Monday, August 13, 2012

How are homeopathic pillules really made?

Some homeopathic remedies are dispensed as little sugar pills  or pillules (as shown above). A few days ago I read a post on the Quackometer blog titled FDA Raises Serious Concerns About UK’s Nelsons Homeopathics.

Last November a representative of the U.S. Food and Drug Administration (FDA) inspected the Nelson’s plant in London. He observed how they were filling a batch of their trademarked Clikpak containers with Kali Phosphoricum (potassium phosphate) 30C pillules. (They also use Clikpaks for both Lycopodium and Gelsemium, which I’ve previously blogged about having been recommended for public speaking anxiety). FDA was alarmed enough to send them a warning letter pointing out significant violations of Current Good Manufacturing Practice (CGMP) regulations.

One example was that:

“a. During the inspection, the investigator observed glass fragments present during the manufacture of Kali Phos 30 c Clikpak, Batch #36659. Specifically, glass fragments were observed in the Clikpak Assembly (b)(4) enclosed area where open glass vials are inserted into the outer plastic Clikpak sheaths and move uncovered on the conveyance mechanism. Your firm failed to implement adequate measures to prevent glass contamination and had no documentation to demonstrate that appropriate line clearance and cleaning is conducted following occurrences of glass breakage, which has been a recurring problem.”

A second was, amazingly, that 1/6th of the pill containers weren’t getting anything added to the inert sugar pills at all:

“b. The investigator also observed for Batch #36659 that one out of every six bottles did not receive the dose of active homeopathic drug solution due to the wobbling and vibration of the bottle assembly during filling of the active ingredient. The active ingredient was instead seen dripping down the outside of the vial assembly. Your firm lacked controls to ensure that the active ingredient is delivered to every bottle.”

A third example was that:

“c. The dosing process has not been validated appropriately. Specifically, your surrogate validation study, “Medication of un-medicated pillules with (b)(4),” visually demonstrates the variability of the amount of (b)(4) for the pillules in one vial. Your firm lacks control of the variation for the amount of the active ingredient in the pillules.

The validation study demonstrated that pillules at the top of the bottle contain more active ingredient than pillules at the bottom. There are no controls in place to ensure that the dosing procedure is homogenous and reproducible.”

I would have expected they’d try to uniformly dose their pillules. So, I looked in Dr. Steven B. Kayne’s book Homeopathic Pharmacy: theory and practice to see how it’s usually done. On pages 103 and 104 of the second edition he said that:

“On a large scale, blank lactose tablets, granules or sucrose pills can be surface inoculated by spraying on the liquid remedy in alcoholic tincture or as syrup in a revolving pan, rather like the old method of sugar coating. The exact amount of remedy to be applied to ensure an even covering is determined using dyes.

In smaller scale production the solid dose forms are placed in glass vials and medicated by placing drops of high alcohol medicating potency on the surface, depending on the amount of solid dose form being medicated.

....It is not necessary for every tablet to be coated to the same uniform amount.”

Finding out how it’s actually being done reminded me of the old Monty Python comedy sketch about a box of chocolates called Crunchy Frog, which you can watch here on YouTube

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