A New “Ritalin”: Extended-Release Quillivant Liquid & Chew

Quillivant Quillichew

In light of the ongoing problems with Concerta generics, yesterday I updated this 2013 post about a novel methylphenidate (MPH) product: Quillivant XR. Now, given new information, I’m again re-updating today, May 19, 2020.

Before getting into the details about the (apparently) resolved problems with Quillivant XR, let me explain what I mean by novel. I mean novel delivery systems. With Quillivant XR, the delivery system is a liquid. The chewable version, QuilliChew XR, came out in 2015.

You might already know that all MPH-based stimulant products (e.g. Ritalin, Concerta, Daytrana Aptensio XR, Metadate CD, Methylin, Jornay PM, Adhansia XR, and Cotempla) contain the same medication. It’s the delivery system that makes all the difference in how fast the medication enters the bloodstream—and the rate in which it exits.

That’s why, even though these products contain the same medication, they vary in efficacy for individuals.

The Problematic History with Quillivant: Resolved?

I’m constantly aware that more choices mean more people have a better chance of finding a stimulant that works best for their unique neurochemistry and preferences. For example, many people with ADHD have a “gag reflex” that makes swallowing pills difficult. Hence, a liquid or chew might be a useful alternative.

At any rate, initial interest in the Quillivant products subsided amidst product shortages and, later, a recall. When I checked the FDA website recently, I found no more shortages. It seemed time for an update.

Minutes after the updated post went out yesterday, however, a kind reader alerted me to some alarming news about Quillivant’s history. I investigated and raised these concerns with a company representative.

Overall, it seems that much confusion resulted from Pfizer purchasing the product from NextWave/Tris—and then Tris buying it back—all in the space of about 3 years.  (It’s very hard to follow the trail, though, given all the subsidiaries.) At any rate, those problems seem to have been resolved. More details below.

In This Post:

In this post, you’ll find:

  1. A reader’s concerns
  2. A brief explanation of each Quillivant product
  3. Status update from my conversation with a company representative
  4. Consumer tips from the company in making sure your pharmacy follows instructions properly
  5. How food and food products such as citric acid might affect these products’ absorption and efficacy (judging from the traffic to this post, this is a common question:  Can Acidic Foods Affect Stimulant Medications for ADHD? 
  6. The Quilllivant Savings Program

A Reader’s Concerns: Mistrust for Quillivant

I’m grateful to a kind reader named Ed for writing this in a comment:

Regarding Quillivant XR: early in Jan 2018, our son’s Dr called us to an urgent appointment to discuss a change of medication.
Reason being “Quillivant production is halted”. We had to jump to another medication for his next prescription due the next day.

No one knew anything about the why, only a vague rumor about the uneven dissolution in the bottle, leading to uneven mix for every dose taken from each bottle. I found several other parents from other doctors also surprised by last-minute change.

A couple of weeks later I found this recall document. https://s3.amazonaws.com/prod-mdmembers-content/content-files/News/recalls/2017/Quillivant1.pdf

Quillivant XR had been recalled 4+ months before I was told. They clearly communicated to their distribution chain. As for the consumers? Nothing. They put their focus on avoiding commercial liability, and manage product stocks.

Hence, I can’t help but feel a deep mistrust for everything Quillivant XR: did they fix the dissolution problem? how safe is the solution? Will they communicate any better next time?

I first reported on Quillivant XR in January of 2013. That’s when I published an earlier version of this post. Shortly after that, the medication experienced widespread shortages. In 2012, Pfizer had acquired Quillivant from developer NextWave, with manufacture and distribution by co-developer Tris Pharma.

As of December 2019, the FDA Drug Shortages reporting site indicated available supply for Quillivant XR.  In addition, a chewable option, QuilliChewXR, had been introduced in 2015. That was my main impetus in writing this update. Then Ed, a kind ADHD Roller Coaster reader, clued me into the rest.

Quillivant XR: Liquid Extended-Release Form of MPH

Quillivant XR is a liquid, extended-release formulation designed to last 12 hours. (As always, your mileage may vary, given your unique neurochemistry).

Basically, it comes as a powder that your pharmacist will mix for you into a liquid. You will receive:

  • Glass bottle (containing the liquid)
  • Oral dosing dispenser, and
  • Bottle adapter.

You’ll find the question-and-answer page on this product here: Questions/Quillivant XR.

Quillivant XR

 

Easier to Swallow; Enables Precise Dosing

Quillivant XR liquid offers two obvious benefits:

  1. A liquid stimulant might be an extremely useful option for individuals who have a hard time swallowing pills or capsules. Many individuals with ADHD have a “gag” reflex.
  2. A liquid stimulant also enables more precise and individualized dosing – for children, teens, or adults. After all, sometimes a person’s ideal dose lies somewhere between the available dosage strengths of the pills or capsules. (This is not a claim made by the company.)

This isn’t the first liquid-stimulant formulation. It does, however, seem the most sophisticated in its extended-release profile.

Simply put, a profile refers to the pattern the medication follows from the time it’s taken to the time it wears off.  Below is the profile for Quillivant XR, compared to an immediate-release (IR) methylphenidate oral solution.

Quillivant XR profile

Note that  Quillivant XR appears to avoid the “roller coaster” ups and downs that are so common with the IR products.

Also worth noting: Other extended-release methylphenidate options, such as Concerta, also show more sustained and smooth profiles compared to the immediate-release formulations.  So do some amphetamine-class stimulants such as Vyvanse.

A Preferred Profile for Some, Not for Others

At the same time, this profile might not work best for you or your loved one.

Quillivant profile

For example, let’s look again at the profile for the immediate-release (IR) methylphenidate oral solution. See that “spike” between 5 and 10 hours (on average)? That might be exactly what some folks need—an extra boost of the medication at that time. Compared to this, Quillavant starts a steady decline at about 5 hours.

Each person will have a profile preference, either due to cognitive demands during the day or simply the way his or her body metabolizes the medication.

QuilliChew XR: Chewable, Extended-Release Form of MPH

QuilliChew has its own FDA product insert. It’s difficult to compare the two profiles (Quillivant XR liquid and QuilliChew) because they use different labels. Roughly, they seem very similar.

Quillichew profile

QuilliChew XR comes in a blister pack, as a chew. Two doses (20 mg and 30 mg) are scored to allow half doses. That is not the case with the 40 mg dose.

Status Update

Given the problems with the Quillivant XR liquid in the several years following its introduction, I asked a Tris company representative for an update—and some explanations.

Here is a summary:

  • The 2017 recall (linked to above) happened when Pfizer owned the company. Trist since purchased the company, NextWave.
  • The recall concerned two lots of the product that “did not meet the specification for dissolution.”  There was no contamination or other severe problem. But the dosing apparently was affected (which, I know, can present its own kind of problem). There have been no recalls since that one.
  • There is no longer a product shortage.

Quality Depends on Pharmacist And Consumer Following Instructions

According to the Tris representative, there have been reports of pharmacists not properly following instructions with the Quillivant XR liquid product.

The product kit, as depicted above, includes an empty glass bottle. The pharmacist should add the powder to that glass bottle, mix with the indicated amount of water, and shake vigorously.  (Consumers should also shake the bottle vigorously before each use.)

Apparently, some pharmacists have ignored instructions and opted to mix the solution in alternate containers, including plastic and amber-colored.

Why is this a problem? Because, according to the Tris representative, proper emulsification (the water mixing well with the powder) depends on the liquid hitting that type of glass.

Given this information, it behooves consumers to directly question the pharmacist about the procedure before purchasing Quillivant XR liquid.

Now, onto the other issues.

Does Food Interfere With Either Quillivant? Uncertain

Generally, there are two areas to consider when it comes to stimulant medications potentially reacting with food or vitamins:

  1. Citric Acid
  2. Dietary Fat

Citric acid is in orange juice and some multi-vitamins. You’ll also find it as a preservative in many food products (check the label).

To varying degrees, Citric acid can interfere with some stimulant medication’s effectiveness.  (See one of my most popular blog posts: Can Acidic Foods Affect Stimulant Medications for ADHD?)

Some stimulant medications are affected by dietary fat.

Each “Quill” product can be taken with or without food, according to the product inserts.

Let’s examine each Quillivant XR product for these two factors: citric acid and dietary fat.

1. Quillivant XR Liquid: Affected by  Citric Acid or Fat?

I find no evidence on the drug insert for Quillivant XR liquid—that consuming citric acid is a concern. In fact, the inactive ingredients include one type of citric acid (anhydrous citric acid).

What’s anhydrous citric acid? From the definition at Drugs.com:

It is found naturally in citrus fruit such as lemons and limes and is used as a natural preservative.

Anhydrous citric acid has had the water molecules removed and is usually in a dry, powdered formulation.

Meanwhile, consider this item about consuming high-fat meals, also found on the drug insert:

 In a study in adult volunteers to investigate the effects of a high-fat meal on the bioavailability of QUILLIVANT XR at a dose of 60mg, the presence of food reduced the time to peak concentration by approximately 1 hour (fed: 4 hours vs. fasted: 5 hours).

Overall, a high-fat meal increased the average Cmax of QUILLIVANT XR by about 28% and the AUC by about 19%. These changes are not considered clinically significant.

I am not a psychopharmacologist. But I interpret this to mean that fasting prolongs the time it takes to achieve peak concentration by one hour.  Consuming a high-fat meal reduces the time it takes to achieve peak concentration.

You can read more details about Quillivant XR here.

2. QuilliChew XR: Affected by  Citric Acid or Fat?

The product insert indicates no warning about citric acid. In fact, citric acid is an inactive ingredient. I’ll list all the inactive ingredients here. Sometimes there are food/chemical sensitivities. If so, this should be checked before taking any new medication:

Inactive Ingredients: aspartame, cherry flavor, citric acid, crospovidone, D&C red #30 (for 30 mg strength), D&C red #7 (for 40 mg strength), guar gum, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl acetate, polyvinyl alcohol, povidone, silicon dioxide, sodium polystyrene sulfonate, talc, triacetin, xanthan gum.

Regarding the only potential food effect:

High-fat meal had no effect on the time to peak concentration, and increased Cmax and systemic exposure (AUCinf) of methylphenidate by about 20% and 4%, respectively, after a single dose administration of 40 mg QuilliChew ER.

Quillivant Savings Program

Quillivant Savings Program

In my initial post (2013), I noted various problems with using the Quillivant XR savings card. Perhaps those problems resolved in the interim.

According to the company website, the savings program ended on 3/3/20.  Yet, if you click on “Get Savings Card,” you come to this page. It says the offer expires 3/31/21.

If you have questions about the product or the savings program, call 1-844-865-8684.  The Tris representative I spoke with says you can also text to this number to immediately receive your savings card: 844-970-2343.  (If you have trouble, you can call 888-840-7006, M-F, 9-6 Eastern Time.)

With Either Product: A Caveat About “Fruit Flavored”

I want to emphasize one feature of these medications: flavor. Quillivant XR liquid comes in banana flavor. QuilliChew uses cherry-flavoring.

Of course, stimulant medications in any form flavored to taste like fruit or candy require extra diligence.   It might be wise to explain to a child taking the medication that neither form of Quillivant XR is candy. Of course, as with all medications, also keep it safely out of a child’s reach.

Both Quillivant products are FDA-approved for children, adolescents, and adults.

In the comments, you’ll find plenty of first-hand experiences with this medication, along with some questions. Most of them date to the original post, in 2014. Feel free to join in.

Please note that I accept no support of any type from pharmaceutical companies. My advocacy is entirely self-funded. This ongoing report is a public service.

—Gina Pera

285 thoughts on “A New “Ritalin”: Extended-Release Quillivant Liquid & Chew”

  1. Quillivant has actually been a lifesaver for us however from start to finish we get less than 5 hours of relief and our psychiatrist doesn’t want to give a booster dose as he also suffers from insomnia. We are loosing our minds with this child. He barely sleeps and is so defiant and out of control I am not sure what to do anymore. Every day is struggle and everything is a fight or an argument. He just turned 6 and we have been struggling with this since he was 3 and every year it just gets worse and worse. No one in my family wants to babysit him because he is too hard to control his older brother who is 18 can’t stand to be around him because he is always trying to hit him, and it just makes for a miserable life, I feel like I am failing my child and I constantly look at him like what happened to my sweet loving adorable boy. I feel hopeless and lost. Please don’t judge me I truly love my child I just don’t know what to do anymore.

    1. Dear TM,

      I’m sorry that you felt it necessary to end with “please don’t judge me I truly love my child.” 🙁

      Of course you do. You wouldn’t be looking so hard for answers to help him live his best life.

      You are not failing your child. The mental-health field is failing your child.

      Is it possible to find another prescriber?

      For one thing, only five hours of symptom mitigation per day is not treatment — it’s nonsense. If that MD doesn’t know better, you’ll have to learn more and advocate advocate advocate.

      Seeking to get more than 5 hours of symptom mitigation/day is not a “booster dose.” It’s treating the symptoms throughout the day and into the evening.

      Another misconception: prescribers who assume that a stimulant being in effect during the nighttime always results in insomnia. Or that a child diagnosed with ADHD who has insomnia cannot take a stimulant. Sometimes, in fact, it helps the child go to sleep and sleep better. Adults, too.

      If your child does get insomnia from the medication, then it might be that a lower dose later in the day would help. Or, perhaps he also has anxiety. In which case, that should be treated.

      It can be difficult to separate the threads. That is, is it ADHD-induced anxiety or an anxiety disorder? Two different things and two different medications.

      Some children benefit from a second medication, such as Intuniv. This is not a first-line treatment for ADHD, but it sometimes can help with the aggression and defiance.

      Overall, if you feel your child gets good symptom mitigation from the Quillivant, he should have that throughout the day and into the evening. (If you haven’t tried it in the evening, you don’t know how it might affect insomnia, positively or negatively. It’s worth a trial, on an evening when being alert, etc. the next day is not important.)

      Please read this article I wrote on ADHD and sleep for CHADD’s Attention magazine. It should explain a lot: https://chadd.org/wp-content/uploads/2018/06/ATTN_12_10_Pera_on_Sleep.pdf

      good luck!
      g

    2. Hi TM,

      I’m so sorry your provider is not supporting you better. As Gina indicated, the fault lies with them, not with you. You are trying.

      What I wanted to tell you is that my 11 year old was in a similar predicament. He had ADHD and also insomnia before he started Methylin. So in addition to Methylin, his paediatrician also gave us Clonidine for his sleep disturbances. The Methylin is ER and runs out about 7-8 pm. Then I give him Clonidine. He typically sleeps through the night or nearly does. And he goes to sleep without a meltdown from hours of trying and still being awake. Both have been game changers.

      I wish you luck and my heart goes out to you.

      All the best,
      RM

    3. Hi TM, I just stumbled across your post while looking for information about orange juice and Quillivant. My daughter is 7 and we’ve struggled the same, so I wanted to first tell you how un-alone you truly are. It feels very isolating, and the whole range of emotions on top of that. Also, I hope you have someone to talk to, whether friends, or therapy. It’s really hard. So from another Mom, I see you and offer you my virtual hugs.
      I wanted to ask if you had tried the quillichew? My daughter metabolizes stimulants very quickly, too. Same thing, 5 hrs, roughly. She’s on the 20 mg dosage. What’s nice about that is that it is scored, meaning you can titrate. I give her half in the morning before school, and the other half when she comes home. She also takes guanfacine er to help with the crash.. because afternoons have been hard FOR YEARS, because of the crash. Obviously you would have to talk to the psychiatrist/prescriber, but this has been the best way so far. She’s almost 8 and we’ve been trying different meds since she was 5. I wish you luck. I also realize this is months later, so hopefully this finds you.

  2. Hi Gina, txs for always keeping everyone updated.

    Regarding Quillivant XR: early in Jan 2018, our son’s Dr called us to an urgent appointment to discuss a change of medication.
    Reason being “Quillivant production is halted”. We had to jump to another medication for his next prescription due next day.

    No one knew anything about the why, only a vague rumor about the uneven dissolution in the bottle, leading to uneven mix for every dose taken from each bottle. I found several other parents from other doctors also surprised by last minute change.

    A couple of weeks later I found this recall document. https://s3.amazonaws.com/prod-mdmembers-content/content-files/News/recalls/2017/Quillivant1.pdf

    Quillivant XR had been recalled 4+ months before I was told. They clearly communicated to their distribution chain. As for the consumers? Nothing. They put their focus on avoiding commercial viability, and manage product stocks.

    Hence, I can’t help but feel a deep mistrust for everything Quillivant XR: did they fix the dissolution problem? how safe is the solution? Will they communicate any better next time?

    1. Yikes, Ed! Thank YOU for bringing this to my attention. I’m horrified that I missed this. And I definitely understand your concern.

      I will update the post right away. So sorry.

      It’s gotten harder and harder to get solid pharma news of any type. Companies no longer routinely issue press releases, and the trade journals seem to cover less. But I should have looked more thoroughly.

      Misdeeds of this magnitude have seemed much less common with Big Pharma than with Big Generic. Tris seems to bring us the worst of both worlds. (It’s NextWave subsidiary apparently manufactures Quillivant.)

      The FDA violations for Tris are listed here:
      https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tris-pharma-inc-534537-03262018

      Tris was also called out for violating pediatric ibuprofen standards (but that article also says that Tris no longer makes Quillivant, but maybe the reporter didn’t know that NextWave is Tris): https://www.cbsnews.com/news/drugmaker-behind-ibuprofen-recall-has-history-of-fda-violations/

      The FDA chief who scoffed at FDA scientists’ concerns about bioequivalence for novel delivery-system drugs such as Concerta? When he left after his short tenure (appointed by Trump), he went to the Pfizer board. (And the Heritage Foundation, from when he came.)

      Thank you, Ed!!

      g

    2. Hi again, Ed.

      Quillivant’s manufacturer wrote to me, asking for more information.

      I have forwarded their message to the e-mail address you used here.

      g

    3. After a few successful years on Quillivant, my son switched to Ritalin when it stopped being manufactured. When I learned that it was available again, I wanted to switch back, as it seemed to be a gentler drug for my kiddo (less rebound effect, longer duration, etc.).

      Well, we’ve had a nightmare week with this experiment! We have discontinued Quillivant and I’ve been doing a little research, which brought me to this thread. I don’t know what has changed, but this time Quillivant produced a reaction and my child became the devil. First day, same dose as previously, my son was practically speaking in tongues. Absolutely wired and out of control. Aggressive, mean, etc. I called the doctor, who encouraged me to stick with it a few more days but give a half dose. Next day was still bad so I gave a quarter dose the next day. A little better but still unable to focus on school. The following day I gave even less and we had a good few days.

      Then Monday, back to a freak show so we discontinued it. It took a couple days until he was back to himself, but man! I’m curious if anyone else has had this experience with Quillivant (liquid) since it has been back in production. It worked beautifully the first time. Thanks!

    4. Hi, I am unsure if I am posting in the correct way as I only saw a reply.

      I am a 44 year old single mom who also suffers from ADD. My 8 year old also has Severe ADHD along with anxiety and sensory processing disorder.

      I’ve tried many different medications for him and 20 mg Focalin works the same as 5 mg Focalin. The effectiveness of the medicine has seemed to level him out finally.

      He takes the 5mg instant release Focalin twice a day. Time release doesn’t work for him at all, as his body burns through it in two hours. That was a real struggle with his pediatrician to get her to understand. Anyway, again the effectiveness of the Focalin is working for his impulsiveness and inability to sit still or concentrate, however, by 4pm he’s rocking and swinging his head, banging into everything, and appears to be coming out of his skin.

      It’s the longevity of the meds that I am struggling with. We had tried another dose of 2.5mg but then he won’t sleep. He was on a non stimulant at one time with an afternoon dose of Focalin, which I loved. Everything was great until his blood pressure spiked and we were forced to go back to only the Focalin.

      I did try the patch for him but it left his hip swollen and blistered.

      I have to be careful with changes in medication because even one day at school without proper medication and they are calling me because he’s out of control. Very disruptive. I am looking for something that lasts until the evening so he can still participate in swim meets etc.

      Any suggestions? Combos? Something? When he’s medicated he’s a different child and much more manageable but when it wears off its a nightmare for us both.

      Struggles to make friends, and well, you get the idea. I have no family and it’s just the two of us, so I am struggling to help my little boy with no support system.

      Not sure what I am expecting but advice would be great. I also struggle with memory function and keeping up with everything.

      I have begun writing most things in a book, when I am not so addled I forget. Thank you in advance for any advice.

      Please no criticism as I do enough of that to myself .

      LM

    5. Dear Lovie,

      I would not dream of criticizing you, but I understand your fear of that.

      The truth is, you are remarkably intelligent, astute, and observant about this issue. I wish all care providers could match your knowledge—and exceed it, so as to help you and your son.

      So, you say that what has worked best so far was an additional dose of 2.5 mg in the afternoons along with a non-stimulant. That seems the best starting point.

      Question: I assume the non-stimulant you/he tried was Strattera? What dosage?

      It might be that a lower dose (e.g. 10-18-25 mg) might help while avoiding the cardiovascular side effects. If the prescriber gives you 10 mg, you can later double if it not enough and still be at a lower-than-average dose.

      He might also take it at a different time. But remember that Strattera builds up in the system over time, so it’s best to wait until increasing the dosage until you have a good “read” of how it’s working.

      (It’s crazy that most people, including many prescribers, see non-stimulants as somehow safer than stimulants; in fact, Strattera has a higher cardiovascular side-effect profile!)

      When you respond, let me know the dosage you tried. If it already was a low dosage, we can brainstorm other avenues.

      Stay strong. You are RIGHT.

      Gina

  3. Thank you I hope other parent let me no what they went through I’ll try it tomorrow with him plus its lower dose they started him on

    1. Anna — Chances are, there will be only positive effects and few side effects.

      Sometimes, the side effects go away after taking the medication daily for several days…it’s an adjustment.

      But the stimulant medications clear the system quickly. It’s unlikely that, even if he were to experience a side effect, it would last very long.

      He might get a little anxious, for example. Maybe as if he’d had a cup of coffee. If so, it goes away.

      Wishing you and your son the best,
      g

    2. Hi Anna my son had the WORST reaction to Quillivant. Similar to Jennifer’s experience mentioned above it was like my son was possessed!!!! I cannot begin to explain how much anger he had. His tantrums. He even started saying things like “I want to kill myself!!” I know that was exaggerated emotions from him but it was a godawful stressful situation. There was NOTHING we could do to calm him down. It went on for two nights. I am not continuing the liquid form and am going back to pill form medication for him.

Leave a Comment

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Stay in Touch!
Ride the ADHD Roller Coaster
Without Getting Whiplash!
Receive Gina Pera's award-winning blog posts and news of webinars and workshops.
P.S. Your time and privacy—Respected.
No e-mail bombardment—Promised.
No Thanks!
close-link