a comparison of the physical properties of some commercial aspirin tablets elaine armstrong...

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


10.12±1.04 SC


0.17±0.001 in


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%


0.94±.02 g


9.5±1.01 SC


0.17±0.001 in


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%


0.92±0.01 g


14.14±2.96 SC


0.17±0.03 in

Disintegration (time) 8 min 55 sec


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%


0.94±0.01 g


11.18±1.15 SC


0.171±0.002 in



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%


0.94±0.01 g


8.68±1.06 SC


0.172±0.002 in



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%


0.93±0.01 g


13.81±1.9 SC


0.171±0.001 in



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%


0.95±0.01 g


9.83±0.91 SC


0.174±0.001 in



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%


0.93±0.01 g


16.15±1.41 SC


0.171±0.002 in



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

a comparison of the physical properties of some commercial aspirin tablets elaine armstrong...

Documents

dissolution testing

disintegration testing

friability testing slide

mean slide

step slide

weight variation testing

total weight slide

available aspirin tablets