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I would like to know whether anyone knows of a list of 'pulse release'
products registered in the US market. It appears that pulse release
products are listed in Orange Book under the general category of
'extended release'. The official FDA definition of formulations in
this regulatory category is:
"...one that allows at least a twofold reduction in dosing frequency
as compared to that drug presented as a conventional dosage form
(e.g., as a solution or a prompt drug-releasing, conventional solid
This is different from the 'delayed release' formulation that is
"...one that releases a drug (or drugs) at a time other than promptly
after administration. Enteric\0x00coated articles are delayed
\0x00release dosage forms. Drug products in delayed release dosage
forms containing the same active ingredients are subject to
significant differences in absorption."
Not unexpectedly, it appears that most of the formulations in the
'extended release' category are actually sustained release. I had
assumed that it would be possible to easily identify pulse release
(timed release or dual-release) by comparing the Cmax of the modified
release product with the immediate release product to determine
differences of several hours. Alternatively, I expected that the label
would clearly identify 2 plasma drug peaks (one corresponding to
immediate release and one to the delayed pulse). This doesn't seem to
be the case at all. In fact, the labelling for Cardizem CD doesn't
even specifically mention the pulse release nature of this product.
I was hoping that there might be a review article on pulse products or
similar that I could use to look at regulatory precedent for these
formulations. Alternatively, a simple list of product would be an
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