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Recently I was approached about a product named DiffusiMax for general
application to hospitalized patients. This product is referred to as a
'pluronic lecithin organogel' (PLO gel) which is being recommended for the
general of a variety of drugs. The brochure suggests that your pharmacist
can make up any topical NSAID preparation with this gel. The suggestion,as
well, is that you could also try mixing it with narcotics, anti-nauseants,
and hormones in order to achieve systemic levels. The individual
approaching me, wanted to consider mixing it with clonidine. Knowing the
great variability with systemic absorption (rate of, and extent) with other
transdermal products I would be very concerned about the general
application of this product to a wide variety of pharmaceuticals in an
untested fashion. Is it just me or is this a bad idea!
Rob Ariano, Pharm.D.
Robert Ariano, Pharm.D.,BCPS
Clinical Pharmacist Critical Care
St.Boniface General Hospital
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Here are all 4 references I found on IPA using "organogel" as a key word:
TIGel relieves arthritis pain
SOAm-Drug American-Druggist); 1998; 215(May); 56 .
ABA formulation for compounding KCL gel, a topical gel containing
cyclobenzaprine hydrochloride 1%, and lidocaine 5% in a poloxamer
is presented and its mechanism of action, efficacy in arthritis,
adverse effects, and dosage are
INonionic surfactant based organogels incorporating niosomes
AUMurdan-S; Gregoriadis-G; Florence-AT
SOSTP-Pharma-Sci STP-Pharma-Sciences); 1996; 6(1); 44-48 .
ABThe formulation and characterization of a novel anhydrous organogel
formulated as a
potential delivery vehicle from a solution of 2 nonionic surfactants,
(Span 60) and polysorbate 20 (polyoxyethylene sorbitan monolaurate;
Tween 20), in
hexadecane at 60DGC, which cools to a white, semi-solid,
thermoreversible gel at room
temperature, are described. The addition of an aqueous phase (water
suspensions) up to 17% v/v to the oil phase at 60DGC produced
vesicle-in-water-in-oil systems, respectively. The release rate of
hydrophilic solute from these
gels was found to be lowest when a disperse system of spherical water
droplets in the
continuous oil phase was formed at high temperatures, compared to the
faster release from
the gel where the fibril structures acted as nearly continuous
aqueous channels running
through the organic medium, providing a means of traversing the oil
TILecithin organogel as matrix for transdermal transport of drugs
AUWillimann-H; Walde-P; Luisi-PL; Gazzaniga-A; Stroppolo-F
SOJ-Pharm-Sci Journal-of-Pharmaceutical-Sciences); 1992; 81(Sep); 871-874
ABOrganogels obtained by adding water to solutions of lecithin in
isopropyl palmitate or
cyclooctane solvents were studied in vitro as matrices for the
transdermal transport of
scopolamine and broxaterol through human skin. Preliminary histology
studies showed that
the lecithin organogels have no harmful effects when applied to the
skin for prolonged
periods. The transport rate of scopolamine obtained with the lecithin
gels was about 1 order
of magnitude higher than that obtained with an aqueous solution of
the drug, and the same as
that obtained with a microemulsion solution of scopolamine prior to
observations were made for the transport of broxaterol, in which case
the flux through the
skin was directly proportional to the concentration of drug in the
gel. On the basis of these
results and others demonstrating the successful transport of amino
acids and peptides, it was
concluded that lecithin gels may be efficient vehicles for the
transdermal transport of various
TIPhysical and chemical characteristics of water soluble, semisolid,
anhydrous bases for
possible ophthalmic use
AUNewton-DW; BeckerCH; Torosian-G
SOJ-Pharm-Sci Journal-of-Pharmaceutical-Sciences); 1973; 62(Sep);
ABEighty-four semisolid, water soluble, anhydrous bases for possible
ophthalmic use were
formulated and evaluated. Of these bases, 5 were designated
evaluatory bases for further
study on the basis of apparent pH and/or desirable physical
spreadability characteristics over
the temperature range of 0-50DG. Four of the 5 bases were further
rotational viscometer studies, and an organogel was selected on the
basis of several of its
listed attributes as the best attempt in this investigation to
formulate the type of semisolid base
desired for possible ophthalmic use.
As you can see there's nothing about blood levels, efficacy, etc. Perhaps
PCCA in Texas has additional information. Caveat emptor.
Richard Molitor, R.Ph.
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From: "KEIA (Keith Anderson)"
Subject: RE: PharmPK DiffusiMax - transdermal delivery
Date: Fri, 11 Jun 1999 12:54:38 +0200
Regarding lecithin organogels- I have personally worked with a
rheumatologist in completing a placebo-controlled, double-blinded,
randomized clinical trial investigating the use of 2% diclofenac in a
lecithin organogel for osteoarthritis of the knee in geriatric patients
(n=80). This paper should be published shortly in J. Rheumatol. A
significant effect was noted for the active group as measured by the WOMAC
Osteoarthritis Index V 2.0 (developed at the U. Of Western
Ontario/Macmaster). Patients and physician noted significant improvement in
knee function, however quality of life measures remained unchanged, which is
not an unusual finding for this patient group.
I strongly agree that development of such products need to be addressed in a
Currently, I am aware of clinical groups and suppliers which are actively
working in the areas of pain management, or more recently, erectile
dysfunction with similar topical products. Unfortunately, there is alot of
anecdotal reports and claims being made in many areas. I am currently
unaware of the nature/status of the Diffusimax product but agree that
extreme caution is warranted in the use of potent compounds when little
clinical evidence is available.
I am quite suspect of a gel which can claim consistent transdermal delivery
for a wide-range of compounds, and, on top of this, maintain some sort of
adequate shelf-life in terms of stability- from this brochure it looks like
the panacea of drug delivery.
Keith Anderson, PhD.
Date: Fri, 11 Jun 1999 09:31:43 EDT
Subject: Re: PharmPK DiffusiMax - transdermal delivery
Personal experience with PLO gel and Ketoprofen has produced very
satisfactory results. We use a 1 or 2% Ketoprofen gel applied locally. We
have also utilized Ibuprofen. Advantages are no GI upset with good
anti-infalmmatory & anagesic properties.
PLO gel will provide a controlled release environment based on Flick's Law
(constant diffusion). I wuold not hesitate to use narcotic analgesics where
we would titrate to effect, ie., Hospice patients who cannot swallow.
You may want to contact Liposome Technology, Inc (sorry no #) and/or
Professional Compounding Centers of America, Inc 800-331-2498 for more
Lecithin Organogel as MAtrix for Transdermal Transport of Drugs, Journal of
Pharmaceutical Sciences, 81:9 9/92 p871-874
Henry Resnick, RPh, MS
Date: Fri, 11 Jun 1999 15:53 -0600
From: "Trish Kogan"
Subject: Yeah, it's a bad idea!
Sounds like a very bad idea to me! Absorption rates are sure to
change, so I would think this would require an ANDA filing with the
FDA to use with a drug such as clonidine.
Trish Kogan, Ph.D.
Texas Biotech Corporation
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The use of PLO gel is extensive in pharmaceutical compounding of topically
absorbed drugs. In a former job, I managed an apothecary style pharmacy
affiliated with a hospital (and also, the hospital's inpatient pharmacy).
We did a very steady business in topical ibuprofen gel after introducing the
local rheumatologist to the concept and supplying free samples. One of the
staff pharmacists was very into compounding and he researched all the
formulations. He had many recipes for various NSAID's, hormones, etc.
Apparently, they all worked well enough to convince both the patients and
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