An innovative, anhydrous sublingual base that accommodates a variety of drug molecular weights
Designed to efficiently deliver a wide range of drugs with varying molecular weights — including high molecular weight (HMW) substances — SubMagna SL HMW is a state-of-the-art, anhydrous, self-emulsifying and permeation-enhancing sublingual suspension vehicle.
SubMagna was initially developed as an alternative dosing form for commercially available semaglutide in nonsterile compounded preparations. However, it also accommodates a broad range of active pharmaceutical ingredients (APIs).
- Sublingual, anhydrous base that forms an emulsion when exposed to saliva, improving the solubility and dispersibility of APIs.
- Permeation-enhancing and unique mucoadhesive properties help drive molecules into mucosal tissue, potentially delivering greater drug absorption and increased contact time.
- Sublingual route of administration provides the opportunity to circumvent gastrointestinal factors that can influence the bioavailability of APIs.
- Offers the potential for longer beyond-use dates (BUDs).*
- Developed to provide an alternative dosing delivery system for commercially available semaglutide, and a broad range of other APIs.
- Semaglutide (commercially available tablets)
- Oxytocin
- Ketamine
- Melatonin
- Progesterone
- Testosterone
- Sildenafil
- Tadalafil
Frequently Asked Questions
What flavors are recommended for use in SubMagna formulations?
PCCA developed a new Natural Caramel Flavor (PCCA #30-5062) that works very well masking the bitterness of semaglutide (utilizing commercially available tablets as the source of the API) in SubMagna formulations. This is an anhydrous flavor, which we generally use at a concentration of 1-3%.
For higher strength semaglutide suspensions (2 mg/mL and above), we suggest combining the Natural Caramel Flavor at 2% with Banana Creme Artificial Flavor (PCCA #30-2169) at 1% for optimal taste and bitterness reduction. This flavor combination does contain some water; however, water activity testing of the final formulation was below 0.6, therefore keeping it as an anhydrous compound. Other flavors such as peppermint/spearmint oil combination, creme de menthe or tangerine oil may be used. We recommend you refer to the PCCA formulas for suggested flavors based on the API.
What is the max powder load for SubMagna?
Testing of powder loads up to 10% worked well. If increasing above 10%, we suggest you test a small batch as the preparation can become too viscous, causing the potential for inaccurate dosing.
How do you recommend dispensing SubMagna preparations?
Bottle, Prescription Oval Amber Plastic (PCCA #35-2303 [2 oz]), #35-1975 [4 oz])
SealSafe® 24MM Self-Sealing Dosing Adapter (PCCA #35-4262)
Syringe, 1 mL, Oral/Topical - Amber (PCCA #35-4483)
We recommend dispensing with a self-sealing adapter. SubMagna formulas are viscous, so using these adapters prevents buildup of suspension in the neck of the dispensing container and reduces the potential loss of dosages. Dispense the preparation to the patient along with a 1 mL oral syringe to measure and administer the dose under the tongue. We also recommend compounding 10% extra to cover loss on the walls of the prescription bottle.
What are the suggested compounding procedures when working with this base?
We suggest referring to PCCA Formula #15045 Sublingual Suspension — General Formula (SubMagna SL HMW) — to use as a guide when developing new formulas. We also recommend mixing all formulas using an electronic mortar and pestle (EMP) for two (2) minutes on a medium setting, then transferring to an appropriate-sized dispensing container. Due to the viscosity of the preparation, using the EMP mixing method will help obtain optimal content uniformity.
What if someone prefers to use an alternate sublingual-suspension vehicle?
Pharmacies may continue to compound their own sublingual-suspension formula as a vehicle; however, SubMagna was created with permeation-enhancing properties and the ability to deliver high molecular weight drugs. These properties, along with the increased contact time, potentially improve absorption.
Why does the SubMagna bottle say shake well before each use?
As with any suspension vehicle, slight separation may occur after the compounded preparation sits undisturbed for a while. That is why we recommend to shake well before each use.
How should we market and/or promote a compounded preparation to our patients, prescribers and community?
We encourage our members to focus on the factual and technical aspects of compounded preparations and ingredients by citing or using published articles, case studies and technical reports.
It’s important to avoid making any claims that a compounded preparation or its ingredients can treat, cure or mitigate the effects of a disease or condition. Do not say that the compounded preparation is safe and effective, or that it can alter a structure or function of the body. Additionally, we recommend use of the following disclaimer in all promotional and marketing content, including but not limited to communication via social media, websites and print material: The FDA does not review any compounded medication for safety or efficacy.
We advise against comparing compounded preparations directly to FDA-approved commercial products in a manner that suggests the compounded preparation is equivalent or superior without the backing of rigorous scientific evidence (e.g., peer-reviewed research and case studies) and regulatory approval. Any comparisons should clearly explain the basis of comparison, such as formulation differences or patient-specific needs, to avoid misleading impressions. Also, any comparisons that cite only scientific evidence should also include a disclaimer that such references are for informational purposes only and do not imply FDA endorsement or evaluation.
To ensure compliance in an evolving regulatory landscape, we recommend that you regularly consult with legal counsel familiar with FDA regulations and state pharmacy laws.
*USP 795 establishes BUD limits by type of preparation in the absence of a USP−NF Compounded Preparation Monograph or CNSP-specific stability information.
Always make sure you have checked the PCCA Formula Database and are following the most up-to-date version of a formula, as changes are continuously made to existing formulations to provide the highest quality. The formulas and/or statements listed are provided for educational purposes only. They are compounding ideas that have commonly been requested by physicians and have not been evaluated by the Food and Drug Administration. Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.