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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 7 of 7. This is the beginning of the thread.
Posted by Zyprexa on July 27, 2010, at 17:42:15
Some one on here told me that the active ingredients in generics are exactly the same as brand. And that the only difference is the fillers. So why don't generics use the same fillers and every thing would be the same?
Posted by Phillipa on July 27, 2010, at 18:19:20
In reply to Fillers in meds, why not the same? Generics, posted by Zyprexa on July 27, 2010, at 17:42:15
I guess then the med would be the brand name. Good question why not use the same and label it generic? They say greenstone xanax is same as brand? Phillipa
Posted by Christ_empowered on July 27, 2010, at 20:12:51
In reply to Fillers in meds, why not the same? Generics, posted by Zyprexa on July 27, 2010, at 17:42:15
I think fillers vary by company. Sometimes companies change their formulas--I seem to recall reading on here that one company did that for their brand-name version of an MAOI. The new formula apparently caused problems for a lot of people, though. I don't know why some companies choose certain fillers; maybe cost is a deciding factor?
Posted by ed_uk2010 on July 28, 2010, at 15:17:13
In reply to Fillers in meds, why not the same? Generics, posted by Zyprexa on July 27, 2010, at 17:42:15
>Some one on here told me that the active ingredients in generics are exactly the same as brand.
The active ingredient is the drug itself. Clearly, this has to be the same.
>So why don't generics use the same fillers and every thing would be the same?
Sometimes they do, sometimes they don't. They might choose to use different colourings, for example.
Posted by ed_uk2010 on July 28, 2010, at 15:38:46
In reply to Re: Fillers in meds, why not the same? Generics, posted by Christ_empowered on July 27, 2010, at 20:12:51
The term 'filler' is best avoided because it wrongly suggests that the substances in question have no purpose. The term used in the pharmaceutical industry is excipient. Excipients used in tablets have a wide variety of uses eg. binders (to prevent the tablet from falling apart), disintegrants (to help the tablet disintegrate rapidly in the stomach), colours and lubricants (to prevent the tablet ingredients from sticking to the machinery during the manufacturing process). In many cases, there are several alternative excipients which can be used for the same purpose.
Generics manufacturers may choose to use different excipients to the original brand for several reasons. It can depend on the machinery used in the tablet manufacturing process. It can depend on the choice of packaging. In some cases, manufacturers may favour excipients which they already use for other products in their portfolio.
>maybe cost is a deciding factor?
All common excipients are inexpensive.
Posted by bleauberry on July 30, 2010, at 19:04:58
In reply to Re: Fillers in meds, why not the same? Generics, posted by ed_uk2010 on July 28, 2010, at 15:38:46
Well, the active ingredient is theoretically the same, but no one has proven it to be clinically the same. Anecdotal evidence suggests just the opposite.
One could write a book on the whole generic/brand thing. There are so many issues and details it would surprise you.
Assuming exact same ingredient....generics only have to be within a certain percentage of brand. If one pill is 6% short, and the other 6% over, guess what, you just go a 12% difference in your dose. What if the entire bottle was 10% short?
Even plain jane fillers have an influence on the absorption of the ingredient. Somemay interfere, some may speed it up, some may help carry it to the brain, some may not.
There is alot to this issue. All I know for sure is that if I counted all the accounts I have seen of people having trouble with a generic, it would be in the hundreds. One of my docs won't even prescribe generics, so that tells ya something right there.
Posted by ed_uk2010 on July 31, 2010, at 10:01:04
In reply to Re: Fillers in meds, why not the same? Generics, posted by bleauberry on July 30, 2010, at 19:04:58
> Well, the active ingredient is theoretically the same, but no one has proven it to be clinically the same.
I'm not sure what you mean here. Sertraline hydrochloride, for example, is sertraline hydrochloride. Generic sertraline tablets do not contain a different 'type' of sertraline to Zoloft. It is the same chemical entity.
>Assuming exact same ingredient....generics only have to be within a certain percentage of brand. If one pill is 6% short, and the other 6% over, guess what, you just go a 12% difference in your dose. What if the entire bottle was 10% short?
Generic products must contain the same quantity of drug (active pharmaceutical ingredient) as the brand leader. A generic 50mg sertraline tablet has to contain 50mg of sertraline, for example. It is not permitted to contain 45mg...or 56mg...or 44mg This has to be precise.
It is often claimed that generics can be up to 20% less bio-available or 25% more bio-available than the brand leader. This is not correct. The 0.8 to 1.25 range is part of the complex statistical analysis used to determine bio-equivalence.
In Europe, for example, two medicinal products are considered to be bioequivalent if the 90% confidence intervals of the transformed natural log ratios, between the two preparations, of Cmax and AUC lie in the range 0.80-1.25.>Even plain jane fillers have an influence on the absorption of the ingredient.
Yes, they can do, but whatever excipients are chosen, dissolution tests and bio-availability studies will be performed to assess bio-equivalence.
>...some may help carry it to the brain, some may not.
Excipients used in tablets and capsules do not 'carry' the drug to the brain. Their effect on bioavailability, if any, ends once the API has been absorbed.
>One of my docs won't even prescribe generics.....
That's unusual. I have not come across such a doctor in the UK. I suspect that doctors in the US are more susceptible to the influence of representatives from the major (branded) pharmaceutical companies.
In general, branded prescribing is only necessary for a relatively small proportion of medications. Ciclosporin (Neoral) is a good example; extremely precise blood levels have to be maintained to prevent transplant rejection whilst minimising toxicity. Most commonly used drugs have a wide therapeutic index and at any rate, the bio-availabilities of the various generics may differ little more from each other than between different batches of the branded version itself. This has been demonstrated by the FDA.
This is the end of the thread.
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