Oestrogel: new packaging (yet again)?

[Cosmetichamster]

Hi ladies,

Just got this month's prescription for Oestrogel, and I have been issued with a bottle that is new (to me at least). Have a look at the photo: left is what I have known and used since June this year, on the right is the new bottle, also from Besins, same labels, same ingredients, and long use by date (07/25). Obtained from a reputable pharmacy, which has filled all my previous HRT prescriptions.

Has anyone seen this sort of thing? Slightly freaked out here.

Just for info and nothing else, the very old bottles which I first used many years ago (white with gold writing) had the same spout system as the cylindrical ones.

It was possible to re-attach the protective 'cover' onto the spout (which doesn't seem possible now) but I think the only purpose was to prevent accidental spillages if you were carrying it away from home and the plunger was pressed down. I never used the spout cover as it wasn't really necessary.

Louise Newson has a poll on her stories asking how many women have been affected

I said I was going to ignore you but one thing has occured to me.. a bit off topic... who am I talking to? @JinglingXmasbells @JinglingSpringbells @JinglingHellBells because you all have many posts on HRT (+ 10,000)... I thought multiple accounts weren't allowed on MN.

Back to the topic... If the stopper is there to prevent spills, that would mean that the gel is in direct contact with the external environment and the pump would not be 'accidentally' pressed if the cap was on. And why wouldn't the conical bottle pump need a stopper? Because the gel is not in contact with air, due to the fact that their airless pouch and pump mechanism is different and doesn't allow direct contact with air. I could be wrong but the facts don't lie.

@BatshitCrazyWoman Thanks! Although I would advise her to use a different photo because that cylindrical bottle with the orange swirl is really old 😂

I can't see that on Insta..

It's in her stories

@BatshitCrazyWoman I can't see her stories because I'm not following her on IG and even if I follow her it doesn't show up until she accepts me. Would you be kind to keep us posted on the numbers?

I have been thinking (but not too much haha) about the different pumps and after checking them out again on the respective manufacturers' websites I think I have found one possible explanation for the different amounts of gel delivered by the cylindrical bottle v conical bottle, but it doesn't explain the lack of consistency between doses of the same cylindrical bottle (what scientists call inter- and intra- variation).

The pump/pouch manufactured by Nemera is the one used in the Oestrogel and Oestrodose conical bottles and It can deliver 1000, 1420 or 1500 microliters of gel (1.0, 1.42 or 1.5 ml).

If we consider the fact that hydroalcoholic gels have densities varying from 0.8 to 0.9 g/cm3 (or g/ml), 1.25 g is not exactly equivalent to 1.25 ml.

Although I don't know the exact density of Oestrogel, it cannot be equal to the density of water, 1 g/ml where 1 g = 1 ml.

In order to deliver 1.25 g (one pump) the amount of gel should be around 1.388 to 1.5625 ml.

One of the pumps available delivers 1.5 ml so it's in the right range, delivering from 1.2 to 1.35 g of gel.

Lablabo (the manufacturer of the cylindrical bottles) says the pouch volume can be adapted to your needs, but not the dosage volumes of the pumps, that are available as 1.0, 1.25, 1.35, 1.5, 2.0, 2.5, and 3.0 ml.

If the gel is exactly the same, regardless of the bottle and pouch/pump, then the cylindrical bottle possibly has the 1.35 ml pump and it is delivering less gel than the conical bottle pump that delivers 1.5 ml, meaning that each actuation contains 1.08 to 1.215 g of gel.

If it had the 1.5 ml pump it would be delivering amounts in the same range as the pump of the conical bottles.

This is taking into account that the different pouch/pump design is not affecting the 'metered dose'.

The wider differences found by bloomingthroughthemenopause on Instagram could be explained by the fact that the scale is not analytical grade. Even talking near the scales can affect the measurement.

@gabbyaggy What dosage of gel were you on? And what dosage of Lenzetto are you using? I’ve switched to patches but, would you believe, the pharmacy now has no stock?!

@JoCushion I was on 3 pumps of Oesteogel and switched to 4 sprays of Lenzetto.

@Azaleah this morning the poll is showing 77% of respondents had had a return of symptoms.

Got it now. Thanks.

Thank you. I was on 4 pumps of gel so I don’t think I can use Lenzetto.

@gabbyaggy sorry, that reply was meant for you! 🥴

@JoCushion l think the maximum is 3 however my GP prescribed 4 sprays.

If anyone is interested Besins Zarazoga has a review option but no website online.

@JoCushion i went upto 4 doses of oestrogel but had return of migraines etc. I found out later that I wasn’t getting the right dose of progesterone once that was sorted I went down to two does of the gel and have felt much better. So I would check that your progesterone is at the right level. In my case it was a faulty coil causing the issues.

I think it’s worth noting lots of women has a return of symptoms when using the orange square 74…. Batch numbers regardless to bottle shape, it would appear there are two issues at play here

Not necessarily, 3 doses of Lenzetto have 3 x 1.58 mg = 4.74 mg of estradiol hemihydrate and 4 pumps of Oestrogel have 4 x 0.75 mg (750 µg) = 3 mg of estradiol hemihydrate, and considering the absorption rate could be better with Lenzetto, it could be just what you need to control symptoms.

Yes, that's probably because the manufacturer's team has changed in Belgium.

The Drogenbos manufacturing site belonged to Besins until January 2012 when it was acquired by Delpharm, a large Contract Development Manufacturing Organisation, which took over the production of Oestrogel until as recently as April 2022.

Besins bought the factory back (published in June 2022) to 'boost HRT production', apparently because the manufacturing site will become 'solely dedicated to the production of hormonal products including Besins Healthcare’s Oestrogel® (Estradiol (0.06% w/w))'.

As far as I know, that manufacturing site was already dedicated exclusively to the production of hormonal products, so this is absolute bullshit.

What could happen is that Estreva Gel, which is the estradiol gel sold by Theramex in Europe, will no longer be manufactured at this site, but so far the leaflet has not changed.

What Besins actually did was increase production in France because now the gel is also being manufactured at Besins Laboratoires International, Montrouge, France, hence the recent changes to the leaflet.

For a decade Besins have kept the leaflets saying the manufacturer is Besins Manufacturing Belgium, when in fact it was Delpharm, but in 2020 they have changed it to Delpharm, and now they have changed it back to Besins Manufacturing Belgium (BMB) OR Laboratoires Besins International (LBI).

No wonder the confusion!

Thanks @Azaleah , that’s really helpful. I have some Lenzetto from a while back that I didn’t use so I might try it.

@Azaleah I wonder why my GP prescribed 4 sprays of Lenzetto for 3 pumps of Oestrogel?

This is based on the so called pharmacokinetic properties of both formulations that differ.

The equivalence tables published by the BMS and other websites are based on this study

https://journals.lww.com/greenjournal/Abstract/2008/06000/Low_Dose_Estradiol_Spray_to_Treat_Vasomotor.15.aspx

They're considering average absorption rates, which seem to be lower for Lenzetto (less than 2%) than the 'expected' average absorption rates for Oestrogel, of 'approximately 10%', 'when applied topically to a large area of skin'.

If these numbers are to be trusted, the equivalence tables aren't correct.

These studies provide an idea of how the products will behave, but there are many variables as skin type, fat content, temperature, to name a few.

I would start with the lowest dose and increase gradually based on symptoms, because two different products are never truly equivalent.

Because each woman is unique regarding hormonal status, history and genetics, HRT is always trial and error within the safety limits.

@gabbyaggy I forgot to say that it is very important to give the product time to work because, as the graph (attached below) from the same study mentioned above shows, it takes 12 weeks for the product to reach a steady state.

I'm trying to find the study that backs up the absorption rates of Oestrogel. I have found an error in the Summary of Product Characteristics Updated 08-Sep-2023 | Besins Healthcare (UK) Ltd (SmPC) regarding the results of the study, pending confirmation.

The snapshot of this section is attached below. Can anyone spot the error?

@azaleah Thankyou so much.

www.thepharmaletter.com/article/besins-healthcare-unveils-state-of-the-art-hrt-factory

I've just put on a request on my gp for a hrt consultation and got a message back saying I have lots of patients to talk to about hrt. I may not be able to get to you today but I will ring you in a weeks time.
I'm currently using patches but they aren't the same as gel.
I'm so fed up with struggling after the new bottles of gel don't work 😒