a comparison of the physical properties of some commercial aspirin tablets elaine armstrong...
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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
Objective
Compare physical properties of commercially available aspirin tablets
Methods
Testing of Aspirin Tablets
• Friability
• Hardness
• Thickness
• Disintegration
• Weight Variation
• Dissolution
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 % ×⎟⎟
⎠
⎞⎜⎜⎝
⎛ −=
Friability Testing
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
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
Hardness/Thickness Testing
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
Weight Variation Testing
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
Disintegration Testing
Dissolution
• The purpose of dissolution testing is to see how much of the tablet goes into solution after a given time period
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
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.
Dissolution Testing
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
Standard Curve
Dissolution Analysis
Results
Lite Coat Aspirin(Coats Pharmacy)
• Distributed by Quality Choice
• NOVI Michigan 48376-0995
• Cost: $4.19• Expires:9-04• Lot #: P25814
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
Equate (Wal-Mart Brand) Aspirin Tablets
• Manufactured by Perrigo Co.
• Alegan, MI 49010• Cost: $0.97• Expires: 12-03• Lot #: 20E0033
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
CVS Brand Aspirin
• Distributed by CVS Pharmacy, Inc.
• Woonsocket,RI 02895• Cost: $1.99• Expires: 1-04• Lot #: 2DE0280
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
Medical Center (Bookstore) Aspirin
• Distributed by Diamond Products
• Seffner,FL 33583• Cost: $1.09• Expires: 4-02• Lot #: 1639
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
Kroger Brand Aspirin
• Distributed by the Kroger Co.
• Cincinnati,Ohio 45202
• Cost: $1.99• Expires: 8-03• Lot #: 1LE0732
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
Target Brand Aspirin
• Distributed by the Target Corporation
• Minneapolis,MN 55402
• Cost: $2.64• Expires: 1-04• Lot #: 2CE0334
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
American Fare (Kmart) Brand Aspirin
• Made for Kmart Corporation
• Troy, Michigan 48084• Cost: $1.99• Expires: 8-04• Lot #: P25463
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
Bayer Aspirin
• Distributed by the Bayer Corporation
• Morristown,NJ 07962-1910
• Cost:$3.99• Expires: 1-04• Lot #: 241812B
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
Pharmacy School Aspirin
• Packaged by Paddock Laboratories Inc.
• Minneapolis,MN 55427
• Expired:12-97• Lot #: 5G6529
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
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
Conclusions
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