Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

ANALYSIS OF DRUG USE DISSOLUTION RATE FOR DD SOLVER

Farannisa As’ad, Hexes Wianchi, Novilia Megi Annisa, Ummi Heryana, Yuni Fitriani

PHARMACEUTICAL STUDIES PROGRAM FACULTY OF MATHEMATICS AND

NATURAL SCIENCE

UNIVERSITY OF SRIWIJAYA INDRALAYA

email: farmasiunsri2014@gmail.com

ABSTRACT

Disolus test is very important to ensure the quality of a medicinal product by looking at the
release profile of the drug in the carrier medium and to predict drug dissolution profile is
happening inside. This study aimed to compare aspirin tablet dissolution profile in SGF
medium / Simulated Gastric Fluid and artificial intestinal fluid SIF / Simulated Intestinal
Fluid. Artificial gastric fluid having a pH of 1.2, while the artificial intestinal fluid having a
pH of 6.8. With both types of testing on this solution, it will be known whether aspirin 100mg
coated tablet is better dissolved in the stomach or intestine. The dissolution test temperature
is kept at 37 ± 0.5 ° C, with a rotation speed of 50 rpm. Samples were taken (5 ml) at minute
5, 10, 20, 30 and 45 and the volume taken will be replaced with a new medium to maintain
the condition of SINK. The sample is then read by a spectrophotometer absorbance at λ
maximum. The dissolution test results show that the concentration of the drug-coated aspirin
tablets have better dissolution in the intestine rather than the stomach. This result is clearly
different from that supposed. Supposedly aspirin tablet dissolved better in the stomach.
Aspirin is acidic. While also acidic gastric fluid. Effect of pH on the solubility has principles
like disoolve like, so acidic drug would be more soluble in the stomach. After knowing better
aspirin tablet dissolved in which, it can be done also an analysis of the release of a model
drug, either manually or DDSolver From the analysis of models of drug release is done, it is
known that the drug is to follow the model of drug release order of 0. Determination of the
model release this drug can be determined from the value of R2 (value Rqsr on DDSolver) on
the graph of each model of drug release. Values closest one is the best and the release of a
model drug.

Keywords: aspirin, Simulated Gastric Fluid, Simulated Intestinal Fluid, sink, DD Solver

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

CHAPTER I
INTRODUCTION

Dissolution of the drug is an active Noyes and Whitney as follows (Ansel,

compound dissolution process of a solid 1993):
dosage form into the carrier solvent.
dM.dt-1: The dissolution rate
Solvents an active substance is very
D: diffusion coefficient
important for the availability of a drug Cs: solubility of solids
depends on the ability of these substances C: concentration of substances in solution
dissolved into the solvent medium before at the time
it is absorbed into the body. Dosage should h: thickness diffusion layers
be tested dissolution is solid or semi-solid
form, such as capsules, tablets or
Factors that affect the dissolution
ointments (Ansel, 1985).
rate is (Martin, 1993):
In order for a drug is absorbed,
1. temperature
initially the drug should be a solution in
the liquid in place of absorption. For Heightened temperatures generally
example, a drug that is given orally in increase the solubility (Cs) a substance that
tablet or capsule form can not be absorbed is endothermic and enlarge the diffusion
until the particles dissolve in the liquid coefficient of the substance. According to
drug at a point in the gastrointestinal tract. Einstein, the diffusion coefficient can be
In cases where the solubility of a drug expressed by the following equation
depends on whether the medium acidic or (Martin, 1993):
alkaline medium, the drug is dissolved in a
row in the stomach and the small intestine. D: diffusion coefficient
r: radius of the molecule
The process of dissolution of a drug called
k: Boltzmann's constant
dissolution (Ansel, 1985). ή: solvent viscosity
T: temperature
If a tablet or other pharmaceutical
preparations included in the GI tract, the 2. Viscosity
drug began to enter into the solution of the
solid form. If the tablet is not coated with a The fall in the viscosity of the solvent will
polymer, a solid matrix also disintegrate increase the speed of dissolution of a
into granules, and these granules undergo substance in accordance with Einstein's
breakage into fine particles. Disintegration, equations. Heightened temperatures also
deagregasi and dissolution could take decreases the viscosity and increases the
place simultaneously with removing a drug speed of dissolution.
from the form in which it is given (Martin,
3. pH solvents
1993).
solvent pH affects the solubility of the
The dissolution rate is a measure that
substances that are weakly acidic or
states the amount of a solute in a particular
alkaline.
solvent per unit of time. Speed equation by

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University
For a weak acid:
If (H +) small or large, the solubility pH
will increase. Thus, the dissolution rate is
also increasing substances.
For a weak base:
If (H +) big or small pH increases the
solubility. Thus, the dissolution rate also
increased.
4. Stirring
Mixing speed will affect the diffusion
layer thickness (h). if the agitation is rapid,
then the diffusion layer thickness to be
quickly reduced.
5. Particle Size
If small particles of matter, the effective
surface area becomes large so that the
dissolution rate increases.
6. Polymorphism
The solubility of a substance is influenced
by the presence of polymorphism. The
internal structure of different substances
that can provide different levels of
solubility as well. Meta-stable crystal is
generally more soluble than other forms of
instability, so the speed of dissolution is
great.
7. Nature of Surface Materials
In general, substances that are used as a
medicinal ingredient is hydrophobic. The
presence of surfactant in the solvent, the
surface tension between particles of matter
with a solvent will decrease so that the
substance is wetted and dissolution speed
increases.
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There are two methods of
determining the dissolution rate is (Martin,
1993):
1. Method of suspension
Powdered solids are added into the solvent
without controlling the surface area of the
particles. Samples were taken at certain
times and the amount of dissolved
substances is determined in an appropriate
manner.
2. Constant Surface Method
Substance is placed in a container that is
known to the extent that the difference
variable effective surface area can be
ignored. Generally, a substance converted
into a tablet first, then determined as the
suspension method.
The working principle dissolution
apparatus can be done in two ways:
(Director General of POM, 1995):
1. The tool consists of a closed container
made of glass or transparent inert material,
a metal rod driven by a motor and a
cylindrical basket and tangas heated with
water at a temperature of 370C.
2. The tool used is a paddle that consists of
leaves and stems as a stirrer. Stems are in a
position so that its axis is not more than 2
mm at any point on the axis vertikel
container and rotates smoothly without
significant wobble.
The DDSolver program was
developed to facilitate the modeling and
comparison of drug dissolution data. The
program can fit drug release data using
nonlinear optimization techniques in an
easy-to-use spreadsheet environment. It is
the first reported program which is
specifically designed to assess the
 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University
similarity between dissolution profiles.
The program is capable of performing
most existing techniques for comparing
drug release data, including exploratory
data analysis, univariate ANOVA, ratio
test procedures, the difference factor f1, the
similarity factor f2, the Rescigno indices,
the 90% CI of difference method, the
multivariate statistical distance method,
the model-dependent method, the
bootstrap f2 method, and Chow and Ki’s
time series method. In addition, several
user-defined functions for characterizing
drug-release curves and for assessing the
similarity between dissolution profiles are
also implemented in the program(Lu
DR,1996)
These additional functions can be
conveniently used in the same way as the
built-in functions in Microsoft Excel.
Sample runs of the program demonstrated
that DDSolver can be considered a reliable
program for dissolution data analysis. The
DDSolver program is freely available. The
interested reader can obtain the program
from the supplementary material to this
article. The program was developed and
tested in Microsoft Excel 2003 (both
English and Simplified Chinese versions)
in a Windows XP SP2 environment and
was compatible with Microsoft Excel 2007
and 2010 on Windows platform(Lu
DR,1996)
CHAPTER II
RESEARCH METHODOLOGY
2.1 Time and place
Trial drug dissolution rate and the
DD Solver was conducted at the
Laboratory of Pharmacology, Faculty of
Mathematics and Natural Sciences,
University of Sriwijaya Inderalaya. The
execution time on Friday, October 21,
2016.
2.2 Tools and materials
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2016
The tools used are glass beaker, stir
bar, a stopwatch, a pipette, waterbath, a
measuring cup, UV-Vis
spectrophotometer, cuvette, erlenmeyer,
flask, and laptop computers and stationery.
The materials used include aspirin tablets
are used as samples, akuadest, dissolution
media SIF and SGF, and active substances
of pure aspirin, as well as reagent FeCl3.
2.3 Procedures
Determination of standard curve
Made of pure raw concentration
series (1,2,3,4,5 mg%) in a suitable
solvent. Read on and do scanning
spectrophotometers wavelength. Then
determined the maximum wavelength and
the line of linear equations.
DD Solver test
Open MS-Excel and click the
install program DD Solver add-ins select
DD Solver, click the analytical methods
used and then put the data in the format
and then input time and concentration
column and set according to the data of
dissolution and then click Run. Open the
note sheet DD result disolution basic
invitro results of data processing. Specified
model of drug release and compare data
using statistical applications.
Dissolution test
Weighed weights and measured the
diameter of the tablet aspirin. Entered 200
mL dissolution medium (SIF and SGF) in
a glass beaker. Glass beaker is placed in
the water bath at 37 ° C ± 1 ° C and then
put aspirin tablet that has weighed into the
beaker constant manual stirring for 60
minutes while holding the stopwatch.
Taken sampling as much as 5 mL per
 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

minute to 5, 10, 15, 20, 25, 30, 35, 40, 45, t (15’) y = 0,221 + 0,536x
50, 55, and 60. Return by 5 mL dissolution
0,079 = 0,221 + 0,536x
medium (SIF or SGF) into the beaker.
Observed uptake of the results of each 0,0536x = 0,142
sampling with a spectrophotometer at a
x = 0,264
wavelength of maximum has been
obtained. Calculated levels of drug t (20’) y = 0,221 + 0,536x
dissolved using the linear equation derived
0,081 = 0,221 + 0,536x
from the standard curve determination.
0,0536x = 0,14
2.4 Calculation
x = 0,2611
1. The standard curve
t (25’) y = 0,221 + 0,536x
0.0005 mg / ml = 0.0005 mg / ml x 100 ml
0,081 = 0,221 + 0,536x
= 10 ml + 90 ml of mother liquor
dissolution medium (SIF / SGF) 0,0536x = 0,14

0.005 mg / ml = 0.005 mg / ml x 100 ml = x = 0,2611

10 ml + 90 ml of mother liquor dissolution
t (30’) y = 0,221 + 0,536x
medium (SIF / SGF)
0,083 = 0,221 + 0,536x
0.05 mg / ml = 0.05 mg / ml x 100 ml = 10
ml + 90 ml of mother liquor dissolution 0,0536x = 0,138
medium (SIF / SGF) x = 0,2574
0.5 mg / ml = 0.5 mg / ml x 100 ml = 10 t (35’) y = 0,221 + 0,536x
ml + 90 ml of mother liquor dissolution
medium (SIF / SGF) 0,088 = 0,221 + 0,536x
0,0536x = 0,133
2. Contens in solution SGF
x = 0,2481
With the equation y = 0.221 + 0,536x
• Replication 1 t (40’) y = 0,221 + 0,536x

t (5’) y = 0,221 + 0,536x 0,092 = 0,221 + 0,536x

0,040 = 0,221 + 0,536x 0,0536x = 0,129

0,536x = 0,181 x = 0,2406

x = 0,337 t (45’) y = 0,221 + 0,536x

t (10’) y = 0,221 + 0,536x 0,164 = 0,221 + 0,536x

0,074 = 0,221 + 0,536x 0,0536x = 0,057

0,536 x = 0,147 x = 0,1063

x = 0,2742 t (50’) y = 0,221 + 0,536x

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0,179 = 0,221 + 0,536x 0,092 = 0,221 + 0,536x

0,0536x = 0,042 0,0536x = 0,129
x = 0,0733 x = 0,2406
t (55’) y = 0,221 + 0,536x t (30’) y = 0,221 + 0,536x
0,183 = 0,221 + 0,536x 0,097 = 0,221 + 0,536x
0,0536x = 0,038 0,0536x = 0,124
x = 0,0708 x = 0,2313
t (60’) y = 0,221 + 0,536x t (35’) y = 0,221 + 0,536x
0,201 = 0,221 + 0,536x 0,102 = 0,221 + 0,536x
0,0536x = 0,02 0,0536x = 0,119
x = 0,0373 x = 0,2220
• Replication 2 t (40’) y = 0,221 + 0,536x
t (5’) y = 0,221 + 0,536x 0,181 = 0,221 + 0,536x
0,055 = 0,221 + 0,536x 0,0536x = 0,04
0,0536x = 0,166 x = 0,0746
x = 0,3097 t (45’) y = 0,221 + 0,536x
t (10’) y = 0,221 + 0,536x 0,194 = 0,221 + 0,536x
0,085 = 0,221 + 0,536x 0,0536x = 0,027
0,0536x = 0,136 x = 0,0503
x = 0,2537 t (50’) y = 0,221 + 0,536x
t (15’) y = 0,221 + 0,536x 0,175 = 0,221 + 0,536x
0,087 = 0,221 + 0,536x 0,0536x = 0,046
0,0536x = 0,134 x = 0,0858
x = 0,1250 t (55’) y = 0,221 + 0,536x
t (20’) y = 0,221 + 0,536x 0,205 = 0,221 + 0,536x
0,089 = 0,221 + 0,536x 0,0536x = 0,016
0,0536x = 0,132 x = 0,0298
x = 0,2462 t (60’) y = 0,221 + 0,536x
t (25’) y = 0,221 + 0,536x 0,268 = 0,221 + 0,536x

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

0,0536x = 0,047 0,0536x = 0,02

x = 0,0876 x = 0,0373
• Replication 3 t (40’) y = 0,221 + 0,536x
t (5’) y = 0,221 + 0,536x 0,225 = 0,221 + 0,536x
0,060 = 0,221 + 0,536x 0,0536x = 0,004
0,0536x = 0,161 x = 0,007
x = 0,3003 t (45’) y = 0,221 + 0,536x
t (10’) y = 0,221 + 0,536x 0,265 = 0,221 + 0,536x
0,071 = 0,221 + 0,536x 0,0536x = 0,035
0,0536x = 0,15 x = 0,0652
x = 0,2798 t (50’) y = 0,221 + 0,536x
t (15’) y = 0,221 + 0,536x 0,273 = 0,221 + 0,536x
0,091 = 0,221 + 0,536x 0,0536x = 0,052
0,0536x = 0,13 x = 0,0970
x = 0,2425 t (55’) y = 0,221 + 0,536x
t (20’) y = 0,221 + 0,536x 0,364 = 0,221 + 0,536x
0,162 = 0,221 + 0,536x 0,0536x = 0,143
0,0536x = 0,05 x = 0,2667
x = 0,1100 t (60’) y = 0,221 + 0,536x
t (25’) y = 0,221 + 0,536x 0,414 = 0,221 + 0,536x
0,196 = 0,221 + 0,536x 0,0536x = 0,193
0,0536x = 0,025 x = 0,3600
x = 0,0466 3. Content in solution SIF

t (30’) y = 0,221 + 0,536x With the equation y = 0.277 + 0,845x

0,198 = 0,221 + 0,536x • Replication 1
0,0536x = 0,023 t (5’) y = 0,277 + 0,845x
x = 0,0429 0,200 = 0,277 + 0,845x
t (35’) y = 0,221 + 0,536x 0,845x = 0,077
0,201 = 0,221 + 0,536x x = 0,0911

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t (10’) y = 0,277 + 0,845x 0,260 = 0,277 + 0,845x

0,202 = 0,277 + 0,845x 0,845x = 0,017
0,845x = 0,075 x = 0,0201
x = 0,0887 t (50’) y = 0,277 + 0,845x
t (15’) y = 0,277 + 0,845x 0,418 = 0,277 + 0,845x
0,208 = 0,277 + 0,845x 0,845x = 0,141
0,845x = 0,069 x = 0,1668
x = 0,0816 t (55’) y = 0,277 + 0,845x
t (20’) y = 0,277 + 0,845x 0,424 = 0,277 + 0,845x
0,138 = 0,277 + 0,845x 0,845x = 0,147
0,845x = 0,139 x = 0,1739
x = 0,1644 t (60’) y = 0,277 + 0,845x
t (25’) y = 0,277 + 0,845x 0,463 = 0,277 + 0,845x
0,202 = 0,277 + 0,845x 0,845x = 0,186
0,845x = 0,075 x = 0,2201
x = 0,0887 • Replication 2
t (30’) y = 0,277 + 0,845x t (5’) y = 0,277 + 0,845x
0,208 = 0,277 + 0,845x 0,204 = 0,277 + 0,845x
0,845x = 0,069 0,845x = 0,073
x = 0,0816 x = 0,0863
t (35’) y = 0,277 + 0,845x t (10’) y = 0,277 + 0,845x
0,233 = 0,277 + 0,845x 0,209 = 0,277 + 0,845x
0,845x = 0,044 0,845x = 0,068
x = 0,0520 x = 0,0804
t (40’) y = 0,277 + 0,845x t (15’) y = 0,277 + 0,845x
0,269 = 0,277 + 0,845x 0,268 = 0,277 + 0,845x
0,845x = 0,008 0,845x = 0,009
x = 0,009 x = 0,0106
t (45’) y = 0,277 + 0,845x t (20’) y = 0,277 + 0,845x

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0,293 = 0,277 + 0,845x 0,845x = 0,43

0,845x = 0,016 x = 0,5088
x = 0,018 t (60’) y = 0,277 + 0,845x
t (25’) y = 0,277 + 0,845x 0,892 = 0,277 + 0,845x
0,356 = 0,277 + 0,845x 0,845x = 0,615
0,845x = 0,079 x = 0,7278
x = 0,0934 • Replication 3
t (30’) y = 0,277 + 0,845x t (5’) y = 0,277 + 0,845x
0,441 = 0,277 + 0,845x 0,327 = 0,277 + 0,845x
0,845x = 0,164 0,845x = 0,05
x = 0,1940 x = 0,0591
t (35’) y = 0,277 + 0,845x t (10’) y = 0,277 + 0,845x
0,443 = 0,277 + 0,845x 0,324 = 0,277 + 0,845x
0,845x = 0,166 0,845x = 0,047
x = 0,1964 x = 0,0556
t (40’) y = 0,277 + 0,845x t (15’) y = 0,277 + 0,845x
0,533 = 0,277 + 0,845x 0,376 = 0,277 + 0,845x
0,845x = 0,256 0,845x = 0,099
x = 0,3029 x = 0,1171
t (45’) y = 0,277 + 0,845x t (20’) y = 0,277 + 0,845x
0,594 = 0,277 + 0,845x 0,380 = 0,277 + 0,845x
0,845x = 0,317 0,845x = 0,103
x = 0,3751 x = 0,1218
t (50’) y = 0,277 + 0,845x t (25’) y = 0,277 + 0,845x
0,595 = 0,277 + 0,845x 0,393 = 0,277 + 0,845x
0,845x = 0,318 0,845x = 0,116
x = 0,3763 x = 0,1372
t (55’) y = 0,277 + 0,845x t (30’) y = 0,277 + 0,845x
0,707 = 0,277 + 0,845x 0,448 = 0,277 + 0,845x

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0,845x = 0,171 x = 0,5420

x = 0,2023 t (50’) y = 0,277 + 0,845x
t (35’) y = 0,277 + 0,845x 0,804 = 0,277 + 0,845x
0,477 = 0,277 + 0,845x 0,845x = 0,527
0,845x = 0,2 x = 0,6236
x = 0,2366 t (55’) y = 0,277 + 0,845x
t (40’) y = 0,277 + 0,845x 0,890 = 0,277 + 0,845x
0,533 = 0,277 + 0,845x 0,845x = 0,613
0,845x = 0,256 x = 0,725
x = 0,3029 t (60’) y = 0,277 + 0,845x
t (45’) y = 0,277 + 0,845x 0,907 = 0,277 + 0,845x
0,735 = 0,277 + 0,845x 0,845x = 0,63
0,845x = 0,458 x = 0,7455

CHAPTER III
RESULTS AND DISCUSSION

3.1 Calculation Results

1 REPLICATION IN SOLUTION SIF

The
absorbance number of correction the total amount % of drug
t (min) of 1 level 1 dissolved factor release release AUC
5 0,2 0,0911 18,22 0,0022775 18,2222775 18,2222775 45,55569375
10 0,202 0,0887 17,74 0,0022175 17,7422175 17,7422175 89,9112375
15 0,208 0,00816 1,632 0,000204 1,632204 1,632204 48,43605375
20 0,138 0,1644 32,88 0,00411 32,88411 32,88411 86,290785
25 0,202 0,0887 17,74 0,0022175 17,7422175 17,7422175 126,5658188
30 0,208 0,0816 16,32 0,00204 16,32204 16,32204 85,16064375
35 0,233 0,052 10,4 0,0013 10,4013 10,4013 66,80835
40 0,269 0,009 1,8 0,000225 1,800225 1,800225 30,5038125
45 0,26 0,0201 4,02 0,0005025 4,0205025 4,0205025 14,55181875
50 0,418 0,1668 33,36 0,00417 33,36417 33,36417 93,46168125
55 0,424 0,1739 34,78 0,0043475 34,7843475 34,7843475 170,3712938
60 0,463 0,2201 44,02 0,0055025 44,0255025 44,0255025 197,024625
TOTAL 1054,641814
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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

the cumulative
SQUARE ROOT OF amount % of drug log % of HIXSON
DE60 TIME release drug release CROWEL
17,57736 2,236067977 18,2222775 1,260602656 1,964735088
3,16227766 35,964495 1,249007899 1,987595204
3,872983346 19,3744215 0,212774438 3,39540103
4,472135955 34,516314 1,516986092 1,404192918
5 50,6263275 1,249007899 1,987595204
5,477225575 34,0642575 1,212774438 2,057748366
5,916079783 26,72334 1,017087623 2,404979332
6,32455532 12,201525 0,255326789 3,356772444
6,708203932 5,8207275 0,604280337 2,988131208
7,071067812 37,3846725 1,523280325 1,389011343
7,416198487 68,1485175 1,541383861 1,34493901
7,745966692 1,643704322 1,084118917

2 REPLICATION

absorbance The number correction

t (min) of 2 level 2 of dissolved factor the total amount release
5 0,204 0,3097 0,0015485 0,0077425 0,009291
10 0,209 0,2537 0,0012685 0,0063425 0,007611
15 0,268 0,25 0,00125 0,00625 0,0075
20 0,293 0,2462 0,001231 0,006155 0,007386
25 0,356 0,2406 0,001203 0,006015 0,007218
30 0,441 0,2313 0,0011565 0,0057825 0,006939
35 0,443 0,222 0,00111 0,00555 0,00666
40 0,533 0,0746 0,000373 0,001865 0,002238
45 0,594 0,0503 0,0002515 0,0012575 0,001509
50 0,595 0,0858 0,000429 0,002145 0,002574
55 0,707 0,0298 0,000149 0,000745 0,000894
60 0,892 0,0876 0,000438 0,00219 0,002628

% of drug the cumulative amount % of log % of drug

release AUC DE60 drug release release
0,009291 0,023228 0,012479 0,009291 -2,03193754
0,007611 0,038055 0,016902 -2,118558278
0,0075 0,05625 0,015111 -2,124938737
0,007386 0,07386 0,014886 -2,131590697
0,007218 0,090225 0,014604 -2,141583122
0,006939 0,104085 0,014157 -2,158703113
0,00666 0,11655 0,013599 -2,176525771
0,002238 0,04476 0,008898 -2,650139918
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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

0,001509 0,033953 0,003747 -2,82131076

0,002574 0,06435 0,004083 -2,589391457
0,000894 0,024585 0,003468 -3,048662481
0,002628 0,07884 0,003522 -2,580374639
TOTAL 0,74874

3 REPLICATION

absorbance The number correction the total amount

t (min) of 3 level 3 of dissolved factor release
5 0,327 0,3003 60,06 0,0075075 60,0675075
10 0,324 0,2798 55,96 0,006995 55,966995
15 0,376 0,2425 48,5 0,0060625 48,5060625
20 0,38 0,11 22 0,00275 22,00275
25 0,393 0,0466 9,32 0,001165 9,321165
30 0,478 0,0429 8,58 0,0010725 8,5810725
35 0,477 0,0373 7,46 0,0009325 7,4609325
40 0,533 0,007 1,4 0,000175 1,400175
45 0,735 0,0652 13,04 0,00163 13,04163
50 0,804 0,097 19,4 0,002425 19,402425
55 0,89 0,2667 53,34 0,0066675 53,3466675
60 0,907 0,36 72 0,009 72,009

% of drug the cumulative amount % of log % of drug

release AUC DE60 drug release release
60,0675075 150,1688 27,92516 60,0675075 1,778639611
55,966995 290,0863 116,0345025 1,747931989
48,5060625 261,1826 104,4730575 1,685796022
22,00275 176,272 70,5088125 1,342476964
9,321165 78,30979 31,323915 0,969470196
8,5810725 44,75559 17,9022375 0,933541571
7,4609325 40,10501 16,042005 0,872793111
1,400175 22,15277 8,8611075 0,146182319
13,04163 36,10451 14,441805 1,115331875
19,402425 81,11014 32,444055 1,287856013
53,3466675 181,8727 72,7490925 1,727107295
72,009 313,3892 125,3556675 1,85738678
TOTAL 1675,509

4 REPLICATION

absorbance The number of correction the total amount

t (min) of 4 level 4 dissolved factor release

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

5 0,0612 0,2547 0,0012735 0,0063675 0,007641

10 0,089 0,2224 0,001112 0,00556 0,006672
15 0,0082 0,3181 0,0015905 0,0079525 0,009543
20 0,1647 0,1328 0,000664 0,00332 0,003984
25 0,0889 0,2226 0,001113 0,005565 0,006678
30 0,0821 0,2306 0,001153 0,005765 0,006918
35 0,055 0,328 0,00164 0,0082 0,00984
40 0,008 0,3183 0,0015915 0,0079575 0,009549
45 0,212 0,3027 0,0015135 0,0075675 0,009081
50 0,1671 0,1364 0,000682 0,00341 0,004092
55 0,1741 0,1217 0,0006085 0,0030425 0,003651
60 0,221 0,0662 0,000331 0,001655 0,001986

the cumulative amount % log % of drug

% of drug release AUC DE60 of drug release release
0,007641 0,019103 0,006554 0,007641 -2,1168498
0,006672 0,035783 0,014313 -2,175743962
0,009543 0,040538 0,016215 -2,020315076
0,003984 0,033818 0,013527 -2,39968067
0,006678 0,026655 0,010662 -2,175353585
0,006918 0,03399 0,013596 -2,160019442
0,00984 0,041895 0,016758 -2,007004902
0,009549 0,048473 0,019389 -2,020042107
0,009081 0,046575 0,01863 -2,041866324
0,004092 0,032933 0,013173 -2,388064375
0,003651 0,019358 0,007743 -2,437588167
0,001986 0,014093 0,005637 -2,702020756
TOTAL 0,39321

5 REPLICATION

absorbanc The number of the total amount

t (min) e of 5 level 5 dissolved correction factor release
5 0,0915 0,2195 0,0010975 0,0054875 0,006585
10 0,081 0,2319 0,0011595 0,0057975 0,006957
15 0,0105 0,3153 0,0015765 0,0078825 0,009459
20 0,0109 0,3149 0,0015745 0,0078725 0,009447
25 0,094 0,2165 0,0010825 0,0054125 0,006495
30 0,195 0,097 0,000485 0,002425 0,00291
35 0,1967 0,095 0,000475 0,002375 0,00285
40 0,3031 0,0308 0,000154 0,00077 0,000924
45 0,3755 0,1165 0,0005825 0,0029125 0,003495
50 0,3765 0,1177 0,0005885 0,0029425 0,003531
55 0,5089 0,1217 0,0006085 0,0030425 0,003651
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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

60 0,7281 0,0662 0,000331 0,001655 0,001986

% of drug the cumulative amount % of log % of drug

release AUC DE60 drug release release
0,01646 0,00477
0,006585 3 5 0,006585 -2,181444221
0,03385
0,006957 5 0,013542 -2,157577997
0,009459 0,04104 0,016416 -2,024154775
0,04726
0,009447 5 0,018906 -2,024706085
0,03985
0,006495 5 0,015942 -2,187420845
0,02351
0,00291 3 0,009405 -2,536107011
0,00285 0,0144 0,00576 -2,54515514
0,00943
0,000924 5 0,003774 -3,034328029
0,01104
0,003495 8 0,004419 -2,45655282
0,01756
0,003531 5 0,007026 -2,452102282
0,01795
0,003651 5 0,007182 -2,437588167
0,01409
0,001986 3 0,005637 -2,702020756
0,28648
TOTAL 5
6 REPLICATION

absorbance the total amount

t (min) of 6 level 6 correction factor release
5 0,0872 0,2246 0,005615 0,006738
10 0,0571 0,2602 0,006505 0,007806
15 0,1173 0,1889 0,0047225 0,005667
20 0,1225 0,1828 0,00457 0,005484
25 0,1375 0,165 0,004125 0,00495
30 0,2024 0,0882 0,002205 0,002646
35 0,2025 0,3973 0,0099325 0,011919
40 0,315 0,0449 0,0011225 0,001347
45 0,551 0,3242 0,008105 0,009726
50 0,6239 0,4105 0,0102625 0,012315
55 0,731 0,5372 0,01343 0,016116
60 0,7457 0,5546 0,013865 0,016638
the cumulative
% of drug amount % of
release AUC DE60 drug release log % of drug release
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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

0,006738 0,016845 0,007753 0,006738 -2,171468993

0,007806 0,03636 0,014544 -2,107571453
0,005667 0,033683 0,013473 -2,246646787
0,005484 0,027878 0,011151 -2,260902554
0,00495 0,026085 0,010434 -2,305394801
0,002646 0,01899 0,007596 -2,57741016
0,011919 0,036413 0,014565 -1,92376018
0,001347 0,033165 0,013266 -2,870632404
0,009726 0,027683 0,011073 -2,012065735
0,012315 0,055103 0,022041 -1,909565584
0,016116 0,071078 0,028431 -1,792742741
0,016638 0,081885 0,032754 -1,77889888
TOTAL 0,465165

1 REPLICATION IN SOLUTION SGF

absorbance The number correction the total amount

t (min) of 1 level 1 of dissolved factor release
5 0,04 0,337 0,001685 0,008425 0,01011
10 0,074 0,2742 0,001371 0,006855 0,008226
15 0,079 0,264 0,00132 0,0066 0,00792
20 0,081 0,2611 0,0013055 0,0065275 0,007833
25 0,081 0,2611 0,0013055 0,0065275 0,007833
30 0,083 0,2574 0,001287 0,006435 0,007722
35 0,088 0,2481 0,0012405 0,0062025 0,007443
40 0,092 0,2406 0,001203 0,006015 0,007218
45 0,164 0,1063 0,0005315 0,0026575 0,003189
50 0,179 0,0733 0,0003665 0,0018325 0,002199
55 0,183 0,0708 0,000354 0,00177 0,002124
60 0,201 0,0373 0,0001865 0,0009325 0,001119

the cumulative amount % of log % of drug

% of drug release AUC DE60 drug release release
0,01011 0,025275 0,006031 0,01011 -1,995248844
0,008226 0,04584 0,018336 -2,084811295
0,00792 0,040365 0,016146 -2,101274818
0,007833 0,039383 0,015753 -2,106071873
0,007833 0,039165 0,015666 -2,106071873
0,007722 0,038888 0,015555 -2,112270203
0,007443 0,037913 0,015165 -2,128251981
0,007218 0,036653 0,014661 -2,141583122
0,003189 0,026018 0,010407 -2,496345481
0,002199 0,01347 0,005388 -2,657774771
0,002124 0,010808 0,004323 -2,672845488
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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

0,001119 0,008108 0,003243 -2,951169913

0,361883

2.REPLICATION

absorbance The number correction the total amount

t (min) of 2 level 2 of dissolved factor release
5 0,055 0,3097 0,0015485 0,0077425 0,009291
10 0,085 0,2537 0,0012685 0,0063425 0,007611
15 0,087 0,25 0,00125 0,00625 0,0075
20 0,089 0,2462 0,001231 0,006155 0,007386
25 0,092 0,2406 0,001203 0,006015 0,007218
30 0,097 0,2313 0,0011565 0,0057825 0,006939
35 0,102 0,222 0,00111 0,00555 0,00666
40 0,181 0,0746 0,000373 0,001865 0,002238
45 0,194 0,0503 0,0002515 0,0012575 0,001509
50 0,175 0,0858 0,000429 0,002145 0,002574
55 0,205 0,0298 0,000149 0,000745 0,000894
60 0,268 0,0876 0,000438 0,00219 0,002628

the cumulative amount % of log % of drug

% of drug release AUC DE60 drug release release
0,01761
0,009291 0,77425 2 0,009291 -2,03193754
0,04225
0,007611 5 0,016902 -2,118558278
0,03777
0,0075 8 0,015111 -2,124938737
0,03721
0,007386 5 0,014886 -2,131590697
0,007218 0,03651 0,014604 -2,141583122
0,03539
0,006939 3 0,014157 -2,158703113
0,03399
0,00666 8 0,013599 -2,176525771
0,02224
0,002238 5 0,008898 -2,650139918
0,00936
0,001509 8 0,003747 -2,82131076
0,01020
0,002574 8 0,004083 -2,589391457
0,000894 0,00867 0,003468 -3,048662481
0,00880
0,002628 5 0,003522 -2,580374639
1,05669
TOTAL 3

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

3 REPLICATION

jumlah Faktor jumlah total yang % of drug

Replikasi 3 terdisolusi terkoreksi terdisolusi release
0,3003 0,0015015 0,0075075 0,009009 0,009009
0,2798 0,001399 0,006995 0,008394 0,008394
0,2425 0,0012125 0,0060625 0,007275 0,007275
0,11 0,00055 0,00275 0,0033 0,0033
0,0466 0,000233 0,001165 0,001398 0,001398
0,0429 0,0002145 0,0010725 0,001287 0,001287
0,0373 0,0001865 0,0009325 0,001119 0,001119
0,007 0,000035 0,000175 0,00021 0,00021
0,0652 0,000326 0,00163 0,001956 0,001956
0,097 0,000485 0,002425 0,00291 0,00291
0,2667 0,0013335 0,0066675 0,008001 0,008001
0,36 0,0018 0,009 0,0108 0,0108

the cumulative amount % of log % of drug

AUC DE60 drug release release
0,022523 0,004188 0,009009 -2,045323413
0,043508 0,017403 -2,076031035
0,039173 0,015669 -2,138167002
0,026438 0,010575 -2,48148606
0,011745 0,004698 -2,854492829
0,006713 0,002685 -2,890421453
0,006015 0,002406 -2,951169913
0,003323 0,001329 -3,677780705
0,005415 0,002166 -2,70863115
0,012165 0,004866 -2,536107011
0,027278 0,010911 -2,09685573
0,047003 0,018801 -1,966576245
0,251295

4 REPLICATION

absorbance The number correction the total amount % of drug

t (min) of 4 level 4 of dissolved factor release release
5 0,335 0,2126 0,001063 0,005315 0,006378 0,006378
10 0,275 0,1007 0,0005035 0,0025175 0,003021 0,003021
15 0,2641 0,084 0,00042 0,0021 0,00252 0,00252
20 0,2615 0,0755 0,0003775 0,0018875 0,002265 0,002265
25 0,2612 0,075 0,000375 0,001875 0,00225 0,00225

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

30 0,2575 0,068 0,00034 0,0017 0,00204 0,00204

35 0,2483 0,0509 0,0002545 0,0012725 0,001527 0,001527
40 0,2412 0,0376 0,000188 0,00094 0,001128 0,001128
45 0,1065 0,2136 0,001068 0,00534 0,006408 0,006408
50 0,0735 0,2751 0,0013755 0,0068775 0,008253 0,008253
55 0,071 0,2798 0,001399 0,006995 0,008394 0,008394
60 0,0376 0,3421 0,0017105 0,0085525 0,010263 0,010263

the cumulative amount % of log % of drug

AUC DE60 drug release release
0,015945 0,00411 0,006378 -2,195315485
0,023498 0,009399 -2,519849275
0,013853 0,005541 -2,598599459
0,011963 0,004785 -2,644931794
0,011288 0,004515 -2,647817482
0,010725 0,00429 -2,690369833
0,008918 0,003567 -2,816160963
0,006638 0,002655 -2,9476909
0,01884 0,007536 -2,193277497
0,036653 0,014661 -2,083388155
0,041618 0,016647 -2,076031035
0,046643 0,018657 -1,988725671
0,246578

5 REPLICATION

absorbance The number correction the total amount % of drug

t (min) of 2 level 2 of dissolved factor release release
5 0,3098 0,1656 0,000828 0,00414 0,004968 0,004968
10 0,2541 0,0617 0,0003085 0,0015425 0,001851 0,001851
15 0,253 0,0597 0,0002985 0,0014925 0,001791 0,001791
20 0,2463 0,0472 0,000236 0,00118 0,001416 0,001416
25 0,241 0,0373 0,0001865 0,0009325 0,001119 0,001119
30 0,2315 0,0195 0,0000975 0,0004875 0,000585 0,000585
35 0,225 0,0074 0,000037 0,000185 0,000222 0,000222
40 0,0743 0,2736 0,001368 0,00684 0,008208 0,008208
45 0,051 0,3171 0,0015855 0,0079275 0,009513 0,009513
50 0,0861 0,2516 0,001258 0,00629 0,007548 0,007548
55 0,0231 0,3692 0,001846 0,00923 0,011076 0,011076
60 0,0875 0,249 0,001245 0,006225 0,00747 0,00747

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

the cumulative amount % HIXSON

AUC DE60 of drug release log % of drug release CROWEL

0,01242 0,004336 0,004968 -2,303818413 4,39720585

0,017048 0,006819 -2,732593581 4,445497319

0,009105 0,003642 -2,746904414 4,446853381

0,008018 0,003207 -2,848936747 4,456105952

0,006338 0,002535 -2,951169913 4,464684485

0,00426 0,001704 -3,232844134 4,485146248

0,002018 0,000807 -3,653647026 4,50860937

0,021075 0,00843 -2,085762652 4,365908109

0,044303 0,017721 -2,021682503 4,355680654

0,042653 0,017061 -2,122168109 4,37150055

0,04656 0,018624 -1,955617053 4,344601791

0,046365 0,018546 -2,126679398 4,372182843

0,26016

6 REPLICATION

absorbance The number of correction the total amount

t (min) of 2 level 2 dissolved factor release
5 0,3005 0,1483 0,0007415 0,0037075 0,004449
10 0,2799 0,1098 0,000549 0,002745 0,003294
15 0,243 0,041 0,000205 0,001025 0,00123
20 0,112 0,2033 0,0010165 0,0050825 0,006099
25 0,0467 0,3251 0,0016255 0,0081275 0,009753
30 0,043 0,332 0,00166 0,0083 0,00996
35 0,0375 0,1835 0,0009175 0,0045875 0,005505
40 0,008 0,3973 0,0019865 0,0099325 0,011919
45 0,0653 0,2904 0,001452 0,00726 0,008712
50 0,0971 0,2311 0,0011555 0,0057775 0,006933
55 0,2665 0,0848 0,000424 0,00212 0,002544
60 0,365 0,3442 0,001721 0,008605 0,010326

% of drug the cumulative amount % of log % of drug

release AUC DE60 drug release release

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

0,004449 0,011123 0,006297 0,004449 -2,351737594

0,003294 0,019358 0,007743 -2,482276405
0,00123 0,01131 0,004524 -2,910094889
0,006099 0,018323 0,007329 -2,214741367
0,009753 0,03963 0,015852 -2,010861776
0,00996 0,049283 0,019713 -2,001740662
0,005505 0,038663 0,015465 -2,259242677
0,011919 0,04356 0,017424 -1,92376018
0,008712 0,051578 0,020631 -2,059882133
0,006933 0,039113 0,015645 -2,1590788
0,002544 0,023693 0,009477 -2,594482893
0,010326 0,032175 0,01287 -1,986067879
TOTAL 0,377805

OBSERVATIONS RESULTS DATA DDSOLVER

DATA DISSOLUTION

DATA DISSOLUTION

Time Cp1 Cp2 Cp3 Cp4 Cp5 Cp6

(min) (mg/mL) (mg/mL) (mg/mL) (mg/mL) (mg/mL) (mg/mL)
5 8,24 7,78 8,44 8,5 8,06 8,56
10 19,46 21,28 19,42 20,64 20,34 18,34
15 48,88 50,7 48,58 45,48 51,08 48,44
20 72,52 76,32 73,32 69,56 76,7 71,94
30 130,66 128,3 138,02 122,18 122,66 122,44
45 172,94 165,72 171,5 177,36 180,48 172,94
60 197,18 188,12 200,58 186,16 186,32 184,52

% FRACTION DISSOLUTION
Time (min) % FD1 %FD2 %FD3 %FD4 %FD5 %FD6
5 20,6 19,45 21,1 21,25 20,15 21,4
10 48,65 53,2 48,55 51,6 50,85 45,85
15 122,2 126,75 121,45 113,7 127,7 121,1
20 181,3 190,8 183,3 173,9 191,75 179,85
30 326,65 320,75 345,05 305,45 306,65 306,1
45 432,35 414,3 428,75 443,4 451,2 432,35
60 492,95 470,3 501,45 465,4 465,8 461,3

DATA RESULTS SPSS

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

3.2 discussion

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

Dissolution of drugs classified as dissolved into the carrier medium.

one of the parameters that determine the Calculation percent of drug release
bioavailability of drugs in the body. To be replication 1 SIF solution, the value of
absorbed, a tablet to be disintegrated and drug release from 18.22% to 44.02%.
dissolved in advance in order to improve Percent of drug release on the second
the bioavailability of drugs in the body. replication of 0.009% to 0.002%. Percent
The better the higher the dissolution of drug release on 3 replication by 60% to
bioavaibilitasnya so that the drug can bring 72%. In the fourth replication of 0.007% to
a more optimal effect. 0.002%. In replication 5 0.006% to
0.002%. Then on replication 6 0.006% to
Drugs that are taken orally will be
0.017%. The difference is very volatile on
heading to the gastrointestinal tract
the data obtained percent of drug release
(stomach and intestines). Stomach and
may be due to differences in the treatment
intestinal fluid conditions differ, mainly
of each replication instance of stirring
from factors pH and composition of the
speed factor or factors temperature
liquid. Therefore, in this study tested the
experiments.
dissolution of the artificial gastric fluid
Having tested the SIF solution, dissolution
(SGF / Simulated Gastric Fluid) and
was also tested in a solution of SGF. Based
artificial intestinal fluid (SIF / Simulated
on the experimental results obtained
Intestinal Fluid). Artificial gastric fluid
replication 1 percent of drug release by
having a pH of 1.2, while the artificial
0.01% sampaii 0.002%. In the second
intestinal fluid having a pH of 6.8. With
replication of 0.009% to 0.003%. In the
both types of testing on this solution, it
third replication of 0.009% to 0.011%. In
will be known whether aspirin 100mg
replication 4 0.006% to 0.01%. At 5
coated tablet is better dissolved in the
replication of 0.004% to 0.007%. Then at 6
stomach or intestine.
replication of 0.004% to 0.01%.
To find out how much drug can be
From the results of dissolution
dissolved then calculated the percent of
testing to obtain percent release of the
drug release. Percent drug release is
drug, it can be concluded that the coated
calculated at each sampling interval every
aspirin tablet has a better dissolution in the
5 minutes starting from the 5th minute to
intestine rather than the stomach. This
the 60th minute. The higher the percent of
conclusion can be seen from the
drug release then sebakin many of the drug
percentage of drug release in SIF solution
22 | J o u r n a l B I o f a r m a s e t i k a a n d p h a r m a c o k i n e t i c s o f P h a r m a c y

than SGF. This result is clearly different
from that supposed. Supposedly aspirin
tablet dissolved better in the stomach.
Aspirin is acidic. While also acidic gastric
fluid. Effect of pH on the solubility has
principles like disoolve like, so acidic drug
would be more soluble in the stomach. The
more easily soluble drugs, the better
dissolution. The difference is the result of
which should be attributed to differences
of treatment on each replication. Supposed
to produce more accurate results, all
treatments in each replication should be
equated, both in terms of pH, temperature
and stirring
After knowing better aspirin
dissolved in which, it can be done also an
analysis of the release of a model drug,
either manually or DDSolver. DDSolver or
drug dissolution solver is one application
that can be used to determine the model of
drug release were analyzed. Test models
ibi drug release was tested against seven
models of drug release, the order 0, 1
order, Higuchi, Hixson-Crowell,
korsmeyer Peppas, Hopfenberg,
weibull.
From the analysis of models of
drug release is done, it is known that the
drug is to follow the model of drug release
order of 0. Determination models of drug
release can be determined from the value
of R2 (value Rqsr on DDSolver) on the
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Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016
graph of each model of drug release.
Values closest one is the best and the
release of a model drug. Odel drug release
at this time tested manually using
Microsoft Excel.
After testing the model of drug
release, performed statistical analysis
SPSS application receipts. Test done of
normality test, correlation, and test the T-
Test. Of normality test results can be seen
that the significant value in the Hixson-
Crowell model of the smallest that is
0.210, while the 0-order model has the
most significant value of which is 0.815.
speed.
However, the release of all models tested
tablet
gave the same results that all the data are
significant and have the data distribution is
not normal. In correlation, the highest
correlation value is generated on the order
of 0, while the t-test T-Test produced the
lowest value on the order of 0.
Besides tested against aspirin
tablet, do also to drug analysis DDSolver
O. From the analysis can be concluded that
and the drug O has a model drug release order
0 and better dissolved in the intestine. It
can be seen from the Rqsr on the order of 0
is the closest one than the other models of
drug release. While the results of the drug
release, drug release in SIF value is higher
than the SGF so that it can be said that the
drugs O dissolved better in the stomach.
 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

Once you know the model release the 18.1489 / hour. It also obtained a part-time
medicine, it can be seen the value of the value of a secondary parameter T50 is
dissolution rate constant Ko value on best- equal to 170 hours.
fit parameter values that is equal to

CHAPTER IV
CONCLUSIONS AND RECOMMENDATIONS

4.1 Conclusions Analysis of the dissolution rate of

To be absorbed by the body, the drugs can be made by DD solver software

drug must go through a process of so that it can determine the model of drug

disintegration and dissolution release testing. Model release of the drug

dahulu.Disolusi first is the process of selected by the value of R ² on the results

releasing the active substance from a solid of the linear regression equation of each -

dosage form into the dissolution medium. each model release drugs that are most

The dissolution rate is influenced by close to 1. From these results, we can

temperature and stirring speed. The faster determine the model of drug release test

you stir, then the process will be more asetosal follow the model of zero-order

rapid dissolution. The higher the release of the drug. Zero order ata often

temperature, the faster the drug dissolves used in tablet dosage has modified release,

and dissolved. Stirring time also affect the such as coated tablets

dissolution rate of drugs. Supposedly%

release of the drug will increase as stirring 4.2 Recommendations

time, but the results obtained from the 1. to produce results more accurate
experiments did not show an increase in% drug dissolution, all treatments in
each replication should be equated,
of drug release. In the medium SGF,
both in terms of pH, temperature
dissolution constant value greater than the and stirring speed.
medium SIF. Aspirin tablet drug more 2. Would obtained normal
distribution of data if the data
quickly dissolved in the stomach than in
obtained is not significant.
the intestine, because the stomach more
acidic.

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 Journal Biofarmasetika and Pharmacokinetics Sriwijaya University 2016

BIBLIOGRAPHY Departemen Kesehatan Republik

Indonesia, Jakarta.
Ansel, Howard C. 1985. PENGANTAR Martin. A, 1993, Farmasi Fisika, Edisi III,
BENTUK SEDIAAN FARMASI EDISI Jilid II, Indonesia University Press.
IV. UI press. Jakarta. Lu DR, Abu-Izza K, Mao F. 1996 Nonlinear
Departemen Kesehatan Republik Indonesia, data fitting for controlled release devices:
1995, Farmakope Indonesia, IV, an integrated computer program. Int J
Pharm

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