Liquid and Chew “Ritalin”: Quillivant XR & Quillichew XR

With the introduction of a  liquid and a chew, people with ADHD gained yet another novel way to benefit from stimulant medication. That’s increasingly important these days, as the Concerta authorized-generic (most recently distributed by Patriot) is discontinued and brand Concerta not widely covered. I link to my story about that at the end of this post.

Since I first wrote about these new options, in 2013 and 2015, corporate juggling has made supply erratic. As a result, many people are unfamiliar with Quillivant XR and Quillichew XR. Now in 2022, the supply seems relatively stable. For now!

Today’s dizzying array of stimulant choices can feel overwhelming. But it also means more people have a better chance of finding a stimulant that works best for their unique neurochemistry and preferences.

But First, What About Older Methylphenidate Options?

We might also revisit some old options. Here’s a 2004 paper comparing Metadate to Concerta. I can’t vouch for the real-world application. I don’t know anyone taking Metadate, an older methylphenidate formulation. But head-to-head comparisons of medications are rare, co-authors include several well-known ADHD researchers, so it’s worth checking out:

Efficacy of two once-daily methylphenidate formulations compared across dose levels at different times of the day: preliminary indications from a secondary analysis of the COMACS study data

Who Might Benefit From Quillivant XR or Quillichew XR?

I find at least four reasons why one of these stimulants might be a welcome option:

1. Difficulty swallowing: Many people with ADHD (and not just children)  have a “gag reflex.” It makes swallowing pills difficult. Hence, a liquid or chew comes as a useful alternative.
   
2. Fear of losing control: When a person is especially fearful of taking a stimulant for the first time, feeling more in control can be helpful.  With Quillivant XR, you control the dose precisely (see illustration below).
3. Ultra-slow drug metabolism: Some people find they metabolize stimulant medications very slowly. That means even the lowest dose of a pill can be too much.  Again, the dropper allows more customized dosing, with the prescriber’s guidance.
4. More precise dosing: Sometimes a person’s “sweet spot” lies somewhere between the available dosage strengths of the pills or capsules. A liquid might allow more precise dosing. (This is not a claim made by the company. Talk with your prescriber.)
5. Easier titration: The basic rule of thumb when beginning to take a stimulant medication is, “Start low, Titrate slow.”  That is, increase slowly until maximum benefit is attained.  This is not always easily accomplished with other medication choices. The risk is starting too high and, with a negative response, deciding that medication isn’t for you.  Obviously, the liquid is easily titrated. Yet, the chew is also scored, so that you can split it (see illustration below).

Both Quillivant products are FDA-approved for children, adolescents, and adults. For more on this topic:

• Quillivant XR Dosing and Administration.
• Quillichew XR Dosing and Titration

Delivery System Makes All the Difference

These two medications fall into the methylphenidate (MPH) class of stimulants.  Also in this class: Ritalin, Concerta, Daytrana Aptensio XR, Metadate CD, Methylin, Jornay PM, Adhansia XR, and Cotempla.  In other words, all of these choices contain the exact same active ingredient, methylphenidate.

Why then might one of these choices work well for a given individual while others don’t?   It’s all in the the delivery system. For example, in addition to this liquid and chew, there are pills, an osmotic pump, a patch, and various types of time-release capsules. The delivery system determines how and how fast the medication enters the bloodstream—and the rate in which it exits.

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

Problematic History with Quillivant: Resolved?

Initial interest in the Quillivant products subsided amidst product shortages and, later, a recall. 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.  But drug shortages can happen for any number of reasons.  You can always check supply status at the U.S. Federal Drug Administration’s FDA Drug Shortages.

I asked a Tris company representative for an update and explanations of this medication’s roller-coaster history, including with a 2017 recall:

• The recall happened when Pfizer owned the company. Tris 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 can present its own kind of problem). I’m aware of  no recalls since that one.You can read more here: CMO for Pfizer ADHD drug hit with US FDA warning

A Few More Details:

Here is an overview of each “Quilli” choice.

Quillivant XR: Liquid Extended-Release Form of MPH

Quillivant XR is a liquid, extended-release formulation of the stimulant methylphenidate (MPH). It’s 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.

This isn’t the first liquid-stimulant formulation. It might, however, be 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 XR 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 their 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.

Quality Relies on Pharmacist, Consumer Following Instructions

Last I spoke with Tris, there had 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  ignored instructions and opted to mix the solution in alternate containers, including plastic and amber-colored. Why is this a problem? Because, according to Tris, 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 Product? 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.

Full disclosure: I am not a psychopharmacologist. 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. Please ask your pharmacist or prescriber.

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 (e.g. aspartame). 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 XR & Quillichew XR Savings Program

Click here to learn about the current Tris Savings program.

If you have questions about the product or the savings program, call 1-844-865-8684.

A Caveat About Fruit-Flavored

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

To my mind, stimulant medications tasting similar to 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.

UPDATE ON CONCERTA GENERICS:

I’ve followed the Concerta generics story since 2014. The latest news is that the authorized-generic (brand sold as a generic) will be discontinued in January, 2023.

Janssen Quietly Ends Concerta Authorized-Generic

Please keep in mind about the comments section: Many first-hand experiences with this medication date to the original post, in 2014.

Some issues have been resolved, as I explained in the post.

Please note that I have never accept  support of any type from the pharmaceutical industry. My advocacy is entirely self-funded. This ongoing report is a public service.

—Gina Pera