PharmTech Talk - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

PharmTech Talk
INTERPHEX 2008 offered visitors novel experiences and many stimulating sessions.


Pharmaceutical Technology


Erik Greb
Various groups have questioned the efficacy and safety of generics lately. That this topic is now being widely debated serves as a reminder that a drug is more than an active pharmaceutical ingredient, or API.

A prominent generic currently at the center of controversy is Teva's "Budeprion XL 300" (bupropion HCl), a generic version of GlaxoSmithKline's "Wellbutrin XL 300" antidepressant. Some patients who switched from Wellbutrin XL 300 to Budeprion XL 300 reported having panic attacks, anxiety, nausea, depression, and suicidal tendencies.

The reports spurred the independent http://ConsumerLab.com/ to study Teva's drug. The study showed that after two hours, Budeprion released four times as much API as did Wellbutrin.

Although bupropion HCl is no longer patent-protected, the drug-delivery technology in Wellbutrin still is. This could explain the large disparity in dissolution between Teva's and GSK's products.

Drug companies, doctors, and patients mostly focus on APIs as the solutions to any disease. Though it's true the API is what relieves symptoms or cures a condition, it's not the end of the story.

We might think, as generics companies have argued, that generic treatments deserve less scrutiny because the drugs have already been tested and approved. But this argument does not take into account excipients, stability, formulation, or drug delivery mechanism. These elements influence a drug's safety and efficacy, and they could mean the difference between a beneficial treatment and a harmful substance.

Have a comment on this subject? Log onto Pharmaceutical Technology's new blog, http://blog.pharmtech.com/, and share your thoughts today.

Erik Greb is an assistant editor of Pharmaceutical Technology,

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
Click here