Found a pill cutting gadget...

[Levo50]

Following my recent post ‘Cutting Levo tablets’ and very grateful of the comments/advice received. I wanted to share with you a photo and link to one of the many gadgets I bought as I was very impressed. With a little patience I can’t believe how well this gadget cut my small 50mcg Accord Levo tablet into 1/4’s, and as an added bonus it also serves as a handy storage area 😀.

amazon.co.uk/gp/product/B07...

[Levo50]

Yes I am very happy with it, a few days ago I didn’t know such a thing existed so thought must be worth a share 😁

[Hibs1]

Just ordered to add to my collection 🙂

[Hidden]

If a tablet isn't scored to be cut either in half or quarters there is no guarantee that you will get an equal amount of the active ingredient in each cut part. If they are scored to be cut then you can assume that it equally distributed.

[helvella Administrator in reply to Hidden]

I know of no simple way of determining whether a tablet is scored to be split accurately, or scored as an aid to identification, or scored to allow division to make swallowing easier. Or the reasons are lost in the mists of time.

In some specific cases, the documentation (e.g. Patient Information Leaflet) might make it clear. In others that leaves the question unresolved.

If in doubt, contact the manufacturer.

A few snippets of information:

Manufacturers also state that the score line is not intended for breaking the tablet.

whatdotheyknow.com/request/...

Misleading score-lines on tablets: facilitatedintake or fractional dosing?

core.ac.uk/download/pdf/182...

Revised SPC: Cozaar – Comp (losartan potassium with hydrochlorothiazide) 50/12.5mg, 100/12.5mg and 100/25mg Film-Coated Tablets

Source:

electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 18 October 2017

The SPC now specifically states that the score line on the tablets is not intended for breaking the tablet and the tablets should be swallowed whole.

evidence.nhs.uk/search?om=[...

New guidelines for breakmarks on tablets

The US Food and Drugs Administration (FDA) produced their guidance for industry on tablet scoring in March 2013 to ensure that tablet scoring (breakmarks or breaklines) on generic tablets would enable them to be split in the same effective way as their reference listed products (RLD).

These breakmarks on tablets were originally developed to allow tablets to be split into two or four equal parts to help the ingestion of large tablets or to allow a reduction in dose, e.g. for children or the elderly. However, some generic drugs have included breakmarks just so that they look like the RLD without the breakmarks being functional. Thus, the FDA desired consistent scoring between a generic product and its RLD. There is also the problem of insurance companies and doctors increasingly recommending that patients split high dosage tablets and take those halves or quarters to save money on their medicines bills. It is interesting that the FDA considers that tablet splitting is manufacturing under the Federal Food, Drug and Cosmetic Act and therefore establishments that do this must register with the FDA and comply with Current Good Manufacturing Practice (CGMP). However, this would not apply to a pharmacy dispensing a prescription for individually identified patients.

The new guidance relates to new drug applications (NDAs) and abbreviated drug applications (ANDAs) for scored tablets and is not retrospective. The characteristics of split tablets to be evaluated include: dose, safety, effect of spitting on modified release products, stability, dissolution, weight variation or content uniformity, friability and the ability of the intended patient population to be able to successfully split the tablets.

As far as labelling is concerned, the term ‘functional score’ is a term reserved for labelling products that have been demonstrated to meet the recommendations. Products that are not intended to be split, e.g. enteric coated tablets, tablets which are film coated to maintain stability and some modified release preparations, should not be split. However, those modified release preparations using matrix technology or using compressed film coated components could be split.

This FDA guidance comes some 10 years after the publication of the European Pharmacopoeia general monograph on tablets for tablets with one or more breaklines. These requirements have been in force since April 2002 and were revised in 2006. They provide background information on the use of breakmarks and describe the sampling procedure and the number of tablet parts to be tested in detail. As a test procedure, it prescribes determining uniformity of mass, while setting the somewhat wider acceptance criteria of the test of content uniformity, namely 85 – 115 per cent (in this case of the average mass). As with the FDA guidance, the requirements were not retrospective.

As the requirements on subdivision of tablets are listed in the production section of the European Pharmacopoeia general monograph on tablets, it is normally sufficient to perform the test during pharmaceutical development. There is no need to include the test in the release specification. However, in situations where there is a significant change in tablet hardness during storage, it may be necessary to repeat the test at the end of the product’s shelf life in order to ensure that the use of tablet breaklines has not changed the tablet’s hardness. The whole thrust of the requirements is to ensure that subdivision is assessed and authorised by the competent authority in order to ensure that the patient will receive the intended dose.

There are few differences between this new guidance from the FDA and the existing requirements of the European Medicines Agency / European Pharmacopoeia, so that manufacturers should easily meet both sets of recommendations.

One last thought. It is often the elderly who split tablets to ease their taking or reduce the dose and they often do it by hand and not using a tablet splitting device. What variation might we expect to see at the level of the patient?

europeanpharmaceuticalrevie...

[Hidden in reply to helvella]

I think the thing to remember that if you are splitting the tablet to obtain a smaller dose the you need to check with the manufacturer that all of the split pieces will contain the same amount of the active ingredient, as not all of them will. This comes up quite frequently in another group that certain brands of the same medication can not be split to obtain a smaller dose. This occurs when the medication prescribed does not come in smaller preparations, for example a 10mgs tablet does not have a 5mgs or 2.5mgs equivalent, therefore if the patient is on a smaller dose they need to break the tablet. If a tablet is not scored then there is no guarantee that the active ingredient is equal in the split parts, however if the tablet is scored then the manufacturer has tested the tablet to ensure that the active ingredient is equal in all parts of the tablet.

[helvella Administrator in reply to Hidden]

if the tablet is scored then the manufacturer has tested the tablet to ensure that the active ingredient is equal in all parts of the tablet.

I suspect you might have missed this:

Manufacturers also state that the score line is not intended for breaking the tablet.

whatdotheyknow.com/request/...

AND

The SPC now specifically states that the score line on the tablets is not intended for breaking the tablet and the tablets should be swallowed whole.

evidence.nhs.uk/search?om=[...

These quotes directly contradict your statement. Obviously, without myself running tests (and I don't have the tablets, the equipment, or the detailed knowledge required to do so), I cannot demonstrate whether or not they break acceptably. But the quotes do appear to be clear statements.

[Hidden in reply to helvella]

I'm only stating what we have found in the Addison's group when people have had considerable issues with brands of Hydrocortisone that aren't scored so they haven't been receiving the correct amount of the drug, which with adrenal insufficiency is incredibly essential as it is a life threatening condition. Many of us take small amounts of the drug which only come in 10mgs tablets, so have to be split. Some of the cheaper makes of the drug are not guaranteed to have the same amount of the active ingredient in all parts of the tablet, usually these don't have the scored marks. Perhaps it's not so important in other drugs but for us it's essential to know that we are getting the correct dosage - otherwise we risk going into adrenal crisis & dying.

[helvella Administrator in reply to Hidden]

I think it is just as important for at least some other medicines. But I do agree that hydrocortisone has been checked inasmuch they say:

A white, 10.8 mm x 7.0 mm, oval, tablet, engraved with 'HC 10' on one side and break-marked on both sides.

The tablet can be divided into equal doses

medicines.org.uk/emc/produc...

20mg tablets: white, half-scored tablets, marked 'HYD 20'. The tablet can be divided into equal doses.

medicines.org.uk/emc/produc...

Trouble is, the presence or non-presence of a score mark means absolutely nothing in respect of many other medicines. Your perfectly proper and correct point, unfortunately, does not crossover to all the thyroid hormone medicines.

Unless the documentation says so, or the manufacturer confirms, we have to assume a scoreline has no real meaning.

[Levo50 in reply to Hidden]

Hi thank you for your reply... I checked with my GP whether my medication can be split and as my medication Levothyroxine is a storage hormone then cutting the tablet is acceptable. The reason I choose to cut my tablet is because the brand I use does not manufacture it in 12.5 or 25mcg and other brands may not suit.

This is only a recommendation for a pill cutter which I personally found useful; any individuals looking at cutting their own medications would do so through personal choice - most using a kitchen knife I’d guess. You would hope they had cleared this with their GP or Pharmacist inline with their prescription.

[EbonyEvans]

Those are 99p on ebay.

[Levo50 in reply to EbonyEvans]

Oh haha! Probably £5 postage knowing my luck 😂

[EbonyEvans in reply to Levo50]

50 days delivery more likely 🤣🙈