Physician Base Preparation Kit 

Mixing Instructions

For Healthcare Providers & Compounding Pharmacies 

For Medical Use Only. This product has not been evaluated by the Food and Drug Administration (FDA) and is not intended to diagnose, treat, cure, or prevent any disease.

These instructions are intended exclusively for healthcare professionals and compounding pharmacies and are designed to assist in preparing customized regimens to support precise daily food exposure using the Integreat™ Physician Base Preparation Kit. Follow the steps below to mix solid food (powder) formats with the inert toothpaste base provided in each kit. Kits completed with food powder provide a 12-week supply. 

Please follow all preparation steps carefully to ensure accurate incorporation and a consistent final mixture.

    • Unguator jar containing inert, fluoride-free base toothpaste (either mint or berry flavor) 

    • Empty metered-dose toothpaste pump 

    • Empty mixing container 

    • Tongue depressor (mixing implement) 

    • Piston and flat white disc for pump assembly 

    • Patient labels 

    • Food powder  

    • 50% glycerin solution (pharmaceutical grade) 

    • Sodium fluoride (if ordered by physician) 

    • Kits can accommodate single or multiple food proteins  

    • Maximum food powder loading (of either single or multiple food proteins) is 7 grams of powder in total per kit 

    • Avoid using chunky food powder sources for patient comfort, toothpaste consistency, and protein availability 

    1. Determine glycerin and food powder(s) amounts required to mix with the base toothpaste referencing the physician’s prescribed daily dose 

    2. Add food powder mixture to glycerin in the mixing jar and mix thoroughly 

    3. Add food powder/glycerin mixture to base toothpaste contained in the unguator jar. Mix thoroughly. 

    4. Slowly dispense the mixture into the pump 

    5. Seal pump and affix patient label(s) 

Calculation to determine glycerin amount 

Formula for determining 50% glycerin volume: 

15mL − grams of food powder = mL of 50% glycerin needed

Examples: 

1.To add 5g of peanut powder:

15ml − 5g peanut powder − 5g walnut powder = 10 ml of 50% glycerin to finalize payload mix

2. To add 2g of peanut powder and 2 g of walnut powder: 

15ml − 2g peanut powder − 2g walnut powder = 11 ml of 50% glycerin to finalize payload mix

Calculation to determine grams of food powder to add to base toothpaste to provide the target amount of protein per pump actuation 

grams of food
protein powder
to add to base
toothpaste
=
target mgs of protein
per actuation
% fraction of protein
in powder
× 90 actuations ×
0.001 mg
g

Single Food Protein Example: Calculate grams of peanut powder containing 50% protein needed to yield ≈25 mg peanut powder per actuation.

25 mg peanut protein
0.5
50% protein content
in powder
× 90 ×
0.001 mg
g
= 4.5g peanut powder

Glycerin addition: Add 10.5ml 50% glycerin (15 mL – 4.5 grams) to 4.5g of peanut powder (peanut powder with 50% protein content) 

Two Food Proteins Example: Calculate grams of peanut powder containing 50% protein, and grams of walnut powder containing 40% protein needed to yield ≈ 11 mg peanut protein per actuation and ≈ 9 mg walnut protein per actuation.

11mg peanut protein
0.5
50% protein content
in powder
× 90 ×
0.001 mg
g
= 1.9g peanut powder
9mg walnut protein
0.4
40% protein content
in powder
× 90 ×
0.001 mg
g
= 2.03g walnut powder

Glycerin addition: Add 11.0 mL 50% glycerin to 1.98 g of peanut powder (with 50% protein content) and 2.03 g of walnut powder (with 40% protein content) 

Formulas for Mixing

Detailed Mixing Instructions

  1. Prepare the payload mixture: In the mixing container, first add the calculated volume of 50% glycerin and then add the prescribed amount of food protein powder. 

  2. If desired, add sodium fluoride to the powder mixing container. {Note: To get 0.243% NaF (approximately 1100 ppm fluoride), add 0.2673 grams of NaF to the mixing container} 

  3. Mix until smooth and homogeneous. Note: The more food powder is added, the thicker the mixture becomes. 

  4. Unscrew the larger lid from the unguator jar. Using the tongue depressor provided, gently push down on the bottom of the jar to maximize mixing space. 

  5. Add the payload mixture to the base toothpaste in the unguator jar and press down repeatedly until the payload mixture is fully incorporated into the base paste. 

  6. Mix until smooth and uniform, ensuring complete incorporation with no visible lumps. 

    *Important: Be sure to mix for at least 1 - 2 minutes to ensure even mixing. 

  7. Replace the larger lid and remove the small cap on top of the unguator. Press the button on the bottom of the unguator until the prepared toothpaste reaches the opening of the spout. 

  8. Unscrew the cap of the toothpaste pump. Remove and discard the small plastic plug found in the pump nozzle. Screw the cap back on. 

  9. Invert the unguator, rest the spout over the bottom of the pump, and slowly dispense approximately 25-30% of the toothpaste from the unguator into the pump. 

  10. Tap the pump firmly against the countertop several times until the paste in the pump levels out to release trapped air bubbles. Repeat the filling and tapping process until all paste has been dispensed into the pump. At the end of the filling process, make sure that the toothpaste is fully expressed from the unguator jar by firmly pressing the button at the base of the unguator to completely dispense the contents of the unguator jar. 

  11. Insert the piston, convex side first, into the bottom of the pump to the level of the toothpaste. Press gently until the toothpaste is visible at the opening of the pump nozzle. You may need to remove the pump cap to verify proper priming. 

  12. Place the flat white disc over the bottom of the pump until it snaps securely into place. If the disc does not stay in place, insert the piston slightly further and retry until the disc locks properly. 

  13. Replace the cap onto the top of the pump if removed. The pump is now primed and ready for patient use.

    • Press the dispensing actuator down completely to ensure full dose delivery 

    • Use once daily as prescribed 

    • Each pump should last at least 12 weeks with daily use 

    • If toothpaste has been refrigerated, please remove from refrigerator several hours before use. Refrigeration is not required for Integreat™ toothpaste. However, if two pumps are supplied at once, please refrigerate second pump until ready to use. Similarly, if a single pump is not immediately dispensed to the patient, please store it in the refrigerator. 

    • Schedule next kit preparation at least 2 weeks before current supply is exhausted to avoid therapy interruption 

    • If the pump lasts longer than 13 weeks, the dispenser may not be fully depressed with each use. Press the actuator all the way down with each use to ensure adequate dosing each day as prescribed by your physician 

  • For technical support regarding kit preparation or patient questions, contact Intrommune at info@intrommune.com 

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