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The following message was posted to: PharmPK
Hello,
I require information on BCS Class of the drug"Escitalopram"
I read somewhere that it belongs to BCS Class-I (Pls correct me if I am
wrong)
Thanks for your reply
Regards
Kaushik
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The following message was posted to: PharmPK
Kaushik,
Please look at E. Ramirez et al, British Journal of Clinical
Pharmacology, 70(5), pp. 694-702 (2010). It is rated as Class 1.
Regards,
V. Lee
CEO-CSO
Adesis Inc.
New Castle, DE 19720
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Dear Mr.Kaushik,
As per the available literature, Escitalopram belong to BCS Class I.
Reference: See Serial no. 118 in the Table provided in the page 06 of 14
in PDF document from the below link
http://bpca.nichd.nih.gov/collaborativeefforts/initiatives/upload/Formulations_Table_for_Web_11-02-11.pdf
Regards,
Dr.S.Gunasakaran, MD
Head - Clinical Research & Medical Affairs,
Azidus Clinical Research Organization, India
www.clinicalresearchsociety.org
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The following message was posted to: PharmPK
Dear Kaushik,
Escitalopram indeed belongs to BCS Class I.
If your question is related to bioequivalence waiver, take attention
that
despite this BCS classification, FDA still recommends to conduct
escitalopram BE studies under both fast and fed conditions:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm086250.pdf
Best regards,
Fabrice Nollevaux,
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I want to make few points on classifying any particular drug falling
under particular BCS category;
We can not simply assume whether a compound is a BCS 1 or 2 from 1
publication or lack of published information (molecular Pharmaceutics
paper, J, med Chem paper) You have to look at various sources and make
your conclusions and experimentally verify your conclusion. The
following resources might be of some use.
1. BEBA guidance for individual drugs by FDA under each compound they
give specific recommendation whether BCS waiver is an option.
3. Physico-chemical properties of your drug gives an idea what class
your drug might fall into. you need to apply little SAR knowledge and
there is a Gordon Amidon paper on how to predict permeability based on
logP values.
4. You have to document that your drug is absorbed more than 80-90% this
doesn't mean automatically absolute bioavailability, so you have to look
into Mass Balance (ADME papers)
5. You will be lucky if you drug is eliminated completely (more than 80%
of the dose) through renal route.
6. Even after it is Highly permeable issues with solubility might come
and haunt you.
7. Software like GastroPlus, SimCyp come very handy but they may be
prohibitively expensive.
8. I start my research with Classic Books like Wilson and Gisvold text
Book of Medicinal Chemistry (couple of pages on the back listing
Physico-Chem properties of many drugs), and Merck index.
Hope this information helps.
Finally, one teaser question to you all, is there BioTech product that
falls under BCS Class 1?
Prasad NV Tata, Ph.D., FCP
St. Louis, MO 63134
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The following message was posted to: PharmPK
For structure drawing and physicochemical property predictions related
to BCS Classification, check out the free download of MedChem Designer
at the Simulations Plus, Inc. web site
http://www.simulations-plus.com/Products.aspx?grpID=1&cID&pID=25
Mike
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *
* Michael B. Bolger, Ph.D.
* Simulations Plus, Inc.
* Lancaster, CA 93534
* U.S.A.
* http://www.simulations-plus.com (NASDAQ: SLP)
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The following message was posted to: PharmPK
Since I know citalopram and escitalopram (enantiomer) very well - here
is a reference to the ADME study of citalopram (racemate): xenobiotica
1999 vol 29 no. 10, 1033-1041.
Lars
Www.admeconsult.com
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