Lactose

[willsie01]

The lactose in some meds. Why is it in Levothyroxine and what is it, actually? I tend to think of it in general as something to do with milk.

[helvella Administrator]

Lactose is also known as milk sugar. Milk usually contains between 2 and 8% lactose (by weight).

The issue all manufacturers have is that both levothyroxine and liothyronine doses are incredibly small. So they have to use something to make tablets large enough to be seen and handled.

Lactose was always considered a pretty safe, inexpensive substance. Many other potential ingredients might, overall, be little better.

Humans are born able to digest lactose as it is a fundamental constituent of human milk. But a lot lose that ability as we mature. Continuing to consume milk can mean that people continue to produce lactase (the enzyme that digests it) into adulthood but not everyone does so. Particularly those who are not of European ethnicity.

Many humans are intolerant of lactose. However, the amount in tablets is small and even some who cannot digest it are able to tolerate the amounts in medicines. We are talking about, maybe, 50 milligrams in a tablet.

Some people cannot tolerate milk protein (casein). Despite that, lactose is usually pure enough not to be a problem.

Some makes (in the UK, only Teva) switched from Lactose to mannitol. Unfortunately, for reasons that are still poorly understood, a considerable number of people cannot tolerate Teva levothyroxine.

Aristo contains neither lactose nor mannitol.

UK Levothyroxine Tablets

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Last updated 28/08/2020.

This is a list of currently marketed levothyroxine tablets in the UK.

Please note that re-branding (whether by a manufacturer or as an ‘own label supplier’) – which has happened with several products – does not mean any change to formulation.

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🔹 Accord (marketing authorisation holder) – formerly Actavis

🏭 Accord-UK (manufacturer)

🥛 contains lactose

  50  PL 0142/0104

  100  PL 0142/0105

🟢 50 micrograms and 100 micrograms PIL: mhraproducts4853.blob.core....

🟣 100 Micrograms SPC: mhraproducts4853.blob.core....

🟣 50 Micrograms SPC: mhraproducts4853.blob.core....

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🔹 Advanz (marketing authorisation holder) – branded both “Mercury Pharma Levothyroxine” and “Mercury Pharma Eltroxin” which are identical

🏭 Custom Pharmaceuticals Ltd. (manufacturer)

🥛 contains lactose

  25  PL 12762/0016 5.5mm diameter

  50  PL 10972/0031

  100  PL 10972/0032

🟢 Eltroxin 25 PIL: mhraproducts4853.blob.core....

🟢 Eltroxin 50 & 100 PIL: mhraproducts4853.blob.core....

🟢 Levothyroxine 25 PIL: mhraproducts4853.blob.core....

🟢 Levothyroxine 50 & 100 PIL: mhraproducts4853.blob.core....

🟣 Eltroxin and Levothyroxine 25 SPC: mhraproducts4853.blob.core....

🟣 Eltroxin and Levothyroxine 50 SPC: mhraproducts4853.blob.core....

🟣 Eltroxin and Levothyroxine 100 SPC: mhraproducts4853.blob.core....

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🔸 Almus ‘own label supplier’ – (a brand owned by Walgreen Boots Alliance – Boots pharmacies and Alliance distributor)

  50 – This is repackaged Accord – formerly Actavis.

  100 – This is repackaged Accord – formerly Actavis.

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🔹 Aristo (marketing authorisation holder)

🏭 Aristo Pharma GmbH (manufacturer)

No lactose ingredient

  100  PL 40546-0159

🟢 PIL: mhraproducts4853.blob.core....

🟣 SPC: mhraproducts4853.blob.core....

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🔸 Northstar ‘own label supplier’ – (a brand owned by McKesson – Lloyds pharmacies and AAH distributor)

  25 – This is repackaged Teva. ❗

  50 – This is repackaged Accord – formerly Actavis. ❗

  100 – This is repackaged Accord – formerly Actavis. ❗

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🔹 Teva (marketing authorisation holder)

🏭 PLIVA Croatia Ltd (manufacturer)

No lactose ingredient

  12.5  PL 00289/1971

  25  PL 00289/1972

  50  PL 00289/0038

  75  PL 00289/1973

  100  PL 00289/0039

🟢 12.5 and 50 microgram PIL: mhraproducts4853.blob.core....

🟢 25, 75 and 100 microgram PIL: mhraproducts4853.blob.core....

🟣 12.5 microgram SPC: mhraproducts4853.blob.core....

🟣 25 microgram SPC: mhraproducts4853.blob.core....

🟣 50 microgram SPC: mhraproducts4853.blob.core....

🟣 75 microgram SPC: mhraproducts4853.blob.core....

🟣 100 microgram SPC: mhraproducts4853.blob.core....

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🔹 Wockhardt (marketing authorisation holder)

🏭 CP Pharmaceuticals Ltd (manufacturer)

🥛 contains lactose

  25  PL 29831/0130

🟢 PIL: mhraproducts4853.blob.core....

🟣 SPC: mhraproducts4853.blob.core....

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🔹 – identifies marketing authorisation holder

🔸 – identifies ‘own label supplier’ products

🏭 – identifies manufacturers (where known)

🥛 – contains lactose

❗ – Take particular note of the actual product which varies by dosage.

🟢 PIL – Patient Information Leaflet

🟣 SPC – Summary of Product Characteristics document

🟢🟣 Single document combining typical PIL and SPC information

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Numbers refer to tablet dosages in micrograms.

Only products which definitely contain lactose are identified (🥛 contains lactose). Please always check other products. Where products are ‘own label supplier’, check the marketing authorisation holder for the specific product.

There are links to product information on the MHRA (Medicines and Healthcare products Regulatory Agency) website. products.mhra.gov.uk/ These are the latest versions known.

If there is anything inaccurate in this information, please let me know by Private Message, or on the forum:

healthunlocked.com/user/hel...

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This document is updated whenever I am aware of any changes or enhancements are needed. Please check the Last updated date. The current version is available as a PDF here:

dropbox.com/s/6h3h0qi4eqwi6...

[willsie01 in reply to helvella]

So, the lactose used, where/what does it derive from? Animal? Chemical? Plant?

[SlowDragon Administrator]

A high percentage of autoimmune thyroid patients are lactose intolerant...and often unaware

ncbi.nlm.nih.gov/pubmed/240...

Lactose intolerance was diagnosed in 75.9 % of the patients with HT

read.qxmd.com/read/24796930...

These findings show that lactose intolerance significantly increased the need for oral T4 in hypothyroid patients.

[willsie01 in reply to SlowDragon]

Not another thing! How do I find out if I’m lactose intolerant?

[SlowDragon Administrator in reply to willsie01]

Try cutting it out

Goats milk and cheese is lactose free

Lots of lactose free items available in large supermarkets

If you are gluten intolerant, often lactose intolerance improves after year or so on strictly gluten free diet

coeliac.org.uk/information-...

[willsie01 in reply to SlowDragon]

I’m vegan. The only lactose I could get would be from quite obscure sources...like meds and products that accidentally contain it, like cross contamination on shared production lines.

[SlowDragon Administrator in reply to willsie01]

So you need lactose free levothyroxine

[willsie01 in reply to SlowDragon]

So you’re saying it’s animal derived. That’s what I needed to know. I had seen a definition of it in terms of chemistry.

[SlowDragon Administrator in reply to willsie01]

No idea....if it’s chemically made

[helvella Administrator in reply to willsie01]

I would be absolutely amazed if any lactose were not derived from animal milks:

Occurrence and isolation

Lactose composes about 2–8% of milk by weight. Several million tons are produced annually as a by-product of the dairy industry.

Whey or milk plasma is the liquid remaining after milk is curdled and strained, for example in the production of cheese. Whey is made up of 6.5% solids, of which 4.8% is lactose, which is purified by crystallisation. Industrially, lactose is produced from whey permeate – that is whey filtrated for all major proteins. The protein fraction is used in infant nutrition and sports nutrition while the permeate can be evaporated to 60–65% solids and crystallized while cooling. Lactose can also be isolated by dilution of whey with ethanol.

en.wikipedia.org/wiki/Lactose

[helvella Administrator in reply to SlowDragon]

Goats milk isn't lactose-free according to one of the largest producers in the UK:

3. Slightly Lower in Lactose

Goats’ milk is not recommended for anyone who has been diagnosed with lactose intolerance. However, goats' milk typically contains slightly less lactose (the natural sugar found in milk and other dairy foods) than cows' milk,8 and the amount of lactose people can tolerate varies.9,10 This may help to explain why some people who experience sensitivity to lactose are able to enjoy goats' milk without any repercussions. However, do consult your GP or a health professional before making any changes to your diet.

sthelensfarm.co.uk/health-b...

[AndrewT]

Dear willsie01,

Having worked for a Company, that manufactured Tablets, I can explain Why this is used. Lactose is 'Milk Sugar', in pure form it is a, fairly non descript, white powder. However Lactose, along with Silica (a sand derivative) and Stearates (harmless 'Soap' derivatives), can help the 'Tabletting' process. Most tablets are formed in a 'Di- Press', of some kind- the powder enters a 'two part' press before pressure is applied. The 'Tabletting Aids', as they are called, help produce Good tablets.

From the Quality Control point of view, which is where I worked, the tablets need to have a good Stability, Hardness and Friability (resistance to mechanical damage).

The Company, that I worked for, DIDN'T actually use Lactose- something that we were quite Proud of.

I hope that this has, at least to some extent, clarified 'why' Lactose is used.

AndrewT

[helvella Administrator in reply to AndrewT]

Thank you.

What did your company use where other companies might have chosen lactose?

[AndrewT in reply to helvella]

We were tabletting Yeast mostly and, we found, the Silica- and Stearate- worked well for us. We DID have have some Very Modern, and Very good quality, 'high speed' Tabletting Machines.

AndrewT