On Sat, Apr 29, 2017 at 07:09 am, Nancy C wrote:
I had a convo with them last summer asking about stability testing. They said they indeed have it and would share with me if I needed it. This was via telephone so no copy of discussion.
I just had a chat with Laura, a pharmacist at PHP. I had already corresponded via email with another pharmacist (twice) requesting any data they had that demonstrated 6 months stability fro compounded pergolide capsules, but did not get a response that included data/studies. Today, Laura informed me that they had no study, but were working on it because they understand many of their customers share compounded pergolide stability concerns.
Laura informed me that the basis for their claim for 6 month stability is based wholly on a USP recommendation - not based on studies. (I don't get that, but apparently it can work that way.) So there is no study data available to back that up, according to what I was just told. Laura mentioned that they did intermittent checks on the capsules and are endeavoring to provide a study to share, but none yet exists.
I appreciated Laura's time and patience with me as I went over my concerns and answered many questions. She even looked up the compounding date of the pergolide capsules that are available to ship now at my mare's dose, which are unfortunately the same as last order: 2/27/17. She suggested I might consider pergolide prepared in an oil suspension for which USP grants 9 month stability (again, no data to back that up) and is available in their inventory with a 4/14/17 compound date. They ship out whatever inventory they have that can be used within the 6 months from compounding. They only compound fresh capsules of a dose when ordered if they are out of that dose or it would "expire" within use interval. Otherwise, she noted, the cost of the drug would be much higher. She told me there was no minimum order size for which they would make up a fresh batch.
One anecdotal factor here is that on a 9mg dose, my mare's ACTH went from 19pg/ml (on 1/27/17) to 26 (on 5/8/17), with the last test about one week into starting the two month old pergolide capsules. That is not determinative of loss of potency, but it's not reassuring either.
Up until they labelled their last order with the compound date, I naively assumed they made up a fresh batch with each order. I've got to say that this stability issue, so important to tightly controlling PPID, seems quite under supported in the compounding world. I think it would helpful, if with every order of pergolide, we all requested the compound date and discuss our concerns over lack of data that demonstrates claimed stability.
Claudia & Silhouette 02/2014
California Central Coast
Silhouette Case History