Frequently Asked Questions about Anhydrous SUSPENDIT
Is Anhydrous SuspendIt safe for use in animals?
Yes, the ingredients are safe for use in animals; however, in animals
with pancreatitis, the use of any anhydrous vehicle that contains MCT
or other fixed oil is not recommended. Additional caution must be
exercised for use in certain animal species — such as birds — to ensure
the formula/vehicle is appropriate for the species
Does Anhydrous SuspendIt replace PCCA Fixed Oil Suspension Vehicle for
oral suspension formulations?
While our Fixed Oil Suspension Vehicle is a well-established oral
suspension, Anhydrous SuspendIt is a new anhydrous option to consider
when starting a patient on an oral suspension formula. If a patient and
their prescriber are pleased with their current compounded medication,
we recommend not changing that compound formulation.
Should pharmacy compounders transition patients who are using other
oral suspension bases to Anhydrous SuspendIt?
It depends on the situation. Anhydrous SuspendIt is a great option when
starting a new patient on an oral suspension formulation. In the same
respect, if a patient is experiencing issues with their current
medication, changing the base instead of the dose may be a good option.
However, if a patient and their prescriber are pleased with the current
compounded medication, including taste and compliance, we recommend not
changing.
What are the suggested compounding procedures when working with this
base?
We suggest referring to PCCA’s formula #14432 Oral Suspension — General
Formula (Anhydrous SuspendIt) — to use as a guide when developing new
formulas. We also recommend all formulas are mixed using an electronic
mortar and pestle (EMP) for two (2) minutes on a medium setting, then
transferred to an appropriate-sized dispensing container. Due to the
viscosity of the preparation, using the EMP mixing method will help
obtain optimal content uniformity.
Could you dilute the dose before administration?
Some patients may be more sensitive to the ‘mouth feel’ or minor throat
irritation of an anhydrous base; therefore, diluting the single dose
with juice or water at time of administration is an option.
Is Anhydrous SuspendIt appropriate for use in patients on ketogenic
(Keto) diets?
We recommend reviewing the Nutritional Facts to determine appropriate
use for an individual patient. Anhydrous SuspendIt contains approximately 1.54 calories per 5 mL from
carbohydrates.
What is the max powder load?
Because of the viscosity of Anhydrous SuspendIt, approximately 10% (100
mg/mL) is the max powder load. To date, formulations with a powder load
over 10% have not been tested. Should you have a need to make such a
formulation, we recommend you engage in appropriate testing of the
formulation prior to proceeding.
Is a wetting agent required in the formulation?
The use of wetting agents often depends on the API. Some agents that
could be used with Anhydrous SuspendIt are Glycerin USP or Medium Chain
Triglycerides NF; however, the majority of the formulas use the base
itself as the wetting agent.
Is it necessary to dispense with SealSafe® 24MM Self-Sealing Dosing
Adapter (PCCA #35-4262) as noted in the formula procedure?
Yes, it is advised to dispense with the self-sealing adapter. Since
formulas are viscous, using these adapters prevents buildup of
suspension in the neck of the dispensing container and reduces the
potential loss of dosages.
Can other adapta-caps be used instead of the SealSafe Self-Sealing
Dosing Adapters?
No. We recommend using only the Seal-Safe Self-Sealing Dosing Adapters
because they fit within the neck of the dispensing bottle. Other
adapta-caps fit on the top threading of the bottle and do not seal the
inner neck to prevent buildup.
Can aqueous flavors be used and would they impact the USP default BUD?
Yes, aqueous flavors may be used in Anhydrous SuspendIt up to 3% and water activity testing remained under 0.6. The addition of an emulsifier is not required due to the self-emulsifying properties of the base. The exception is with concentrate flavors as they are not compatible with the base.
What types of nasogastric (feeding) tubes may be used with Anhydrous SuspendIt?
Anhydrous SuspendIt tests were conducted only in nasogastric
polyurethane (feeding) tubes. After administering 5 mL suspension, the
tube was flushed with 10 mL purified water. No significant residues or
clogging were seen. Nasogastric (feeding) tubes constructed with other
materials were, to date, not tested. We strongly recommend knowing the
nasogastric (feeding) tube material prior to administering.
Can this base be used in oil-filled capsule formulas?
Yes, this is an anhydrous suspension base that can be used to create
oil filled capsules. See PCCA Formula #14401 – General Formula, Anhydrous SuspendIt Capsules Size #1.
Does an anhydrous vehicle provide stability for all preparations?
No. Anhydrous bases decrease hydrolysis and microbial growth, but some
APIs may still be susceptible to oxidation.
Does temperature affect the base or compounded formulation?
Temperatures over 35°C may affect the base. High temperatures may cause
the solid ingredients to reach their melting point; therefore, the base
becomes a clear solution. Once the base returns to room temperature,
the emulsion system could separate. This may occur during shipping —
notably if the base or formulation is exposed to high temperatures. Low
temperatures, including refrigeration, do not impact the base.
Why does the label state “Shake well before use”?
Given the system is halfway between an emulsion and a suspension
system, some natural separation may occur over time. Monk fruit is not
soluble; due to this, you may see some visible particles prior to
shaking well. Anhydrous SuspendIt is packaged to allow additional head
space for adequate shaking, which in turn allows re-suspension of the
base vehicle. Additional head space should also be given to compounded
preparations.
What is the specific gravity of Anhydrous SuspendIt?
Approximately 0.96.