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:
- A reader’s concerns
- A brief explanation of each Quillivant product
- Status update from my conversation with a company representative
- Consumer tips from the company in making sure your pharmacy follows instructions properly
- 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?
- 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.
Easier to Swallow; Enables Precise Dosing
Quillivant XR liquid offers two obvious benefits:
- 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.
- 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.
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.
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 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.
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:
- Citric Acid
- 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
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.