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VOLUME
Vol.05 Issue03 2025
PAGE NO.
21-30
10.37547/ijmscr/Volume05Issue03-05
Selection of the optimal composition and technology of
the recommended capsules "PROSTAD"
Kh.M. Yunusova
Professor, The Department of Industrial Technology of Medicines, Tashkent Pharmaceutical Institute, Uzbekistan
Sh.Kh. Sunnatov
Agency for the Development of the Pharmaceutical Industry, Uzbekistan
Received:
28 January 2025;
Accepted:
27 February 2025;
Published:
29 March 2025
Abstract:
In the process of searching for new effective drugs for the treatment of prostate and prostate adenoma,
special attention should be paid to drugs based on natural origin. It is generally accepted that drugs obtained from
natural origin are less toxic. The action of these drugs is carried out through ready-made dosage forms that are
easy to use. The purpose of our work is to develop the composition and technology of an encapsulated dosage
form based on Fireweed.This article presents the results of studies on the development of tablet technology based
on the recommended dry extract "Prostad". An encapsulated dosage form, unlike others, does not require the
mandatory introduction of excipients if the drugs have satisfactory technological properties. They can be filled
into gelatin capsules, which significantly simplifies the technological process of production.
Having a complete description of the properties of the compressed substance, it is possible to scientifically
approach the solution of this problem.
Keywords:
Hygroscopicity, humidity, substance, dry extract, compressibility, fractional composition, bulk density,
flowability, physicochemical.
Introduction:
Selection of the optimal composition and
technology of the recommended capsules "Prostad".
The main important technological properties of
powders - substances in relation to solid dosage forms
include the following indicators: appearance, fractional
composition, solubility, flowability, bulk density, angle
of repose, porosity, compactibility, hygroscopicity,
residual moisture [1].
Based on the above (Chapter II), in preliminary studies
we studied the obtained dry extracts according to our
recommended technology and conditions. The
obtained extract is dry hygroscopic, finely dispersed
powders from red to dark brown color with a specific
odor. When shaken with water, it forms a colloidal
solution. It has a unique smell and taste. Microscopic
examination of the powders was carried out using a
Neophot-21 microscope manufactured by Carl Zeiss at
a magnification of 170 times, followed by photography.
The results of the study showed that the dry extract
"Prostad" is a finely dispersed homogeneous powder
with particle sizes from 2.9 μm to 4.8 μm. The increased
force of attraction between the particles of the extract,
due to the particle size (2.75-
4.62 μm), is the reason for
poor flowability and relatively low bulk density. Along
with the above, it should be noted that the fractional
composition of the extract is the following indicators: -
3000 + 2500 μm ~ 14.91%,
-
2500 + 1000 μm
- 29.65% -
1000 + 315 μm
- 40.18%, -
315 + 250 μm
- 10.99%, -250
μm
- 4.34%.
The above results of the study indicate that the dry
extract "Prostad" is an amorphous, finely dispersed
powder and in a free state is prone to the formation of
conglomerates. Such powders in relation to their solid
dosage forms are difficult and to achieve the necessary
technological properties of the mass it is necessary to
use the appropriate compositions of auxiliary
substances, as well as to carry out special technological
methods. The study of the physicochemical properties
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of the dry extract of Fireweed showed that the extracts
are dry hygroscopic, finely dispersed powders of dark
brown color with a specific odor, the loss in mass during
drying was 3.56%, heavy metals 0.0092, when
determining the moisture content of the dry extract of
the extract is equal to 4.77%, the quantitative content
of biologically active substances is 91.78%.[2-6].
The recommended dry extract is characterized by
hygroscopicity, insufficient flowability, the angle of
natural slope it is not possible to obtain granules (for
the preparation of, for example, encapsulated dosage
forms) without introducing auxiliary substances into
the composition that improve the technological
characteristics of the mass.
Experimental section
METHODS
This study develops encapsulated dosage forms from
Epilobium angustifolium (narrow leaved fireweed)
extract utilizing an experimental, analytical, and
comparative methodology which integrates an
approach designed to address the potential
pharmaceutical use of this extract to treat prostatitis
and prostate adenoma. The extract was evaluated
systematically in terms of physicochemical and
technological properties including moisture content,
bulk density, flowability and compressibility. The
moisture absorption kinetics of the dry extract and
encapsulated mass were analyzed using advanced
gravimetric techniques in response to varied
environmental humidity conditions. Excipients were
selected in order to improve technological parameters
of the extract and thus optimize the formulation
process by the achievement of higher flowability,
compactness and diminished hygroscopicity. Further
study of the technological properties of dry extract
showed that when developing the technology of solid
dosage forms, it will be necessary to use a set of
auxiliary substances and technological operations.
Since when studying the technological indicators
(fractional composition, bulk density, flowability, angle
of natural repose, compressibility coefficient,
compactibility
coefficient,
porosity,
residual
moisture...) unsatisfactory values of almost all
technological properties were predicted.
RESULTS AND DISCUSSIONS
Selection of the optimal composition and technology of
the recommended capsules "Prostad". The study of the
physicochemical and technological properties of the
substance have a predictive value in the selection of the
optimal composition and technology of dosage forms
[2].
Further study of the technological properties of the dry
extract showed that when developing the technology
of solid dosage forms, it is necessary to use a set of
auxiliary substances and technological operations.
Since when studying the technological indicators
(fractional composition, bulk density, flowability, angle
of natural repose, compressibility coefficient,
compactibility coefficient, porosity, residual moisture
...) predicted unsatisfactory values of almost all
technological properties. Since the dry extract is
characterized by hygroscopicity, poor compressibility,
insufficient flowability, it is not possible to obtain
granules (for the preparation of, for example, tablets,
encapsulated dosage forms) without introducing
auxiliary substances into the composition that improve
the technological characteristics of the mass.
Further research was devoted to studying the fractional
composition of the dry extract [3].
The results of the study of the fractional composition of
the dry extract "Prostad" are shown in Figure 1.
Fig. 1. Results of the study of the fractional composition of the dry extract "Prostad"
2%
19%
20%
28%
31%
2000
-1000
-500
250
-250
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As can be seen from Figure 3.1, the main part of the
dry extract 31% is contained in the -250 fraction. This in
turn shows that the dry extract is a fine powder. The
nature of the fractional composition in turn affects the
technological parameters.
Therefore, the research continued with the study of the
technological properties of the dry extract "Prostad"
obtained by us using the recommended technology.
The following technological properties were studied:
appearance, flowability, natural slope carbon, bulk
density. In appearance, the extracts are dry
hygroscopic, amorphous powders from red to dark
brown in color with a specific odor. Research on the
technological properties of the recommended dry
extract such as flowability, natural slope carbon, bulk
density, dry extract, as can be seen from the obtained
research results, show negative properties of the dry
extract such as flowability and natural slope angle [4,5].
The results of the study of the technological properties
of the recommended dry extract are presented in Table
1.
Table 1
Results of the study of the technological properties of the recommended dry extract
"Prostad"
Studied indicators
Dry extract
Appearance
Powders from brown to dark brown in color
Flowability, 10
-3
кг/с
0,575±0,354
Angle of natural slope, degrees
59,46±3,11
Bulk density
, кг/м
3
578,42±3,09
Compaction coefficient
1,85±3,65
Residual moisture, %
4,76±3,22
The following studies were devoted to the
development of the technology of Prostad capsules
based on the dry extract obtained by us using the
recommended methods and conditions. Since the dry
extract is characterized by hygroscopicity, insufficient
flowability, and the angle of natural repose, it is not
possible to obtain granules for the preparation of
encapsulated dosage forms without introducing
auxiliary substances into the composition that improve
the technological characteristics of the dry extract.
Encapsulation of drugs obtained from medicinal plants
is a complex and labor-intensive process that requires
a thorough study of the structural, mechanical and
technological properties of the substance, granulated
materials, which has a predictive value for determining
the technological process [5, 6].
To select the optimal composition of the recommended
capsules under the conventional name "Prostad" based
on the dry extract, certain excipients were used and
their corresponding quantities were calculated based
on the study of the effectiveness, mechanisms of
action, and influence on the properties of the active
substance.
In order to develop the composition and technology of
capsules, more than twenty compositions were
studied. The compositions were selected taking into
account
the
negative
physicochemical
and
technological properties of the dry extract "Prostad".
Since the dry extract is characterized by hygroscopicity,
poor compressibility, insufficient flowability, it is not
possible to obtain granules for the preparation of
encapsulated dosage forms without introducing
excipients into the composition that improve the
technological characteristics of the mass. Since the
selection of the type and quantity of excipients when
developing a dosage form is based on the feasibility of
improving the substance indicators.
Based on the above studies, it was found that the dry
extract has almost no flowability, they have a low angle
of natural repose. Based on the analysis of the obtained
technological properties of the dry extract, to eliminate
the identified deficiencies and obtain high-quality
capsules with maximum therapeutic effect with
minimum side effects, it was used to improve the
negative technological properties of the dry extract.
Also, as an encapsulated dosage form, unlike others,
does not require the mandatory introduction of
auxiliary substances into the composition if the drugs
have satisfactory technological properties. They can be
used to fill gelatin capsules, which significantly
simplifies the technological process of production. If
the required conditions for filling capsules are not met,
it is necessary to introduce auxiliary substances that
would improve the technological properties of drugs.
To determine the type and amount of auxiliary
substances when developing capsules with dry extract
"Prostad", the above physicochemical (Chapter II) and
technological properties of the extract were taken into
account.
Based on the results of previous studies, auxiliary
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substances were used that would reduce caking,
reduce the moisture absorption property and improve
the negative technological properties in the production
of capsules. To select the most rational composition,
we used mathematical planning of the experiment
using the Latin square 3×3 method and conducted
dispersion analysis. When selecting the components of
the composition from auxiliary substances, fillers (A),
binders (B) and antifriction substances (C) were used.
The parameters of the Latin square for selecting
auxiliary substances in the capsule composition are
given in Table 2.
Table 2
The meaning of the Latin square for the selection of excipients in the composition of the
capsule "Prostad"
Excipients
Fillers (
А)
А
1
А
2
А
3
А
4
Starch+lactose
+MCC
Starch + lactose +
magnesium oxide
Starch +
lactose
Starch + lactose +
sucrose
Binding (
В)
В
1
В
2
В
3
В
4
2%-10%
starch paste
5% PVP solution
Ethanol
Purified water
Antifriction
substances (
С)
С
1
С
2
С
3
С
4
Calcium stearate
Magnesium
stearate
Stearic acid
Aerosil
Pharmacological studies established a therapeutic dose
of 0.3 g of the dry extract "Prostad", on the basis of
which, taking into account the above factors, the
optimal capsule size was selected. Based on the bulk
density of the extract, the volume occupied by 0.3 g of
the drug was calculated. The study continued with the
selection of the optimal capsule size. For this, based on
the bulk density of the dry extract, the volume occupied
by 0.3 g of the drug was calculated [5,6,7].
Based on the analysis results, capsules No. 3 (Table 3)
can be selected for filling.
The selection of larger capsules will lead to an
unjustified increase in the amount of excipients (over
50%).
Table 3
Choosing the optimal capsule size
Capsule
number
Average capsule
capacity, cm3
Объем, который
занимает 0,3г сухой
экстракт %
Volume occupied by
0.3g dry extract %
000
1,37
12,3
87,7
00
0,95
17,2
82,8
0
0,68
24,4
75,6
1
0,50
31,9
68,1
2
0,37
41,7
58,3
3
0,30
53,4
46,6
4
0,21
75,9
24,1
5
0,13
> 100
—
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To establish the optimal composition of capsules with
dry extract "Prostad", we conducted a study of the
technological characteristics of mixtures of the extract
with various auxiliary substances (Table 4).
Table 4
Technological characteristics of the compositions of dry extract "Prostad" with excipients
Studied
technological
properties
Mixture of extract with excipients
Dry extract with fillers
Starch+lactose
+MCC
Starch +
lactose +
magnesium
oxide
Starch +
lactose
Starch +
lactose +
sucrose
Flowability, g/sec
6,21 ± 0,15
3,99 ± 0,23
3,87 ± 0,45
4,68 ± 0,14
Bulk density kg/m3
0,52± 0,09
0,59 ± 0,17
0,58 ± 0,12
0,51 ± 0,07
Angle of natural
slope, deg
39 ± 2,67
29 ± 3,34
35 ± 2,54
33 ± 2,95
Bulk density,
g/cm3
0,79 ± 0,09
0,77 ± 0,11
0,78 ± 0,05
0,75 ± 0,14
Residual moisture,
%
3,38 ± 0,11
3,98 ± 0,06
3,67 ± 0,15
4,36± 0,08
Studied
technological
properties
Dry extract with antifriction substances
Calcium stearate
Magnesium
stearate
Stearic acid
Aerosil
Flowability, g/sec.
5,42 ± 0,31
5,97 ± 0,54
4,65 ± 0,14
7,44 ± 0,15
Насыпная масса
кг/м
3
0,58 ± 0,21
0,46 ± 0,34
0,49 ± 0,25
0,56 ± 0,04
Bulk density kg/m3
37 ± 2,45
34 ± 3,61
36 ± 2,32
36 ± 2,54
Bulk density,
g/cm3
0,78 ± 0,11
0,78 ± 0,19
0,79 ± 0,08
0,76 ± 0,17
Residual moisture,
%
3,87 ± 0,14
4,59 ± 0,03
3,99 ± 0,11
3,22± 0,05
As can be seen from Table 3, the results of the obtained
data showed that almost all compositions of auxiliary
substances showed positive data except for flowability,
angle of repose. Of the obtained research results, the
most positive data is shown by the composition starch
+ lactose + MCC. Next, we studied the compositions of
dry extract with antifriction substances. The obtained
data on flowability and moisture absorption of the
composition are most significantly affected by the
presence of aerosil, which shows the most positive data
on flowability (- 7.44 ± 0.15) and on residual moisture
indicators (3.22 ± 0.05). In addition, close values of bulk
density and bulk density of this mixture predict that it
will not compact (press) under different conditions -
during transportation and storage. The other indicators
were closer and more positive.
The next stage of the study was devoted to the
selection of the concentration of aerosil. According to
literature, aerosil in a concentration of 0.05-1%
improves the flowability of the powder mixture, and in
1-2% it is a good loosening agent. Therefore, it was
advisable to determine the optimal concentration of
aerosil, which would allow obtaining the required
mass. For this purpose, the effect of different
concentrations of aerosil on the flowability of the dry
extract "Prostad" was studied. The results of the
studies showed that with the addition of 0.3-0.5% of
aerosil, the flowability of the composition increases
from 1.2 to 1.5 times. Increasing the content of aerosil
did not improve the flowability by more than 1.6 times.
Therefore, as an antifriction substance, it is sufficient to
take aerosil in an amount of 0.3-0.5%. At a
concentration of 2%, aerosil contributes to a significant
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decrease in the moisture-sorption properties of the
extract. Further increase in the aerosil content (more
than 2%) does not lead to significant changes in the
moisture absorption properties of the composition.
Therefore, the most optimal concentration of aerosil is
2%.[18-22].
Based on the bulk density of aerosil, we calculated that
the volume occupied by it together with the active
substance is insufficient to fill capsules No. 3 (0.185
cm3). Therefore, we conducted research on the choice
of filler and, based on the data obtained, chose MCC.
Thus, as a result of the research, a composition of
capsules with dry extract "Prostad" was developed,
excipients - 46.6%. Hard gelatin capsules No. 3, average
weight 0.04 g. Average weight of one filled capsule - 0.5
g. When developing the technology, the properties and
state of powders, losses during grinding and the
quantitative ratio of ingredients were taken into
account. Table 4 shows 7 compositions of capsules
"Prostad" selected for the study.
Table 5
Recommended compositions of Prostad capsules
Ingredients
Составы
П
-1
П
-2
П
-3
П
-4
П
-5
П
-6
П
-7
Dry extract
"Prostad"
0,3
0,3
0,3
0,3
0,3
0,3
0,3
Sucrose
0,053
0,053
Lactose M-80
0,053
0,053
0,053
Lactose М-200
0,053
0,053
Magnesium oxide
0,042
0,042
0,052
Potato starch
0,095
0,095
0,095
0,095
0,090
0,090
0,090
Microcrystalline
cellulose
0,042
0,042
0,052
Aerosil
0,01
0,01
0,01
0,01
Calcium stearate
0,005
Stearic acid
0,005
Magnesium
stearate
0,005
Average weight
0,50
0,50
0,50
0,50
0,50
0,50
0,50
In
further
studies,
comparative
technological
properties of granulated masses obtained from the
above-mentioned
compositions
were
studied.
Technological properties were determined in
accordance with the methodology given in the
literature [8-11].The study of the fractional
composition of granulated masses obtained from seven
recipes is shown in Fig. 2.
Fig. 2. Results of a comparative study of the fractional composition of granulated
masses
0%
20%
40%
П-1 П-2 П-3
П-4
П-5
П-6
П-7
Ф
ра
кц
ии
ны
й
со
ст
ав,
%
П-1
П-2
П-3
П-4
П-5
П-6
П-7
150+100
22%
23%
7%
19%
12%
20%
17%
2000 +1000
9%
8%
10%
11%
16%
14%
11%
1000 +500
19%
17%
24%
18%
22%
18%
15%
500 +250
24%
25%
28%
27%
27%
27%
22%
250+150
26%
27%
31%
25%
23%
21%
24%
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As can be seen from the obtained values, the P-3
composition shows a more positive value of the
fractional composition. However, other masses also
give a forecast for improved technological properties of
granules by fractional composition than dry extract
powders separately. The results of a comparative study
of flowability and bulk density of the granulated mass
are shown in Fig. 3 and 4. The study of the technological
characteristics of the granules showed that the
flowability of the obtained granules increased
compared to the powder mixture (3.87 g / sec.). It can
also be noted that the highest (7.99 g / sec.) indicator
relates to the P-3 composition. According to the results
of the study, it is clear that the bulk density indicators
are almost the same as the mixture of these recipes.
Other technological properties (angle of repose,
residual moisture) of the encapsulated mass were close
to powder mixtures. [16-18].
Fig. 3. Results of a comparative study of the flowability of the granulated mass
Fig. 4. Results of a comparative study of the bulk density of the granulated mass
In the future, we used the method of obtaining
capsules after preliminary granulation by the wet
method according to the scheme of granulated powder
shown in Figure 4.
As can be seen from the figure, the initial stage of the
technological process of preparing the production
workshop, equipment, personnel, raw materials.
In the next stages of the technological process
according to the recommended technologies, which is
given above, the technology itself begins according to
the selected composition. Study of quality indicators of
the recommended capsules "Prostad". The research
was continued with the study of the quality of the
recommended capsules "Prostad". The study of the
quality of capsules obtained in the recommended
composition was carried out on the basis of the State
Pharmacopoeia of the Republic of Uzbekistan, literary
sources and relevant ND [18-23]. The following quality
indicators were studied: appearance, average weight
and deviation, disintegration, solubility, etc. The results
obtained are presented in Table 6.
3.98
4.56
7.99
6.45
5.79
5.41
6.11
0
1
2
3
4
5
6
7
8
9
П-1
П-2
П-3
П-4
П-5
П-6
П-7
С
ы
п
уч
ест
ь,
г/
сек
Compositions
498
475
595
546
489
575
455
0
100
200
300
400
500
600
700
П-1
П-2
П-3
П-4
П-5
П-6
П-7
B
ulk
densi
ty,
kg/m
3
Compositions
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Table 6.
Results of the study of quality indicators of capsules "Prostad"
Composit
ions
Appearance
Average weight
and deviations
from it, g, %
Capsule
disintegratio
n, min
Solubility of
capsules, %
P-1
Size No. 3, white gelatin
capsules,
encapsulated
mass of pale brown color
with inclusions, with a
peculiar smell.
0,502±3,35
21
79,67
P-2
-//-
0,502±2,87
20
79,84
P-3
-//-
0,502±3,09
14
88,95
P-4
-//-
0,501±3,64
22
81,31
P-5
-//-
0,501±3,78
20
81,78
P-6
-//-
0,498±3,78
20
80,19
P-7
-//-
0,499±3,83
22
83,71
Рекомендуемый Based on the results of the study, it
was determined that the obtained encapsulated mass
in all formulations met the requirements for
appearance.
The color of the encapsulated mass is pale brown with
inclusions, with a peculiar odor. According to the other
parameters studied, the granules prepared on the
compositions P-1, P-4 and P-7 did not meet the
requirements of the State Pharmacopoeia of the
Republic of Uzbekistan for disintegration (21-22 min.).
Also, the encapsulated masses P-1 and P-4 did not meet
the solubility requirements, i.e. the values were equal
to the requirement. However, this fact can change
during storage of dosage forms. Therefore, it was
considered unsatisfactory. [22-25].
Based on the above, the composition shown in Table 6
was selected for further research.
Table 7.
Recommended composition of the capsule "Prostad"
Name of ingredients
Количество
г
%
Dry extract "Prostad"
0,3
60
Лактоза
М
-80
0,053
10,6
Potato starch
0,095
19
Microcrystalline cellulose
0,042
8,4
Aerosil
0,01
2
Average weight
0,5
100
CONCLUSIONS
Thus, the above results indicate a rational approach to
selecting
the
excipient
complex
during
the
development of encapsulated dosage form technology.
The study results showed that at 100% relative
humidity, the granulated mass lost its flowability within
5 days, absorbing 22.16% moisture. By the end of the
7th day, it had absorbed 29.42% moisture and turned
into a wet mass. At 58% and 79% relative humidity, the
0 50 1 2 3 4 5 6 7 Moisture Absorption% Time, days 58%
79% 90% 100% 167 granulated mass absorbed 4.02%
and 9.44% moisture, respectively. Samples placed in all
three containers retained their flowability until the end
of the experiments, absorbing between 1.06% and
1.21% moisture. Based on the results, it can be
concluded that increasing the surface area of the
sample slightly enhances the moisture absorption
properties of the studied mass.
Tsvet kapsuliruemoy massy bledno korichnego tsveta s
vkrapleniyami, svoeobraznym zapaxom. Po ostalnym
izuchaemym parametram granuly, prigotovlennye na
kompozitsiyax P-1, P-4 i P-7, ne sootvettvovali
trebovaniyam GF RUz po raspadaemosti (21-22 min.).
Takje kapsulirovannye massy P-1 va P-4 ne
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udovletvoryala trebovaniyam po rastvorimosti, t.e.
znachenie byli ravny trebovaniyu. Odnako etot fakt
mumkin byt izmenen pri hranenii lekarstvennyx form.
Rezultaty issledovaniy pokazali, chto pri dobavleii 0,3
–
0,5% aerosila supchest kompozitsii povyshaetsya ot 1,2
dan 1,5 gacha. Uvelichenie soderjaniya aerosila ne
uluchshalo sypuchest bolee chem v 1,6 raza.
Sledovatelno, qanday antifriksionnoe veshchestvo
aerosil dostatochno vzyat v kolichestve 0,3
–
0,5%. V
kollegiali 2% aerosil sposobstvuet znachitelnomu
snijeniyu
vlagosorbtionnyh
svoystv
ekstrakta.
Dalneyshee uvelichenie soderjaniya aerosila (bolee 2%)
ne
qabul
k
sushchestvennym
izmeneniyam
vlagosorbtionnyh svoystv kompozisiya. Poetomu
naibolee optimalnoy yavlyaetsya konsentratsiya
aerosila 2%.
Ishodya iz nasypnoy massy aerosila, my rasschitali, chto
ob'em, zanimaemyy im vmeste s deystvushhim
veshchestvom, nedostatochen uchun zapo
lneniya № 3
kapsul (0,185 sm3). Poetomu nami byli provedeny
issledovaniya po vyboru napolnitelya va po
poluchennym dannym vybrali MKTs.
Takim obrazom, natijada provedennyh issledovaniy
razrabotan sostav kapsul va suxim ekstraktom
«Prostad», vspomogatelnyh veshchestv - 46,6%.
Tverdye jelatinovye kapsuli № 3, sredney massoy 0,04
g. Srednyaya massa odnoy napolnennoy kapsuli - 0,5 g.
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