alexa Analytical Techniques For Tracking Counterfeit And Substandard Medicines | 19770
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

Like us on:

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

5th World Congress on Bioavailability and Bioequivalence Pharmaceutical R&D Summit

Badr Aljohani, Essam Ghazaly, David Perrett and Atholl Johnston
ScientificTracks Abstracts: J Bioequiv Availab
DOI: 10.4172/0975-0851.S1.017
Abstract
Background: Counterfeit and substandard medicines are a global problem affecting both developed and developing countries. Counterfeit medicines are fake, while substandard medicines are true medicines that do not meet the requirements for quality, safety and efficacy of the branded drug. Both counterfeit and substandard drugs can be life threatening and have caused deaths. Thus, it is important to have simple and rapid methodology for detecting counterfeit and substandard medicines. In this study, we used capillary electrophoresis (CE) to detect impurities in lisinopril, high performance liquid chromatography (HPLC) to quantify ciclosporin active ingredients, Ultra Performance Liquid Chromatography with tandem mass spectrometry (UPLC- MS/MS) for detecting impurities in both ciclosporin and azithromycin. Method: 44 lisinopril, 8 ciclosporin and 19 azithromycin products were obtained from hospitals and pharmacies from 11 countries. In-vitro dissolution testing was used to identify differences between products. It was performed to United States Pharmacopeia (USP) guidelines with sampling at intervals up to 120 min. The samples were quantified by CE, isocratic reverse phase liquid chromatography (RPLC) and UPLC-MS for lisinopril, ciclosporin and azithromycin, respectively. Results: Impurities were detected in all lisinopril tablets: ranging from 4-27%. For ciclosporin, all capsules met the USP requirements, rupturing within 15 minutes. Statistical analysis showed significant differences (p<0.0001) between the mean contents of brand and generic formulations, the confidence interval (CI) 95% range for the brands were (79-108), (71-98), (81- 110), (85-117) and (73-100), (83-114), (45-62), for the generics, 95% CI were calculated based on the reference sample being 100%. All brands and two generics showed more than 80% of ciclosporin after 90 minutes (99, 100, 94, 84, 92, 85 and 97%). One generic, contained less than 54% of labelled amount (54?10%). Relative to the brand the mean % content of all capsules were significantly lower (p<0.0001). Ciclosporin degradation impurities were detected in one generic preparation. Conclusion: Based on the results, it is concluded that some of the ciclosporin preparations did not contain the exact mass labelled. Both ciclosporin and lisinopril preparations contained significant impurities. These results have important implications especially with ciclosporin, which has a narrow therapeutic window. Switching among and between branded and generic ciclosporin may lead to irreversible kidney damage or acute rejection.
Biography
Aljohani Badr is originally from Saudi Arabia he received his BSc Pharm from King Saud University in Riyadh and his Master and MPhil degree in Clinical Drug Development from Queen Mary University of London, UK. His professional interests include internal medicine, critical care, pediatrics and clinical research. Now, he is in final year PhD in Clinical Pharmacology, Drug Bioequivalence in QMUL
image PDF   |   image HTML
 

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2018-19
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

[email protected]

+1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

 
© 2008- 2018 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
Leave Your Message 24x7