Break-marks on UK liothyronine tablets

[helvella]

By chance, happened across this Freedom of Information Request from Thyroid Ninja. As the issue of break-marks, espcially on liothyronine, has been raised many times, I though it possibly interesting. (Bit of a long read - you can probably skip lots of it.)

Thyroid Ninja 4 February 2019

Dear Medicines and Healthcare products Regulatory Agency,

All UK licenced liothyronine thyroid tablets are 20mcg. The Patient Information Leaflets of all these tablets now state that for doses smaller than 20mcg:

1. The tablet must be dissolved (for periods of time between 5 & 10 minutes depending on manufacturer) and a portion of the liquid drawn up & dispensed.

2. The remaining liquid must be disposed of. As most patients are on multiple doses per day, this is wasteful of medication & financial resources.

whatdotheyknow.com/request/...

(Of course, Thyroid Ninja could be a member here! )

[SilverAvocado]

I hope Thyroid Ninja is a member or sees this thread some other way, as this work is so important to so many of us!

They have the patience of a saint, and I'm so grateful to warriors like them and you Helvella, who do this painstaking work on our behalf.

[jimh111]

Somebody is on the ball. I always thought these marks were to aid identification but in retrospect this was a bit daft! For sure these tablets are made by mixing up a uniform paste (or whatever) and pressing into a tablet. It is absurd to think that there is someone dropping 20 microgrammes of L-T3 into each tablet. If this action is successful I will chase up the Competition and Markets Authority (CMA) as this is another example of unfair practice.

[helvella in reply to jimh111]

Some time ago, I came up with an idea for making tablet more consistent and break-friendly.

The active ingredient, such as liothyronine, could be made into tiny micro-tablets of, say, 5 micrograms each - or even smaller. Larger tablets, broadly similar to those of today, could be made by embedding one, two, four (or any other number) of micro-tablets into a matrix.(Preferably a matrix of readily soluble and innocuous substances.)

So long as the break line is appropriately aligned to the embedded micro tablets, all breaks will be in inactive matrix - not active ingredient.

It would also mean that, apart from minor variations in the surrounding matrix, all dosages could be manufactured from the exact same micro-tablets. None of the variation in proportions of excipients depending on final dosage that we now have.

Would even be feasible to put micro-tablets into capsules in order to avoid the matrix altogether. And the technique could produce combination T4+T3 tablets in a wide range of dosages.

Of course, this could only work for tablets where the ratio of active ingredient to excipient is small.

[jimh111 in reply to helvella]

Tablets are licenced for the whole tablet meeting potency limits, levothyroxine used to be 90% to 115% if I remember. Once a tablet is split this accuracy cannot be guaranteed but it doesn't really matter. The split tablets will still be very close to the required dose. If the mix is not uniform they cannot guarantee that one tablet will have the same dose as another. The other consideration is that when you take half a tablet you will still have a good proportion of the previous half tablets in your blood and tissues. Bear in mind that if a patient is taking half or quarter tablets these tablets are making a small contribution to their overall T3 levels, so variations have little overall effect. Also, the tablets supply total T3 and free T3 is regualted by the body along with transport of T3 into cells. When all this is factore in minor variances in T3 content really don't matter. It's just a smokescreen to rip off patients and the lazy NHS management who don't care about patient care or cost.

[helvella in reply to jimh111]

Levothyroxine is now 90 to 105% in the UK. (95 to 105% inthe USA.) I do not know the ranges for liothyronine.

I agree that, subject only to loss of crumbs, reasonably careful tablet splitting is not an issue.

It used to be said that the break lines allowed people who could not swallow whole tablets to divide before swallowing. Of course, that is just as prone to loss of crumbs as splitting to achieve a dosage.

[jgelliss in reply to helvella]

Helvella Thank You for all your efforts and hard work . Praying it's not in vain. Scoring our thyroid meds T4 T3 and make it easily to split would be of great great help . Further more having a 1.25 and 2.5 T3 denominations is another very welcome addition for our meds dosing needs .

[SilverAvocado in reply to helvella]

It seems to me that if T3 tablets were dealt with sensibly they would just come in sizes of 5mcg and below.

It's bizarre that they come in these whopping huge dose size tablets, that are useless for reasonable dosing. Everyone is having to cut these at some stage, and it encourages doctors to dose inappropriately.

[JGBH]

Thanks for that information. So when cutting a 20 mcg in half or in quarters we’re not actually getting the doses we think we are...

[helvella in reply to JGBH]

Three issues - or you might find more! Imperfect distribution of active ingredient, imperfect cutting and loss of particles when cutting.

[Mickeydooley in reply to helvella]

I often wondered what effect cutting the tablets into four would have. They never split evenly in my experience.

[helvella in reply to Mickeydooley]

See jimh111's response (above as I am viewing this).

I think far too much is made of variations.

[Mickeydooley in reply to helvella]

Thank you! I had scanned the post earlier but didn’t absorb the info so it was useful (and comforting) to reread.

[JGBH in reply to Mickeydooley]

I found the same problem....

[SlowDragon Administrator]

Splitting a 20mcg tablet into smaller doses through the day is probably accurate enough, if you're taking 20mcg per day

The problem arises over inaccurate splitting if only taking 15mcg or 10mcg per day (as many people do ) ....Or 25mcg, 30mcg etc

Morningside have now produced 5mcg and 10mcg tablets......but they come with hefty increase in cost to NHS (and presumably, as yet, no competition to drive price down)

My post from earlier this week on cost of different dosages of T3

healthunlocked.com/thyroidu...

[TSH110 in reply to SlowDragon]

I tried 100 mcg - hopeless after dividing into 25 mcg quarters anything smaller was a lottery! Still didn’t cause me any problems but deffo not ideal

[SlowDragon Administrator in reply to TSH110]

Seems extraordinary anyone even makes 100mcg T3

Vast majority of patients use 20mcg or 25mcg tablets ....frequently as divided doses

[helvella in reply to SlowDragon]

There are several around the world. Including Thybon Henning which comes in 20, 50 and 100.

[TSH110 in reply to helvella]

Perhaps I am correct then.

[TSH110 in reply to SlowDragon]

I’ll check I haven’t misread the label, it would explain why they have not made much impression! But I am pretty sure that’s the dosage.

[SlowDragon Administrator in reply to TSH110]

Typical dose of Liothyronine (T3) is 5mcg 3 times a day alongside Levothyroxine

[TSH110 in reply to SlowDragon]

I was aiming for c 6mcg with my NDT to see if it helped as I have not felt so good this last year, but I gave up because it was impossible to divide those tablets up with any certainty and I didn’t think it was a sensible approach. I tried to get a diy blood test done and failed miserably with the spigots my blood does not seem keen to flow. I keep meaning to try and sort out a venous draw as the blood I did finally submit (from my leg via a cut caused when my shins were so itchy I accidentally broke the skin with my vigorous scratching - so I though mmm worth a try 🙄- it did fill the phial!) was no good so I was sent a new test gratis. If only we got a better choice of treatment on the NHS all this hassle could be greatly reduced. I remain unsure as to why I have not felt my usual self& what best to do about it.

[SlowDragon Administrator in reply to TSH110]

Important to regularly retest vitamin levels

strictly gluten free diet helps thousands

[TSH110 in reply to SlowDragon]

Yes it’s a comprehensive one with vits and minerals, antibodies, frees etc. I am gluten free have been for c5years now, it really made a difference.

[ThaiDogRescue]

seems they never responded to his question about t3 not being soluble in water