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Hi everyone,
I'am currently working on a controlled peptide release formulation (GEL).
I use a USP dissolution test Apparatus 1 to measure peptide liberation from the
gel during 44 hours
The gel is put in a dialysis bag (cut off 15KD) from spectrum. From
the 1st tests I did it seems that there is a wide variability with the
membrane concerning diffusion between batch and intra batch
Question :
Does anyone has experience in thisn field and what kind of suitability test
on the membrane could I use to be sure that the membrane i use is
reproducible and comply to my specif.
Thanking you in advance for your help
Eric MAGNAN
BEAUFOUR IPSEN - Ipsen Pharma Biotech
Dpt Contrôle Qualité/Quality control Dept
Service Pharmacologie/Pharmacology Unit
eric.magnan.-at-.beaufour-ipsen.
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Hi everyone,
I'am currently working on a controlled peptide release formulation in gel.
I use a USP dissolutest Apparatus 1 (baskets) to measure (UV VIS
spectrophotometer) peptide release from the gel during 44 hours through a
dyalisis bag (15KD MBNE FROM spectrapor, SPECTRUM)
>From the 1st tests I started it seems that there is a great variability in
the results with the membrane (both intra and inter batch).
Question :
So i would like to set a simple control test to be sure of the
reproducibility of the mbne I use before I start my tests.
Does anyone has experience in this field and what kind of suitability test
( quality control test) on the menbrane could I use to be sure that the
menbrane i use is reproducible and comply to my specif.
Thanking you in advance for your help
Eric MAGNAN
Dpt Contrôle Qualité/Quality control Dept
Service Pharmacologie/Pharmacology Unit
eric.magnan.-a-.beaufour-ipsen.
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Eric,
I am not an expert but I would suggest you check the membrane integrity.
I suppose that the membrane supplier can provide you with test kits
containing reference substances that will go through the membrane and others
that are known to keep retained. You can visit the "spectrumlabs.com" site.
Hope this helps,
Frederic
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