New Stability Testing Data for Pergolide #pergolidestrength


Claudia Goodman
 

The folks at Pet Health Pharmacy have been kind enough to listen to my concerns about pergolide stability claims that have been made without studies to back them up. (Once I learned that the capsules I received were compounded 2-3 months prior to my order, I contacted them to share the only study I've seen of the powder capsules that contradicts their stability claim of 6 months post compounding.)

They informed me that stability studies for their capsules are in the works, but the study is not yet complete, so no news to share about that, BUT they had just completed a 6 month study of liquid pergolide in oil suspension (testing done by an outside lab) that supports the claim of stability of this product through six months.

Pergolide was prepared to 2mg/ml, as liquid in an oil suspension and stored at room temp. (No info on dating of bulk used.)
One solution of 55ml was sent to an analytical lab where testing was done between October 2016 and April 2017.
Results:
Tested on 10/24/16, concentration found was 2.057mg/ml. (102.8%)
Tested on 2/24/17, concentration found was 2.063mg/ml. (103.1%)
Tested on 4/28/17, concentration found was 2.112mg/ml. (105.6%)

The Lab's findings:

"Meets USP potency requirements. Formulation appears to have remained stable under Room Temperature conditions for 6 months.
This concludes the requested stability study."


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Claudia & Silhouette  02/2014

California Central Coast 

Silhouette Case History


 

Excellent information, Claudia - thank you for sharing!
--

Jaini Clougher (BSc,BVSc)

Merlin (over the bridge) ,Maggie,Gypsy, Ranger

BC 09
ECIR mod/support

https://ecir.groups.io/g/CaseHistory/files/Jaini%20and%20Merlin-Maggie-Gypsy

 

 


 

The oil suspension is intriguing for its longevity at room temperature.

 -Is it administered using a dosing syringe? 
 -Must the user use latex or other disposable gloves for safety?

I am assuming the answer to both these questions is yes. If anyone knows, I'm interested, as my 13 yo mare is probably early PPID:

--
Cass for Satra and Cayuse
Sonoma County, Calif. Oct. '12

https://ecir.groups.io/g/CaseHistory/files/Cass%20and%20Satra%20-%20Cayuse


Claudia Goodman
 

Cass,

The liquid pergolide in oil suspension comes in a cough syrup like container with a dispensing top that couples to a syringe also supplied by PHP.
Pretty easy to use: after shaking vigorously, insert syringe into the coupler on top of container, turn upside down and syringe out specified amount (printed on label). Caution - use a permanent marker to show where the required volume is on the syringe as the volume marks fade with repeated use. I fill the syringe in the house and carry it down to the barn; the syringe has a cover on the tip to keep contents from leaking out or contamination.

I experimented (successfully) to find a way to get the dose into my mare: Using pellets (I use LMF low starch stage one), make a mash - then add enough water to be able to mold a portion of it into a meatball sized ball. I played with the consistency a bit to get it just right so that it held together well as I handled it. Once the "meatball" is firm, push a hole into it, about halfway in, deliver about .5ml of the syringe into the hole, then cover the hole with a bit more mash. Feed immediately.(My mare requires two "meatballs" for her 1 ml daily dose. Trying to get a full 1 ml into the ball didn't work as well for me.) She eats the balls up easily! 

If you try this approach, I suggest you feed "blanks" first to make sure your mare easily takes it before adding the pergolide suspension. Once my mare tries it and likes it, she just gobbles up the medicated balls. 

So far, it seems to be working well. Not as easy as administering a capsule, but I have much more confidence at this point in the stability of this product from PHP.
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Claudia & Silhouette  02/2014

California Central Coast 

Silhouette Case History


Claudia Goodman
 

Cass - Sorry I did not address your question about protective gloves. I saw no note from PHP about that, nor discussed it when I  spoke with them on the phone, so I don't really know. They will certainly answer any questions you have -- they were very helpful when I spoke with their pharmacist on the phone and via email.
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Claudia & Silhouette  02/2014

California Central Coast 

Silhouette Case History


Amy
 

I am syringing it directly in the mouth. Is that ok??!!
--
Amy   May 2016

 

Hammondsport New York

Kat Case History


Lavinia Fiscaletti
 

Syringing directly into the mouth is fine.
--
Lavinia and George Too

Dante, Nappi and George over the Bridge

Jan 05, RI

EC Support Team


Sara Gooch
 

Hi, I'm coming in late on this thread, and I apologize, but is the Pet Health Pharmacy pergolide suspension in oil really more stable longer than their capsules?  Is there a link somewhere to their Stability Testing Data?  Also, thanks for the idea of LMF "meatballs."  I plan on trying that with the capsules.
Thanks--
Sara, 2011, NE California


Claudia Goodman
 

I didn't think the direct approach would work with my mare, but if it works with yours, it sure makes things easier!
(Hiding things in food almost always works for us.)
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Claudia & Silhouette  02/2014

California Central Coast 

Silhouette Case History


Claudia Goodman
 

Sara,
The results of this stability testing appears at the top of this thread. PHP indicated that I could share the study results but not post the document with the results. I didn't ask questions; I was just glad to see some data on this. It was an outside lab (not PHP) in Colorado that ran the study and provided a Certificate of Study Analysis. They are in process of running this "Time Point Study" for the powder capsules as well.
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Claudia & Silhouette  02/2014

California Central Coast 

Silhouette Case History


 

Claudia, thank you for this excellent information and especially about delivering the daily dose in a yum ball - great idea.

I do have concerns about human exposure to liquid formulations of pergolide and about how easily they're absorbed through the skin. After I talk my newest vet into a prescription for compounded pergolide, I'll look into that. 
--
Cass for Satra and Cayuse
Sonoma County, Calif. Oct. '12

https://ecir.groups.io/g/CaseHistory/files/Cass%20and%20Satra%20-%20Cayuse