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Q: Tri-mix in a Gel Form, for impotence. ( Answered,   5 Comments )
Question  
Subject: Tri-mix in a Gel Form, for impotence.
Category: Health > Men's Health
Asked by: panchito-ga
List Price: $200.00
Posted: 09 Jan 2003 19:16 PST
Expires: 08 Feb 2003 19:16 PST
Question ID: 141025
I need to know pharmacies that today sell "tri-mix gel" and also
phisicians that prescribe this tri-mix gel. Tri-mix Gel is a mix of 3
drugs "in a gel form": Papaverine, Prostaglandine E1 and Phentolamine;
in the form of gel. Used for the treatment of erectile dysfunction.
Also need to know about papers wrote for this tri-mix gel,  like
phisicians that writes about it. Please inform me only with regard of
"tri-mix Gel" I do not need information as tri-mix inyectable; it's a
must the "gel form"
Thank's.
F.

Request for Question Clarification by tj-ga on 09 Jan 2003 21:35 PST
I have found information on clinical trials done with Prostaglandin E1
gel on erectile dysfunction (ED). From what I've found, prostaglandin
E1 topical gel is a promising solution for some cases of ED, although
it won't be released to the general public until late 2003, early
2004.

I haven't been able to find any research on trimix gel though. It
appears from what I've found that trimix is only used in the
injectable form. Would you be interested in what I've found on the use
of Prostaglandin E1 gel?

Thanks, 
tj-ga

Clarification of Question by panchito-ga on 10 Jan 2003 21:25 PST
I only can use information on the tri mix: prostaglandine E1,
Papaverine, and phentolamine used as a "Gel" used for the treatment of
ED. It's a must the 3 ingredients and also the Gel form.
Can't use any other product, not good any ingredient by itself, or any
other.
Sorry.
Please advise me, because I will pay only for the research ask, not
for nothing nor for any other issue.
Thanks
Pancho.

Clarification of Question by panchito-ga on 10 Jan 2003 21:38 PST
I only can use information on the tri mix: prostaglandine E1,
Papaverine, and phentolamine used as a "Gel" used for the treatment of
ED. It's a must the 3 ingredients and also the Gel form.
Can't use any other product, not good any ingredient by itself, or any
other.
May be you can find the answer through "compounding pharmacies" that
are the ones that compund these drugs for phisicians with a
prescription.
Sorry.
Please advise me, because I will pay only for the research ask, not
for nothing nor for any other issue.
Thanks
Pancho.

Request for Question Clarification by tj-ga on 10 Jan 2003 22:06 PST
Thanks panchito. I'm going to try to find access to the tri-mix gel
for you. I have a lead on a pharmacy that may be able to make it up
for you. What country and region (state or province) and city do you
live in? Are you willing to pay to have it shipped, if I can't find a
pharmacy within reasonable driving distance of where you live?

Cheers, 

tj-ga

Clarification of Question by panchito-ga on 11 Jan 2003 07:15 PST
Thank's but I don't actually need myself the product. this is a
research to help a friend of mine on a legal issue. We don't care
where we found it, but we need to found the product it self and the
phisicians that prescribe the products. We will request them to
testify on the matter; both the phisicians and the pharmacies.
Basically we need to demonstrate that is a real product and that
phisicians still use it; it doesn't matter how little is the market,
it is that simple, and that difficult.
Thanks again
Panchito.
Answer  
Subject: Re: Tri-mix in a Gel Form, for impotence.
Answered By: vitalmed-ga on 17 Jan 2003 09:32 PST
 
Panchito,

The information I have found may not be exactly what you are hoping
for, but I believe it is a definitive answer to your question, and I
shall refer you further to the best sources for this subject.

First, researcher czh-ga has apparently also done an excellent job
investigating this area in general, and the information listed in the
response to the previous question is quite complete.
(see http://answers.google.com/answers/main?cmd=threadview&id=126137 

I proceeded further and contacted a sample of compounding pharmacies
as well as the most pertinent institutions and organizations that I
list for you below, and I have conducted an exhaustive search of both
the medical and pharmaceutical literature, and found that nothing
whatsoever has been reported in print about the use of tri-mix in gel
form. I also searched manually the recent years of International
Journal of Pharmaceutical Compounding, which may not have been
catalogued and indexed. A pharmacist information specialist at a major
school of pharmacy looked at the literature as well and found the
same.

An additional thorough search of intellectual property and other
relevant sources turned up only one single source in which tri-mix as
a gel is mentioned. It is in a patent from the company Genetronics
(www.genetronics.com), and is mentioned incidentally in context of
their research and development, which was done on New Zealand White
Rabbits.
The title of the patent is:

ELECTRICALLY ASSISTED TRANSDERMAL METHOD AND APPARATUS FOR THE
TREATMENT OF ERECTILE DYSFUNCTION, and the references are: WO 9965563
and A1 19991223.
The relevant portion reads:
"PGEl (10 mg/100@tl) or trimix (10 mg papaverine + 0.5 mg phentolamine
+ 0.2 mg PGEI in 100 gl) was applied to the glans, penile shaft and
electrode."


One compounding pharmacy in Beverly Hills, CA responded that they have
dispensed this formulation, but they said it is not effective, and
they do not make it any longer. I would note that the B&B Pharmacy and
Health Care Center that czh-ga lists
(http://www.bbpharmacy.com/intracavernosal.htm#Phentolamine)
(Telephone: 1-800-231-8905) does show on their web site that they are
making this formulation. None of the others that I have checked
indicate that are stilll making it, whether or not they have made it
in the past. I am told by some compounding pharmacists that
essentially any of them can make it or anything else with FDA-approved
ingredients, and many have in the past. It has been discussed at at
least one meeting of the Professional Compounding Centers Association
(PCCA, listed below), but again, its lack of effectiveness seems to be
the reason that few physicians and pharmacists if any at all, can be
found today that are prescribing and selling it.

A leading urologist expert in erectile dysfunction has told me that
the gel form is not used because it needs a transdermal enhancer, in
other words, something that will enable it to be absorbed through the
skin. Another urologist, who is at the Boston University Institute of
Sexual Medicine (listed below) corroborated this, but he noted that
the tri-mix should be no less effective than other prostaglandin E1
containing transdermal formualtions, but that no evidence exists about
its usage or effectiveness. Some favored formulations, such as MUSE,
are made as a pellet. It is not provided in gel form, but it does melt
and turn into a gel after it is administered. This might perhaps be a
direction that clinicians interested in the tri-mix might be looking
to go.


I can suggest that if you wish to pursue this further you might turn
to the sources I list below, however they are mostly membership
organizations, and while extremely cordial, they generally do not have
much information available to non-members. One of them (PCCA)
suggested when I contacted them that one of their compounding pharmacy
members could request information and a consultation on behalf of a
non-member, but they seem to have provided all of the information that
they have available on this subject.

Following are the key professional sources of information:

Professional Compounding Centers Assocation (PCCA)
"An independent pharmacist's complete resource for
bulk pharmaceuticals, equipment, devices, flavors,
ACPE-accredited training courses and programs, 
as well as technical and marketing consultation 
used for compounding customized dosage forms."

http://www.pccarx.com
Phone: 800/331-2498 or 281/933-6948  
Fax: 800/874-5760 or 281/933-6627  

9901 South Wilcrest Drive
Houston, TX 77099

See especially their link to member compounding pharmacies:
http://www.pccarx.com/links.asp

This would be the ones to survey completely, as researcher
nellie-bly-ga suggests. I have sampled some as I mentioned. A full
survey would entail significantly more time than is practical in this
context. We can find survey research firms to do it, or suggest ways
that the task could be divided up, if you find a need for it.
**************************

Spectrum Pharmacy Products
"A customer-focused manufacturer and distributor of high quality
chemicals, equipment, and supplies for compounding pharmacies and
health professionals."
http://www.spectrumrx.com/spectrumrx/
Phone: 800-791-3210 
**************************************************************************

Boston University Medical Center, Institute for Sexual Medicine
http://www.bumc.bu.edu/Departments/HomeMain.asp?DepartmentID=371
Note that this is a clinical center with expert in the field, and it
has a strong research department. They could not name anyone who is
now prescribing it or making the gel, but they do know the state of
the art in this field.
*************************************************************************

International Academy of Compounding Pharmacists
http://www.iacprx.org
P.O. Box 1365 
Sugar Land, TX 77487 

Phone: 281-933-8400
800-927-4227 
Fax: 281-495-0602 

************************************

American Urological Association
www.auanet.org
Headquarters Office
1120 North Charles Street
Baltimore, MD 21201
Voice: 410-727-1100
Fax: 410-223-4370

Since urologists are most typically the physicians who would prescribe
drugs for erectile dysfunction, this is the most relevant medical
association to inquire with. The American Medical Association, and the
American College of Physicians are two of the major general medicine
organizations that may have some information but not likely  more than
the specialists on this topic. They also serve their members primarily
and do not seem to have more information available regarding
prescribing physicians and dispensing pharmacists.


I hope that this information is of help and that I can be of further
help to you in the future.

vitalmed-ga
Comments  
Subject: Re: Tri-mix in a Gel Form, for impotence.
From: tehuti-ga on 09 Jan 2003 19:27 PST
 
I've only come across a gel with SEPA/alprostadil 
http://www.pslgroup.com/dg/2d206.htm
Subject: Re: Tri-mix in a Gel Form, for impotence.
From: vitalmed-ga on 10 Jan 2003 12:47 PST
 
I am well under way in researching this, have some key leads and have
found a patent in which such a formulation is described. It is not the
subject of the patent itself, so relevant information in that source
is limited. I believe I shall have definitive information reasonably
soon, so I appreciate if my fellow researchers bear with me.

vitalmed-ga
Subject: Re: Tri-mix in a Gel Form, for impotence.
From: czh-ga on 10 Jan 2003 14:47 PST
 
Hello panchito-ga,

See prior question on same topic.
http://answers.google.com/answers/main?cmd=threadview&id=126137

My conclusions  were that some compounding pharmacists are willing to
make up a trimix gel as long as they have a prescription from a
physician. The product is readily available as an injectible but is
not generally available as a gel. My literature review showed that
there is a lot of research going on in the field of erectile
dysfunction and many new products are in the pipeline but it's
difficult to get FDA approval.

I hope the material I posted will help you and fellow researchers to
track down the information you need.

czh
Subject: Re: Tri-mix in a Gel Form, for impotence.
From: nellie_bly-ga on 12 Jan 2003 17:36 PST
 
Probably the best approach to this problem would be to contact the
1,300 compounding pharmacists in the United States (or a sample
thereof) and query whether they have ever filled a tri-mix gel
prescription.  If so, they may be willing to supply the name of the
prescribing physician.
Subject: Re: Tri-mix in a Gel Form, for impotence.
From: vitalmed-ga on 13 Jan 2003 20:26 PST
 
Panchito,

I can report good progress. A supplier to compounding pharmacies has
informed me that many pharmacies do make this up in the gel form and
that it is common. A related trade association lists the combination
in gel form among its mixtures it has indexed and is a likely source
for further information. I shall document these for you as soon as I
can provide you the full answer to your question, which I am now
closing in on. I appreciate your patience and that of my fellow
researchers just a short while longer while I get the remaining
details for you.

Regards,

vitalmed-ga

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