Posts Tagged ‘PharmaTechnologist’

New Weapon for Flu Pandemic: Jello Shots up Your Nose!

09/28/2007 , 10:41 AM by Alex Sicre

This article is from US – PharmaTechnologist. No real comments save I think this is pretty neat. It will definately help with flu shots, as a number of people hate needles. It could be kind of gross however, if the jelly stays to long! Everyone laughed at me in college, but I knew investing in an aloe vera farm would pay off one day!

No wobbles for jelly nasal spray vaccine
By Katrina Megget

9/27/2007 – It is not the same as jellied pig’s trotters, but a jelly nose has the ‘exciting potential’ to be the next weapon in the arsenal against pandemic flu.

Researchers at Texas A&M University, in conjunction with DelSite Biotechnologies, are working on a pandemic flu vaccine based on a powder nasal spray that forms a jelly in the nose.

While still at animal trial level, studies have so far shown the jelly substance that forms in the nose after spraying keeps the vaccine antigen in the nasal passage for longer giving the immune system a greater and prolonged stimulus.

“When this powder vaccine is puffed into the nose, it forms a jelly-like substance that clings to the inside of the nose and is absorbed into the body much more effectively. It stays longer and it has more time to do its work,” Texas A&M University College of Veterinary Medicine and Biomedical Sciences pathobiology professor Dr Ian Tizard said.

The vaccine is formulated using an undisclosed carbohydrate from the Aloe vera plant which is mixed with the vaccine component and dried together to form a powder.

On contact with the moisture of the nasal passage, the powder is reconstituted; dissolving the product and interacting with the carbohydrate to form a jelly.

“This powder form is more effective than a liquid spray because the nose tends to clear liquid sprays out, while the powder turns into a sticky gel and can be a much more potent vaccine,” Tizard said.

One or two puffs into the nose was all that was needed to get results. The length of time the jelly would stay in a human nose was currently unknown.

The unique Aloe vera carbohydrate was yet to be approved as an excipient in the vaccine, but meetings with authorities were expected next month to discuss the ingredient, Tizard told US-PharmaTechnologist.com.

The carbohydrate is extracted from the leaves of the Aloe vera through a number of extraction steps thereby removing the other beneficially therapeutic compounds the plant is famous for.

“There is no other evidence the carbohydrate has any other effect other than reducing clearance from the nose,” Tizard said.

Besides being retained in the nose for longer in the jelly form, the vaccine had other benefits Tizard said, including being a needle-free vaccine, being formulated as a dry powder which was more stable and could be stored for longer, and showing “significant dose sparing relative to other intranasal vaccines” without the use of an adjuvant.

The vaccine was currently being developed for pandemic bird flu, but Tizard said the technology could work to develop vaccines for other diseases.

“The plan was to try this first as a vaccine for bird flu in humans because there was an immediate concern there, and there still is the possibility that a widespread bird flu epidemic could break out somewhere in the world. But there is no reason to think this method of vaccine treatment would not work for many other diseases too. We think it’s an exciting breakthrough that has great potential,” Tizard said.

While the development of the vaccine was still early, tests on humans were expected to begin next year.

MedImmune has had its liquid nasal spray flu vaccine, FluMist, on the market since 2003, which was the first needle-free flu vaccine available on the market, and the company is developing a next generation nasal mist flu vaccine.

The nose jelly project is funded in part by a $6m grant from the National Institutes of Health awarded to DelSite Biotechnologies in conjunction with the Texas A&M teams.

More Problems with Skin Patches

09/05/2007 , 10:59 AM by Alex Sicre

I found this article on the website in-pharmatechnologist.com – a website I have never heard of until today. I think that the use of patches are fantastic for medication adherence, but as you can see, some have their problems. Written by Katrina Megget.

05/09/2007 – Shire and Noven Pharmaceuticals have announced the voluntary withdrawal of a limited amount of Attention Deficit Hyperactivity Disorder (ADHD) transdermal patches following reports of a mechanical problem when applying the patch.

Up to five per cent of patients reported having trouble removing the release liner from the sticky part of Daytrana (methylphenidate transdermal system) patches, which are used for the treatment of ADHD.

While the mechanics did not affect the release of the drug, Shire decided to take the “proactive step” to withdraw the product. The UK company, which has the global license for Daytrana, said in a statement the patches could continue to be used as long as they were not damaged.

Meanwhile, Noven and Shire, in the first quarter of this year, implemented enhancements to the Daytrana release liner by increasing the release coating on the liner to provide an easier removal.

The improved patches would replace those being withdrawn, which are Daytrana packages with an expiration date of March 31, 2009 or earlier, and Daytrana packages with lot numbers 2563511, 2563611, 2570411.

The withdrawal was not believed to have any affect on either Shire or Noven or on the patches’ manufacturing, Shire spokeswoman Jessica Mann told in-PharmaTechnologist.com.

The withdrawal should cost less than $10m (€7.35m), according to a report by Reuters.

Daytrana, developed and manufactured by Noven, was approved in the US by the FDA last year, and is the first and only transdermal medication approved to treat the symptoms of ADHD. It is approved for children aged six to twelve years with the disorder.

Since its approval, an estimated 700,000 patches have been sold, with last year’s sales to Shire totalling $8.6m, with $5.9m recognized in related license revenues.

At the end of July, Shire’s net sales of Daytrana exceeded $50m in the 12-months preceding June 30, 2007, triggering a $25m milestone payment to Noven.

The product is based on Noven’s proprietary DOT Matrix transdermal technology, which the company claims has significant advantages over standard patch products.

The system uses a patented multiple adhesive mix of silicone, acrylic and the required drug so that the drug is mixed in with the adhesive that holds the patch on the skin. Each patch is a thin, three-layer laminate made up of the patch backing, the drug/adhesive mix and the release liner (the part that gets peeled off and thrown away once the patch is applied).

The patches themselves are compatible with a wide range of medications, and as they deliver the drug more effectively than other competing products they tend to be smaller than other transdermal systems. In addition to this, the patches use one adhesive to hold the drug, and another to make the patch stick to the skin, resulting in superior adhesion to the skin.

The Noven transdermal system is already in use in other products beyond Shire’s ADHD patch, including DentiPatch (a transmucosal patch for dental pain), Vivelle-Dot (the world’s smallest transdermal estrogen patch), and a number of other hormone therapy patches.

In June, Shire acquired development rights to a new transdermal patch product for ADHD, using amphetamine, after Shire and Noven decided to proceed with clinical development of the patch.

According to Noven, amphetamine products represent about half the US market for stimulant ADHD therapies, and a patch product could bring significant advantages to patients and enhance compliance.