July 4, 2009 - 8:50pm
Does anyone know if there have been any independent lab tests done to confirm the amount of opiods in different generic meds? For example, I read on this forum and I know from personal experience that different brands have different levels of pain relief.
I am prescribed 15mg oxycodone IR. Three different brands have been dispensed to me. Every pharmacist that I've ever asked about generics have told me that they ALL have the same amount of oxycodone, as labeled. My doctor and other health care providers have told me that there may be a 30% variation in the amount of opiods in a given dosage, as long as the variation is on the down side. Of course, if this is true, it certainly isn't published in FDA literature nor by the pharmacutical industry!
So, is there any documented scientific evidence that tests have been performed by independent labs, that don't have a horse in this race, to confirm that the actual amount of oxycodone is, in fact, present in the different strengths of the meds manufactured by the different pharmacutical companies.
In other words, does a 15 mg oxy IR, in fact, have 15 mg of oxycodone? Does a 30 mg oxy IR, in fact, have 30 mg of oxycodone? If independent tests have been performed, what are the results? If independent tests have been performed, which brands were tested?
With all due respect, I'm seeking documented evidence, not hearsay nor pain patients' personal preference of manufacturer. Thanks in advance for any links to studies done on this subject.
July 4, 2009 - 9:52pm
#2
Much Appreciated
Chemistry certainly isn't my strong subject either! I'm going to keep searching for any independent tests that may have been done on this subject. I suppose that it would cost a small fortune for an individual to hire the services of an independent lab for such tests.
Thanks again for your info. I've never seen one of the package inserts that you mention. I looked at and saved the file that was attached to your post.
Kindly,
July 4, 2009 - 10:03pm
#3
It would be nice to get a
It would be nice to get a package insert with my meds each time I get a new dosage or brand but I'm not sure they would be willing to hand them out. I don't suppose it could hurt...maybe NJRx would know? What say you, NJ? Would you be willing to give a patient the package insert that came with the original bottle of their prescribed medication? If so, under what conditions?
July 5, 2009 - 1:50am
#4
For the OP
It's obviously impossible for the FDA to verify the potency of every pill distributed in the country...If you've got a GC-MS, let's get to work; I'll be glad to help you out! 
July 5, 2009 - 2:32am
#5
Active ingredient?
I dont really know anything about the process of pill manufacturing... but wouldnt the active ingredient be distributed evenly like in osmosis?
An online package insert for the Mallinkrodt oxycodone IR produts is available here--> http://pharmaceuticals.mallinckrodt.com/_attachments/PackageInserts/57_Oxy%20HCl%20Tabs_REV122308.pdf
You will see on the first page it says "The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base."
Each value is 10% less than the advertised amount.
I've searched for other package inserts for other brands of oxy ir generics but have not found any. I have found them for other oxycodone products (ER, percocet) and found a statement similar to that one above. Usually it says it contains __mg of oxycodone freebase. The _ always being 90% the advertised amount.
This could mean that it actually contains less than the advertised amount or it could be some issue with the conversion of oxycodone to a hydrochloride salt. Perhaps some amount is lost in the chemical bonding process? I don't know. Chemistry was never my strong subject...
hope this helps...