I have noticed lately that drug companies are warning not to split tablets that are not scored (I don’t mean time release tablets, which are obviously dangerous to mess with). The reason, I was told by the nurse in my doctor’s office, is that the medication may not be evenly distributed in the tablet, so that you might possibly get maybe 60% in one half and 40% in the other. I’m suspicious of this claim and wonder how likely it is that the active ingredient, when mixed with a carrying agent, would bunch up in one part of the tablet.
Another theory I read is that there will be a dosage variation as a result of the slight imprecision in dividing the tablet, but that is altogether different and a risk I am willing to take. Incidentally, I wrote to a drug company for the straight dope (sorry), and not surprisingly, got a thank you for my interest, but no information.
As an example of how irritating this is, look at Imitrex: the 100mg dose is about the same (about $150 for 9 pills) as the 50mg, so that I can cut my cost in half by buying the higher dose and splitting the pill. Are drug companies simply trying to stop this practice, avoid litigation , or is there really something to the uneven distribution theory?
A drug I was taking had such a warning. I suspected it was because the coating served to release the drug slowly. If it was crushed, I would get the entire dose all at once, which would be dangerous with that particular drug. Also, I imagine the coating might help protect your stomach.
Sounds like a scam to me. But I know nothing about pharmaceutical manufacturing procedures, so I can’t really comment on the variable concentration thing, except to say that it sounds really implausible to me.
Well, okay, so I can comment on it, but you shouldn’t take my comment seriously.
There is quite a following of “splitters” who cut their Viagra pills in half to stretch it, as you stated, based upon the cost being the same for double the dose. There are even splitting dealie tools that hold the pill and slice it.
Well, since the OP said “I don’t mean time release tablets, which are obviously dangerous to mess with,” and since I have a long-term prescription for a delayed-release drug (enteric coated, actually, I see it’s mentioned in your link), I’d venture to say the person here without a clue is you, not me. Obviously breaking a coating which is an integral part of the medication (as opposed to a cosmetic part, like with coated painkillers off the shelf) is a bad thing. The question is, barring that, is there any reason not to cut a pill. I said I don’t think so.
This blueberries in a muffin analogy sounds very suspect to me. If they can’t control how much medication is in half a pill, how can they control how much medication is in a whole pill? Do they whip up a seperate batch of carrier and medication for each individual pill? Do they have entirely different manufacturing procedures for scored tablets which are meant to be cut, and often are cut in hospitals and pharmacies? Sounds very unlikely. My guess is that they produce a mixture of carrier and medication where the relative concentrations are consistent, but I don’t know that to be the case, nor does your link comment on pharmaceutical manufacturing processes. I can only think of way of making pills which would render the dosage of whole pills constant, but the dosage of half-pills inconstant, and it doesn’t seem suitable for large-scale production to me, but that could just be a fault of my imagination.
Of the concerns raised by the linked article that are relevant to the OP’s question, the cutting accuracy one seems most germane.
The safety of the practice depends on what kind of medication you’re taking. There was just a study released that determined that you can safely split some medications. From this site: http://www.insure.com/health/pillsplitstudy902.html
Each type of pill, scored or not, is made through a different manufacturing process. If the pill is not scored to provide the opportunity for a half-dose versus a full dose, then there is likely a reason for it. Pharmaceutical companies DO test active ingredient distributions throughout each half of a split pill. If tests do not meet appropriate standards (USP/EP/JP), then the pill is not one which can/will be provided with a score, EVEN IF THE DOSE IS CONSISTENT THROUGHOUT THE WHOLE PILL. Feasability stages, in which all of these, and more, things are tested, last YEARS, as do Stability and Clinical testing stages.
If your pill does not have a score, then either it a) did not pass USP/EP/JP standards or b) it wasn’t tested for it, in which case it isn’t KNOWN whether active ingredient distribution is consistent. Either of these situations have the potential to be very dangerous if the pill is split. There might be a liability factor, however I would hope that anyone who gets sick or worse from taking a pill against manufacturers/doctors instructions would be found fully responsible for his/her stupidity.
That said, there are probably cases where nothing bad would ever happen. But I would never take that chance, personally.
-mnem, who worked in a pharmaceutical testing laboratory, which DID have tests for scored and unscored pills.
I just reread that, and I see that I am kind of insulting in the second paragraph. I appologise for it, I did not mean it against any of you, but rather against people who sue because they get hurt doing things that they are explicitly told NOT to do.
I guess I have more to say on it, too…
The reason some pills might not be tested is often just one of cost…it is ridiculously expensive to put a medication out on the market, and if the company can save money by simply providing 50 and 100mg tablets rather than 100mg-scored ones, then so be it (Scoring requires the use of an entire additional machine, IIRC).
Standards are incredibly rigourous, and if they are not met, then the “possibility” isn’t there, as far as the FDA is concerned. I suppose this means that 99.9% of the time, splitting a pill will give you a 50-50 dose, but what if you grab that one that doesnt? Some mixiers or molds might allow active ingredients to settle before final binding ingredients are added for example, therefore causing an uneven distribution…you just don’t know. So it is safer to be cautious, and not try and save money unless more information comes to light about the medication in question.
Again, appologies if I was insulting to anyone. Its only Monday, but dammit, its been a long week!
I previously worked in a pharmaceutical company for five years, and at least when we were preparing drugs for animal (pre-clinical) trials, we made up large batches and split them out into individual doses. The belief was that for a certain molarity of any drug, it should distribute evenly thoughout the mix, unless it was some kind of suspension which few drugs I ever saw were. Even if they did have some separation in the pill form, my thought is this:
Wouldn’t the drug still settle evenly across the individual pill? That is, if it is symmetrical, even if the active ingredient settles to the top or bottom of the solution as it crystalizes, it should still do so evenly. Therefore, splitting the pill should still result in 50% ending up in each half.
Assuming I’m wrong and the dosage is off, it is my understanding that if the therapeutic index of the drug is SO EXACT that splitting it might result in you killing yourself (i.e. chemotherapy drugs come to mind) they are probably drugs that aren’t administered in pill form, and otherwise would be administered by a physician, not something you get from the pharmacist. After all, if that was the case, everyone who had a condition involving such a drug would end up dead eventually when they accidentally double dosed because they forgot they had already taken a pill a few hours before.
My own personal belief, and I have no evidence to back this up, is that it is done entirely for legal reasons. If you put a score line in the pill, I could argue that you are ENCOURAGING me to split it. Now if I am poor, and have a bunch of 100mg pills, BUT NEED TO TAKE 100MGS AS MY DOSE, I may do something stupid like say “Oh, if I cut the pills in half, I get double the number”, and underdose myself because I am only taking 50mgs at a time. Now my infection doesn’t go away, gets worse, I die, and my next of kin sues the ‘evil’ pharmaceutical company because of my own stupidity.
In a similar vein:
Every time I see an old person with a walker, they have cut open tennis balls on the end so they can slide with them as they walk, rather than having to pick it up every step. When I asked a doctor why they don’t just manufacture walkers with those tennis ball things on them already, he told me “Because then the walker manufacturer would be liable for every broken hip every time an old person slipped with their walker and they go out of business tomorrow”
