Sekolah Tinggi Farmasi Indonesia 2017/ 2018

THERMAL ANALYSIS SOLID DISPERSION OF IRBESARTAN WITH

POLIVYNIL PYROLIDON (PVP) K-30 AND CONNECTION WITH SOLUTION
AND DISOLUTION
Salman Umar1 Fifi Harmely2 dan Aulia Hayati Syafnur
1
Sekolah Tinggi Farmasi Indonesia Yayasan Perintis Padang

ABSTRACT

A thermal analysis of solid dispersion of irbesartan with polyvinylpyrrolidone

K-30 and its relation to solubility and dissolution have been performed. Irbesartan is an
antihypertensive drug of the angiotensin receptor blocker group. The irrants solid
dispersion was prepared by using a PVP K-30 carrier with a dissolution method
prepared in three ratios Irbesartan: PVP K-30 that is F1 (1: 0,5), F2 (1: 1) and F3 (1: 3).
The three formulas are tested, they are thermal analysis, solubility test and dissolution
test. Based on the characterization of physics using DTA instrument shows the decrease
of melting point and decrease of energy marked by the formation of endothermic peak
of irbesartan. Based on the solubility test results obtained on the formula F1, F2, F3
have increased the level with the change of solubility classification from practically
insoluble to very soluble in F3 and the dissolution test of formula F3 has the highest
dissolution efficiency value indicated by solid dispersion F3 that is 72,65%. From the
data obtained the relationship between thermal analysis with solubility and dissolution.
The more ΔH decreases the heat, the more solubility and dissolution of the solid
dispersion of irbesartan-PVP K-30. Based on ANOVA one way statistical analysis there
were significant differences in solubility test, dissolution test and dissolution efficiency
at (P <0,005).

Keywords : Thermal analysis, Solubility, Dissolution, Solid Dispersion, Irbesartan and PVP
K-30

INTRODUCTION Irbesartan is one of the antihypertensive

Irbesartan is an angiotensin II
receptor antagonist (Angiotensin II
receptor antagonist / ARB) used in the
treatment of hypertensive diseases. In
general, angiotensin II receptor
antagonists such as irbesartan bind to
angiotensin II type 1 (AT1) receptor with
high affinity which causes inhibition of
angiotensin II action in smooth muscle of
blood vessels, thus causing a decrease in
arterial blood pressure (Sweetman, 2009).
The availability of pharmaceuticals
is related to the Biopharmaceutics
Classification System (BCS), most of
which are classified into BCS class II.
drugs belonging to BCS II
(Biopharmaceutical Classification System
II) with low solubility but high
permeability. Drugs with low solubility
but high permeability often exhibit low
gastrointestinal absorption due to poor
drug solubility in gastrointestinal fluids
resulting in low oral bioavailability of the
oral drug (Kumar, et al., 2011).
According to BCS the drug is considered
to be highly soluble when the rate of
absorption in humans is over 90% of the
given dose (Chawla & Bansal, 2007).
Various approaches are being made
to increase the solubility and speed of

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 Sekolah Tinggi Farmasi Indonesia 2017/ 2018
drug dissolution, one of which is the most
practical solid dispersion technology to
improve the solubility of insoluble drugs.
The solid dispersion is a dispersion
system comprising one or more active
substances dispersed in a solid state on a
carrier. The solid dispersion is obtained
by melting, dissolving and by means of a
combined method of melting and dilution
(Fudholi, 2013).
During the process of solid
dispersion formation it is possible to
change the properties and parameters of
both physical and chemical preparations,
causing differences in properties between
irbesartan and polyvinylpyrrolidone. The
differences in properties and parameters
may include differences in solubility,
particle size, melting point and
decomposition. Some differences in
properties and parameters can be
thermally analyzed (Purnawan et al.,
2008).
To know the thermal properties of a
material required a method of
measurement called thermal analysis.
Thermal analysis can be defined as a
measurement of the physical properties of
a material that is a function of
temperature. This analysis can determine
specific properties such as enthalpy, heat
capacity, and material thermal
coefficients (Dodd et al., 1987).
One of the techniques for thermal
analysis is Differential Thermal Analysis
(DTA) and Differential Scanning
Calorimetry (DSC). Differential Thermal
Analysis is a thermal analysis that works
according to temperature changes. That is
by comparing the temperature between
the reference material and the sample
material. The sample temperature and the
referent will always remain the same until
some thermal event occurs such as
melting, decomposing or altering the
crystal structure of the sample. Both
temperature differences continue to be
detected and recorded as a curve peak.
Page 2
The temperature of the sample may be
below (if the change is endothermic) or
above (if the change is exothermic) the
reference temperature (Grega Klančnik,
2010).
DSC and DTA analyzes are
typically used to study phase transitions,
such as melting, glass transition
temperature (Tg), or exothermic
decomposition, as well as analyzing the
stability of oxidation, the heat capacity of
a material, and changes in the envelope of
the material (Yang & Wolcott, 2005).
Solubility is one of the
physicochemical properties of drug
compounds that are important in
predicting the degree of absorption of
drugs in the gastrointestinal tract. Drugs
that have poor soluble drugs often show
low bioavailability and dissolution rate is
the rate limting step in the drug
absorption process (Shargel & Yu, 1999).
In general, water soluble drugs (poorly
soluble drugs) are a challenge in the
pharmaceutical industry (Ansel, 1989).
Dissolution is the process of
dissolving an active substance or drug in
a dissolution medium where its velocity
is affected by the surface area of the
active substance particles, the particle
size, the dosage form, and the auxiliary
materials used (Banakar 1991). The rate
of dissolution is the number of dissolved
drugs of time union. Drugs given in solid
dosage form should be soluble in the
gastrointestinal tract before absorption
into the blood circulation to the receptor
and will provide the desired therapeutic
effect (Abdou, 1989).
Based on the above, the present
study will analyze an existing formula
that is practically insoluble in water,
soluble in ethanol using a hydrophilized
polyvinyl pyrrolidone (PVP) K-30 in the
form of solid dispersion by a method
dissolution. Interaction results were
characterized using thermal analysis,
 Sekolah Tinggi Farmasi Indonesia 2017/ 2018
solubility and dissolution
determination.
METHODOLOGY
Tools
The tools used in this research are
laboratory standard equipments, digital
analytical scales (Adventurer OHAUS),
desiccator, vacuum oven (DAIHAN
Scientific), sieve (The Tyler Standard
Screen Scale), Differential Thermal
Analysis (Shimadzu TG 60,
Simultaneous DTA -TG Apparatus),
Orbital Shaker (VRN-480 GEMMY Orbit
Shaker), UV-Vis Spectrophotometer
(SHIMADZU UV-1700 Pharma Spec),
capillary tubes and dissolution test kits
(Hanson SR8PLUS).
Material
Pure powder (Dr.Reddy's), Polyvinyl
Pirolidon (PVP) K-30 (Nanhang
Industrial Co., Ltd), Ethanol 96% (CV
Akamasada), HCl 0.1 N, Aqua Bidestilata
(Novalindo CV), Aquades ( CV
Novalindo) and Whatman no.42 filter
paper.
Research procedure
Preparation of Physical Mixture
Irbesartan - Polivinilpirolidon K-30
Table 1. Comparison of Physical Mixture
Formulas Irbesartan - Polivinil
Pirolidon K-30
Material Comparison
Irbesartan
polivinil pirolidon K-30
The physical mixture of irbesartan -
polyvinyl pyrrolidone K-30 was crushed
with mortar for 15 min until
homogeneous, then passed to a mesh
sieve 60 and stored in a desiccator.
. a constant rate. Irbesartan thermogram,
profile Making of Irbesartan Solid Dispersion
- Polivinil Pirolidon K-30 (Novinda,
2016)
Table2.Comparison of Powdered
Soybean DispersionFormulation
Irbesartan- Polivinil Pirolidon K-
30
No Material F1 F2 F3
1. Irbesartan 1 1 1
2. Polivinil Pirolidon 0,5 1 3
The solid dispersion of irbesartan -
polyvinyl pyrrolidone K-30 is prepared
by dissolution method. Weigh each
material according to the composition.
The irrantsartan powder - polyvinyl
pyrrolidone K-30 was each diluted with
ethanol p.a. until a clear solution is
formed. To the solution of irbesartan, the
solution of polyvinyl pyrrolidone K-30 is
added slowly while stirring. The resulting
solution is then evaporated and dried in a
vacuum oven at a temperature of 40 ° C
to 50 ° C to dry. The resulting solid is
scraped and crushed and then passed to a
mesh screen of 60 and stored in the
desiccator.
Determination of Differential
Thermal Analysis (DTA) Analysis of
Irbesartan, PVP, Physical mixture and
Solid Dispersion
The thermal analysis test of the
sample is done by using DTA tool. A 5-
1
10 mg sample is placed on an aluminum
1
pan. The DTA device is programmed in a
heating temperature range from 30- 500 °
C with a heating rate of 10 ° C per
minute. In DTA heat is absorbed or
emitted by chemical systems of materials
performed by inert comparators
(Alumina, Silicon, Carbide or glass
beads) and both temperatures are added at
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 Sekolah Tinggi Farmasi Indonesia 2017/ 2018
PVP and solid dispersion irbesartan -
PVP is measured as a function of
temperature (Gennaro, 1985).
Determination of Solubility Test
The solubility test was performed on
the physical mixture of irbesartan-PVP
K-30, solid dispersion F1, F2, and F3.
The physical mixture, solid dispersions
F1, F2, and F3 were weighed as much as
50 mg then into a 100 mL erlemeyer,
then add aqua bidestylata ad 100 mL.
This test is done for 6 hours using orbital
shaker tool. After that the sample was
filtered using Whatman filter paper
no.24. The filtrate solution was taken 2
mL then diluted into a 10 mL measuring
flask. Then measure the level using UV-
Vis spectrophotometer using maximum
absorption wavelength.
Determination of Irbesartan Retrieval
Level (Novinda, 2016)
a. Determination of the maximum
absorption wavelength of irbesartan
in 0.1 N HCl.
A total of 50 mg irbesartan is
weighed inserted in a 100 mL measuring
flask, add a bit of 96% stirring ethanol
until dissolved then simply volume up to
the limit marker with 0.1 N HCl. From
the mother liquor, dipipet 0.8 mL insert
into a 50 mL measuring flask is sufficient
volume up to the limit marker with 0.1 N
HCl. Furthermore, the maximum
absorption wavelength was measured
using UV-Vis spectrophotometers at
wavelength range 200-400 nm.
b. Making irbesartan calibration curve
Dilutions of the 500 μg / mL
irrantsartan parent solution in 0.1N HCl
each with a concentration of 8, 10, 12, 14,
16 μg / mL in a 25 mL measuring flask
were performed. Each solution was
measured uptake at maximum absorption
wavelength by using a UV
spectrophotometer. Create a calibration
Page 4
curve (the relationship between
concentration and absorption).
c. Determination of levels of irradiant
recovery in physical mixture and
solid dispersion
Weighed Physical Mixture, F1, F2
and F3 equivalent to 150 mg irbesartan ie
300 mg CF, 225 mg F1, 300 mg F2 and
600 mg F3. Then dissolve with 0.1 N HCl
in a 100 mL measuring flask until the
boundary marks. Then pipette 0.5 mL
then put in a 50 mL measuring flask,
simply volume up to the limit mark with
0.1 N HCl. Measure uptake at maximum
absorption wavelength. The concentration
of irbesartan in the powder is determined
using the calibration curve and calculate
the level of each formula and determine
the percent of recovery gain.
Determination of Dissolution Profile of
Physical Mixture and Solid Dispersion
Irbesartan-Polyvinyl Pyrrolidone K-30
Determination of irbesartan
dissolution profile based on Farmakope
Indonesia V was done using method 2
with paddle. The container is filled with
water and the temperature is set to 37 ° C.
The flask was filled with 1000 mL of
HCL 0.1 N medium at a speed of 50 rpm,
then the physical mixture of irrantsartan-
polyvinylpyrrolidone K-30 and solid
dispersion F1, F2 and F3 were weighed
equivalent to 150 mg irbesartan and then
inserted into the capsule. The capsule is
inserted into a rowing container and
rotated. The dissolution solution is plated
5 mL at 5, 10, 15, 30, 45, and 60 minutes.
In each piping it is replaced with medium
of dissolution medium (same volume and
temperature at the time of insertion).
Each of the dipped liquid samples is then
fed into a 25 mL measuring flask and it is
sufficient until the boundary marks, then
the absorption is measured at the
maximum absorption wavelength
obtained (Departemen Kesehatan RI,
2014).
 Sekolah Tinggi Farmasi Indonesia 2017/ 2018
RESULTS AND DISCUSSION
In this research, firstly, the
manufacture of physical mixture and
solid dispersion powder. The physical
mixture is a mixture of two or more
solids prepared by grinding the material
up homogeneously. This physical mixture
was made by mixing irrants and
polyvinylpyrrolidine K-30 with a ratio of
1: 1 then crushed to homogeneous.
The solid dispersion powder is
prepared in 3 formulas in the ratio of each
of the respective formulas 1: 0.5; 1: 1 and
1: 3 using the dissolution method. The
solvent used is ethanol p.a. wherein each
irbesartan and a polyvinylpyrrolidone K-
30 were dissolved with ethanol p.a.
separately in a beakerglass until a clear
solution is formed. The K-30
polyvinylpyrrolidone solution is added to
the irrational solution slowly while
stirring. The solution mixture is
evaporated and dried in the vacuum oven
at 40 ° C-50 ° C to dry. The solid
obtained is scraped and crushed, then
passed to a mesh screen of 60 and stored
in the desiccator. Then the physical
mixture and solid dispersion formulas
that have been formed are evaluated to
see the nature and character of the solids.
Evaluation includes thermal analysis,
solubility, determination of irradiant
recovery rate and dissolution test.
First evaluates the thermal analysis
test of the physical mixture and solid
dispersion formulas F1, F2 and F3 using
DTA-TG tools. Differential Thermal
Analysis Analysis (DTA) is used to
evaluate the change in thermodynamic
properties occurring at a given sample of
heat energy, indicated by an endothermic
or exothermic peak on a DTA
thermogram. Where on the endothermic
occurrence of heat absorption is
characterized by a decrease in
temperature whereas in the exothermic
occurrence of heat release characterized
Page 5
by a rise in temperature during the
reaction took place.
The thermal change of interaction
between the physical mixture and the
solid dispersion of Irbesartan and PVP K-
30 is shown in Appendix 6. According to
Pharmacopeia Indonesia Edition V,
Irbesartan has a melting distance between
180°C-181°C,while polyvinylpyrrolidone
has a melting range of 150 ºC. In
irbesartan and PVP K-30 which have
been made in the form of solid dispersion
with various comparisons a slight
decrease of melting point from the
melting point of irbesartan.
From the results of irregular amber
DTAs requiring heat of -10.37 kJ / g to
melt at a temperature of 191.52 ° C,
whereas in the K-30 PVP it melts at
102.49 ° C with a heat flow of -44 , 32 kJ
/ g. Then on the physical mixture formed
endothermic peak at 105.73 ° C with a
heat flow of -5.52 kJ / g. In irbesartan and
PVP K-30 which have been made in the
form of solid dispersion with various
comparisons experienced a slight
decrease of melting point from the
melting point of irbesartan.
In solid dispersion F1 forms an
endothermic peak at a temperature of
185.80 ° C with a heat flow of -2.15 kJ /
g. For solid dispersion F2 also forms an
endothermic peak at 176.15 ° C with a
heat flow of -1.67 kJ / g. As well as on
solid dispersion F3 formed endothermic
peak at a temperature of 95.23 ° C with a
heat flow of -28.88 kJ / g. From the data
obtained the heat flow on solid dispersion
F3 is greater than other solid dispersion
formulas this may be due to the formula
F3 there has been a merging of irbesartan
with PVP so that the peak obtained wider
and melting temperature closer to the
melting temperature in PVP.
In the data thermogram of the solid
dispersion preparation there are formed
several other peaks such as exothermic,
this is due to the process of heat release
 Sekolah Tinggi Farmasi Indonesia 2017/ 2018

DTA
in the preparation marked by the uV
100
occurrence of temperature rise during
reaction.
Thus, in the solid dispersion 0
produced by various comparisons, the
presence of wide peaks at temperatures
-100
between 95.23 ° C to 176.15 ° C. In
general, from this DTA data it can be 100 200 300 400 500
seen that the PVP K-30 component in the Temperatur °C
solid dispersion system affects the
endothermic peak position and the Figure 3. Physical Mixed Thermogram
endothermic peak sharpness. The more (1: 1)
DTA
PVP K-30 is used, the endothermic peak uV

shifts to a lower melting point. This 100

indicates that there is a physical

interaction between the dispersed drug 0
(irbesartan) in the PVP carrier K-30. This
possibility is also based on studies found
-100
in the study of glycosidic solid dispersion
systems using polyvinyl pyrrolidone K- 100 200 300 400 500

30 (PVP K-30) and tween 80 (Halim et Temperatur °C

al., 2011).
Figure 4. Thermogram F1 (1: 0.5)
Figure Thermogram DTA
DTA
uV
DTA
100 uV

100

0
0

-100
-100

-200
100 200 300 400 500 -200
100 200 300 400 500

Temperatur °C Temperatur °C

Figure 1. Pure Irbesartan Thermogram Figure 5. Thermogram F2 (1:1)

DTA
DTA uV
uV

0
0

-100

-100
-200

-300 -200
100 200 300 400 500 100 200 300 400 500
Temperatur °C
Temperatur °C

Figure 2. Pure PVP Thermogram Figure 6. Thermogram F3 (1:3)

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 Sekolah Tinggi Farmasi Indonesia 2017/ 2018

Determination of solubility, the amount of soluble irbesartan, ie from

dissolution and recovery rate begins with
determination of the maximum
absorption wavelength of irbesartan in
HCL medium 0,1 N and in aquabidest
media. Based on the result of
determination of the maximum
absorption wavelength of irbesartan, on
0.1 N HCl medium obtained maximum
absorption wavelength of 245.8 nm;
while in aquabidest media obtained
maximum absorption wavelength of 209
nm. This is very different from the
maximum absorption wavelength of
irbesartan in 0.1 N HCl. Due to the
considerable difference, we used the
maximum absorption wavelength of
5.129 mg, 7.935 mg, 8.585 mg and
10.591 mg. In F3, it is found that
irrarsartan has undergone a change of
solubility classification from practically
insoluble to very soluble. This is because
the manufacture of solid dispersions will
lead to the formation of molecular
dispersions compared to just the usual
physical mixing so that the dissolved
content in the solvent can increase.
Table 4. Solubility test results
Sampel Absorban Level (mg) % Level Soluble Clasification
Campuran 1:19496,9
Fisik 0,437 5,129 10,26 (Practical Not Soluble)

irbesartan in 0.1 N HCl in testing the F1 (1:0,5) 1:12602,3

irbesartan solubility. 0,5883 7,935 15,87 (Practical Not Soluble)

F2 (1:1) 1:11648,2
Table3.The maximum absorption 0,624 8,585 17,17 (Practical Not Soluble)

wavelength data of irbesartan in F3 (1: 3) 1:9441,9

0.1 N HCl at a concentration of 0,7343 10,591 21,18 Very dificult to dissolve)

8 μg / mL

Furthermore, the determination of

irradiant recovery rate in the physical
mixture and solid dispersion is made.
Each formula was weighed equivalent to
150 mg then dissolved with 0.1 N HCL in
a 100 mL measuring flask. After that
dipipet as much as 0.5 mL and put in a 50
mL measuring flask then enough with
HCL 0.1 N and measured by using UV
spectrophotometry. There was an
irradiant recovery rate in the physical
mixture, and solid dispersion of F1, F2,
and F3 in HCl 0.1 N medium were
83.68%; 80.8%; 85.04% and 89.26%
respectively.
Figure7. The maximum absorption
wavelength spectrum of
irbesartan in HCl 0.1

From the results of the irrarsartan

solubility test in the physical mixture and
in the solid dispersion formula obtained

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Table5. Results of determination of Table 6. Results of dissolution of physical

reacquisition rate mixture and solid dispersion F1,
F2, F3
Level of % zat terdisolusi
Sam Absor %
Dilution substance
ple ban Recovery Waktu
aktif (mg) CF F1 F2 F3
CF 5 15,90 32,43 27,18 45,83
0,497 100 x (50/0,5) 125,527 83,68
(1:1)
10
34,33 38,59 36,39 62,85
F1 0,485 100 x (50/0,5) 121,2 80,8 15 51,73 49,27 45,17 72,52
30
F2 0,501 100 x (50/0,5) 127,56 85,04 70,69 57,73 58,96 76,58
45 78,85 68,06 67,90 84,47
F3 0,520 100 x (50/0,5) 133,89 89,26
60 85,07 90,01
85,66 87,12

The dissolution rate was then In Pharmacopoeia Indonesia Edition

performed with dissolution medium of
0.1 N HCl of 1000 mL, at a temperature
of ± 37 ºC with a rotation speed of 50
rpm and tested for 60 min using a rowing
method. Interpretation of dissolution data
can be done by observing the profile of
irradiant dissolution, physical mixture
and solid dispersion in 0.1 N HCl
medium. Prior to dissolution, a
calibration curve of 8 μg / mL, 10 μg /
mL, 12 μg / mL, 14 μg / mL and 16 μg /
mL, we get the equation of line y =
0,0275x + 0,1518 and r = 0,9996.
The dissolution profile obtained
through the relationship between the
percentage of dissolved substances in the
60th minute was as follows the physical
mixture 85.66%, solid dispersion F1 (1:
0,5) 87.12%, F2 (1: 1) 85.07% and F3 (1:
3) 90.01%. The complete data can be
seen in table 5. From the dissolution
profile obtained, the percentage increase
of the highest dissolution is in solid
dispersion F3 where irbesartan is as much
as 90,01%. This increase occurs because
the formation of solid dispersion can
reduce the particle size, increase the
ability of wettability and solubility and
the drug can be dispersed molecularly in
the form of amorphous particles, resulting
in an increase in the dissolution rate of an
active substance (Craig, 2002).
V stated that in the 20th minute irbesartan
must be dissolute not less than 80%. In
each formula was obtained dissolution
percentage at minute 30 amount of
physical mixture 70,69%, F1 57,73%, F2
58,96% and F3 76,58%. In this study at
the 30th minute it was seen in the best
formula of F3 percentage of dissociated
content of 76.58%, this means that the
dispersionirbesartanpolyivinylpyrrolidone
K-30 in F3 formula is almost closer to the
requirements listed in the literature.
Where the percentage yield from the
initial minutes has already shown a larger
percentisable percentage of the other
formulas.
Another parameter used for
dissolution evaluation is the efficiency of
dissolution (ED) (Abdou, 1989). The
efficiency of the irradiation dilution is
obtained from the area under the curve,
where the dissolution efficiency results
from the physical mixture and solid
dispersions F1, F2 and F3 are 60,9%,
56,46%, 54,57% and 72,65%
respectively. Similarly with the
dissolution rate, the solid dispersion F3
has the greatest dissolution efficiency
because it is well-disisolved in its
disolutions medium. In the literature, the
irrantsartan tolerance within 20 minutes
should dissolve not less than 80%, it is
proved that the dispersion of the
irbesartan solid - polyvinylpyrrolidone K-

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 Sekolah Tinggi Farmasi Indonesia 2017/ 2018

30 meets the requirements as stated in the The data obtained were analyzed by
literature ( Departemen Kesehatan RI, one-way anova followed by duncan test
2014). using SPSS 16 application. The result
showed that the influence of solid
Table 7. Results of Dissolution Efficiency dispersion formula of irbesartan to
solubility there was a significant
Sampel
Dissolution Efficiency difference where the sig value was
(%) obtained 0,00 (P <0,005) and clarified
Campuran fisik 1:1 60,90
with presence of duncan test.
Furthermore, the results obtained on the
Dispersi Padat 1:0,5 (F1) 56,46 influence of solid dispersion formula of
Dispersi Padat 1:1 (F2) 54,57
irbesartan to dissolution seen from the
analysis of dissolution test and
Dispersi Padat 1:3 (F3) 72,65 dissolution efficiency are significant
differences where the sig value obtained
After the data obtained from all test 0.00 (<0.005) and clarified the result in
experiments it can be seen the the presence of duncan test.
relationship between thermal analysis
with solubility and dissolution. Where CONCLUSION
from the solubility data compared with 1. From the research that has been done
the thermal analysis data that is ΔH the can be concluded that: 1. From the
heat decreases while the solubility data obtained, the manufacture of a
increases. Likewise with the dissolution solid dispersion of Irbesartan-PVP
seen from the results of the efficiency of K-30 leads to a physical interaction
dissolution where the value of ΔH heat as shown in the DTA thermogram.
decreases while the disolusinysemakin The influence of thermal properties
increases. on solid dispersion signifies a
decrease in melting point or a
Table 8. Data Recapitulation of Thermal decrease in HH of heat characterized
Analysis, Solubility and Dissolution by the formation of endothermic
peaks.
2. From the data can be seen the
Sam Peak (°C) ∆H Soluble Classification Dissolution
pel Efficiency relationship between thermal
analysis with solubility and
CF 105,73 -5,52 kJ/g 19496,9
Practical Not Soluble
60,9
dissolution, the decreasing ΔH heat
then the increasing solubility and
F1 185,80 -2,15 kJ/g 12602,3 56,46 dissolution of the solid dispersion
Practical Not Soluble
irbesartan - PVP K-30. In soluble
F2 176,15 -1,67 kJ/g 11648,2 54,57
dispersion solubility test, there was
Practical Not Soluble an increase in the level indicated by
the change of solubility classification
F3 95,23 -28,88kJ/g 9441,9 72,65 from practically insoluble to very
Very dificult to
dissolve difficult to dissolve on solid
dispersion F3 (1: 3), and in
dissolution test seen from the highest
dissolution efficiency value indicated
by solid dispersion F3 ie amounted to
72.65%.

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SUGGESTION Grega Klančnik. (2010). Differential

It is suggested to further investigators to Thermal Analysis (DTA) and
carry out further research related to solid Differential Scanning Calorimetry
dispersion of irbesartan - polyvinyl (DSC) as a Method of Material
pyrrolidone K-30 using another method Investigation. Materials and
Geoenvironment, 57(1), 127–142.
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Halim, A., Shilvi, A., & Erizal. (2011).
Abdou, H. M. (1989). Dissolution, Studi Sistem Dispersi Padat
Bioavaibility and Bioequivalence. Gliklazid menggunakan Polivinil
Mark Publishing Company Easton: Pirolidon K-30 dan Tween 80.
Pennsylavania. Jurnal Sains Dan Teknologi
Farmasi, 16(2), 95–103.
Ansel, H. C. (1989). Pengantar Bentuk
Sediaan Farmasi Edisi IV, , Kumar, G. A., Ram, K. C & CH. C.,
Penerjemah: Farida Ibrahim. 2011, Enhancement of Solubility
Jakarta: Universitas Indonesia. and Dissolution Rate of Irbesartan
by Solid Dispersion Technique.
Chawla, G., & Bansal, A. . (2007). A
comparative assessment of solubility Asian, Journal of Pharmaceutical
advantage from glassy and and Clinical Research, vol.4,
crystalline forms of a water- issue 2, ISSN 0974-2441.
insoluble drug. Eur. J. Pharm. Sci.,
32, 45–57. Novinda, J. (2016). Kajian Sifat
Fisikokimia Dispersi Padat
Craig, D.Q.M., 2002, The Mechanism of Irbesartan dengan PVP K-30. STIFI
Drug Release from Solid YP PADANG.
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