ARKRAY USA

Assure® Slide swallowing aid is a simple solution for those who have difficulty swallowing pills, capsules or tablets.

Click here for the latest news on the NEW Swallowing Aid.

Assure Slide is a swallowing aid that makes swallowing tablets, capsules and powders safer and easier.

Clinical Need

  • 15-33% of residents in skilled nursing facilities suffer from some level of swallowing difficulty.1
  • Patients with swallowing difficulties may need extra care when taking solid form oral medications and supplements.
  • Slide can provide a simple, quick solution to both medication administration challenges experienced in professional healthcare facilities.
  • Slide guides the medication from the mouth to the stomach, easing the swallowing process and may provide more comfort for the patient.
  • CMS guidelines published November 2017 address medication administration procedures:
    • The revisions now dictate that the standard of practice prohibits combining crushed medications or mixing them in food for administration orally or by feeding tube.2
When to use Assure Slide

(click to enlarge image)

Slide Forte and Slide Zero

  • Slide Forte, Level 4, extremely thick, is sweetened with sugar and has a pleasant vanilla taste.
  • Slide Zero, Level 3, moderately thick, is sweetened with xylitol and has a pleasant raspberry taste.
  • Slide acts as a carrier and stimulates saliva in the mouth and throat cavity and may help to minimize the chance that the dose will get stuck during swallowing.
  • The slippery lubricating gel encapsulates the tablet or capsule, making it easier to swallow and more likely to reach the stomach without delay.
  • Slide can be used with tablets, capsules and powders.
  • The fresh flavor of Slide may eliminate the unpleasant taste and smell of tablets, capsules and powders.
  • Slide comes in easy-to-dispense 500ml pump bottles.

Assure Slide is safe to use

  • Slide breaks down quickly in the stomach by the gastric acid and does not form a barrier for the body to absorb the medication or supplement; hence, Slide does not affect the absorption rate or effectiveness of medication.
  • Slide has no known interactions.
    • Slide is formulated with food-based ingredients that do not interact with medications.
  • Slide can be used when an empty stomach is required.

Assure Slide is easy to use

  • Slide is a clear, gel-like substance, lightly flavored, that is taken with a spoon.
  • A small amount is dispensed, via a pump, into a med cup or spoon along with the capsule/tablet and then consumed in one swallow.
  • Over time, you may increase the number of tablets you take per mouthful, increase the number of doses, and reduce the amount of Slide required per tablet.
References
1. Morris, H. “Administering drugs to patients with swallowing difficulties.” Sept 2005. https://www.nursingtimes.net/clinical-archive/medicine-management/admini....
2. Department of Health & Human Services (DHHS), Centers for Medicare & Medicaid Services (CMS). (2017). Medication Errors of the CMS Manual System, Pub. 100-07 State Operations Manual.

Instructions for use

Intended use: For people with swallowing difficulties, a gel that helps to swallow tablets, capsules and powders.

1. Remove bottle cap and replace with pump assembly before initial use.
2. Place tablet/capsule on spoon or in med cup.
3. Add one complete pump of Slide (approximately ½ tbsp, 1 tsp, or 5mL) to cover tablet/capsule.
4. Swallow.

Tips for Use

  • It may or may not be necessary to crush tablets or open capsules when using this product to help swallow.
  • Slide may assist with the swallowing reflex if chilled.
  • If using Slide for the first time, try it first without tablets.
  • Drink liquids as prescribed before or after swallowing tablets and capsules with Slide.
  • Slide is gelatin-free.
  • Slide is gluten-free.
  • Slide Zero is sugar-free.

Cautions

  • Store between 35-77°F (2-25°C).
  • Do not use if cap seal is broken or missing.
  • Use Slide within 2 months of opening the bottle.
  • Keep out of reach of children.
  • Use medication as directed.
  • Slide is for all patients who can swallow independently and is not suitable for children younger than 2 years old.
  • Do not use in the case of known hypersensitivity to any of the ingredients.

FAQ

  • Assure Slide is a swallowing gel designed to help those with difficulty swallowing tablets, capsules, and powders.
    • If the text refers to `tablets and capsules' it is referring to all medications or supplements in solid form, such as pills, tablets, lozenges and capsules, as well as pre-packaged powders. The following forms are explicitly excluded: water soluble and dispersible tablets, medications or supplements in liquid form, such as syrups and drinks.
  • If you have questions about this information or this product, please contact ARKRAY.
  • Consult with your doctor or pharmacist before using Assure Slide.
  1. Place tablet, capsule or powder to be taken on a teaspoon.
  2. Apply a full pump from the 500mL bottle onto the tablet, capsule or powder.
    • Approximately 1 teaspoon, one half tablespoon, or 5mL
  3. Place in your mouth and swallow at once.
Slide Forte has a vanilla flavor. It contains the following ingredients: water, dried glucose syrup, sugar, maltodextrin, seaweed extract, potassium sorbate, citric acid, and natural flavor. It has an extremely thick consistency.
Slide Zero has a raspberry flavor. It contains the following ingredients: water, xylitol, maltodextrin, seaweed extract, potassium sorbate, citric acid, sodium citrate, carmine, and natural flavor. It has a moderately thick consistency.
Slide works in four ways:
  1. The gel is thick and smooth to allow for easy swallowing of tablets and a smooth passing through the esophagus to the stomach and can be used with tablets, capsules and powders.
  2. Slide moistens the mucous membranes in the mouth and throat cavity allowing the tablet, capsules or powders to pass smoothly through the esophagus.
  3. Slide breaks down immediately in the stomach and does not affect the absorption rate of medication.
  4. The fresh flavor and aroma of Slide may eliminate the unpleasant taste and smell of tablets, capsules and powders.
Slide breaks down immediately in the stomach and does not affect absorption rate of medication. Consult with your physician or pharmacist for more information.
  • Slide can be used by anyone who has difficulty swallowing tablets, capsules and powders but can swallow independently.
  • Slide is suitable for anyone over the age of 2.
  • Slide does not contain gluten, common allergens or gelatin. For a list of common allergens reviewed, contact us.
  • Slide Zero is sugar-free.
Consult with a physician or pharmacist if using Slide with capsules. It may or may not be necessary to open the capsule.
Consult with a physician or pharmacist if using Slide with tablets. It may or may not be necessary to crush your medication.
  • Approximately 1 teaspoon, ½ tablespoon, or 5mL of Slide is the recommended dosage. With this volume of Slide, tablets, capsules and powders may go down smoothly.
  • A larger quantity of Slide can be used with larger quantities of tablets, capsules and powders.
  • Slide can also be used in several doses.
  • Chilling Slide before use may assist with the swallowing reflex.
  • A maximum of three doses per day is recommended for children between two and six years of age.
  • It is recommended that Slide is used by adults as often as pills are taken. However, Slide is made with food-safe ingredients and presents a low health risk if consumed in large quantities by mistake.
It is not necessary to take water with Slide, but it may be necessary to take water with your medication. Follow complete instructions provided by the manufacturer for taking any medications or supplements and consult with your physician or pharmacist.
You may take more than one tablet or capsule with Slide. Consult with your physician or pharmacist when taking more than one medication or supplement at a time.
  • Slide has not been developed specifically for patients with an impaired swallowing reflex.
  • Slide is not a solution for patients who choke on solid substances.
  • Slide should not be used for swallowing medicines in liquid or effervescent form.
  • If you are over-sensitive to one or more of the components in Slide, consult with your physician or pharmacist before using.
  • Slide Forte contains sugar. Consult with your physician or pharmacist before using.
  • Slide Zero contains xylitol. Consult with your physician or pharmacist before using.
There is insufficient data available to establish the safety of Slide during pregnancy or breastfeeding. Consult with your physician or pharmacist.
  • Keep out of reach of children.
  • Slide can be stored between 35°F and 77°F (2°C and 25°C).
  • The use-by date is printed on the bottle.
  • Once opened (bottle seal broken), Slide should be used within 60 days.
  • Slide can be disposed of with ordinary household waste after the use-by-date.
Healthcare professionals may consider the use of Assure Slide to address the concerns in this section, §483.45(f) Medication Errors, of the CMS Manual System, Pub. 100-07 State Operations, published by the DHHS, Centers for Medicare and Medicaid Services, effective November 28, 2017. See this section for further information: F760 The facility must ensure that its— §483.45(f)(2) Residents are free of any significant medication errors.1

1. Department of Health & Human Services (DHHS), Centers for Medicare & Medicaid Services (CMS). (2017). Medication Errors of the CMS Manual System, Pub. 100-07 State Operations Manual.

Clinical Articles

Food-Drug Interactions

Bushra, R, Aslam N, and Yar Khan, A. Food-Drug Interactions. Oman Medical Journal. Jan 2011: 26(2): 77-83.
This review gives information about various interactions between different foods and drugs and will help physicians and pharmacist prescribe drugs cautiously with only suitable food supplement to get maximum benefit for the patient. Food-drug interactions can produce negative effects in safety and efficacy of drug therapy.

McCabe-Sellers B., Frankel E.H., Wolfe J. “Handbook of Food-Drug Interactions.” Boca Raton, FL: CRC Press. 2003; 12: 262-266.
Mixing medication with foods is a common practice that may adversely affect efficacy. Commonly prescribed drugs such as aspirin, steroidal and nonsteroidal anti-inflammatory agents can cause acute inflammation if delayed in their passage through the esophagus. Food intake in relation to drug administration can have a significant impact on drug dissolution and absorption. The presence of food changes gastric motility, changes the gastric pH, and provides substances for drug and nutrient absorption.

Pediatric Pill Swallowing Difficulties

Jacobsen, L. “A Pilot Study of the Pediatric Oral Medications Screener (POMS).” Hospital Pediatrics. 2015. DOI:10.1542/hpeds.2015-0027
In 2010, pediatric outpatient prescriptions totaled 263.6 million in the United States. Nonadherence with a treatment regimen is correlated with increased health care utilization, costs, and increased antibiotic resistance. Pill swallowing has been identified as a major barrier to medication adherence in chronic conditions such as inflammatory bowel disease and HIV infection. Inability to swallow pills can result in expensive, hard-to-find formulations, treatment failures, and patient and family stress and anxiety.

Patel, A . et al. “Effectiveness of Pediatric Pill Swallowing Interventions: A Systematic Review.” D OI: 10.1542/peds.2014-2114
The pediatric population has a unique set of barriers with oral medication compliance and administration due to children’s inability to swallow pills, factors that can affect a child’s success in swallowing pills include developmental stage, fear, anxiety, intolerance of unpleasant flavors and failure to understand the risks when not taking the medication. 50% of parents have children who cannot swallow standard-size pills. The failure to swallow pills is a barrier that can be overcome in the pediatric population with the right targeted intervention.

General Pill Swallowing Difficulties

Carnaby-Mann, G. and Crary, M. Pill swallowing by adults with dysphagia. Archives Otolaryngology Head and Neck Surgery. Nov 2005: 131(11):970-975.
Dysphagia is currently estimated to affect more than 18 million adults in the United States. A recent national survey revealed that over 40% of adults in the general community experience problems swallowing pills. Of adults who reported difficulty swallowing pills, 14% disclosed that they had delayed taking a dose of their medication, and 8% had skipped a dose completely.

Eidex, B. Achieving medication adherence: creativity, consultation and community. Drug Store News. June 2019.
Improving rates of medication adherence in the patient population has long remained an area of focus among pharmacists. Patients who regularly take their medications as prescribed demonstrate better clinical outcomes. Moreover, adherence results impact the retail pharmacy financially.

Forough, A. A spoonful of sugar helps the medicine go down? A review of strategies for making pills easier to swallow. Patient Preference and Adherence. 2018:12: 1337-1346.
Making modification to medication such as crushing or splitting for ease of swallowing difficulties have been associated with increased risk of medication misadventures, adverse drug reactions, and in some cases have fatal consequences.  Foods or drinks such as yogurt, jam, juices, and milk are used as an aid in which the whole pills can be hidden, or crushed tablets or capsules contents are mixed to facilitate swallowing and improve palatability of the medication particles. Mixing medicines with food or drinks increases the possibility of food-drug interactions and can potential result in increased or decreased therapeutic effect by altering the bioavailability of the drug. While understanding and resolving the underlying cause of medication swallowing problems is generally the preferred approach, sometimes this may not be possible.

Jaspersen, D. “Drug-induced oesophageal disorders: pathogenesis, incidence, prevention and management.” Drug Saf. Mar 2000. PMID: 10738847
Drug-induced injury of the oesophagus is a common cause of oesophageal complaints. More than 70 drugs can cause esophageal disorders such as esophagitis, an inflammation of the lining of the esophagus. Capsule or tablets that are commonly delayed in their passage through the oesophagus can also lead to acute inflammation. Many physicians and patients are not aware of this problem.

Community Blog

Difficulty Swallowing Pills? Learn REAL Strategies to Help You Swallow Your Pills Easily!
by Karen Sheffler, MS, CCC-SLP, BCS-S of SwallowStudy.com
https://www.swallowstudy.com/trouble-swallowing-pills-what-to-do-for-pill-dysphagia/

PDF icon

Difficulty Swallowing Pills?

Learn REAL Strategies to Help You Swallow Your Pills Easily!
by Karen Sheffler, MS, CCC-SLP, BCS-S of SwallowStudy.com


Difficulty swallowing Pills blog image

Introduction to People’s Troubles with Swallowing Pills:

When I work with people who have trouble swallowing pills or fear of swallowing whole pills, I hear a lot of detailed descriptions on how hard it can be, such as:

  • “I have to swallow that horse pill?”

  • “I didn’t take my antibiotic pill this morning because I couldn’t swallow it.”

  • “When I take pills whole with water, I choke on the pill and the liquid is probably going down the wrong way.”

  • “I am afraid of swallowing pills whole; they don’t even get out of my mouth.”

  • “I have to lay back at a 45-degree angle or toss my head way back to get the pill out of my mouth.”

  • “I have to push the pill to the back of my mouth before I take a sip of water, to make sure the pill gets out of my mouth. Sometimes that makes me gag!”

  • “My mouth is too dry, and pills get stuck on my tongue.”

  • “When I first wake up in the morning, I am so stiff because of my Parkinson’s Disease, that even swallowing my Parkinson medication (which helps me get moving) is almost impossible.”

I could go on and on about both the physiological and structural reasons that people have trouble swallowing pills, but there are also many people (children, adolescents and adults) who have a real fear of swallowing pills. They may have trouble volitionally sending the pill out of the mouth due to hesitations caused by the fear of swallowing. My twelve-year-old still takes chewable tablets and liquid medications, as he cannot yet imagine the task. He has never had a negative experience swallowing a whole pill with water, but many people have had a feeling of choking and never try it again. I have worked with older adults who avoid whole pills because they vividly remember “that one time” when they were young.

People may also have trouble swallowing pills due to structural abnormalities or physiological problems causing a weak, slow, or discoordinated swallow. There are many different signs and causes of difficulty swallowing (dysphagia). Dysphagia is not a disease in-and of-itself. Dysphagia is a symptom of a variety of different diseases, disorders, congenital abnormalities, structural abnormalities, and more, that cause difficulty swallowing. For example, dysphagia can be caused by: 

  • obstructive tumors of head and neck (and potentially made worse by the subsequent chemoradiation treatments);

  • stroke or head injury;

  • any head, neck or spinal surgeries;

  • neurological diseases like Lou Gehrig’s Disease (ALS), Parkinson’s Disease, Multiple Sclerosis, Dementia/Alzheimer’s;

  • swelling from intubations;

  • side-effects of medications; or even

  • due to a long hospitalization that caused generalized weakness.

That just names a few causes.

See this Nativ-Zeltzer & colleagues 2019 open access article link for a great summary of pill dysphagia (difficulty swallowing pills). This research article discusses the validation of a rating scale called PILL-5, which is 5 questions to help people describe and quantify their severity of difficulty swallowing pills.

Note: This scale from the same team who created the EAT-10 Scale, which helps people quantify the physical and emotional impact that difficulty eating and swallowing pills, foods, liquids has on their lives (Belafsky, et al., 2008). 

For some people with dysphagia, swallowing pills can be even more challenging than swallowing foods and liquids. Pills can get stuck in the natural pockets in the throat (pharynx) or in the food tube to the stomach (esophagus). You do not want pills to hang out in these places, as the pills can start breaking down and causing injury to the lining of the pharynx and/or esophagus, not to mention the fact that the medication will not be absorbed and working for you.

We All Hear: “Take Your Pills as Directed.”

 

That may not be so easy!

 

Speaking of medication absorption, there are so many things to consider to ensure you are taking your medications as directed. Your pharmacist will tell you how many times a day and when during the day to take a specific pill for best absorption, but do not forget to clarify:

 

Do I need to take the medication with meals or on an empty stomach?

 

What foods do I need to avoid when taking certain pills?

 

For examples:

  • The following medications are typically taken on an empty stomach: Reflux medications, many thyroid medications and Sinemet (a medication that people with Parkinson’s may take that is made up of Carbidopa and Levodopa).

  • Bronchodilators (e.g., Advair) require you to rinse your mouth with water, after using the inhaler, to prevent candida (aka, “thrush,” which is a fungal or yeast infection) or to prevent other mouth sores.

  • To prevent pills getting stuck in the esophagus or refluxing back up when you lay down (Stoschus & Allescher, 1993; Akhtar, 2003):

  • Take your evening medications well before laying down in bed (at least 1 hour before bed, especially if you have a large volume of pills and liquid to swallow).

  • Take medications in upright position and stay upright for at least 30-60 minutes afterwards.

  • Take pills with plenty of fluids, if this is safe, to prevent tissue injury from pills staying in the esophagus.


Those ideas may be fine if you are indeed able to easily swallow your pills with a glass of water.

 

However, what if that is too hard?

Strategies for Swallowing Pills:

In the past, before there were any specific products to suggest, speech-language pathologists (SLPs who specialize in swallowing) have recommended three options if a person has difficulty swallowing pills. 

 

Please Note: Specific recommendations are dependent on the type of swallowing problem and the results of comprehensive swallowing studies. The evaluations would determine if the person was safe to take pills by mouth and provide the safest strategy for swallowing pills. See 2 case studies at the end of this blog that show images of the difficulty and the solutions.

1. Change your medications to a liquid form.

  • Some people have difficulty clearing any food, pills or thick substances through the mouth, throat and/or esophagus. Sometimes the only substance that clears is a liquid. (For example, people affected by chemo-radiation treatments to the neck after head/neck cancer, may have such stiffness in the swallowing mechanism that foods, purees, and even very thick liquids may not clear down.)

  • However, liquid medications are not for everyone. What if you will aspirate the liquid? It would be very harmful to your lungs if liquid medications go down the wrong way.

 

2. Swallow them whole embedded in a smooth substance, like applesauce, yogurt, or ice cream. 

  • What if you aspirate ice cream? (For people at risk for aspirating thin liquids, this may not be a safe solution, as ice cream thins out when it melts in your mouth.)

  • What if you are sick of applesauce? (This may be the case if you have been at the hospital or another healthcare institution for a long time.) What if you are allergic to apples?

  • What if the person is confused and is spitting out the pill or holding the pill in the mouth and cheeks, while only swallowing the applesauce? (SLPs call that: “pocketing” the pill.)

  • What if your medication is not absorbed as well due taking them with foods and fruit juices? (See this article by pharmacist, Dr Geraldine Moses, BPharm, DClinPharm, AACPA).

  • Additionally, see Manrique and team’s 2014 article called: Crushed Tablets:Does the administration of food vehicles and thickened fluids to aid medication swallowing alter drug release? They reviewed the literature that showed the impact of fruit juices and foods on:

    • Bioavailability: what percentage of the medication is potentially absorbed by the body within 30 minutes.

    • Studies have looked at the rate that medications dissolve in substances (dissolution rates). For example, Manrique and colleagues commented on research that showed how taking Dilantin (a seizure medication) in pudding may affect the bioavailability more so than in applesauce. We don’t really know the effects of all foods on all pills. This issue is made worse when we crush the pills – see below.)

    • Bottom Line: Some food plus drug combinations can reduce the bioavailability of the medication in your body.


3. Crush the medications and put them in a smooth substance to swallow all at once. 

 

  • What if your pills cannot be crushed (e.g., time-release medications that need to stay whole to dissolve slowly over time)?

  • What if crushing the pill and embedding it in a food causes less of the pill to be available to the body immediately (bioavailability)?

  • What if you are on a thickened liquid? YOU CANNOT PUT CRUSHED PILLS INTO THICKENED LIQUIDS. The corn-starch-based thickeners and gum-based thickeners are polymers that chemically and physically bind with the crushed medications, causing a significant reduction in the dissolution rates. That means the medication itself is not fully available to your body. That is not good!

  • Again, Manrique and colleagues (2014) did research on how quickly certain CRUSHED medications dissolve in liquids, foods and thickened liquids*. Even honey, jam and yogurt affected dissolution rates of some medications, like Tegretol (anti-convulsant/anti-seizure medication that is also used for nerve pain and bipolar) and Warfarin (also known as Coumadin, which helps prevent blood clots and is used often used to prevent strokes). Whereas, the honey, jam and yogurt did not affect other medications, like Norvasc and Atenolol (medications for high blood pressure and chest pain). 

 

*Thickened liquids had the greatest impact on the rate that the medications were able to dissolve in comparison to water, juice, or in food items. For example, when Tegretol was crushed and placed in an extremely thick liquid/pudding thick liquid, only 14% of it dissolved in 30 minutes – that means much less bioavailability to your body.

 

 

See Dr Julie AY Cichero’s article: Thickening agents used for dysphagia management: Effect on bioavailability of water, medication and feelings of satiety. https://nutritionj.biomedcentral.com/articles/10.1186/1475-2891-12-54

See Drs Shane Jackson & Mark Nauton’s article: Optimising medicine administration in patients with swallowing difficulties.

See my prior blog: Hard Pill to Swallow.

See 3D Printed Pharmaceuticals blog for a look into the future!

What Do People Need for Swallowing Pills?

We Need Better Solutions.

According to research by Carnaby-Mann & Crary (2005), people prefer an orally disintegrating tablet, as they require less effort to swallow than regular whole tablets. However, not all medications are available in this formulation (e.g., RapiTab by Schwarz Pharma, Inc). Even easier will be 3D printed pharmaceuticals that dissolve in the mouth faster even than the RapiTab technology. Aprecia, The 3DP Pharmaceutical Company is working to make this a reality, and they already have some medications in a 3D printed form. The future is bright.

For now, we need a substance that adheres to the pill or pill particles to aid in swallowing them.

BUT, this substance cannot interfere with the medications bioavailability (amount of the medication that is absorbed by the body within 30 minutes). Note: The FDA recommendation is for medication to be 85% dissolved in 30 minutes (Guidance for Industry by the US Food and Drug Administration, 1997).

 

The gel substance should form a cohesive ball around the pills, without affecting the pills’ ability to dissolve and be absorbed by the body quickly. A slippery gel may help to safely slide pills out of the mouth, down the throat, through the esophagus and into the stomach. Since you cannot crush medications and put them in corn starch, xanthan gum, or guargum, this substance needs to be made from a food-grade gel that is a thick and slippery vehicle for easier swallowing.

That is why Assure Slide and Phazix have been brought to the USA.

Here in the USA, two brands have been introduced: Assure Slide and Phazix. “Assure Slide” is for long-term healthcare facilities and “Phazix” is for hospitals and individual consumers. The same product has been used and labeled as “Gloup” in Europe and Australia for years. While reading this, please keep in mind that Gloup, Assure Slide and Phazix are the same product with differences only in the names, the thickness options and the flavors available.

Assure Slide/Phazix is made from maltodextrin and seaweed extract (a type of carrageenan that is not a gum-based substance, per the company). These ingredients thicken and make a smooth gel that strongly holds the medications to help them clear through the mouth to the stomach. Assure Slide comes in a moderately thick consistency (per IDDSI.org framework standards, which is the old term of “honey thick” liquid consistency) and in an extremely thick consistency (aka, old term of “pudding thick” or “spoon thick” liquid consistency).

Phazix comes in a moderately thick consistency.

Testing by Malouh, et al. (2018) in Australia confirmed that the fruit flavored “Gloup” products were indeed moderately thick per the IDDSI Flow Tests. They also confirmed that they “Gloup Forte” passed the IDDSI testing for an extremely thick or Level 4, per IDDSI.org Framework. Malouh and colleagues noted that this product was developed to be “suitable” for people with dysphagia who need to swallow pills embedded in a vehicle or need their

pills crushed and placed in a safe substance. However, this particular study only tested the actual viscosities or thicknesses and not the dissolution rates.

Research presented at a 2015 conference shows how placing crushed Acetaminophen (aka, Tylenol or Paracetamol) in Gloup had good dissolution rates, as opposed to when crushed in thickened liquids (Crinò, et al., 2015 and chart below). Both whole pills and crushed pills in Gloup were almost 100% dissolved in well under 50 minutes. See chart below showing testing of whole and crushed Acetaminophen/Tylenol in Gloup (on the left) and in water and thickened liquids (on the right). This research was presented at the Australasian Pharmaceutical Science Association (APSA) conference by Lucia Crinó and team (2015) from The University of Queensland, Australia. (Disclosure: slide provided by Assure Slide/Phazix for this article.)

 

Again, please note: The FDA recommendation is for medication to be 85% dissolved in 30 minutes (Guidance for Industry by the US Food and Drug Administration, 1997).

Gloup and paracetamol dissolution

Is Slide/Phazix Good for Everyone with Dysphagia?

 

No. Everyone is different with different types of swallowing difficulties.

 

This product will not work for everyone.

 

As noted above, some people have difficulty swallowing moderately to extremely thick liquids (thicker liquid viscosities) due to residue getting stuck in the throat/pharynx and food tube/esophagus. These individuals may only be able to swallow thinner liquids.

 

The product does not fix the existing swallowing problem. If someone’s swallow is highly impaired in safety and efficiency, even this substance can get stuck and/or be aspirated (go down the wrong way into the airway).

 

Therefore, it is important to view the safety and efficiency of the swallow on an instrumental examination under the guidance of a speech-language pathologist who specializes in swallowing and swallowing disorders. (Instrumental examinations are the videofluoroscopic swallow study/VFSS for viewing mouth to esophagus via x-ray or the fiberoptic endoscopic evaluation of swallow/FEES for viewing posterior oral cavity through the throat/pharynx to the top of the esophagus).

 

Sometimes the only way to safely administer medications is via a feeding tube or delivered through injections and intravenously.

The Taste and Texture of Slide/Phazix May Help in Swallowing Pills:

 

Some people do not have a structural or mechanical difficulty swallowing, but they may be fearful to swallow pills. This may even be due to a childhood choking event. They may be very hesitant to let the pill out of the mouth with liquid in order to swallow it. People who are fearful of swallowing pills tend to hold the pill in the mouth and say that they cannot swallow it. The texture and taste of Phazix may be just enough to distract the person from the fear of swallowing a pill. If the pill is “hidden” in the Phazix gel, the ball of gel can be potentially swallowed without worrying about the pill inside.

 

People with brain injury or dementia may “forget” how to swallow pills. Remember, the oral phase is completely under our control and requires us to “think” about sending the pill to the back of the mouth. People who are confused may spit out pills or the crushed pill pieces, but if the pill is hidden in something that tastes good, they may be more likely to accept their medications.

 

Assure Slide-Forte is extremely thick, comes in a vanilla flavor, and has a small amount of glucose syrup and sugar added. Assure Slide-Zero is moderately thick, comes in a raspberry flavor, and has no sugar added. (These first two are marketed to long-term healthcare facilities).  Phazix is the product that consumers can purchase, and is moderately thick and has a natural vanilla flavor and a small amount of sugar for taste. However, Phazix has only 0.6 grams of sugar per teaspoon, per the company. This which far less than a typical applesauce, which has 1.26 grams per teaspoon. The person may only need a few teaspoons at most, so it is unlikely to be a significant concern for people with diabetes. (Phazix is gluten-free and contains citric acid.)

 

*******

 

Okay – you read through all those details!

 

Now let’s see Assure Slide/Phazix in action with real people and their swallow studies.

 

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Case Histories and Videos to Understand the Difficulties in Swallowing Pills:

Case History 1:

 

(Note: No gender identifying pronouns used. Will use “they” as needed to indicate the person.) 

 

Our first story is about a person who is 60+ years old with a history of lung cancer in the right upper lobe. They had lung surgery to remove the upper lobe, which occurred about 1 ½ months prior to this repeat video fluoroscopic swallow study. After the operation and due to prolonged endotracheal intubation (aka, a breathing tube going through the voice box/larynx into the trachea/airway), there was vocal cord injury, vocal cord immobility (not moving), swelling, and airway narrowing with granulation tissue below the vocal cords.

Due to these airway problems in the voice box and trachea, they needed a tracheotomy tube placed in the neck below the vocal cords for breathing. (Read more about trach tubes at Dysphagiacafe.com‘s article.)

 

The first swallowing evaluation in the intensive care unit was a FEES examination (fiberoptic endoscopic evaluation of swallowing), which was done 19 days after surgery. They had penetration across all consistencies (i.e., ice chips, puree, nectar thick/mildly thick liquid, and thin liquids getting into the top of the voice box with the inability to clear them out due to poor sensation and a weak cough), as well as aspiration with thin liquid (liquid dropping below the vocal cords into the airway).

 

To briefly summarize for clinicians, this was due to decreased bolus control and containment, a delayed swallow initiation, and delayed and reduced laryngeal vestibule closure. (The laryngeal vestibule is your “voice box.” It is an area that is like a vestibule to your house with your inner locked door being your vocal cords, and this whole vestibule has to close up during the swallow to prevent material from getting down the wrong way). Therefore, there were issues of discoordination, poor timing and suspected weakness. Effective strategies: effortful swallows and follow-up dry swallows to clear the residue in the throat/pharynx. This was deemed a moderate oropharyngeal dysphagia. Due to the risk for aspiration with all consistencies, they were kept not eating (NPO), until a repeat swallow study could occur at rehab.

 

The repeat study was a videofluoroscopic swallow study (VFSS) at the rehabilitation center. They were advanced to regular textures, but they had to continue mildly thickened liquid (aka, nectar thick liquids) due to the persistent aspiration risk. Fortunately, the tracheostomy tube was removed at rehab, which was about 2 weeks prior to this last VFSS as an outpatient.

 

Upon coming in for this outpatient VFSS, an EAT-10 scale was provided to rate the effort of swallowing and the impact on quality of life. The effort needed to swallow pills was still rated as a 2 out of 4 on the EAT-10 scale. They felt pills frequently getting stuck with the need to wash them down with a lot of liquid. The total EAT-10 rating was 12/40, showing that eating still feels stressful, there is some fear of swallowing pills, and there is still a significant impact on the pleasure of eating and drinking.

Video Image 1.JPG

Watch Video At: https://youtu.be/sC4qPz_HGho

 

This last VFSS showed significant improvement. There was minimal oropharyngeal and esophageal dysphagia and with no aspiration. There were only small amounts of penetration, well above the level of the vocal cords, due to slight delays in swallowing, but the penetrations were ejected with completion of the swallow. This is considered within normal limits and was not considered an aspiration risk. The only time there was an elevated risk, was when trying to swallow the barium pill with thin liquids (as seen in the video above – pill is the black disc on the tongue). The patient used a potentially dangerous strategy of tossing the head back to clear the pill off the tongue. This caused the liquid to spill to the bottom of the throat and into the airway just before the swallow. One time a trace bit of liquid reached the vocal cords but was fortunately ejected out of the laryngeal vestibule/voice box with completion of the swallow.

 

That barium pill was spit out.

 

Next, we embedded the pill in “Assure Slide – Zero” (a moderately thick gel). The pill (black disc) and gel (invisible on x-ray) cleared safely through the throat without getting stuck or having the risk of aspiration on thin liquids.

Video Image 2.JPG

Watch Video At: https://youtu.be/bAK6SumKXRc

 

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Case History 2:

 

Our second story is about a person who is 70+ years old with a history of multiple cerebral cavernous malformations (CMM). These were first identified 6 years prior to this outpatient videofluoroscopic swallow study (see images below). They had their first complication of bleeding 5 years ago with the need for a resection (right craniotomy).

 

Note: CMM are collections of abnormally formed and enlarged capillaries with thin walls that can vary in size but are prone to leaking or causing brain bleeding.

 

They started having new leaking six months prior. In those 6 months, there was a challenging course of hospitalizations, rehabilitation stays, followed by visiting nurse association follow-ups, and then this repeat VFSS. Complications from the multiple brain bleeds were: confusion, dizziness, headaches, blurry vision, and unsteady gait/difficulty walking. MRIs over the hospital course confirmed multiple bilateral intracranial hemorrhages.

 

Two months prior, this person was found unresponsive and had aspiration on vomit. That lead to a few days of intubation (a breathing tube through the vocal cords). There was a prolonged intensive care stay. They also had increased agitation, paranoia, confusion and delirium (which can be common during intensive care stays). They received an antipsychotic medication called Haldol after extubation, which may have further caused exacerbated his difficulty swallowing. The dysphagia was likely due to the combination of bilateral neurological insults, significant mental status changes/confusion, intubation, medications, generalized weakness and de-conditioning of the muscles. Several days after extubation and the discontinuation of Haldol, they were evaluated with the first videofluoroscopic swallow study. A cautious start to eating by mouth was with a pureed diet (blended foods)and mildly thick liquids (aka, old term of “nectar” thick liquids).

 

During the rehabilitation stay, the liquid was changed to moderately thick liquids (aka, old term of “honey” thick liquids) during the next month, potentially due to noted difficulty with the thinner liquid (mildly thick/nectar thick liquid).

 

Once home (over one month and a half prior to this repeat VFSS), they were followed by an SLP and slowly upgraded to moist and soft solids (“Soft & Bite-Sized” per IDDSI.org Framework, but they were also having some soft breads, French toast, scrambled eggs, tuna fish). They remained on mildly thick liquids (nectar thick liquids) until this repeat VFSS. They have been trying thin liquids at home, but the spouse noted increased congestion and wheezing since these trials of thin liquid. There had been significant weight loss, feelings of food and pills stuck, significant coughing with meals, and an overall significant impact to quality of life. The spouse reported that they miss going out for meals.

 

Regarding swallowing pills, they noted that swallowing pills had been effortful, rating the severity of effort to swallow pills as a 2 out of 4 on the EAT-10 scale. They have been embedding them in applesauce, but the spouse worried that pills may still be getting stuck, especially since there are 5 pills in the morning and 10 pills at night to take.

 

During the VFSS, the barium pill was embedded in applesauce. We first see the pill getting stuck in the throat in a space called the valleculae (“pocket” between the base of the tongue and the epiglottis – in the throat/pharynx). When dry effortful swallows were not working, we tried a liquid wash. Washing pills down with liquid can be dangerous, causing aspiration on the liquid or pill, and this particular individual had a tendency to tip the head back. Therefore, we tried a small sip and chin tuck, which worked to clear the pill plus liquid out of the throat/pharynx without aspiration. However, then the pill got held-up in the food tube/esophagus.

Video Image 3.JPG

Watch Video At: https://youtu.be/E7RUeiKCxDU

 

In this next video, we see the pill embedded in “Assure Slide – Forte” (which is an extremely thick gel). It all clears easily out of the mouth and through the throat without getting stuck this time. It even pushes the other pill down through the esophagus with no further hold-up (no further esophageal retention). Both pills were emptying through the esophagus quickly.

Video Image 4.JPG

Watch Video At: https://youtu.be/gXxEVpDRaJc

 

We will not go into all the details of the video fluoroscopic swallow study here, but there was significant improvement since the last study 2 months prior. There was still a mild oropharyngeal dysphagia with safety and efficiency issues. The recommendations were to upgrade to Regular diet/Level 7 Easy to Chew (per IDDSI Framework), avoiding dry/hard/crumbly textures and foods that could elevate a choking risk (e.g., tough meats and breads). An effortful swallow was effective for more challenging foods. They were upgraded to thin/regular liquids with the caution of small single sips by cup with a chin tuck.The person was quite good at the supraglottic swallow strategy (i.e., breath hold, swallow, release breath with a cough, and reswallow). After further practice with that strategy, they could drop the use of the chin tuck maneuver. Due to the pills getting stuck in the both the pharynx and esophagus, we recommended pills to be embedded in “Assure Slide” (aka, “Phazix”). We also recommended good oral hygiene to help with aspiration pneumonia prevention, as well as pulmonary clearance exercises in case of trace aspirations of thin liquid.

 

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Financial Disclosure: Assure Slide/Phazix hired this author (Karen Sheffler, MS, CCC-SLP, BCS-S) as a dysphagia consultant, and paid a small consultant fee to research and review this product. Author does not make any commission on the individual sales of the product.

 

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References:

Akhtar, A.J. (2003). Oral medications-induced esophageal injury in elderly patients. The American Journal of the Medical Sciences, 326(3), 133-135. https://doi.org/10.1097/00000441-200309000-00005

 

Belafsky, P.C., Mouadeb, D.A., Rees C.J., Pryor, J.C., Postma, G.N., Allen, J., & Leonard, R.J. (2008). Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol, 117, 919-924.

 

Carnaby-Mann, G. & Crary, M. (2005). Pill swallowing by adults with dysphagia. Archives Otolaryngology Head and Neck Surgery, 131(11), 970-975.

https://www.ncbi.nlm.nih.gov/pubmed/16301368

 

Cichero, J.A.Y. (2013). Thickened agents used for dysphagia management: Effect on bioavailability of water, medication and feelings of satiety. Nutrition Journal, 12, 54. 

https://nutritionj.biomedcentral.com/articles/10.1186/1475-2891-12-54

 

Crinò, L., Manrique Torres, Y.J., Cichero, J.A.Y. & Steadman, K.J. (2015, November-December). Characterisation of Gloup: Is it suitable for medication delivery in dysphagic patients? Session presented at Australian Pharmaceutical Association (APSA) Annual Conference, Hobart, Tasmania, Australia.

 

Guidance for Industry. Dissolution testing of immediate release solid oral dosage forms. United States Food and Drug Administration, Rockville, MD, 1997.

 

Malouh, M.A., Cichero, J.A.Y, Manrique, Y.J., Crinò, L., and Steadman, K.J. (2018, December). Helping patients to swallow their tablets: Is Gloup appropriate for use in dysphagia? Session presented at Australian Pharmaceutical Association (APSA) Annual Conference, University of South Australia, Adelaide, Australia. 

 

Manrique, Y.J., Lee, D.J., Islam, F., Nissen, L.M., Cichero, J.A.Y, Stokes, J.R. & Steadman, K.J. (2014). Crushed tablets: Does the administration of food vehicles and thickened fluids to aid medication swallowing alter drug release? Journal of Pharmacy and Pharmaceutical Sciences, 17(2), 207-219.

 

Nativ-Zeltzer, N., Bayoumi, A., Mandin, V. P., Kaufman, M., Seeni, I., Kuhn, M. A., & Belafsky, P. C. (2019). Validation of the PILL-5: A 5-Item Patient Reported Outcome Measure for Pill Dysphagia. Frontiers in surgery, 6, 43. doi:10.3389/fsurg.2019.00043 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6667828

 

Stroschus, B., & Allescher, H.D. (1993). Drug-induced dysphagia. Dysphagia, 8, 154-159.

Ordering Information

Product Flavor Oz Case Qty. Product # UPC 015482-
Assure Slide Swallowing Aid - Forte Vanilla 16.9 6 1000002 10002-5
Assure Slide Swallowing Aid - Zero Raspberry 16.9 6 1000003 10003-2

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