A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong...
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![Page 1: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/1.jpg)
A Comparison of the A Comparison of the Physical Properties of Physical Properties of
Some Commercial Some Commercial Aspirin TabletsAspirin Tablets
Elaine ArmstrongElaine Armstrong
6-14-026-14-02
STEPSTEP
![Page 2: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/2.jpg)
Objective
Compare physical properties of commercially available aspirin tablets
![Page 3: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/3.jpg)
Methods
![Page 4: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/4.jpg)
Testing of Aspirin Tablets
• Friability
• Hardness
• Thickness
• Disintegration
• Weight Variation
• Dissolution
![Page 5: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/5.jpg)
Friability Testing
• USP test to determine how well tablets will stand up to coating, packaging, shipping, and other processing conditions– Ten tablets were dusted and weighed on the analytical
balance– The tablets were placed in the section 1 of the drum of
the friability tester and rotated 100 times– The tablets were re-dusted and re-weighed– According to USP, the tablets should not lose more
than 1% of their total weight
100 weightInitial
weightFinal weightInitialLoss % ×⎟⎟
⎠
⎞⎜⎜⎝
⎛ −=
![Page 6: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/6.jpg)
Friability Testing
![Page 7: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/7.jpg)
Hardness
• Determine the crushing strength of the tablets– Using forceps, the 10 tablets were individually
placed between the platens of the hardness tester
– The test button was pushed and the instrument gave a visual reading of tablet hardness
![Page 8: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/8.jpg)
Thickness
• Determines the tablet thickness– Ten tablets were dusted and using forceps
were individually placed between the calipers of the thickness tester
– The instrument gave a visual reading of tablet thickness
![Page 9: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/9.jpg)
Hardness/Thickness Testing
![Page 10: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/10.jpg)
Weight Variation
• Shows the uniformity of tablet weights– Ten tablets were dusted and weighed using the
analytical balance – The mean tablet weight and standard deviation
was calculated – According to the USP, the requirements for
uniformity are met if each individual tablet is within 85% to 115% of the mean
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Weight Variation Testing
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Disintegration
• USP test to determine the time required for tablets to disintegrate– A 900 mL beaker was filled with 37±2º C water
– Six tablets were placed into the basket-rack assembly and connected to the disintegration apparatus
– The apparatus and the timer were started simultaneously and the time required for the last tablet to disintegrate was recorded
![Page 13: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/13.jpg)
Disintegration Testing
![Page 14: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/14.jpg)
Dissolution
• The purpose of dissolution testing is to see how much of the tablet goes into solution after a given time period
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Preparing the 0.05M Acetate Buffer
• Sodium Acetate Trihydrate was weighed and placed into a 2000 mL volumetric flask
• Glacial Acetic Acid was then pipeted into the flask
• The flask was filled with water up to the mark
• The resulting solution was thoroughly mixed and the pH was determined using the pH meter
• 500 mL of buffer was measured three times and added into three round bottom dissolution vessels
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Dissolution Testing
• The vessels were added to a circulating water bath maintained at 37ºC and allowed to equilibrate
• Once the desired temperature was obtained, the tablets were added to the mesh cylindrical baskets and the baskets were lowered into the vessels and rotated at 50 rpm for 30 minutes.
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Dissolution Testing
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Dissolution Analysis
• A sample was removed from each vessel using a syringe and then filtered with a 0.45 m nylon filter
• The sample was diluted with buffer and the concentration was determined by measuring the absorption at 265 nm using an Ultrospec 3300 pro UV/Visible Spectrophotometer and comparing to a Standard Curve
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Standard Curve
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Dissolution Analysis
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Results
![Page 22: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/22.jpg)
Lite Coat Aspirin(Coats Pharmacy)
• Distributed by Quality Choice
• NOVI Michigan 48376-0995
• Cost: $4.19• Expires:9-04• Lot #: P25814
![Page 23: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/23.jpg)
Lite Coat Tablet ResultsFriability (percent loss) 0.34%
Weighing Variation (average/st. dev.)
0.98±0.18 g
Hardness (average/st. dev.)
13.56±1.3 SC
Thickness (average/st. dev.)
0.169±0.002 in
Disintegration (time) 21 sec
Dissolution (average/st. dev.)
247.5±21 mg
![Page 24: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/24.jpg)
Equate (Wal-Mart Brand) Aspirin Tablets
• Manufactured by Perrigo Co.
• Alegan, MI 49010• Cost: $0.97• Expires: 12-03• Lot #: 20E0033
![Page 25: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/25.jpg)
Equate Tablet ResultsFriability (percent loss) -0.14%
Weight Variation (average/st. dev.)
0.94±0.02 g
Hardness (average/st. dev.)
10.12±1.04 SC
Thickness (average/st. dev.)
0.17±0.001 in
Disintegration (time) 17 sec
Dissolution 312.1±14.8 mg
![Page 26: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/26.jpg)
CVS Brand Aspirin
• Distributed by CVS Pharmacy, Inc.
• Woonsocket,RI 02895• Cost: $1.99• Expires: 1-04• Lot #: 2DE0280
![Page 27: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/27.jpg)
CVS Brand Tablet ResultsFriability (percent loss) 0.42%
Weight Variation (average/st. dev.)
0.94±.02 g
Hardness (average/st. dev.)
9.5±1.01 SC
Thickness (average/st. dev.)
0.17±0.001 in
Disintegration (time) 17 sec
Dissolution 263.7±2.4 mg
![Page 28: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/28.jpg)
Medical Center (Bookstore) Aspirin
• Distributed by Diamond Products
• Seffner,FL 33583• Cost: $1.09• Expires: 4-02• Lot #: 1639
![Page 29: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/29.jpg)
Medical Center Tablet ResultsFriablility (percent loss) 0.9%
Weight Variation (average/st. dev.)
0.92±0.01 g
Hardness (average/st. dev.)
14.14±2.96 SC
Thickness (average/st. dev.)
0.17±0.03 in
Disintegration (time) 8 min 55 sec
Dissolution (average/st. dev.)
267.9 ±16.6 mg
![Page 30: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/30.jpg)
Kroger Brand Aspirin
• Distributed by the Kroger Co.
• Cincinnati,Ohio 45202
• Cost: $1.99• Expires: 8-03• Lot #: 1LE0732
![Page 31: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/31.jpg)
Kroger Brand Tablets ResultsFriablility (percent loss) 0.01%
Weight Variation (average/st. dev.)
0.94±0.01 g
Hardness (average/st. dev.)
11.18±1.15 SC
Thickness (average/st. dev.)
0.171±0.002 in
Disintegration (time) 18 sec
Dissolution (average/st. dev.)
259.9±2.8 mg
![Page 32: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/32.jpg)
Target Brand Aspirin
• Distributed by the Target Corporation
• Minneapolis,MN 55402
• Cost: $2.64• Expires: 1-04• Lot #: 2CE0334
![Page 33: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/33.jpg)
Target Brand Tablets ResultsFriablility (percent loss) 0.12%
Weight Variation (average/st. dev.)
0.94±0.01 g
Hardness (average/st. dev.)
8.68±1.06 SC
Thickness (average/st. dev.)
0.172±0.002 in
Disintegration (time) 19 sec
Dissolution (average/st. dev.)
251.4±6.4 mg
![Page 34: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/34.jpg)
American Fare (Kmart) Brand Aspirin
• Made for Kmart Corporation
• Troy, Michigan 48084• Cost: $1.99• Expires: 8-04• Lot #: P25463
![Page 35: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/35.jpg)
American Fare Tablets ResultsFriablility (percent loss) 0.39%
Weight Variation (average/st. dev.)
0.93±0.01 g
Hardness (average/st. dev.)
13.81±1.9 SC
Thickness (average/st. dev.)
0.171±0.001 in
Disintegration (time) 26 sec
Dissolution (average/st. dev.)
270±5.6 mg
![Page 36: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/36.jpg)
Bayer Aspirin
• Distributed by the Bayer Corporation
• Morristown,NJ 07962-1910
• Cost:$3.99• Expires: 1-04• Lot #: 241812B
![Page 37: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/37.jpg)
Bayer Tablets ResultsFriability (percent loss)
0.01%
Weight Variation (average/st. dev.)
0.95±0.01 g
Hardness (average/st. dev.)
9.83±0.91 SC
Thickness (average/st. dev.)
0.174±0.001 in
Disintegration (time) 18 sec
Dissolution (average/st. dev.)
254.1±6 mg
![Page 38: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/38.jpg)
Pharmacy School Aspirin
• Packaged by Paddock Laboratories Inc.
• Minneapolis,MN 55427
• Expired:12-97• Lot #: 5G6529
![Page 39: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/39.jpg)
Pharmacy School Tablets Results
Friability (percent loss) 0.93%
Weight Variation (average/st. dev.)
0.93±0.01 g
Hardness (average/st. dev.)
16.15±1.41 SC
Thickness (average/st. dev.)
0.171±0.002 in
Disintegration (time) 19 sec
Dissolution (average/st. dev.)
280.1±18.1 mg
![Page 40: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/40.jpg)
Overall ResultsFriability
(% Loss)
Weight
Variation
(g)
Hardness
(SC)
Thickness
(in)
Disintegration
(sec)
Disso-lution
(mg)
Lite Coat 0.34 0.98 13.56 0.169 21 247.5
Equate -0.14 0.94 10.12 0.170 17 312.1
CVS 0.42 0.94 9.50 0.170 17 263.7
Bookstore
0.90 0.92 14.14 0.170 535 267.9
Kroger 0.01 0.94 11.18 0.171 18 259.9
Target 0.12 0.94 8.68 0.172 19 251.4
K-Mart 0.39 0.93 13.80 0.171 26 270.0
Bayer 0.01 0.95 9.83 0.174 18 254.1
Pharmacy School
0.93 0.93 16.15 0.171 19 280.1
![Page 41: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/41.jpg)
Conclusions
![Page 42: A Comparison of the Physical Properties of Some Commercial Aspirin Tablets Elaine Armstrong 6-14-02STEP.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649ccf5503460f9499a8f4/html5/thumbnails/42.jpg)
Summary
• The tablets all met USP standards for friability• The tablets displayed uniformity in terms of
hardness, thickness, and weight variation• With the exception of the tablets obtained from
the bookstore, all tablets disintegrated within 30 seconds
• Five of the nine lots tested passed USP standards for dissolution