56 replies to this topic

[fishinghat]

"Nobody seems to know anything about Rising Pharmaceuticals as opposed to Rising Health LLC. I called them today and the lady I spoke to couldn't even give me a satisfactory answer about the capsule with any confidence. So I have NO IDEA if the usual capsules they use are enteric-coated or not..."

I can find that out as it must be specified to the FDA for the FDA approved Drug inserts.

https://dailymed.nlm...39-9bf015dc5a89
GELATIN (UNII: 2G86QN327L)

also;
20 mg is green opaque/green opaque, size ‘4’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on green opaque cap and ‘01’ on green opaque body with black ink.

30 mg is blue opaque/white opaque, size ‘3’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘02’ on white opaque body with black ink.

60 mg is blue opaque/green opaque, size ‘1’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘03’ on green opaque body with black ink.

[fishinghat]

"check with CVS or another pharmacy to see what manufacturer THEY use? That way maybe it is one on the list you made, and we would know whether the capsules needed to be enteric or not"

I called my local CVS and they have access to 5 brands of Cymbalta. yours may be different though. I would pick one of those brands that contains a large number of small beads. I would buy a good quality enteric OR gelatin capsule to use when the original capsules run out. The risk of pharmacobazoars is very low, especially if you are not taking a lot of different meds with it to add to the issue.

[invalidusername]

https://core.ac.uk/d...df/82727033.pdf

 

"Duloxetine hydrochloride (DXH) enteric-coated capsule under the name Cymbalta® has been approved for marketing by the FDA."

 

There are too many differing opinions - and not wanting to disagree with you Hat, but I would take the word of a peer-reviewed journal over the pharma helpline.

 

But, I really do not know. 

[DavidfromTexas]

"Nobody seems to know anything about Rising Pharmaceuticals as opposed to Rising Health LLC. I called them today and the lady I spoke to couldn't even give me a satisfactory answer about the capsule with any confidence. So I have NO IDEA if the usual capsules they use are enteric-coated or not..."

I can find that out as it must be specified to the FDA for the FDA approved Drug inserts.

https://dailymed.nlm...39-9bf015dc5a89
GELATIN (UNII: 2G86QN327L)

also;
20 mg is green opaque/green opaque, size ‘4’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on green opaque cap and ‘01’ on green opaque body with black ink.

30 mg is blue opaque/white opaque, size ‘3’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘02’ on white opaque body with black ink.

60 mg is blue opaque/green opaque, size ‘1’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘03’ on green opaque body with black ink.

 

Okay, so that would mean to go with just a regular gelatin capsule? The description of the appearance of the capsule IS exactly what my capsules look like. 

 

Are there examples of other drug pamphlets that use the language "enteric-coated capsules" as opposed to "hard gelatin capsules"?

 

 

"check with CVS or another pharmacy to see what manufacturer THEY use? That way maybe it is one on the list you made, and we would know whether the capsules needed to be enteric or not"

I called my local CVS and they have access to 5 brands of Cymbalta. yours may be different though. I would pick one of those brands that contains a large number of small beads. I would buy a good quality enteric OR gelatin capsule to use when the original capsules run out. The risk of pharmacobazoars is very low, especially if you are not taking a lot of different meds with it to add to the issue.

 

 

 

Also, if I use an enteric coated capsule once I run out of the originals, wouldn't that mean that the absorption of the drug is going to differ to some degree in those instances because of the difference in the vessel?

 

 

THE OTHER OPTION is to try the compounded powder route. I havent come across anybody else who has tried this version of the drug. But I did talk to my insurance and it apparently it WOULD be covered, though now Im wondering if they were checking on the pellets or the powder version.

Edited by DavidfromTexas, 07 August 2019 - 05:34 PM.

[invalidusername]

There is a paper out there which I am sure we have cited elsewhere on the forum whereby a group tried different coating on duloxetine beads in a "home-made" capsule and published the efficacy of the med. This potentially corroborates the theory that hard gelatine may be used, but the substance of the capsule used is not stated.

[invalidusername]

found it;

 

https://www.research...ic_polymers.pdf

[fishinghat]

"Also, if I use an enteric coated capsule once I run out of the originals, wouldn't that mean that the absorption of the drug is going to differ to some degree in those instances because of the difference in the vessel?"

It only matters that it does not dissolve in the stomach. If it dissolves in the early parts of the small intestines is what counts and the small intestines runs about 19' so it has time.

"Are there examples of other drug pamphlets that use the language "enteric-coated capsules" as opposed to "hard gelatin capsules"?"

The ones I referred to above list gelatin capsules all of the rest of the fda approved drug inserts do not specify.

"THE OTHER OPTION is to try the compounded powder route. I havent come across anybody else who has tried this version of the drug. But I did talk to my insurance and it apparently it WOULD be covered, though now Im wondering if they were checking on the pellets or the powder version."

My opinion agrees with you on both accounts.

[fishinghat]

IUN, you can disagree with me anytime. lol

I do take the word though of the patent as well as the FDA approved literature. If the manufacturers ever violated either one they could loose their production permit and suffer a heavy fine.

[invalidusername]

You'd think there would be some consistency in all this wouldn't you

[fishinghat]

You expect people to use common sense and logic? Not even. lol

[DavidfromTexas]

"Also, if I use an enteric coated capsule once I run out of the originals, wouldn't that mean that the absorption of the drug is going to differ to some degree in those instances because of the difference in the vessel?"

It only matters that it does not dissolve in the stomach. If it dissolves in the early parts of the small intestines is what counts and the small intestines runs about 19' so it has time.

"Are there examples of other drug pamphlets that use the language "enteric-coated capsules" as opposed to "hard gelatin capsules"?"

The ones I referred to above list gelatin capsules all of the rest of the fda approved drug inserts do not specify.

"THE OTHER OPTION is to try the compounded powder route. I havent come across anybody else who has tried this version of the drug. But I did talk to my insurance and it apparently it WOULD be covered, though now Im wondering if they were checking on the pellets or the powder version."

My opinion agrees with you on both accounts.

 

On which do you agree with me?

 

If I went with the powder...I have come to the realization that if I end up needing to go up to a higher dose of even just 5-10mg, the powder would no longer be affordable for me on a monthly basis, since it is already $200 for a 30 day supply of 1mg.

 

You linked to the Rising Health LLC Duloxetine pamphlet and it said it uses Hard Gelatin capsules...SO, assuming that Rising Health and Rising Pharmaceuticals ARE indeed the same company, is it still risky to use a regular gelatin capsule? I mean, I don't consider the gelatin capsules I bought to be "hard" gelatin capsules, they feel softer and more easily bent than the Rising Pharmaceuticals capsules that come in my prescription. So I just need to make a final decision, and it seems like y'all are leaning towards enteric capsules anyway, as opposed to gelatin, no?

 

Another thing is that after opening and then re-closing the capsules with the smaller dosage, the capsules are easier to get apart, they almost feel loose. Is this a danger of coming apart too soon in the stomach?

Edited by DavidfromTexas, 08 August 2019 - 02:46 AM.

[fishinghat]

"THE OTHER OPTION is to try the compounded powder route. I havent come across anybody else who has tried this version of the drug. But I did talk to my insurance and it apparently it WOULD be covered, though now Im wondering if they were checking on the pellets or the powder version."

My opinion agrees with you on both accounts.

 

I also know of no one that has used the powder and I also believe that the insurance was considering the beads not the powder when they made the cost comment.

"is it still risky to use a regular gelatin capsule?"

Not really. The hard gelatin takes a couple of minutes longer to dissolve but not enough to make a diffence. Plus the softer gelatin is easier to handle without damaging it.

"and it seems like y'all are leaning towards enteric capsules anyway, as opposed to gelatin, no?"

Yes, while enteric is not a necessity I would just prefer to be sure the med is released in the intestines and not the stomach. Either way should be fine though.

"Another thing is that after opening and then re-closing the capsules with the smaller dosage, the capsules are easier to get apart, they almost feel loose. Is this a danger of coming apart too soon in the stomach?"

That is an interesting comment. I have never seen a post which mentioned this before. Just a thought but I assume you are talking about your current hard capsules that break easy. It seems like the gelatin would reseat better/ I didn't have any problems with my flexible gelatin capsules though. In case you were wondering about why I didn't use enteric coated, it was because the information about the medicine changing to naphthol was not known at the time. Anyway that is just my opinion certainly no proof with that opinion.


 

[DavidfromTexas]

That is an interesting comment. I have never seen a post which mentioned this before. Just a thought but I assume you are talking about your current hard capsules that break easy. It seems like the gelatin would reseat better/ I didn't have any problems with my flexible gelatin capsules though. In case you were wondering about why I didn't use enteric coated, it was because the information about the medicine changing to naphthol was not known at the time. Anyway that is just my opinion certainly no proof with that opinion.

 

 

Yes, I am talking about the original hard capsules that come with the prescription.

 

What is the naphthol you are referring to? Is that what made one of the members really sick, the ingredient that's toxic to the stomach? That's the thing that has really worried me the most the last couple days when it comes to making the decision about capsules. When you were tapering Cymbalta/Duloxetine, were you using brand name or generic? And did the drug come in the same state it does now (enteric beads inside hard gelatin)?

 

As far as I have been able to find, there are not many third party enteric-coated capsules out there for purchase. At least not on Amazon. I have been trying to find one that at least has some reviews, even though the reviews for the couple I've found (including this one) contain a couple reviews that say they do NOT work as enteric after all...

 

https://www.amazon.c...=gateway&sr=8-3

 

Do any of you guys know of, or have recommendations, for a good brand of enteric capsules?

[fishinghat]

Naphthol is a chemical form of phenol, a double ringed hydrocarbon with side groups. It is formed when the Cymbalta reacts with the stomach acid. It would be my belief that this compound would cause severe gastric symptoms. Unluckily no studies have been done on this reaction nor the amount of naphthol produced. I am sure that it has contributed to the stomach problems of many members who took the beads without a capsule (which is not advised).

 

The Cymbalta I used was the brand name from Eli Lilley as the generic wasn't available yet.

 

Yes, it came in the same state as now as the original patent has not been changed since 1996.

 

You will find that many of the enteric capsules are called acid resistant capsules on Amazon. I did a quick search on Amazon for enteric capsules and came up with around 20. Of course you need to get the right size as well. I don't see anything wrong with the capsule you linked to but I must confess that I have not used any of the brands listed on Amazon. My local compounding pkarmacy gave me about a hundred of theirs.

[fishinghat]

These are the only specific brands that members have mentioned in the past...

https://www.ebay.co....1-/302781915829

https://www.amazon.c...,aps,213&sr=8-1

https://www.amazon.c...0?ie=UTF8&psc=1

[DavidfromTexas]

 

You will find that many of the enteric capsules are called acid resistant capsules on Amazon. I did a quick search on Amazon for enteric capsules and came up with around 20. Of course you need to get the right size as well. I don't see anything wrong with the capsule you linked to but I must confess that I have not used any of the brands listed on Amazon. My local compounding pkarmacy gave me about a hundred of theirs.

 

 

Naphthol is a chemical form of phenol, a double ringed hydrocarbon with side groups. It is formed when the Cymbalta reacts with the stomach acid. It would be my belief that this compound would cause severe gastric symptoms. Unluckily no studies have been done on this reaction nor the amount of naphthol produced. I am sure that it has contributed to the stomach problems of many members who took the beads without a capsule (which is not advised).

 

The Cymbalta I used was the brand name from Eli Lilley as the generic wasn't available yet.

 

Yes, it came in the same state as now as the original patent has not been changed since 1996.

 

You will find that many of the enteric capsules are called acid resistant capsules on Amazon. I did a quick search on Amazon for enteric capsules and came up with around 20. Of course you need to get the right size as well. I don't see anything wrong with the capsule you linked to but I must confess that I have not used any of the brands listed on Amazon. My local compounding pkarmacy gave me about a hundred of theirs.

 

 

 

Ohhh ok. So the members that got sick were from taking the capsules without a capsule at all? I must have misread that part because I was going through the thread pretty fast.

 

In your case, were the capsules you used from the pharmacy enteric capsules or regular gelatin?

 

Ya there are several enteric capsule brands you can find on Amazon, but only a couple or so that actually have some reviews. Maybe I will ask a compounding pharmacy here in town if I can purchase regular or enteric capsules from them...

 

You also mentioned the capsule size matters...I thought as long as you were able to swallow it okay that the size wasn't a big deal. The capsules that most members had been using on the other forum was either size 0 or 00. Those of course are the pretty large ones, but I didn't think the size would matter, as long as you could fit all the beads in it comfortably.

Edited by DavidfromTexas, 08 August 2019 - 08:19 PM.

[fishinghat]

Some were from taking the beads without a capsule and others not. You have to remember that stomach issues are standard with Cymbalta withdrawal as the intestinal tract contains the most serotonin. It can be hard to separate the specific cause for stomach issues due to that fact.

I don't know, I never asked. They had the appearance and feel of a gelatin capsule though.

" but I didn't think the size would matter, as long as you could fit all the beads in it comfortably."

That is the point I was trying to make. Sorry I was not clear on that.

[Dakini]

Hi-   I'm also using the manufacturer, Rising distributed by Rising Health, LLC and have similar concerns. 

 

1. Where is the delayed-release: capsule or the pellet contents?
2. Do I need to put back into the original capsule from Rising?
   1.  If so, can someone recommend a funnel that fits that capsule?
3. Are there any issues with Now, Double "00" Veg capsules?  I found a funnel that fits these perfectly.

 

Many thanks. 

[fishinghat]

The veggie capsules are OK as the enteric coating is on the individual beads. I normally recommend an enteric coated  capsule (some times called an acid resistant capsule). The reason for this is that if the beads are dissolved in the stomach they are changes to naphthol, a very irritating chemical to the stomach so just to be safe I would recommend the acid resistant capsule. Many members have used the veggie capsules with success however.

[invalidusername]

So many variables that can affect the rate at which the capsules can be broken down/metabolised, but as Hat says, we always suggest to stay safe with enteric coated capsules, that way there is no question about the beads being released in the stomach or lower GI.

[Dakini]

Given all the variables, I plan on using the original capsules.

 

Has anybody counted the beads/pellets in the 30mg or 60mg capsules by Rising Pharmaceuticals?

 

 

 

[fishinghat]

Bead manufacturing varies between batches. Members have found that the bead count within a batch is around +/- 4% but from one batch to another varies around 10%. In addition the FDA allows a 10% variation in dose for a given product. For a 60 mg capsule it should be between 54 and 66 mg, That makes it easy to have a consistent slow steady wean right?  NOT!!! 

[invalidusername]

Exactly... which is why it is better to create the capsules from a number of beads yourself rather than taking x amount of beads from each capsule as they might be that far out.

 

Depending on how sensitive you are, this can have quite an impact.

 

Alternative is to weigh using microscales. Not much between that and the counting method given that we can never be sure how much of the weight is attributed to the coating and how much is the duloxetine medicine itself.

[Dakini]

Bead manufacturing varies between batches. Members have found that the bead count within a batch is around +/- 4% but from one batch to another varies around 10%. In addition the FDA allows a 10% variation in dose for a given product. For a 60 mg capsule it should be between 54 and 66 mg, That makes it easy to have a consistent slow steady wean right?  NOT!!! 

 

I spoke with a compounding pharmacist, but he told me he couldn't guarantee a precise daily dose either.

 

I got off this drug before by compounding down by 5mg per month, but I went  back on it 3-4 months later due to severe withdrawal symptoms. 

 

This time, I have a scale and am counting the beads as an additional check for accuracy.      I've counted the contents in four 30mg capsules from Rising: 183, 176, 178, 178.    It would be great to know the bead count and weights from someone else. 

 

I plan to start tapering from 60mg by 10% per month beginning October 1: 60, 54, 49, 44, ....

 

Thanks for the support! 

[fishinghat]

This is the data from other members and your data will be added to the next update to the ebook.

[fishinghat]

I also found this old post...

 

DavidfromTexas

Posted 06 August 2019 - 09:46 PM

The company listed on my prescription bottle is Rising Pharmaceuticals. I am wondering if this manufacturer is "suitable" to use for tapering, as I did not see it in the list provided by either of you.

When opening up the 20mg capsules, I came up with an average of 115 beads (from an average of 5 different capsules). I would think that these are the kinds of "micro-beads" that you guys are referring to as being good for tapering, but I would just like to make sure while I am still early in the game. Perhaps I could still find a pharmacy that uses one of the other generic manufacturers y'all listed above.

[Blooze]

I spoke with a compounding pharmacist, but he told me he couldn't guarantee a precise daily dose either.
 
I got off this drug before by compounding down by 5mg per month, but I went  back on it 3-4 months later due to severe withdrawal symptoms. 
 
This time, I have a scale and am counting the beads as an additional check for accuracy.      I've counted the contents in four 30mg capsules from Rising: 183, 176, 178, 178.    It would be great to know the bead count and weights from someone else. 
 
I plan to start tapering from 60mg by 10% per month beginning October 1: 60, 54, 49, 44, ....
 
Thanks for the support!

I use Rising Health 60 mg and have just started to taper. The average weight of 7 capsules was 0.364 g.