Beruflich Dokumente
Kultur Dokumente
DOI 10.1007/s10973-011-2151-z
G. Pavlovska (&)
Faculty of Technology and Technical Sciences-Veles, University
St. Kliment Ohridski-Bitola, Petre Prlichkov 42, 1400 Veles,
Republic of Macedonia
e-mail: pavlovskagorica@yahoo.com
S. Tanevska
Varus, Skupi 15, 1000 Skopje, Republic of Macedonia
Introduction
As generally known, vitamins are essential substances,
which are necessary for normal health and growth. Vitamin
C is a powerful antioxidant essential for human organism
and needs to be entered in a certain amount through the
food every day, to prevent diseases [1]. If this intake is
insufficient or if exist special dietary requirements, it is
necessary to make something to prevent vitamin deficiency. The lack of vitamin C is supplemented by various
agents and is often formulated as film coated dragee that is
readily available in the market [2]. Vitamin C chewable
tablets are a new vitamin product of Jaka 80 AD, Macedonia and are intended primarily for pediatric and geriatric
patients. They are produced according to all regulations in
the pharmaceutical industry [37].
Vitamin C exists in two forms: ascorbic acid (AA)
where mostly exists and dehydroascorbic acid (DHAA),
which is its oxidation product, but has also vitamin properties. AA is stable in acidic environment, while in weak
acid, neutral and basic environment in the presence of
moisture and oxygen can be easily oxidized to DHAA [8
10]. In the presence of moisture and increased temperature
DHAA oxidize into diketogulonic acid (DKGA) irreversibly, which does not have vitamin properties [912]. The
period of half-life in aqueous solution is 6 min at 37 C,
but the extent of AA oxidation to DHAA and its hydrolysis
to DKGA depends on concentration, temperature, pH,
light, etc. [10, 11]. The speed of degradation of unprotected
AA usually is increased double by increasing the temperature for every 10 C.
The aim of this investigation is production of chewing
tablets of vitamin C, according to the prescribed concentration of ascorbic acid, but also preventing its decomposition before their limit date of use. The great instability of
123
G. Pavlovska, S. Tanevska
Experimental conditions
Apparatus
Applying polymer EC is performed in Fluid-bed granulators GLATT AG (Switzerland). Temperature of input air,
air flow, and other parameters in Fluid-bed granulator are
given in Table 1.
Chewable tablets are packed into four primary types of
packaging:
123
Value
60
200
200
20
Inflicted, mL min-1
510
Temperature of product, C
3035
25
Ascorbic acid/%
100
Parameters
80
Primary packaging
PP
container
for pills
Al/PVC
strips
Glass
bottle
Al.PE/
PE.Al
strips
Color
White
White
White
Strength, kp
10.2
10
10.65
100.08
98.12
104.5
Friability, %
0.6
0.6
0.6
Time of
reintegration,
min
1.4
1.4
1.4
Moisture, %
0.42
2.23
0.4
0.33
After 6 months
White
Dark yellow
spots, soft
tablets
White
White
60
40
After 3 months
20
0
3
12
Ethyl cellulose/%
Parameters
Primary packaging
PP container
for pills
Al/PVC
strips
Glass
bottle
Strength, kp
9.5
Al.PE/
PE.Al strips
93.21
Friability, %
0.8
0.7
0.6
White
Time of
reintegration,
min
1.55
1.5
1.4
Moisture, %
0.56
2.42
0.5
0.33
White
Yellow
spots
White
Strength, kp
88.3
Color
White
White
White
Strength, kp
10.65
10.65
10.65
10.65
104.5
104.5
104.5
104.5
Friability, %
0.6
0.6
0.6
0.6
Time of
reintegration,
min
1.4
1.4
1.4
1.4
Moisture, %
0.33
0.33
0.33
0.33
10
10.65
98.12
104.5
After 12 months
Color
Color
9.2
10
90.2
98.12
Friability, %
0.8
0.9
0.6
Time of
reintegration,
min
1.6
1.6
1.45
Moisture, %
0.6
2.53
0.8
0.4
120
AA/%
100
Initial analysis
80
AA after 3 months
60
AA after 6 months
40
AA after 12 months
20
0
PP container
for pills
Al/PVC strips
Glass bottle
Al,PE/PE,Al
strips
123
G. Pavlovska, S. Tanevska
120
AA/%
100
80
AA initial analysis
AA after 3 months
60
AA after 6 months
40
AA after 12 months
20
0
DHAA/%
PP container
for pills
Al/PVC strips
Glass bottle
Al,PE/PE,Al
strips
14
12
10
8
6
4
2
0
Glass bottle
Al,PE/PE,Al
strips
DKGA/%
25
20
15
10
0
PP container Al/PVC strips
for pills
Procedure
Betting with EC
To prevent the breakdown of AA and maintain its stability
we coat each particle with 10% solution of EC in 96%
solution of ethyl alcohol. This process is performed in the
Fluid-bed granulators. AA particles are moving pneumatically through power from moderately hot air and spraying
with the prepared EC solution that has previously been
turned into very tiny droplets or atomized in the atomizer.
Particles are immediately dried in a warm current of air
after falling down, and other particles move up. The process repeats. In this way we achieve evenly coating of each
particle of the AA solution of EC.
The resulting granules together with other components
of vitamin C in chewing tablets are tableting with firm
compression.
123
Glass bottle
Al,PE/PE,Al
strips
Primary packaging
PP
container
for pills
Al/PVC
strips
Glass
bottle
Al,PE/
PE,Al
strips
Color
Yellow
spots
Yellow spots,
soft tablets
Yellow
spots
White
Strength, kp
10
88.3
88.3
98.12
Friability, %
1.2
Time of
reintegration,
min
1.5
Moisture, %
0.8
After 3 months
0.6
0.9
1.45
2.73
0.7
0.4
Soft,
brawn
tablets
Soft, brawn
tablets
Yellow
spots
Yellow
spots
After 6 months
Color
Strength, kp
N
78.496
88.3
Friability, %
1.5
1.3
Time of
reintegration,
min
1.5
1.45
Moisture
2.1
3.52
0.9
0.8
120
AA/%
100
80
AA initial analysis
60
AA after 3 months
40
AA after 6 months
20
0
PP container
for pills
Al/PVC strips
Glass bottle
Al,PE/PE,Al
strips
DHAA/%
20
15
10
5
0
PP container
for pills
Al/PVC strips
Glass bottle
Al,PE/PE,Al
strips
100
80
DKGA/%
60
40
Al/PVC strips
Glass bottle
Al,PE/PE,Al
strips
123
G. Pavlovska, S. Tanevska
Conclusions
Since AA is a very unstable substance with increased
temperature and humidity, chewable tablets are obtained
with special technology-fluidization. In this process each
piece of AA bets with a layer of polymer EC that is not
soluble in water, to protect from moisture and temperature
changes. The optimum layer thickness is established and it
123
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