Posted by Tomatheus on January 14, 2006, at 15:27:10
In reply to Nardil (phenelzine) information, posted by sdb on January 14, 2006, at 9:30:48
> The "molecule" phenelzine of Pfizer and Concord is the same but not the formula.
sdb,
That's exactly right. In terms of their inactive ingredients, the "old" Pfizer Nardil, the "new" Pfizer Nardil, the U.K. Concord Nardil, and the Australian Link Nardil are all different from one another.
For a breakdown of the excipients of the four Nardil formulations mentioned above, I'm going to paste the text of an e-mail that I recently sent to a Yahoo! group on MAOIs.
Tomatheus
==
And here's a copy of the information from my e-mail...
THE "OLD" PFIZER NARDIL (Parke-Davis Division of Pfizer Inc., 2001)
* Acacia, NF
* Calcium carbonate
* Carnauba wax, NF
* Corn-starch, NF
* FD and C yellow No. 6
* Gelatin, NF
* Kaolin, USP
* Magnesium stearate, NF
* Mannitol, USP
* Pharmaceutical glaze, NF
* Povidone, USP
* Sucrose, NF
* Talc, USP
* White wax, NF
* White wheat flower
THE "NEW" PFIZER NARDIL (Parke-Davis Division of Pfizer Inc., 2003)
* Mannitol, USP
* Croscarmellose sodium, NF
* Povidone, USP
* Edetate disodium, USP
* Magnesium stearate, NF
* Isopropyl alcohol, USP
* Purified water, USP
* Opadry orange Y30-13242A
* Simethicone emulsion, USP
Note: The labeling document that Pfizer submitted to the FDA as part of its supplemental new drug application (dated March 27, 2003) listed "corn starch, NF" as an inactive ingredient using strikethrough formatting.
CONCORD (U.K.) NARDIL (James, 2006)
* Mannitol
* Povidone
* Magnesium stearate and maize starch with the tablet coating containing hydroxypropyl cellulose
* Polyvinylacetatephthalate
* Stearic acid
* Sunset yellow (E110)
* Titanium dioxide (E171)
* Erythrosine (E127)
* Hydroxypropylmethylcellulose (E464)
* Talc
According to David James (2006), Concord's product information and technology executive, the company's formulation "has been in use prior to the current Marketing Authorisation Holder acquiring the rights to the product in 1999."
LINK (AUSTRALIA) NARDIL (Link Medical Products Pty Ltd, 2004)
* Mannitol
* Povidone
* Maize starch
* Magnesium stearate
* Coating (Opadry 20A25096 Red)==
REFERENCES
James, D., personal communication (e-mail), Jan. 4, 2006.
Link Medical Products Pty Ltd. (2004). Nardil Phenelzine Consumer Medical Information. (Available from Link Pharmaceuticals Pty Ltd; Level 1, Bridgeport Centre; 3 Brady St.; Mosman NSW 2088, Australia)
Parke-Davis Division of Pfizer Inc. (2003). Nardil® (Phenelzine Sulfate Tablets, USP), labeling information. Retrieved January 13, 2006, from http://www.fda.gov/cder/foi/label/2003/11909slr033_nardil_lbl.pdf
Parke-Davis Division of Pfizer Inc. (2001). Nardil® (Phenelzine Sulfate Tablets, USP), labeling information. Retrieved January 13, 2006, from http://www.fda.gov/cder/foi/label/2002/11909slr030lbl.pdf
poster:Tomatheus
thread:599003
URL: http://www.dr-bob.org/babble/20060108/msgs/599072.html