Comparison of three pharmaceutical products obtained from Mexico and the United States

A case study

Kelly L. Karlage, Paul B Myrdal

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

In recent years, there has been much debate concerning the relative pros and cons of purchasing medications from foreign markets such as Mexico and Canada. The following study compares the content uniformity and weight variation for three medicinal products, acquired from pharmacies in both Mexico and the United States: amoxicillin capsules (500 mg), amoxicillin/clavulanic acid suspension (400 mg and 57 mg/5 mL, respectively), and furosemide tablets (40 mg). Twenty capsules/tablets were individually weighed and a designated aliquot was taken. Following dissolution in an appropriate solvent and sonication, a sample was taken and analyzed via high performance liquid chromatography (HPLC). The suspensions were prepared according to directions on the label. Five samples of the suspensions were then taken and analyzed via an appropriate HPLC method. The content uniformity for the amoxicillin capsules was found to be 15.4±2.4% and 99.4±9.3%, for Mexican and U.S. capsules, respectively. The percent relative standard deviation (% RSD) for weight variation was found to be 8.7% and 1.5% for capsules obtained from Mexico and the United States, respectively. Content uniformity analysis for the Mexican suspension product resulted in an average of 85.5±1.2% for amoxicillin and 98.6±1.9% for the clavulanic acid content, while the results for the U.S. suspension product were 104.4±3.1% and 117.8±3.6% for amoxicillin and clavulanic acid, respectively. Content uniformity for the furosemide tablets was found to be 90.3±4.8% and 95.6±2.1% for Mexican and U.S. tablets, respectively. The % RSD of weight variation for the Mexican tablets was 2.1%, while the % RSD for the U.S. tablets was found to be 1.0%. From the three products tested, content analysis revealed that the amount of active ingredients for two of the products acquired in Mexico were appreciably less than the concentrations for their U.S. counterparts.

Original languageEnglish (US)
Pages (from-to)993-1000
Number of pages8
JournalDrug Development and Industrial Pharmacy
Volume31
Issue number10
DOIs
StatePublished - Dec 2005

Fingerprint

Mexico
Tablets
Capsules
Suspensions
Amoxicillin-Potassium Clavulanate Combination
Pharmaceutical Preparations
Amoxicillin
Furosemide
High performance liquid chromatography
Weights and Measures
High Pressure Liquid Chromatography
Sonication
Pharmacies
Purchasing
Canada
Labels
Dissolution

Keywords

  • Amoxicillin
  • Content uniformity
  • Foreign markets
  • Furosemide
  • Mexico

ASJC Scopus subject areas

  • Drug Discovery
  • Organic Chemistry
  • Pharmacology
  • Molecular Medicine

Cite this

Comparison of three pharmaceutical products obtained from Mexico and the United States : A case study. / Karlage, Kelly L.; Myrdal, Paul B.

In: Drug Development and Industrial Pharmacy, Vol. 31, No. 10, 12.2005, p. 993-1000.

Research output: Contribution to journalArticle

@article{bc481f14a5834b079cb17873b2d53e10,
title = "Comparison of three pharmaceutical products obtained from Mexico and the United States: A case study",
abstract = "In recent years, there has been much debate concerning the relative pros and cons of purchasing medications from foreign markets such as Mexico and Canada. The following study compares the content uniformity and weight variation for three medicinal products, acquired from pharmacies in both Mexico and the United States: amoxicillin capsules (500 mg), amoxicillin/clavulanic acid suspension (400 mg and 57 mg/5 mL, respectively), and furosemide tablets (40 mg). Twenty capsules/tablets were individually weighed and a designated aliquot was taken. Following dissolution in an appropriate solvent and sonication, a sample was taken and analyzed via high performance liquid chromatography (HPLC). The suspensions were prepared according to directions on the label. Five samples of the suspensions were then taken and analyzed via an appropriate HPLC method. The content uniformity for the amoxicillin capsules was found to be 15.4±2.4{\%} and 99.4±9.3{\%}, for Mexican and U.S. capsules, respectively. The percent relative standard deviation ({\%} RSD) for weight variation was found to be 8.7{\%} and 1.5{\%} for capsules obtained from Mexico and the United States, respectively. Content uniformity analysis for the Mexican suspension product resulted in an average of 85.5±1.2{\%} for amoxicillin and 98.6±1.9{\%} for the clavulanic acid content, while the results for the U.S. suspension product were 104.4±3.1{\%} and 117.8±3.6{\%} for amoxicillin and clavulanic acid, respectively. Content uniformity for the furosemide tablets was found to be 90.3±4.8{\%} and 95.6±2.1{\%} for Mexican and U.S. tablets, respectively. The {\%} RSD of weight variation for the Mexican tablets was 2.1{\%}, while the {\%} RSD for the U.S. tablets was found to be 1.0{\%}. From the three products tested, content analysis revealed that the amount of active ingredients for two of the products acquired in Mexico were appreciably less than the concentrations for their U.S. counterparts.",
keywords = "Amoxicillin, Content uniformity, Foreign markets, Furosemide, Mexico",
author = "Karlage, {Kelly L.} and Myrdal, {Paul B}",
year = "2005",
month = "12",
doi = "10.1080/03639040500306245",
language = "English (US)",
volume = "31",
pages = "993--1000",
journal = "Drug Development and Industrial Pharmacy",
issn = "0363-9045",
publisher = "Informa Healthcare",
number = "10",

}

TY - JOUR

T1 - Comparison of three pharmaceutical products obtained from Mexico and the United States

T2 - A case study

AU - Karlage, Kelly L.

AU - Myrdal, Paul B

PY - 2005/12

Y1 - 2005/12

N2 - In recent years, there has been much debate concerning the relative pros and cons of purchasing medications from foreign markets such as Mexico and Canada. The following study compares the content uniformity and weight variation for three medicinal products, acquired from pharmacies in both Mexico and the United States: amoxicillin capsules (500 mg), amoxicillin/clavulanic acid suspension (400 mg and 57 mg/5 mL, respectively), and furosemide tablets (40 mg). Twenty capsules/tablets were individually weighed and a designated aliquot was taken. Following dissolution in an appropriate solvent and sonication, a sample was taken and analyzed via high performance liquid chromatography (HPLC). The suspensions were prepared according to directions on the label. Five samples of the suspensions were then taken and analyzed via an appropriate HPLC method. The content uniformity for the amoxicillin capsules was found to be 15.4±2.4% and 99.4±9.3%, for Mexican and U.S. capsules, respectively. The percent relative standard deviation (% RSD) for weight variation was found to be 8.7% and 1.5% for capsules obtained from Mexico and the United States, respectively. Content uniformity analysis for the Mexican suspension product resulted in an average of 85.5±1.2% for amoxicillin and 98.6±1.9% for the clavulanic acid content, while the results for the U.S. suspension product were 104.4±3.1% and 117.8±3.6% for amoxicillin and clavulanic acid, respectively. Content uniformity for the furosemide tablets was found to be 90.3±4.8% and 95.6±2.1% for Mexican and U.S. tablets, respectively. The % RSD of weight variation for the Mexican tablets was 2.1%, while the % RSD for the U.S. tablets was found to be 1.0%. From the three products tested, content analysis revealed that the amount of active ingredients for two of the products acquired in Mexico were appreciably less than the concentrations for their U.S. counterparts.

AB - In recent years, there has been much debate concerning the relative pros and cons of purchasing medications from foreign markets such as Mexico and Canada. The following study compares the content uniformity and weight variation for three medicinal products, acquired from pharmacies in both Mexico and the United States: amoxicillin capsules (500 mg), amoxicillin/clavulanic acid suspension (400 mg and 57 mg/5 mL, respectively), and furosemide tablets (40 mg). Twenty capsules/tablets were individually weighed and a designated aliquot was taken. Following dissolution in an appropriate solvent and sonication, a sample was taken and analyzed via high performance liquid chromatography (HPLC). The suspensions were prepared according to directions on the label. Five samples of the suspensions were then taken and analyzed via an appropriate HPLC method. The content uniformity for the amoxicillin capsules was found to be 15.4±2.4% and 99.4±9.3%, for Mexican and U.S. capsules, respectively. The percent relative standard deviation (% RSD) for weight variation was found to be 8.7% and 1.5% for capsules obtained from Mexico and the United States, respectively. Content uniformity analysis for the Mexican suspension product resulted in an average of 85.5±1.2% for amoxicillin and 98.6±1.9% for the clavulanic acid content, while the results for the U.S. suspension product were 104.4±3.1% and 117.8±3.6% for amoxicillin and clavulanic acid, respectively. Content uniformity for the furosemide tablets was found to be 90.3±4.8% and 95.6±2.1% for Mexican and U.S. tablets, respectively. The % RSD of weight variation for the Mexican tablets was 2.1%, while the % RSD for the U.S. tablets was found to be 1.0%. From the three products tested, content analysis revealed that the amount of active ingredients for two of the products acquired in Mexico were appreciably less than the concentrations for their U.S. counterparts.

KW - Amoxicillin

KW - Content uniformity

KW - Foreign markets

KW - Furosemide

KW - Mexico

UR - http://www.scopus.com/inward/record.url?scp=28744448705&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=28744448705&partnerID=8YFLogxK

U2 - 10.1080/03639040500306245

DO - 10.1080/03639040500306245

M3 - Article

VL - 31

SP - 993

EP - 1000

JO - Drug Development and Industrial Pharmacy

JF - Drug Development and Industrial Pharmacy

SN - 0363-9045

IS - 10

ER -