SER Plagiarism Report
SER Plagiarism Report
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Method:
Fast dissolving tablets of Levosalbutamol sulphate were prepared by direct compression method
according to the formula given in Table No. 1. All the ingredients were passed through 60 mesh sieves
separately. The drug and microcrystalline cellulose were mixed by small portion each time of both,
blending it to get a uniform mixture and kept side. Then the ingredients were weighted and mixed in
geometrical order and tablets were compressed of 8 mm sizes flat capsule type punch to get tablet
using Pam Compression Machine.
Post -compression properties:
• Hardness
• Friability
• Weight variation
• Uniformity of thickness
• Drug content uniformity
• Wetting time
• In-vitro disintegration test
• In-vitro dissolution Test
Hardness Test:
Although hardness test is not an official, tablet should have sufficient handling during packing and
transportation. Hardness of tablet was measured using digital hardness tester. It is the pressure
requires for fracturing diametrically placed tablets by applying the force. The hardness of 5 tablets
from each batch was determined and average of reading in triplicate was calculated, which was
expressed in kg/cm².
Friability Test (F):
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Friability of the tablet determined using Roche friabilator. This device subjects the tablet to the
combined effect of abrasion and shock in a plastic chamber revolving at 25 rpm and dropping a
tablet at height of 6 inches in each revolution. Reweighed sample of tablets was placed in the
friabilator and were subjected to the 100 revolutions. Tablets were dusted using a soft muslin cloth and
reweighed. The friability (F) is given by the formula.
F= W initial – W final x 100
W initial
% of Friability of tablets less than 1% is considered acceptable.
Weight Variation Test:
With a tablet designed to contain a specific amount of drug in a specific amount of formula, the
weight of a tablet being made is routinely measured to ensure that a tablet contains proper amount
of drug. Procedure: Weight of 20 tablets was determined and average weight was calculated. Then
individual tablets were weighed and the individual weight was compared with an average weight.
Shows the weight variation tolerance for tablets
Table no.3
Average weight of tablet (mg) Maximum percent deviation allowed
130 mg or less 10%
More than 130 mg and less than 324mg 7.5%
324 mg or more 5%
Uniformity of Thickness:
The crown thickness of individual tablet may be measured with a micrometer which permits accurate
measurements and provides information on the variation between tablets. Other technique
employed in production control involves placing 5 or 10 tablets in holding try, where their total crown
thickness may be measured with a sliding caliper scale, the tablet thickness was measured using
screw gauge.
Drug content uniformity:
The test is applicable for tablets that contain less than 10 mg or less than 10% w/w of active ingredients.
The test for uniformity of content should be carried out only after the content of active ingredient in a
pooled sample and tablets have been shown within acceptable limits of the started content. Ten
tablets were taken and their content was determined by UV spectrophotometry.
Wetting Time:
The method was applied to measure tablet wetting time. A piece of tissue paper folded twice was
placed in a small Petri dish (i.d. = 6.5 cm) containing 10 mL of water to a tablet was placed on the
paper, and the time for complete wetting was measured three trials for each batch were performed
and standard deviation was also determined. The method was reported by Yunxia Bi et al.
Disintegration Time:
The process of breakdown of a tablet into smaller particles is called as disintegration. The invitro
disintegration time of a tablet was determined using disintegration test apparatus as per I.P.
specifications.
I.P. Specification place one each of the basket. Add a disc to each tube and run the apparatus using
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distilled water maintained at 37º±2ºC as the immersion liquid.
The assembly should be raised and lowered between 30 cycles per minute in the tablet with no
palpable mass remaining in the apparatus was measured and recorded.
In vitro dissolution studies: Dissolution rate was studied by using USP type-II apparatus (US XXIII
Dissolution Test Apparatus at 50 rpm) using 900 mL of phosphate buffer pH (6.8) as dissolution
medium. Temperature of the dissolution medium was maintained at 37±0.5ºC, aliquot of dissolution of
filtered was withdrawn at every 1 min interval and filtered, the absorbance of filtered solution was
measured by UV spectrophotometer method at 276 nm and concentration of the drug determined
from standard calibration.
In Vitro Release Studies Details:
Apparatus Used: USPXXIII dissolution test apparatus
Dissolution medium: 6.8 Phosphate buffer solutions
Dissolution medium volume: 900 mL
Temperature: 37±0.5ºC
Speed of basket paddle: 50 rpm
Sampling intervals: 1 min
Sample withdraw: 5 mL
Absorbance measured: 276 nm
Matched Sources :
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4639876/
https://www.sciencedirect.com/science/article/pii/S1773224719316648/
https://www.ijrti.org/papers/IJRTI2304094.pdf/
https://ajdhs.com/index.php/journal/article/view/18/35#:~:text=The%20in%2Dvitro%20disintegra 4%
tion%20time,%C2%B0%C2%B12%C2%B0C.