Compounding Progesterone vaginal suppositories?

I am a pharmacist in NYC, interested in compunding Progesterone vaginal
suppositories. I would appreciate your help in telling me the necessary
equipment, ingredients, correct technique and how to correctly adjust
the pH of the final product.
Do you know of any issues with a pharmacist's liability compunding this?
Would the usual pharmacy policy cover any problems arising from
compounding this product? What is the FDA's position on Progesterone
extemporaneous compounding?
I could not find much using a Google search, except the article below:

: Drug Dev Ind Pharm. 2004;30(10):1069-78. Links
Investigation of product quality between extemporaneously compounded
progesterone vaginal suppositories and an approved progesterone vaginal
gel.
Mahaguna V, McDermott JM, Zhang F, Ochoa F.
PharmaForm, LLC, Austin, TX 78758, USA. vmahaguna@pharmaform.com

The purpose of this investigation was to compare quality parameters,
including product appearance, content uniformity, pH, weight uniformity,
microbial limit testing and preservative effectiveness testing on
extemporaneously compounded progesterone vaginal suppositories obtained
from 10 randomly chosen compounding pharmacies (90 suppositories each)
across the United States, to the Food and Drug Administration (FDA)
approved prescription progesterone gel product (Prochieve/Crinone) which
is manufactured in a cGMP regulated facility. The content uniformity and
pH were determined using qualified methods. The microbial limits testing
and preservative effectiveness testing were conducted according to
compendial methods. Only one pharmacy provided suppositories that were
all within the potency limits required for the prescription progesterone
gel product. The other pharmacies provided at least some suppositories
where progesterone content was either subpotent or superpotent for
progesterone. The pH of most of the compounded suppository products was
in the range of 4.22 to 7.68 with a median of 6.30 (normal vaginal pH is
<5), whereas the gel product was 2.80. For compounded product from one
of the pharmacies, microbial limits testing indicated CDC group IVC-2
and Comamonas acidovorans were detected. This data indicates that
pharmacy compounded delivery systems for progesterone should be used
with caution.

Would appreciate your input - Marty in NY

Compounding Progesterone vaginal suppositories?
25 Sep 2008	Martin
28 Sep 2008	$\$ Dan Warren

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