UNIVERSITI KEBANGSAAN MALAYSIA
LABORATORY REPORT
DEVELOPMENT
OF PHARMACEUTICAL
PRODUCTS
1
(NFNF 2213)
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ASSESMENT OF QUALITY OF TABLETS AND CAPSULES
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TITLE :
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GROUP
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B
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NAME
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SITI NURFATIN ATHIRAH BINTI ALIAS
CHRISTINE SHEK AI JIA
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A148978
A148822
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NUR AMALINA BINTI AZMI
LEE NING HUAN
NUR LIYANA BINTI HASSAN
NUR WAHIDAH BINTI HASSAN
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A148533
A149304
A149008
A149020
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LECTURER’S NAME
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SEMESTER 1,
SESSION 2015-2016
FACULTY OF PHARMACY
Introduction
Like all other dosage forms, tablets and capsules
are subjected to those pharmacopoeial standards which deal with “added
substances” with respect to their toxicity, interference with analytical
methods, etc. However, there are a number of procedures which apply
specifically to tablets and capsules, and which are designed, not only to ensure
that a tablet or a capsule exerts its full pharmacological actions, but also to
determine the uniformity of the physical properties of the official
tablet/capsule, irrespective of the manufacturer.
Such standards are found in the British
Pharmacopoeia and United Pharmacopoeia and include, uniformity of diameter,
uniformity of weight (mass), content of active ingredient, uniformity of
content, disintegration and dissolution. In addition, there are a number of
quality control procedures, which, though widely applied, are not defined by
the pharmacopoeias (non-pharmacopoeial standards) such as thickness, hardness
and friability.
The following experiments demonstrate the
application of a number of selected physical and dosage performance tests on
samples of commercially available tablets and capsules. Students are required
to refer to official pharmacopoeias for detailed description of other tests not
carried out in this practical session.
Procedure
Experiment 1 Uniformity of diameter,
thickness and hardness
Tablet used:
Redon tablets
1. 10 tablets were selected and tests werecarried
out for uniformity of diameter, thickness and hardness using the Tablet Testing
Instrument (PHARMATEST PTB 311).
2. The deviation of individual unit from the mean
diameter should not exceed ±5% for tablets with diameter of less than 12.5 and ±
3% for diameter of 12.5 mm or more.
Experiment 2 Tablet friability
Tablet used:
Redon tablets
1. 10 tablets were selected and weighted.
2. All tablets were put into the drum of the tablet
abration and friability tester. The machine was set with operation of the rate
of rotation to 100 rpm, time to 10 minutes and the operation was started.
3. At the end of the operation, all the tablets were
removed and ensure freedom from dust or powder (use the brush). The tablets
were weighted. The percentage loss of weight was determined.
4. Compressed tablet should nor lose more than 1% of
its weight.
Experiment 3 Uniformity of weight of
tablets and capsules
Tablets
Tablet used:
Redon tablets
1. 20 tablets were previously selected at random. The
average weight was determined.
2. Tablets were weighted individually and recorded.
3. For each tablet, the percentage deviation of it’s
weight from the average weight was determined.
3. The deviation of individual weight from the
average weight should not exceed the limits given below.
Average
weight of tablet
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Deviation
(%)
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Number
of tablets
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Less
than 80 mg.
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±
10.0
±
20.0
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Minimum
18
Maximum
2
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80
mg to 250 mg
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±
7.5
±
15.0
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Minimum
18
Maximum
2
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More
than 250 mg
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±
5.0
±
10.0
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Minimum
18
Maximum
2
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Capsules
Capsule used:
Ampillin capsule
1. 20 capsules were selected at random.
2. One capsule was weighted. The capsule was then
opened and the contents were removed as completely as possible. The emptied
shells were weighted and recorded. The net weight of its contents was
determined, that is by subtracting the weight of the shells from the weight of
the intact capsule.
3. The procedure 2 was repeated with other 19
capsules.
4. The average net weight was determined from the
sum of the individual net weights.
5. The percentage deviation from the average net
weight for each capsule was determined. The deviation of individual net weight
should not exceed the limits given below:
Average
net weight of capsule
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Deviation
(%)
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Number
of tablets
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Less
than 300 mg
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±
10.0
±
20.0
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Minimum
18
Maximum
2
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300
mg or more
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±
7.5
±
15.0
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Minimum
18
Maximum
2
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Results
Experiment 1
Tablet
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Thickness(mm)
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Hardness(N)
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Diameter(mm)
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1
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4.07
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232.23
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12.75
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2
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4.00
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215.60
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12.74
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3
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4.01
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231.30
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12.76
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4
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4.09
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255.50
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12.76
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5
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4.10
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250.52
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12.77
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6
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3.99
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250.70
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12.74
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7
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4.10
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255.32
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12.77
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8
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4.07
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242.20
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12.76
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9
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4.12
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232.04
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12.83
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10
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4.14
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270.25
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12.76
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Experiment 2
Weight of 10 Redon tablets before test: 5.7041g
Weight of 10 Redon tablets after test: 5.6652g
Percentage of loss of weight =
= 0.6820 %
Experiment 3
Tablets
The weight of the 20 Redon tablets : 11.4281g
Average weight(mean) =
= 0.571405g
Percentage of deviation from the average mass (%) =
Where X is the weight of the tablet.
Tablet
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Weight of tablet (g)
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Percentage of deviation from the
average mass (%) (rounded off to 4 decimal places)
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1
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0.5739
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0.4367
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2
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0.5677
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0.6484
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3
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0.5761
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0.8217
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4
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0.5694
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0.3509
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5
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0.5696
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0.3159
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6
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0.5710
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0.0709
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7
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0.5907
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3.3780
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8
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0.5628
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1.5060
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9
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0.5734
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0.3491
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10
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0.5778
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1.1192
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11
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0.5709
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0.0884
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12
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0.5668
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0.8060
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13
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0.5916
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3.5343
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14
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0.5708
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0.1059
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15
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0.5737
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0.4016
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16
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0.5650
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1.1209
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17
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0.5656
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1.0159
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18
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0.5626
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1.5409
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19
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0.5668
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0.8059
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20
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0.5619
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1.6634
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Capsules
Net weight of the content in the capsule = Weight of
capsule - weight of emptied shells
Average net weight =
= 0.29705 g
Percentage of deviation from the average net weight =
Where Y is the net weight of the content in the
capsule.
Capsule
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Weight of capsule (g)
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Weight of emptied shells(g)
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Net weight of the content in the
capsule(g)
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Percentage of deviation from the
average net weight (%) (rounded off to 4 decimal places)
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1
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0.3684
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0.0628
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0.3056
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2.8783
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2
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0.3404
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0.0607
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0.2797
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5.8408
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3
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0.3583
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0.0654
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0.2929
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1.3971
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4
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0.3673
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0.0653
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0.3020
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1.6664
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5
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0.3506
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0.0612
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0.2894
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2.5753
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6
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0.3764
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0.0646
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0.3118
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4.9655
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7
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0.3534
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0.0568
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0.2966
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0.1515
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8
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0.3573
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0.0623
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0.2950
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0.6901
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9
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0.3734
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0.0655
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0.3079
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3.6526
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10
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0.3548
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0.0622
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0.2926
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1.4981
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11
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0.3652
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0.0640
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0.3012
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1.3971
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12
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0.3497
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0.0596
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0.2901
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2.3397
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13
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0.3676
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0.0626
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0.3050
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2.6763
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14
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0.3619
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0.0594
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0.3025
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1.8347
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15
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0.3484
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0.0587
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0.2897
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2.4743
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16
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0.3696
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0.0621
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0.3075
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3.5179
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17
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0.3690
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0.0611
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0.3079
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3.6526
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18
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0.3733
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0.0656
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0.3077
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3.5853
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19
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0.3480
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0.0610
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0.2870
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3.3833
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20
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0.3327
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0.0638
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0.2689
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9.4765
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Sum
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7.1857
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1.2447
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5.9410
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Discussion
This experiment is conducted to test the hardness, thickness and
diameter of the selected tablet brand Redon. For thickness of the tablet, the
result shows that the 10 tablets have the thickness range from 3.99mm to
4.14mm. The
average thickness of the tablet is 4.07mm whereas for diameter of the tablet,
the result shows that the 10 tablets have the diameter range of from 12.74mm to
12.83mm. The thickness and hardness test are both under
non-pharmacopoeial standards and is widely used by the manufacturers itself.
This slight variation in the thickness and diameter of tablet might be due to
the changes in die fill, particle distribution, variation in the granulation process
and force
used to compress the powder.Greater force applied will produce thinner and more
compact tablet, and a more compact tablet will take longer to disintegrate,
dissolve and be absorbed by the body. Tablet size is very important in
packing operation as Very thick tablet affects packaging such
as blister pack or plastic container. Besides, thin tablet will be easily broken
during transportation or packaging. The deviation for the thickness of a
individual tablet should not be more than ±5 % from the average
thickness of the tablet. The data collected shows that all the 10 tablets is
less than ±5 % from the average thickness of the tablet. The thickness of
tablet can affect the therapeutic effectiveness of tablets. On the other hand,
the diameter of a individual tablet should not more than ±3 % from the average
thickness of the tablet.. The data collected shows that all the 10 tablets is
less than ±3 % from the average diameter of the tablet.
Measurement of the thickness of tablet
Measurement of the diameter of tablet
Diametrical crushing
is used in this experiment due to its simplicity. Hardness is being defined as
the force required to break the tablet in a diametric compression test, this is
also known as tablet crushing strength or breaking strength. Tablet hardness
depend on the compression load. Hardness increase when the pressure is
increase, as it will cause the tablet to laminate or cap. The hardness of a
tablet depends on the concentration of the binder used and also the compression
force exerted onto the compound in tableting. The weight of the material to be
compressed and the space between the upper and lower punch at the time of
compression also contribute to the variation in hardness of the tablet. The force
required to exert on the 10 tablets varies from 270.25 N to 215.60 N. Friability
is the tendency for a tablet to chip, crumble, fragment or powder during the
handling of the tablet and this can be considered as another way to test the
hardness of the tablet. This tendency is normally confined to uncoated tablets
during the handling or storing process. Roche friabilator is used to measure the friability of a
tablet. The 10 pre-weighed is placed inside the friabilator and dropped over a
distance of 6 inches during each revolution for speed at 25 rpm for 10 minutes.
The tablets are then dusted and weighed again and the weight loss is recorded. The
friability of the tablet can be affected by the moisture of the tablets.
Besides, it is also inevitable that some fragments of the
previously used tablets are still present in the machine. The percentage of
loss of weight of the tablet after the friability test is 0.6820 %. The result
might be affected if the machine is not clean thoroughly before the next batch
testing starts, it may causes impurities to stick onto the tablets and cause
inaccuracy of the mass of the tablets during weighing process.
The Roche Friabilator
Tablets
are generally manufactured to contain specific amount of active ingredient in
certain weight of tablet. The weight variation test is carried out to
investigate the uniformity of the weight of tablet and capsule. The uniformity
of the drug is important to ensure accurate and consistent dosage form to be
administered by patients. In the
experiment, since the average mass obtained for 20 tablets is 0.571405 g that
is greater than 250mg, thus minimum 18 tablets should not deviate from 0.571405
g by ±5%. The uniformity of weight of tablets is acceptable as all 20 tablets
fall within the range limit of mass (0.5619 g to 0.5739g). For capsule, the
average mass obtained is 297.05 mg that is less than 300mg, thus minimum 18
capsules must not deviate from average netmass by ± 10 %. The uniformity of
capsule is acceptable as all the 20 capsules fall within the range limit (
268.90 mg to 311.80 mg). We assume that the concentration of drug, which is the weight of drug
per weight of dosage form, is uniform. Thus, all the 20 tablets and capsules
pass the test. The results of the test of uniformity of weight may
not be accurate as there is always substance left in the capsules when they are
emptied from the shells. The shell of capsule should be completely emptied
before weight. Besides, the balance should calibrated first before doing the
experiment.
Conclusion
From this experiment,we can conclude that :
1.
The diameters, thickness and the
hardness of this tablet are in uniform range and the tablet fulfil the standard
properties required.
2.
The tablets a percentage loss of weight of 0.6820 %
which is less than 1%. So, we can conclude that the tablets comply with the
friability test.
3.
The percentage deviation from the
average weight of the tablets and capsules does not exceed more than
the percentage deviation stated. So, all the 20 tablets and
capsulesobey the standard properties required.as they have uniform weight.
EXPERIMENT 4 DOSAGE PERFORMANCE TEST
Disintegration test for sugar coated
tablets
1.the apparatus is set up for the disintegration
test according to its operational test.
2.The temperature of the disintegration medium water
37 degree celcius is ensured.
3.the time is set to 60 minutes .the tablet is
introduced one into each tablet,and the disk is added into each tube and the
operation is started.
4.At the end of the operation,check the tablet in
each tube
5.If all 6 tablets disintegrate in 60 minutes,the tablets
comply with the test.the experiment is repeated by using 6 new tablets if there
is any tablet that does not disintegrate but
replacinv the disintegration medium (water) with 0.1M hydrochloric acid
.If all 6 tablet disintegrate in acidic medium,the tablets comply with the
test.
Dissolution test for tablets
1.Each of the dissolution vessel is filled up with
the buffer solution to 900ml mark.The
temperature is set up to 37 degree celcius.
2.the temperature of dissolution medium is checked
and it is ensured at 37 degree celcius.
3.One Ibuprofen tablet is placed into each dry
basket assembly.
4.the stirring speed is set up to 150
rpm..Assembly,the basket is lowered into position I the vessel and the
operation is started.
5.10 samples of the dissoltuyion medium from each vessel
is withdrawed after 30 minutes the solution is filtered by using suitable
filter.From a point half-way between the surface of the dissolution medium and
the top of rotating baslet,the sampling should be done and not less than 10 mm
from the wall of the vessel.The volume of aliquot withdrawn for analysis with
an equal volume of the dissolution medium is replaced .
6.The standard solution ofIbuprofen is prepared by
diluting 10.0 mg of Ibuprofence reference standard to 50 ml with dissolution
medium.
7.2.0 ml of sample solution and 2.0 ml of standard
solution is diluted to 25 m with dissolution medium in separate volumetric
flask.
8.the absorption of both solutions is measured in a
1 cm cell at a wavelength of 221 cm.
9.The percentage amount of Ibuprofen dissolved using
the following formua is calculated.
At/As .W/50 . P.900 .25/2
.100/200
At= absorbance of sample solution
As=absorbance of the standard solution
W=weight of Ibuprofence reference standard
P= purity of Ibuprofen standard.
10.Determine whether the tablets comply with the
requirement of the Britih Pharmacopoeia from the results obtained.
DISCUSSION
DISINTEGARTION TEST FOR SUGAR COATED
TABLETS
Tablets
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Disintegration test with water
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Time needed to fully disintegarte
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1
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Pass
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2.12 minutes
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2
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Pass
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2.15 minutes
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3
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Pass
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2.20 minutes
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4
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Pass
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2.21 minutes
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5
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Pass
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2.27 minutes
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6
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Pass
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2.30 minutes
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Average
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2.21 minutes
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For a drug to be absorbed from a solid dosage
form after oral administration, it must first be in solution, and the first
important step toward this condition is usually the break-up of the tablet; a
process known as disintegration.The disintegration test determines whether
tablets or capsules disintegrate within the prescribed time when placed in a
liquid medium in the experimental conditions prescribed above. Disintegration
is considered to be achieved when there are no residue remains in the tube, or
if there is a residue, it consists of a soft mass having no palpably firm,
unmoistened core, or only fragments of coating (tablets) or only fragments of
shell (capsules) remain in the tube; if a disc has been used (capsules),
fragments of shell may adhere to the lower surface of the disc. Disintegration test is only
applicable for uncoated tablets, sugar coated tablets , enteric-coated tablets,
soluble tablets, dispersible tablets, hard capsules, soft capsules and enteric
capsules. For this experiment,we use the non-steroidal
anti-infalmmatory analgesic tablets.In this experiment, non-steroidal
anti-infalmmatory analgesic tablets passes the disintegration test because no
residue left after 60 minutes.In fact,those tablets The possible errors that occur during the
experiment are the temperature is less than 37°C so the tablet does not
disintegrate according to the body temperature. Other than that, the tablet use
has already reached its expiry date and does not disintegrated properly.
From this test, in average, a non-steroidal anti-infalmmatory
analgesic tablets would need 2.31 minutes to be fully
disintegrate using Apparatus A setup. The standard set for this experiment was
to have the tablet disintegrate not more than one hour in water medium. So, non-steroidal
anti-infalmmatory analgesic tablets
have succeeded this test. But this results did not really imitate how the
preparation would disintegrate in human body. Multiple parameters to really
imitate our body system upon drug intake were not provided. Some of these
parameters include the different pH and motility in different parts of
gastrointestinal tract. This result is not guarantee to be the same as in an
actual person. It might be lot more faster since the motility of human GI tract
were quite vigorous and the pH were lower.
There might be preparation that failed this test but actually would be
able to be fully disintegrate in an actual human.
Some precaution need
to be taken during this experiment. The
coating of a tablet did not subjected to be disintegrate within the time limit.
We must pay close attention on identifying that the content of the tablet
comply with the standard stated. When a formulation have reached the time limit
but still have bit of it that did not fully disintegrate, check by squishing it
to see whether the fragments still have part that did not come in contact with
the water (still in it dry hard tablet or dry powdered tablet form). If the
first batch did not meet the requirement, the test need to be repeated using
same number of new tablet but the medium now is 0.1M hydrochloric acid. The
possible error during this experiment is the tablet already reached its expiry
date and does not disintegrated properly.
DISSOLUTION
TEST FOR TABLETS
A
dissolution test is a means of identifying and proving the availability of
active drug materials in their delivered form. A dissolution test simulates the
availability of active substance and allows the prediction of the time for
complete release of the material from the dosage form. The release of drug
from the tablet into the solution per unit time under standardize condition is
called dissolution test. In this experiment, we using USP apparatus I that using
basket.
In vitro dissolution testing of
solid dosage forms is important because:
Dissolution studies in the early
stages of a product’s development allow differentiation between formulations
and correlations identified with in vivo bioavailability data. The conduct of
such testing from early product development through approval and commercial
production ensures control of any variables of materials and processes that
could affect dissolution and quality standards. Consistent in vitro dissolution
testing ensures bioequivalence from batch to batch. It is a requirement for
regulatory approval of marketing for products registered with the FDA and
regulatory agencies of other countries.
In this experiment by using the
formula, the percentage of ibuprofen dissolve is 23.9%. This amount is does not
achieved USP limit that stated that not less than 75% of stated amount of
ibuprofen dissolve in 30 minutes. The possible errors that may occur during the
experiment are the temperature is less than 37°C so the tablet does not
dissolve properly. Other than that, the tablet use has already reached its
expiry date and does not dissolve to get it optimum percentage concentration.
In order to reduce error, the method of dissolution testing must be controlled
to minimize important variables such as basket rotational speed, vibration, and
disturbances by sampling probes.
In addition to method of
dissolution, formulation and manufacturing controls also play important role
why the tablet does not achieved USP dissolution unit. A number of formulation
and manufacturing factors can affect the disintegration and dissolution of a
tablet, including particle size of the drug substance; solubility and
hygroscopicity of the formulation; type and concentration of the disintegrant,
binder, and lubricant; manufacturing method, particularly the compactness of
the granulation and compression force used in tableting.
Experiment
5
1.20 ibuprofen previously selected at random Tablets
was weighed and powdered.
2.A quantity of powder containing 0.5 g ibuprofen
with 20 ml chloroform was extracted for 15 minutes and filtered through a
sintered glass crucible.
3.The residue was washed with 3 x 10 ml chloroform
and the combined filtrate was evaporated gently just to dryness in a current of
air.The residue was dissolved in 100ml with ethanol (96%) previously
neutralized to phenolphthalein solution.
4.The solution was titrated with 0.1M sodium
hydroxide to end point with phenolphthalein solution as the indicator.The
content of ibuprofen was calculated.
RESULTS
AND CALCULATION
This
experiment had provided a container with 20 crushed 200mg ibuprofen tablet
weighing 7.94g.
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1 of the 200mg ibuprofen tablet ≡ 200mg of
ibuprofen
20 of the 200mg ibuprofentablets ≡ (20×200)/(1)
= 4000mg of ibuprofen in the 7.94g of crushed
tablets
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500mg
of ibuprofen is needed to be extracted for this experiment.
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The
quantityibuprofen needed× Mass of crushed
tablets total = Masss of crushed tablet needed
The
total quantity ibuprofen present
500mg
× 7940mg =Mass of crushed tablet needed
4000mg
992.5mg =Mass of the crushed
200mg ibuprofen tablet needed to extract 500mg of ibuprofen
0.9925g=
|
Mass of ibuprofen powder =0.9934g
Volume of NaOH to reach endpoint=20.8 mL
Concentration of NaOH used= 0.1 M
Moles of NaOH used= (20.8×10-3) L×0.1molL-1=
2.08×10-3mol
Molar mass of ibuprofen(C13H18O2)
= 206.3gmol-1
Moles of ibuprofen (C13H18O2)
present = (0.5g)/(206.3gmol-1) = 2.424×10-3mol
Compound
|
NaOH
|
C13H18O2.
(Ibuprofen)
|
Number of moles (mol)
|
2.08×10-3
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2.424×10-3
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Mole ratio
|
2.08×10-3
2.08×10-3
= 1
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2.424×10-3
2.08×10-3
=
1.165≈ 1
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The
mass of ibuprofen present based on the experiment
1mL of 0.1M NaOH≡ 0.02063g ofC13H18O2
(ibuprofen)
20.8mL
of 0.1M NaOH≡20.8× 0.02063
1
=0.4291g
Discussion
In this experiment,the theory amount is 0.5 g.While
in our experiment,we get 0.4291 g,which is slightly far from the theory
one.There must be some reasons that can cause the value can differ from
theory.Ourtecniques which applied during experiment maybe less effective and
therefore,it effects the results.
One of the possible errors is during we crushed the
tablets.We used the mortar and pestle to in the process.Some of the substance
may drop out and loss during the crushing process.Maybe we crushed too strong
and not efficiently.So,fromthis,we have to to practice crushing gently and
consistently.
Next,the ibuprofen that we used may already
expired.So,its contents already decomposed and not not active anymore.Ibuprofen
is very important component in this experiment as it plays the main role to the
results.Therefore,to ensure the accuracy,we have to use the non expired
ibuprofen.
Another one,the powder has to be filtered
through a sintered glass crucible.But instead of sintered glass crucible,we
only used filter funnel and beaker.Therefore,effect from that,some powder that
not supposed to pass the filter,they got to pass it.This error causes in
alteration of the powder uniformity .The last point is the error might happen
due to titration of solution with sodium hydroxide.Maybe we missed the actual
end point of the solutioin to turn from colorless to pale pink in colour.
Questions
1. 1.What
are the objectives of the tests for uniformity of diameter and uniformity of
content?
The
objectives of the tests for uniformity of diameter are to increase the patient
compliance by increasing the quality of product appearance and also to prevent
any confusion towards the patient about the dosage of the medications. The
objectives of the tests for uniformity of content are to ensure uniform dosage
supplied to the patient and prevent from overdose cases due to non-uniform
amount of active ingredients in the capsules or tablets.
2. 2. State
the types of tablets and capsules that must be tested for uniformity of
diameter and uniformity of content.
Uniformity of diameter tests
involves all the uncoated and coated tablets except for the enteric tablets,
film-coated tablets and sugar-coated tablets. For uniformity of content tests,
it involves all tablets.
3. 3.Give
reasons for the non-compliance to test for uniformity of weight.
The reasons for non-compliance to
test for uniformity of weight are uneven feeding of granules into the die and
due to irregular movement of the lower punch that cause variation in capacity
die space.
4.
Why is dissolution
test suitable to be used for batch to batch quality control?
It is suitable to be
used for the batch to batch quality control because of the small quantity of
the tablets required to ensure the quality and uniformity of the tablets. It is
also suitable due to its ability to measure the amount of active ingredient
that has dissolved in a volume of dissolution medium at the prescribe time.
This guarantees the routine batch release reaches the required level needed for
the tablets if not, it will be rejected and not sold into the market. This test
is also able to test the stability of each batch of tablets manufactured,
ensuring the tablets will not have any defects in terms of dissolution for the
absorption of the active ingredient. It is also needed for the registration of
the tablets manufactured by the companies. This is because to support the
results of the bioequivalence study done by some companies to the generic drugs
manufactured by their company. Finally, it is suitable for batch to batch
quality control because it is able to justify the waiver in the in vivo BE data
5. Describe other
apparatuses that are listed in pharmacopoeias that can also be used in
dissolution testing of tablets and capsules.
The apparatus used in
the experiment was called a basket apparatus. It consists of a vessel that can
be covered, a motor, a drive shaft and a cylindrical basket that acts as a
stirring element. The vessel could be made of glass or other inert, transparent
material.
The other apparatuses
that are listed in pharmacopoeias that can be used in the dissolution testing
of tablets and capsules are the paddle apparatus, reciprocating cylinder and a
flow-through cell. The paddle apparatus uses the same assembly as the Basket
apparatus, except that a paddle formed from a blade and a shaft is used as the
stirring element instead of a cylindrical basket. The shaft is position so that
its axis is not more than 2mm from the vertical axis of the vessel at any
point, and rotates smoothly without significant wobble that could affect the
results.
There is also the
reciprocating cylinder. The assembly consist of a set of cylindrical,
flat-bottomed glass vessel, a set of glass reciprocating cylinders, inert
fittings which are stainless steel type 316 or other suitable material and
screens that are made of suitable nonsorbing and nonreactive material. The
screens are also designed to fit the tops and bottoms of the reciprocating
cylinders horizontally to a different row of vessels. The vessels are partially
immersed to a suitable water-bath of any convenient size that permits holding
the temperature at around 37degree Celsius with a maximum plus or minus of 0.5
degree Celsius during the test. No part of the assembly, including the environment
in which the assembly is placed, contributes significant motion, agitation, or
vibration beyond that due to the smooth vertically reciprocating cylinder. A
device is used that allows the reciprocation rate to be selected and maintained
at the specified dip rate, within plus or minus 5 per cent. The vessels are
provided with evaporating cap that remains in place for the duration of the
test.
Flow-through cell is
also one of the apparatus that can be used to test the dissolution of a tablet
or a capsule. This apparatus consist of a reservoir and a pump for the
dissolution medium, a flow-through cell, a water-bath that maintains the
dissolution at 37 degree Celsius with a plus or minus of 0.5 degree Celsius. A
specified cell size must be used accordingly. The pump forces the dissolution
medium upwards through the flow-through cell. It must beconstant flow, the flow
profile is sinusoidal with a pulsation.
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