80 replies to this topic

[invalidusername]

Furthermore, gelatin capsules would NOT break down in the intestines - they wouldn't make it that far. They breakdown very soon after reaching the stomach acid.

 

Sorry to harp on about this, but Hat and myself are readers and have mild OCD symptoms of always having to make sure something is proven correct

 

But this is not just for our own ego-gratification, this is for the benefit of all.

[fishinghat]

All of the following information is taken directly from the Eli Lilley drug insert.

https://dailymed.nlm...d64ba#section-3

3 DOSAGE FORMS AND STRENGTHS
CYMBALTA is available as delayed release capsules:

11 DESCRIPTION
CYMBALTA® (duloxetine delayed-release capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration.
Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively.

16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
CYMBALTA is available as delayed release capsules in the following strengths, colors, imprints, and presentations:

PRINCIPAL DISPLAY PANEL
delayed release capsules

[DebbieC61]

Furthermore, gelatin capsules would NOT break down in the intestines - they wouldn't make it that far. They breakdown very soon after reaching the stomach acid.

 

Sorry to harp on about this, but Hat and myself are readers and have mild OCD symptoms of always having to make sure something is proven correct

 

But this is not just for our own ego-gratification, this is for the benefit of all.

 

All of the following information is taken directly from the Eli Lilley drug insert.

https://dailymed.nlm...d64ba#section-3

3 DOSAGE FORMS AND STRENGTHS
CYMBALTA is available as delayed release capsules:

11 DESCRIPTION
CYMBALTA® (duloxetine delayed-release capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration.
Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively.

16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
CYMBALTA is available as delayed release capsules in the following strengths, colors, imprints, and presentations:

PRINCIPAL DISPLAY PANEL
delayed release capsules

 

Thank you both for your quick reply. I'm using a compounding pharmacy right now, but when I get down to the lower dosages, I'm anticipating counting beads and I want to get this right.

[DebbieC61]

Where is the best place to get the enteric coated capsules? I've been looking on Amazon, but some reviewers on there are stating that some of the enteric capsules sold turn out to be just regular, plain gelatin capsules.

[fishinghat]

Enteric coated capsules are also sold under the name of acid resistant capsules. I got mine at a local compounding pharmacy. They keep them in stock for make ups of Cymbalta and similar compounds.

[KathyInFL]

I'm on that Facebook group too, they are pretty militant in their instructions. I believe the founder's sister committed suicide while on or tapering off C.

[invalidusername]

Pharmacy is best place if you can for the caps. Most will be able to order them in if they don't carry stock.

 

Yes - the FB are quite militant, but they mean well and offer lots of support. But what sorry circumstances for the founder. 

[mforster]

Help, yes! That FB group is so so militant! Based on their advice, I returned the enteric capsules and bought regular gelatin. I'm going to read that other thread posted. 

[fishinghat]

That is really sad. It is bad enough going through this withdrawal let alone dealing with misinformation.

[invalidusername]

Too many opinions and not enough facts.

 

Someone should mention this to them - any takers??

[KathyInFL]

Someone should mention this to them - any takers??

 

Not me!!    

[mforster]

OK, so wondering about this:

 

"Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach."

 

If the pellets/beads are already enteric-coated, then why would it matter if the capsule were too?

 

(From https://www.rxlist.c...drug.htm#dosage)

[mforster]

From: https://www.ncbi.nlm...les/PMC2695226/

 

"Duloxetine is rapidly hydrolyzed in acidic media to naphthol, which has no antidepressant activity.10 To overcome this issue, the pellets inside the duloxetine capsule are enteric coated, but the capsule is not. This enteric coating of the pellets resists dissolution until pellets reach a segment of the gastrointestinal tract where the pH is favorable. "

[mforster]

However, I'm finding many other sites that reference the enteric capsules! Very confusing and contradictory info.

[invalidusername]

Dude - there is a whole paper on it. It all comes down to the polymers used and the respective coating durability. If you really want to read what it is all about, then this is what you need to read - but take it from me - the capsules as marketed by Eli Lily ARE coated.

 

https://www.scienced...818087616300782

 

"We can draw a conclusion that drug release can be affected if the coating weight, pH of enteric polymers and curing conditions are changed."

 

Long story short, using the wrong capsules will not make the drug work in the way in which it was intended by the manufacturer. The study compares different coating on the pellets and the different types of capsule used; the original Cymbalta and the one they refer to as the "home-made" into which they transfer the beads. The coating on the beads isn't the same stuff as that on the capsule, and the paper that Hat found drew reference to the chemical compounds used in these polymers as harmful when in contact with the stomach lining. If the coating on the pellets come into contact with the stomach acid, it reads as though this is what compromises the integrity of the duloextine medication in the centre of the pellets. It is a bit late and my mental faculties are quite as sharp as they may have been earlier, but hopefully my musing make some sense!!

[mforster]

At the advice of my friend who was a pharmacist, I ultimately decided to go with the information provided directly from my manufacturer (Breckenridge)'s insert, which reads: 

 

"Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide." 

 

I just want to stay consistent with the experience I'm already having with the capsules provided by the manufacturer. 

. 

[fishinghat]

Very good research mforster. I will add your comments to my library I maintain on Cymbalta. Thank you for the additional information. When I get time I will contact Eli Lilley directly for their input.

[invalidusername]

You know what guys - I think there are BOTH types. 

 

Depending on the coating of the beads, the coating of the capsule will be determined from what I read from the paper.

 

This would be logical wouldn't you say?

 

EDIT - ditto on the find there mforster - you are one of us now

[fishinghat]

At this point I am very confused (not unusual). The information is very contradictory.

[invalidusername]

Isn't it just.

 

That paper I linked to specifically mentions enteric all the way through from the genuine article Cymbalta capsules, so there may be extra and/or different coating on the generics which mean they don't have to use enteric capsules. If we think about it, this would be cheaper for the pharmas as the enteric capsules are darn expensive...

[mforster]

I sent my pharmacist friend your paper, and she wrote back:

 

Summary: our patent ran out on Prozac. So out of several compounds we could have marketed to take its place, we chose one that required a complicated resin system. Why? This would limit the number of generic houses able to duplicate. And then someone needed a dissertation topic so they did this study. Drug never should’ve gone to market in the first place

 

She's pretty appalled at our experiences and surprised FDA hasn't taken this off the market. She stopped practicing before Cymbalta came out. 

 

I agree that it seems like there might be both kinds of capsules, and that the most reliable source of info is your specific manufacturer. That info is pretty surprising, though, since in theory all manufacturers should be adhering to Eli Lilly standards.

 

Thank you--I am also a compulsive researcher (perhaps that's why I was prescribed cymbalta, which made me not care about anything or anyone! ha!)

[fishinghat]

Interesting, because I checked the same section in 5 other brands of Cymbalta and they have exactly the same information minus the comment 'hard gelatin capsule'. I called the Eli Lilley help line but like a dum dum I forgot it was a Saturday. DUH

I will try again Monday.

[fishinghat]

Well, well well...I may have an answer...

All of the data sheets for "Cymbalta" state they are enteric coated capsules.

All "Duloxetine" data sheets say the capsules are hard gelatin except Activas, Teva, Cipla, Heritage, Inventia, Lupin, Solco, Sun Phartmaceutical, Zydes and Ascend which did not state the construction of the capsule. In addition, Camber brand is not enteric coated PELLETS but are only film coated only. Film coated is made of the same material but thinner and does not meet the FDA required digestion time to be considered enteric.

Cymbalta Brands
Eli Lilley
Aphena
Carilion Materials Management
H.J. Harkins Company, Inc.
Lake Erie Medical DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
Physicians Total Care, Inc.
Rebel Distributors Corp.
STAT Rx USA LLC

Duloxetine Brands
Aurobindo Pharma Limited
Prasco Laboratories
Rising Health, LLC
Actavis Pharma, Inc.
Teva Pharmaceuticals USA, Inc.
Ajanta Pharma Limited
Ascend Laboratories, LLC
BluePoint Laboratories
Cadila Healthcare Limited
Camber Pharmaceuticals, Inc.
Cipla USA Inc.
Heritage Pharmaceuticals Inc.
Inventia Healthcare Private Limited
Lupin Pharmaceuticals, Inc.
Solco Healthcare US, LLC
Sun Pharmaceutical Industries, Inc.
Zydus Pharmaceuticals (USA) Inc.

[invalidusername]

Wow - breakthru!

 

So my theory is correct?! Fantastic digging around there Hat - thank you. It feels good to have finally got an answer to this one. Still doesn't answer the question of why the Dulox uses a different capsule unless the beads themselves use a different agent for their protective coating. 

[invalidusername]

Bet you never anticipated such a discussion when you came looking for us mforster

[fishinghat]

You were right IUN. Good question on the enteric coating on the beads but that will have to wait to tomorrow. lol

 

I think the generic duloxetine is simply made cheaper. One isn't even enteric coated on the beads. Crazy.

[KathyInFL]

This discussion is way over my head. 

 

Does this mean that the brand of generic Cymbalta determines if you need to use the enteric or non-enteric capsules?

[invalidusername]

Exactly Kath.

[KathyInFL]

Exactly Kath.

EL executives need to be in jail. 

[DebbieC61]

Holy sh*t! This is crazy! I've been using a compounding pharmacy but am about to change pharmacies due to service problems, nothing to do with the drug itself. Current pharmacist's communication skills are sadly lacking so he's really hard to deal with. I'm going to ask my new pharmacist what capsules he uses when I get started there.