08/06/2023
METHYLENE BLUE QUESTON:
"Hello Infuserve America
I have a lot of patients coming to my office that previously tried general methylene blue and placed it themselves in capsules.
What are your thoughts?"
Great question, we have had this query before.
The answer is: Not a good idea, here is why-
We understand the pricing issue but there are fairly large risks regarding the procurement of raw material ("General" Methylene Blue) and self-compounding capsules.
Sorry in advance for the long answer 🙂
First, is the Methylene Blue itself. There are different "grades" of Methylene Blue. For example, It is used for the prevention of fungal infections in fish tanks, in laboratories for staining samples, in analytical chemistry for redox reactions, and water testing, etc. The raw materials used for these applications are not USP grade. To extend this point, "general" Methylene Blue is typically purchased from sources that do not provide a certificate of analysis and are under no obligation to follow the laws or regulations regarding pharmaceuticals for human use. (For Human Use) Methylene Blue that is from a verified source, has a certificate of analysis, and comes from a FDA registered facility... is expensive. If you purchase it off the internet and it is inexpensive then steps are being skipped to insure purity or (at worst) it's not Methylene blue at all...
Trying to create your own capsules at home that are consistent and are the correct dose is a lot harder than it seems. Here a just a few of the very important items regarding compounded capsules.
Weight - An electronic kitchen scale is no match for the electronic balances we use, scales found in compounding pharmacies measure down to milligram quantities and are calibrated/validated frequently by a 3rd party per regulations. Another factor that "home chemists" rarely take into account is Loss on Drying - this is the amount of water that is actually in the powder, and in Methylene Blue can be as much as 14% - we take this into account from the certificate of analysis to create an "activity factor" that gives the correct amount. The actual assay of the product is also on the certificate. Without both the assay and the Loss on Drying, the dose is off by a considerable amount. This is outside USP guidelines and leads to the incorrect dose and dosing inconsistency.
Excipients - Even with high end electronic balances we still use the aliquot method to prepare capsules - because milligrams are really hard to measure consistently. By using simple but effective "fillers" (excipients) it vastly improves the accuracy and repeatability of the measurements. Choosing the correct excipient(s) also have a large role in both the Stability and the Absorbability of the Active ingredient(s) in a capsule. This is not often taken into account when making capsules at home.
Packing Statistics (or Packing Stats) - powders (both active ingredients and excipients) "pack" differently into capsules, to know this you have to fill the capsule with the material and weight it accurately then do this multiple times and take an average. This information is crucial for formulation of the capsule and for establishing quality control parameters, like the accurate weight of the final capsule.
The Mess - Methylene Blue is a very fine powder and goes everywhere, we have PPE and the proper equipment to deal with this, no matter how careful patients are, you can coat a kitchen in blue. Having this around is not just a mess, it can pose a problem for other people and pets in the home whom are exposed to the Methylene Blue, which is after all, a drug. The powder is aerosolized very easily, we use specialized powder hoods to manipulate the drug to ensure no cross-contamination and to protect the personnel that are making the compound.
Repeatability - Making capsules that are consistently the correct dose is difficult and takes the proper equipment, this equipment is expensive and hard to get. Pharmacy Technicians that have the proper training and experience are critical to the safe and accurate compounding of capsules.
Quality Control - We test the final product and the people that make these types of items to ensure quality and consistency.
I know this is a bit lengthy but I wanted to give a complete an answer as possible.
To patients, sometimes compounding is a bit of mystery and because most compounds are not covered by insurance there is financial aspect with regard to compounded medications. The items listed above apply to all the medications we compound, and it is only fraction of all of the procedures we have to follow to produce a quality product and follow state and federal regulations.
