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Q: Need in bulk: medical-grade butyl cyanoacrylate ("Super Glue" for wounds) ( No Answer,   1 Comment )
Question  
Subject: Need in bulk: medical-grade butyl cyanoacrylate ("Super Glue" for wounds)
Category: Health
Asked by: vortex-ga
List Price: $200.00
Posted: 17 Sep 2002 22:36 PDT
Expires: 21 Oct 2002 16:56 PDT
Question ID: 66299
I’m looking to buy a chemical variant of “Super Glue”: 
N-2-butylcyanoacrylate, sometimes called simply butyl 
cyanoacrylate or butylcyanoacrylate. (I'm not currently
interested in variants such as octyl cyanoacrylate.)
I intend to use it in a medical device, so it must be
of medical grade. The glue is used to close wounds,
instead of stitches. (It is typically applied with a
device similar to a medicine dropper, but I’m looking
for just the liquid.) 
 
Here’s an example of the glue in use as Histoacryl, a 
product made by Germany’s Aesculap, a division of 
B. Braun: 
 
  http://www.tmml.com/english/prod_layout.asp?prod=163 
 
However, the quantity of glue in each of these Aesculap 
units is too small for my purposes. I need to have the glue 
in quantities of half of a liter or more. I even phoned  
Aesculap in Germany about buying the glue in larger 
containers, but they don’t sell it like that. 
 
Ideally, I would locate a supplier in the U.S., but I could 
order from a Canadian or European or even Asian supplier who 
would ship to my U.S. address or to my Canadian address. 
The glue is used medically more widely in Canada and Europe 
than in the U.S.
 
P.S. I had previously posted this question at a lower price,
without an answer. As far I can see, Google Answers doesn't
have a mechanism by which a question can be repriced upward,
so I cancelled the original and created this $200 version.
But was there a way to both retain and reprice the original
question?

Request for Question Clarification by slawek-ga on 18 Sep 2002 10:30 PDT
Good Day,

Are you looking to use the glue on human or animal tissue?  The FDA
has not approved the product for use on humans, although it is used by
vets.  Going through the trouble to find it might be worthless if you
are not a vet.

I got this information by phoning World Precision Instruments which
sells the butyl c.  They, as the suppliers you found, only sell in
small quantities (3ml droppers).

Regards,
Slawek
Answer  
There is no answer at this time.

The following answer was rejected by the asker (they received a refund for the question).
Subject: Re: Need in bulk: medical-grade butyl cyanoacrylate ("Super Glue" for wounds)
Answered By: lot-ga on 18 Sep 2002 21:27 PDT
Rated:2 out of 5 stars
 
Hello vortex-ga

There appears to be a few forms for n-2-butylcyanoacrylate, known also
as histoacryl blue, HAB, n-BCA Glustitch™, Periacryl™, (dental
version) Liquid Bandage™ (weaker solution for bandage use) VetGlu™
(veterinary use) nexacryl™ (Cohesive product for treatment of
lacerations and perforations of the cornea) and LiquiBand®

I located this excerpt which highlights the fact GluStitch is a brand
name:
"Dallas - N-2-butylcyanoacrylate glue (GluStitch) is a useful
substitute for cuticular sutures in facial surgery, John W. Skouge,
M.D., said at the joint meeting of the American Society of
Dermatologic Surgery and the American College of Mohs Micrographic
Surgery and Cutaneous Oncology...
- GluStitch is marketed in a preloaded 0.2-mL single use applicator
and in 1 mL and 5 mL multiuse containers that come with pipettes and
autoclavable administration trays. The cost per use for these
different packaging units ranges from about $1 to $7, Dr. Skouge
noted.
- GluStitch is produced by GluStitch, Inc., Vancouver. It is approved
by the FDA only for use on intact skin as a protectant. Dr. Skouge has
no financial interest in this product. DT"
- from "'Super glue' replaces sutures - N-2-butylcyanoacrylate
cost-effective as epidermal closure substitute" Nov 1, 2001 by Cheryl
Guttman Dermatology Times
http://www.dermatologytimes.com/dermatologytimes/article/articleDetail.jsp?id=4114

Here is the technical specification at GluStitch for Butyl
Cyanoacrylate
http://www.glustitch.com/msds_us.asp

GluStitch ( http://www.glustitch.com ) has two websites, a Canadian
and U.S. one. On the U.S. site (
http://www.glustitch.com/products_us.asp ) I didn't see butyl
cyanoacrylate available in the product section, but it is featured on
the Canadian site ( http://www.glustitch.com/products.asp ) The
largest off the shelf size is 5ml presumably as a medical product this
reduces contamination as limited use vessels are designed to be
discarded.

I emailed GluStitch asking if they can supply bulk quantities of
liquid in half liters or more, and the president promptly responded:
"We might consider supplying your customer depending upon the
circumstances. If they are interested in entering the market in the
United States in the areas of dentistry or wound closure, we would not
consider this. If they were interested in bulk n-butyl cyanoacryate
for some other purpose, or in some country where this would not be an
issue, perhaps we might consider supplying.
Regards,
Don Blacklock, President, GluStitch inc."

Your Canadian address 'may' assist arrangements with more flexiblility
in this situation. If you contact them (
http://www.glustitch.com/contactus_us.asp ) it would help if you
indicate quantity, usage, territory so they can evaluate your position
and cost appropriately.

I did a search at FDA and it appears butyl cyanoacrylate is still
subject to approval for topical skin closure, hence why it is not in
the product section of the GluStitch website. Though it has been
approved for certain usage e.g. as a skin protectant (bandage)
blocking blood flow in malformed brain vessels
http://www.fda.gov/cdrh/mda/docs/p990040.html
Excerpt
"The n-butyl formulation named NEXACRYL has undergone clinical study
and is the subject of an approvable PMA for its intended use in
ophthalmology as a protective sealant for corneal and scleral
perforations"
FOOD AND DRUG ADMINISTRATION, CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH GENERAL AND PLASTIC SURGERY DEVICES PANEL Jan 30, 1998
http://fdagov.google.com/fdagov?client=fdagov&q=cache%3Ahttp%3A%2F%2Fwww%2Efda%2Egov%2Fohrms%2Fdockets%2Fac%2F98%2Ftranscpt%2F3371t2%2Ertf+histoacryl%20

GluStitch's 2 octyl cynoacrylate product has FDA approval 510(k) NO:
K013446 for dental use and presumably their other American products
are approved.

Medlogic announced:
" MedLogic Global Corporation, a developer, manufacturer and marketer
of bio-medical adhesives, announced that the Food & Drug
Administration (FDA) has approved its investigational device exemption
(IDE) application for a clinical study of LiquiBand®, the Company’s
topical wound closure glue. LiquiBand®, an n-butyl cyanoacrylate-based
adhesive, is a sterile, clear liquid skin adhesive used in place of
sutures, staples or other traditional closures in the treatment of
external cuts and wounds...
..We are pleased to be working closely with the FDA as we progress
towards bringing LiquiBand® and other innovative MedLogic products to
market."
"MedLogic Global Corporation Receives FDA Approval of IDE to Study its
Topical Skin Adhesive for Use in Place of Sutures" Colorado Springs,
CO - 06/15/2000
http://www.medlogic.com/fdaprovalide.htm

Melogic product range which shows that Liquiband has no U.S. release
yet.
http://www.medlogic.com/products.htm

An Indian Pharmaceutical company Shree Ganesh manufacture
http://www.sgpharma.com/company/mainexplist.htm
In the category "Generics,  & Others" list 'N-Butyl Cyanoacrylate
Inj.' as one of the products they export. (I've emailed them to see if
they can supply in bulk)

I also asked a pharmaceutical friend who works as a buyer in the
industry,
who referred me to William Ransom in the UK 
http://www.williamransom.com who 'mix on demand'. 
Though you need to prove you have good use for it, and lead times are
fairly long around 3 weeks.  (
http://www.williamransom.com/Frames/contractframe.htm )
"Liquid Preparations - using our modern, purpose built factory, Ransom
has the facilities to produce a wide range of liquid pharmaceuticals
including syrups, suspensions, lotions and solutions in batches of up
to 6600 litres. We have the ability to handle flammable and hazardous
solvents, and other difficult products.
Packaging Options - from 1000 litre pallecons, through 25 litre poly
containers to labelled and cartoned OTC bottles, we can deliver your
product in the most appropriate pack for your requirements."

He also recommended Thornton Ross in the UK who formulate and supply
http://www.thorntonross.com
"At Thornton & Ross we are particularly skilled at handling a wide
range of products, packs and batch sizes. We produce a wide portfolio
of licensed pharmaceuticals including solutions, suspensions,
semi-solids, suppositories and powders for both over-the-counter and
prescription use. Quality Assurance is ensured by our large specialist
team in well equipped quality control laboratories with facilities for
both chemical and microbiological testing on site.
Our contract manufacturing, joint ventures and private label contracts
are with national and international companies and currently include
Boots the Chemists, Mars Confectionery, GEHE and Alliance Unichem."
Though I haven't verified if they both can produce
N-2-butylcyanoacrylate, as it is currently out of office hours. There
may also be licensing issues involved.

Search Strategy:
butylcyanoacrylate
http://google.yahoo.com/bin/query?p=butylcyanoacrylate&hc=0&hs=0
glustitch
://www.google.com/search?hl=en&ie=ISO-8859-1&q=glustitch&btnG=Google+Search
"N-2-butylcyanoacrylate"
://www.google.com/search?hl=en&ie=ISO-8859-1&q=%22N-2-butylcyanoacrylate%22&btnG=Google+Search
butylcyanoacrylate
http://www.alltheweb.com/search?cat=web&cs=iso-8859-1&l=any&q=butylcyanoacrylate
"butyl cyanoacrylate" license
://www.google.com/search?hl=en&lr=&ie=ISO-8859-1&newwindow=1&q=%22butyl+cyanoacrylate%22+license&btnG=Google+Search
iBrowse.co.uk > /Business/E-Commerce/Marketplaces/Chemicals
http://www.ibrowse.co.uk/directory_root.php?browse=/Business/E-Commerce/Marketplaces/Chemicals/
butyl cyanoacrylate
http://www.alltheweb.com/search?q=butyl+cyanoacrylate&c=web&cs=iso-8859-1&o=10&l=any&cn=2

If you need clarification on the answer just ask,
kind regards
lot-ga

Clarification of Answer by lot-ga on 19 Sep 2002 16:52 PDT
Status: Still waiting on some emails from Medlogic, Shree Ganesh,
William Ransom and Thornton Ross.
regards lot-ga

Clarification of Answer by lot-ga on 26 Sep 2002 07:23 PDT
Hello vortex-ga,

Unfortunately William Ransom and Thornton Ross do not deal with butyl
cyanoacrylate. 

Medlogic ( http://www.medlogic.com/contactus.htm ) are willing to
supply (subject to certain criteria), as I received the following
response from the Managing Director:
"We could supply material in bulk subject to understanding final sale
point
and if it did not conflict with any current agreements we have in
place.
best regards"

I emailed again the other Indian lead, Shree Ganesh, but still have no
feedback. There might be a language barrier in the interpretation of
the emails.

However, I hope the Medlogic and GluStitch responses, from the
Managing Director and President respectively, are satisfactory for you
to initiate acquiring bulk quantities for your purposes (subject to
their supply terms) for  your Canadian address.

Kind regards
lot-ga
Reason this answer was rejected by vortex-ga:
I think that the researcher gave it a good shot.
However, because I intend to use the adhesive in
to make a human wound closure product to be sold
in the U.S., neither of the two companies mentioned
as good leads in the answer -- GluStitch & Medlogic
-- was willing to supply me with the adhesive. (This
is understandable, since both of them market finished
products for this purpose in the U.S., and therefore
aren't willing to abet a competitor's entry into the
market.) My Canadian address would have been for the
receiving of materials only; I intend to manufacture
and sell in the United States.
vortex-ga rated this answer:2 out of 5 stars
Pending

Comments  
Subject: Re: Need in bulk: medical-grade butyl cyanoacrylate ("Super Glue" for wounds)
From: voila-ga on 19 Sep 2002 15:52 PDT
 
http://www.chemindustry.com

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