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Do different weight tablets affect the amount of active ingredient per tab?


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Hi All,

 

I feel a bit foolish for asking this question again, but because I’m using scales to do a daily micro taper (or will be when ready to resume tapering), I’m wondering if I have slightly different weights from tablet to tablet, dose this mean that the ones that weigh more have a slightly higher amount active ingredient or are the 2mg diazepam tabs exactly 2mg regardless of the slight weight inconsistencies?

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All tablets have a filler as well as the active ingredient. It may be this that varies in weight?

We have to assume that each tablet contains the same amount of active ingredient otherwise we would have no basis to work out our doses.

Hardy.

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While we’re waiting to hear back from Bob7 …

 

Let me address your question about fluctuations in the amount of Active Pharmaceutical Ingredient (API) in tablets.  The answer is yes, it’s possible that the amount of API in one tablet can be slightly different than that in another.

 

Pharmaceutical manufacturing standards allow the amount of Active Pharmaceutical Ingredient (API) in solid dosage forms to vary.  For example, according to the Indian Pharmacopoeia (IP) (Uddin et al), the amount can vary by +/- 10% between tablets (i.e. from 90 to 110%). 

 

I do not have an authoritative source to confirm this, but based on multiple other sources I’ve read, the United States Pharmacopoeia (USP) uses a similar +/-10% standard for most, but not all, drugs (drugs with a narrow therapeutic index have a narrower range).  I do not know what the standards are in your country but my guess is the allowed variability would be similar to that used by the IP and USP.

 

The good news is this high variability is unlikely within a given lot of a drug or even between different lots assuming that the drug manufacturer follows good manufacturing practice guidelines for manufacturing, testing, and quality assurance.

 

Citation:

 

Uddin, Md. Sahab et al. In-process and finished products quality control tests for pharmaceutical tablets according to Pharmacopoeias. Journal of Chemical and Pharmaceutical Research. 2015, 7(19): 180-185.  Accessed online at: https://www.jocpr.com/articles/inprocess-and-finished-products-quality-control-tests-for-pharmaceutical-tablets-according-to-pharmacopoeias.pdf

 

My doctor has told me that in Aus it can vary between 5-10%, so I believe the explanation from Libertas is correct.

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Thank you, guys

 

JB: thanks for finding that previous reply from Libertas, I had trouble remembering her response and couldn’t find the thread for some reason.

 

So, If I was starting at 2mg (for the sake of simplicity) and I my first dose was a full 2mg tab weighing .170 and then the next day my tablet happened to weigh .175, would I first shave it back to .170 and then shave my .002 cut from there? Am I making sense?

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Yes, I understand what you're asking. 

 

When I was crushing-weighing-filling I used to take the average weight of 10 tablets and calculated my weight based on the average.

 

I know member hereforhelp is dry cutting and he is very sensitive to cuts, so I would suggest you send him a PM with a link to this thread and ask if he'd care to share his experiences here. He does very small cuts and has been doing it for quite some time. He' has good knowledge and experience to share.

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  • 2 weeks later...

Hello everyone!

 

I treat every tablet, no matter the weight, as having the same amount of API (clonazepam, in my case) in it. So whether the tablet weighs .170 mg, .164 g, or .181 mg (I've had one this heavy), they all contain 0.5 mg clonazepam (again...my benzo).

 

I decided I wanted to try to make this as accurate as possible, so I made a spreadsheet that calculates my cut (end) weights for tablets with a starting weight ranging from .167 g to .172 g and lists all the corresponding cut weights. If my starting weight is on the low end, I assume I have more API per gram because the API is more densely packed, and if my starting weight is on the high end, I assume my tablet has less API per gram. So I figure out my cut weight based on each tablet I cut and file, and my spreadsheet does these calculations for me.

 

You can't just shave to the starting weight you've want, because you've more than likely lost some API in the shavings. You haven't changed the density. Some people take an average of 10 tablets and do okay just using that number. Some do that and try to only use tablets that fall within a certain range. Many of these people say it's close enough, but as I've been fighting unpleasant symptoms the whole way down, I try to be as accurate as I can and hope and pray for the best. There's only so much you can do. We don't have any control of the manufacturing process that makes these awful drugs.

 

Let me know if you have any other questions.

 

Some notes:

 

Of course all this control and accuracy on my end depends upon having tablets that are manufactured with a fairly high degree of accuracy and precision (same amount of API in every tablet, API evenly dispersed throughout each tablet, etc.). That's probably not the case, but I feel like my scored clonazepam tablets have a decent degree of accuracy and precision, because if I make a miniscule change to my taper rate, I feel it. If they were inaccurate, I would think I would be feeling these kinds of things constantly. A 0.2%-per-14-days change in rate can be the difference, for me, between severe GI symptoms and zero GI symptoms.

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Hi hereforehelp,

 

You’ve been super helpful!

 

Thank you, for such a clear and in-depth explanation of your approach.

 

I have absolutely no idea how these various medications are made, but I kept having these images of a kind of slurry where through a gradual mixing process the API would eventually be evenly dispersed, leading me to believe that if the pills were then pressed at different sizes/weights then the API must be slightly more, or less, depending on that size/weight. But that was just the visual image in my mind, and without any factual basis.

 

The fact you are very sensitive to the smallest fluctuations in reductions only adds weight to your approach.

 

Your input is greatly appreciated.

 

May your taper be smooth from here on out!

 

WS

 

 

 

 

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Hi winters!

I fully understand your concern but in is nothing we can do really. We don't have means to know how much of the drug is on each pill.

I do a mix of pill and suspension and I'm also concerned of the 0.125 mg pill form dose that I take with the liquid reduction dose.

I am at aprox 0.350 mg.  I divide the doses in 1ml in the morning and 1.25 ml at night together with the 0.125 mg pill form. I'm getting the pill part from a non scored 1/2 part of a 0.5 "scored" pill.

Unless you are very sensitive this shouldn't be a big problem IMO. Is the average and the tendency of the taper that matters (going down and not up). Also if we take into account  the long 1/2 life of benzos like diazepam and K, that are mostly taken here, those give a good cushion in terms of time they are active.

I think we became very obsessive trying to get rid of this drugs and it actually becomes counterproductive for our taper.

Mice

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Hello everyone!

 

I treat every tablet, no matter the weight, as having the same amount of API (clonazepam, in my case) in it. So whether the tablet weighs .170 mg, .164 g, or .181 mg (I've had one this heavy), they all contain 0.5 mg clonazepam (again...my benzo).

 

I decided I wanted to try to make this as accurate as possible, so I made a spreadsheet that calculates my cut (end) weights for tablets with a starting weight ranging from .167 g to .172 g and lists all the corresponding cut weights. If my starting weight is on the low end, I assume I have more API per gram because the API is more densely packed, and if my starting weight is on the high end, I assume my tablet has less API per gram. So I figure out my cut weight based on each tablet I cut and file, and my spreadsheet does these calculations for me.

 

You can't just shave to the starting weight you've want, because you've more than likely lost some API in the shavings. You haven't changed the density. Some people take an average of 10 tablets and do okay just using that number. Some do that and try to only use tablets that fall within a certain range. Many of these people say it's close enough, but as I've been fighting unpleasant symptoms the whole way down, I try to be as accurate as I can and hope and pray for the best. There's only so much you can do. We don't have any control of the manufacturing process that makes these awful drugs.

 

Let me know if you have any other questions.

 

Some notes:

 

Of course all this control and accuracy on my end depends upon having tablets that are manufactured with a fairly high degree of accuracy and precision (same amount of API in every tablet, API evenly dispersed throughout each tablet, etc.). That's probably not the case, but I feel like my scored clonazepam tablets have a decent degree of accuracy and precision, because if I make a miniscule change to my taper rate, I feel it. If they were inaccurate, I would think I would be feeling these kinds of things constantly. A 0.2%-per-14-days change in rate can be the difference, for me, between severe GI symptoms and zero GI symptoms.

 

Thank you here for help.

I am struggling to get my head round  your explanation. My brain is slow today.

So once you have decided how much you are going to reduce by - do you mean you then apply that percentage to each tablet individually?

I would like to start tapering diazepam from my tea time dose which is currently 4.75mg in tablet form.

One weighed tablet seems to vary in weigh and the scales - gem 20 - even though I have calibrated them several times are not good at sticking at ten before I add my tablet.

Thank you to WS, mice and you for your help

 

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Hi Miss piggy,

 

That's okay. If you know the dose you need, you can calculate it based on the weight of your current tablet, but now I'm starting to wonder if this is really the best way to do it because of what Winters sun brought up.

 

And Winters sun, yes, I also picture a slurry. I believe that's fairly accurate from what I've read in the past. So honestly, there probably is a fairly uniform density to that slurry, and my approach could be wrong. Problem is, we don't know that density, so what pill weight do we use as our standard for all pills? Maybe it makes more sense to go with the average weight of about .170 g for K and just use that for calculating all cuts as if all pills have that weight/density. That's what most people do and seem to do okay. I haven't noticed that my method really helped improve anything. I need to look back and see if things got tougher after I started trying to account for these differences in pill weights. Because, honestly, how can they ensure all pills, no matter the weight, have the right amount of API? I'm thinking I need to rethink all of this now. Just your mention of the slurry has me wondering.

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Hi hereforhelp,

 

Thanks for that last reply.

 

It’s a real mind boggler, as we don’t know one way or another with any certainty.

 

I guess it makes sense that at some point we just have to let go of all the ‘what ifs’ and just be as sensible and careful as we can with what we do know for sure.

 

I guess we could spend an eternity wondering over this…  ::)

 

WS

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Hi winters!

I fully understand your concern but in is nothing we can do really. We don't have means to know how much of the drug is on each pill.

I do a mix of pill and suspension and I'm also concerned of the 0.125 mg pill form dose that I take with the liquid reduction dose.

I am at aprox 0.350 mg.  I divide the doses in 1ml in the morning and 1.25 ml at night together with the 0.125 mg pill form. I'm getting the pill part from a non scored 1/2 part of a 0.5 "scored" pill.

Unless you are very sensitive this shouldn't be a big problem IMO. Is the average and the tendency of the taper that matters (going down and not up). Also if we take into account  the long 1/2 life of benzos like diazepam and K, that are mostly taken here, those give a good cushion in terms of time they are active.

I think we became very obsessive trying to get rid of this drugs and it actually becomes counterproductive for our taper.

Mice

 

Thanks micedana,

 

I appreciate you weighing in and providing feedback!

 

You’re right, the tendency to become overly obsessive can definitely be counterproductive.  :thumbsup:

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Hi hereforhelp,

 

Thanks for that last reply.

 

It’s a real mind boggler, as we don’t know one way or another with any certainty.

 

I guess it makes sense that at some point we just have to let go of all the ‘what ifs’ and just be as sensible and careful as we can with what we do know for sure.

 

I guess we could spend an eternity wondering over this…  ::)

 

WS

 

Thank you for reminding me of the slurry...As of two nights ago, I'm now doing all my doses based on an average pill weight of .170 g. I'm still trying to pick pills within a range of .168 to .172, but I'm assuming they all have the same density, and so I would cut a .168-g pill the same as a .172-g pill. I'm thinking now this is the most accurate way to do it. This is way easier and somewhat faster, and I believe it's more accurate. There's no way that each one of my pills contains exactly 0.5 mg k, that's why the allowance is made for amount of active ingredient. So now I believe the lighter pills contain a little less API, and the heavier pills contain a little more. Either way, I assume the density is the same and cut them all the same.

 

And yes, you can make yourself crazy. I have done it myself.

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Hi hereforhelp,

 

Thanks for that last reply.

 

It’s a real mind boggler, as we don’t know one way or another with any certainty.

 

I guess it makes sense that at some point we just have to let go of all the ‘what ifs’ and just be as sensible and careful as we can with what we do know for sure.

 

I guess we could spend an eternity wondering over this…  ::)

 

WS

 

Thank you for reminding me of the slurry...As of two nights ago, I'm now doing all my doses based on an average pill weight of .170 g. I'm still trying to pick pills within a range of .168 to .172, but I'm assuming they all have the same density, and so I would cut a .168-g pill the same as a .172-g pill. I'm thinking now this is the most accurate way to do it. This is way easier and somewhat faster, and I believe it's more accurate. There's no way that each one of my pills contains exactly 0.5 mg k, that's why the allowance is made for amount of active ingredient. So now I believe the lighter pills contain a little less API, and the heavier pills contain a little more. Either way, I assume the density is the same and cut them all the same.

 

And yes, you can make yourself crazy. I have done it myself.

 

Here for help - just trying to catch up.here so are you cutting and weighing based on the fact that you are thinking they are all .170g

So can you give me an example of if you are reducing by 0.025g and you have a pill which weighs .172mg - how much are you taking off that pill or what end weight would it be?

My brain is getting boggled. Thank you MP

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Hi MP,

 

So all tablets weighing anywhere from 0.168 to 0.172, we will treat as if they have the same amount of active pharmaceutical ingredient in them, even though we now assume they don’t, however, by staying inside the above tablet weight range we can also assume that any inconsistency in API within this range will be relatively inconsequential to the taper.

 

We may have to adjust this for you to be 0.171 to 0.175 (or something like that), because your tablets seem to be slightly higher on average than mine and hereforhelp’s. It’ll be interesting to see what your next batch is like. Don’t worry, we’ll work through it.

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Right, so I have my average pill weight, and I just cut all pills as if they weigh the same as that and cut to the same amount, because I assume the density of the active pharmaceutical ingredient to be essentially uniform. Because of this, the pill weight doesn't matter. I would cut to the same amount. But I do try to pick pills that are closer to the average and not use the major outliers that weigh much less or much more. But even these pills would most likely be fine, because the density of the slurry was fairly uniform and would be the same in the pill.

 

Essentially, each pill is a portion of a "uniform" slurry/mixture, so we can cut it to the weight we need for our dose, regardless of the pill weight itself.

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