) due to poor
aqueous solubility.
 Glimepiride solid dispersions were prepared to enhance
solubility of drug and there by enhancing bioavailability.
DRUG PROFILE
Solubility: It is insoluble in water, freely soluble in alcohol
Half life :4-5 hrs
Use: treatment of type II diabetes mellitus .
POLYMERS USED: urea and PEG 4000
CALIBRATION CURVE
Calibration curve of Glimepiride was constructed in
6.8 phosphate buffer. The λmax was found to be at 226
nm. It obeys Beer’s law in the range of 10-50 μg/ml.

S.No Concentration (μg/ml) Absorbance

1.2
1 y = 0.0188x + 0.0521
R² = 0.9973

Absorbance
1 10 0.232
0.8

2 20 0.421 0.6
0.4
3 30 0.643
0.2
4 40 0.802 0
0 20 40 60
5 50 0.981 Concentration (µg/ml)
Preparation of Physical mixtures
Prepared by mixing accurate weight of drug with carrier in
different proportions i.e, 1:1, 1:2, (drug:carrier) and triturated
in glass mortar and pestle for 30 minutes and then passed
through 60 mesh sieve size.
Solvent Evaporation Method
Urea and PEG 4000 in proportions viz. 1:1, 1:2
(Drug:Carrier)

Methanol was added to the mixture of drug and carrier

and triturated in dry mortar until the solvent is
evaporated

Dispersions were pulverized in mortar and pestle and

passed through a sieve no 60
S.no Formulation Composition Drug : Polymer
1 PMU1 Glimepiride +Urea 1:1
2 PMU2 Glimepiride +Urea 1:2
3 PMP1 Glimepiride PEG 4000 1:1
4 PMP2 Glimepiride +PEG 4000 1:2
5 SDU1 Glimepiride +Urea 1:1
6 SDU2 Glimepiride Urea 1:2
7 SDP1 Glimepiride +PEG 4000 1:1
8 SDP2 Glimepiride +PEG 4000 1:2
1 • Flow properties

2 • Drug content

3 • Solubility studies

4 • Drug release studies

5 • Drug release kinetics

6 • Stability studies
 Sample Carr’s index Hausner’s ratio Angle of repose(°)
Pure drug 38.37 1.62 45
PMU1 14.94 1.176 27.09
PMU2 15.69 1.186 26.52
PMP1 14.76 1.173 26.47
PMP2 15.19 1.179 27.31
SDU1 15.22 1.179 30.03
SDU2 14.20 1.165 29.56
SDP1 14.29 1.166 26.56
SDP2 14.10 1.164 24.54
Sample Drug content
Pure drug 100
PMU1 97.3
PMU2 99.4
PMP1 98.6
PMP2 99.2
SDU1 98.3
SDU2 98.7
SDP1 98.9
SDP2 100
USP type II Dissolution Testing Apparatus (LABINDIA )
 Dissolution medium - phosphate buffer pH 6.8
Volume – 900ml
 RPM – 50 , Temperature - 37 ̊C±0.5 ̊C
Sampling intervels-5,10,15,20,30,45,60
Sample volume:5ml withdrawn at fixed time intervals &
replaced with 5ml of pH 6.8 phosphate buffer.