Dear Mrs Wafaa ,
Dear All ,
Kindly find below news report about exobera ( the inhaled insulin )
>>>
Inhaled Insulin
Update: January 27, 2006 - The FDA has approved the first inhaled
version of insulin from Pfizer Inc. Exubera was approved for adults
with Type 1 or Type 2 diabetes but should not be taken as a
substitute for all of the insulin shots many need. It is a short-
acting powder form of insulin that can be taken before meals.
Inhaled insulin enters the bloodstream more rapidly than by
subcutaneous injection. Most diabetics will still need to get long-
acting insulin via an injection. In developing Exubera, Pfizer and
Aventis have collaborated with Nektar Therapeutics (formerly Inhale
Therapeutics), a company that specializes in finding delivery
solutions for oral, injectable and pulmonary drug administration to
create an inhaler. It weighs about 4 ounces and is about the size of
an eyeglass case when closed. It is portable, but not necessarily
discreet.
A number of side effects have been reported, including coughing,
shortness of breath, sore throat and dry mouth. Smokers are also
encouraged to avoid use of Exubera because more of the inhaled
insulin enters their bloodstream, increasing the possibility of an
overdose.
Pfizer hopes to make Exubera available sometime in the middle of the
year. The price has not been made available but it is expected to be
more expensive than current means of insulin use. This raises
concern about whether Medicare, Medicaid, and insurance policies
will cover it.
Will It Really Take Your Breath Away?
by John Walsh, P.A., C.D.E.
Inhaled insulin has finally become a possibility for the first time
since injections were introduced 75 years ago. In a breath of fresh
air to people tired of injections, results from Phase 2 trials were
presented at the June, 1998, ADA Convention in Chicago. These
studies involved 70 people with Type 1 diabetes and 51 people with
Type 2 diabetes. Researchers found blood sugar control was
equivalent when inhaled Regular insulin was compared to injected
Regular taken before each meal.
After completion of this study, 80% of Type 1s and 92% of Type 2s
elected to continue on the inhaler when offered this option.
Although press reports have puffed up this technology, some problems
are apparent.
Background
The Real Thing
Artist's Concept, 1996Different attempts have been made to capture
the $3 billion insulin and injector market. Three targets are
obvious for insulin delivery into the upper airways: the mouth, the
nose, and the lungs. (Other methods, such as alternate methods for
delivery across the skin and even suppositories have also been
attempted).
Oral delivery is limited by the acidity of the stomach and digestive
enzymes of the intestines. Two hurdles are involved: getting the
insulin molecules past stomach acidity and intestinal digestion, and
then opening the intestinal membranes to insulin transport. These
problems have stymied researchers for at least 40 years, although a
new novel approach discussed below offers some hope.
Nasal delivery into the bath towel size area of the upper airways
suffers from several problems. Poor transport across the mucous
membranes of the nose required either very large doses of insulin or
a chemical to enhance insulin transport. When insulin alone was used
to deliver 10 units into the blood, about 100 units of insulin would
be required, making costs prohibitive. Transport enhancing chemicals
create nasal irritation and rhinnorhea. And, of course, a mild cold
or stuffiness would easily alter the intended insulin dose change.
Compare this to Insulin inhaled into the lungs brings insulin
directly into the lungs where each breath brings insulin into
contact with a surface area the size of a singles tennis court.
Insulin absorption into the bloodstream occurs through the thin
alveolar wall found in the lung. This appears to be the most
promising approach for delivery at this time. There is some concern
about the effects of chronic inhalation of a growth protein into the
lungs, but the large surface area over which it is spread offers
hope.
How An Inhaler Works
Several companies are competing in this technology. Inhale
Therapeutic Systems (now Nektar) presented their clinical results at
the ADA meeting. The most critical element in delivering a drug to
the massive surface area of the lungs is to create a particle small
enough to get past the back of the throat yet large enough not be
breathed right back out of the lungs into the air.
ITS, with experience in protein delivery, was able to create a
particle containing 20% insulin with a micron size that is just
right for deep lung delivery. The contents in the other 80% of the
particle were not revealed, but are probably albumin, a common
protein in the body that would not trigger the immune system. ITS
created two dry powder blister packs, one with 9 units of insulin
per pack and a smaller one that has 3 units per pack. These can be
combined for a variety of doses in any multiple of 3.
Once the blister packs are loaded into the device, a trigger is
squeezed to disperse the insulin powder as a cloud into the clear
chamber above. A slow, deep breath then brings the finely powdered
air cloud into the lungs. Reproducibility is aided by having the
insulin as only a tiny portion of the inhaled air and placing it
near the front of the air being inhaled. Only one or two breaths is
claimed to be required for delivery.
The insulin powder appears to be stable for 6 to 24 months at room
temperature, which makes it great for travel. A separate study in 16
Type 2 patients showed consistent uptake of the powder. This latter
study involved only a small number of insulin resistant individuals
who consumed 2 Sustacal meals with the inhaler and 2 more with
injections.
Should You Hold Your Breath?
A major problem with ITS's approach at this point is their inability
to deliver more precise insulin doses. Three units of Regular
insulin would make it difficult for many to achieve excellent
control which is the real goal of insulin delivery. Using the 1800
Rule for Regular insulin, someone on 50 units of insulin per day
would drop 90 points (5 mmol) in their blood sugar per 3 unit pack,
while someone on 30 units a day would drop 180 points (10 mmol) per
pack. Precise control flies out the window with this sledge hammer
approach, especially compared to insulin pumps capable of delivering
tenths of a unit with precision.
The device is limited to Regular insulin at this time, so injections
of long-acting insulins that provide around the clock coverage of
background insulin will still be required. It is not known if
Humalog, which is one sixth the size of the Regular hexamer and has
a very different protein structure, can be delivered in the same way
for a more physiologic insulin effect. It is also surprising that
the inhaler, designed for deep lung delivery, has not been reported
to lower blood sugars faster than injected Regular, as has Aradigm's
device below.
A problem seen with inhaled asthma drugs has been poor consistency
of technique by the same individual over time. This problem may be
reduced with the inhaler which utilizes a more normal breathing
approach. The inhaler bypasses the common problem of colds and upper
respiratory infections, but may be less effective during pneumonia.
It may also work differently in those who have asthma, chronic
obstructive pulmonary disease, or who smoke.
Studies so far have been the more limited Phase 2 trials, but with
Phase 3 trials beginning more information on control feasibility and
dosage variations should become available. But the combination of an
efficient, consistent inhaler with a dry powder insulin that can be
inhaled looks very promising.
Inhale with about 150 employees in San Carlos, California, is
collaborating with Pfizer on this project. Prescription availability
could be possible near the start of the millennium. Inhale also has
research contracts involving the delivery of other peptides and
proteins with additional diabetes-directed companies like Lilly and
Baxter. Lilly is likely the supplier for its insulin but this is not
known.
Phone: (650) 354-0700 Fax: (650) 354-0701
Other Players
Aradigm Corporation of Hayward, California, has taken a similar
approach with its patented AERxTM Diabetes Management System.
Reporting on Phase 1 clinical results of four individuals during the
Chicago ADA meeting, they reported that inhaled U250 and U500
Regular insulins were absorbed much more quickly than injected
Regular using their controlled breathing device. Action times of the
inhaled Regular aerosol appear to be closer to that of Humalog than
Regular insulin. (510) 783-0100
Andaris is a privately-held company with about 70 employees in
Nottingham, England. Started in 1994, it began developing injectable
microscopic contrast agents for diagnostic tests with ultrasound. In
the process, they also developed a 5 micron hollow microcapsule of
insulin using a low temperature, spray drying technique that
preserves the insulin structure. This insulin microcapsule can be
inhaled directly into the lungs for absorption.
Noven Pharmaceuticals of Miami has developed transoral patches for
delivery of anesthetics for dental work, and for treating motion
sickness, angina and nicotine withdrawal. They are attempting to use
similar technology to transport insulin across the membranes in the
mouth. This approach faces several problems in maintaining oral
healthy membranes, preventing allergies to the adhesives used,
keeping the patch in place, and not having unwanted compounds or
viruses also cross the oral membrane.
Dr. Alessio Fasano of the University of Maryland reported on
research that might one day allow insulin pills to work. The report
in the March, 1997 Journal of Clinical Investigation (pgs. 1158-
1164), uses a protein called Zonula occludens toxin or Zot. With
Zot, researchers were able to significantly increase insulin
transport across the intestines to lower blood sugar levels to
nearly normal levels in diabetic rats. Zot is derived from Vibrio
cholera. This basic research has many hurdles to pass before
clinical trials begin, but offers an interesting approach to the
problem of protein breakdown in the stomach and intestines.
Forward-looking researchers like Gaozhong Zhu in the Pharmacology
Department at Ohio State University are also looking for responsive
delivery systems that will independently manage blood sugars.
Diabetes requires a closed loop for optimal therapy, a system that
can respond around the clock as needed in real time for control.
Such a system would be self-regulating and adjust insulin delivery
based on immediate physiologic need. Ideas for such devices are
being considered even as you read this. Stay tuned!
--- In [email protected], wafaa hanafy <[EMAIL PROTECTED]> wrote:
>
> SALAMO ALIKOM WA RAHMT ALLAH WA BARAKATOH
> MR. AHMED I WOULD LIKE TO ASK ABOUT ÇßÒæÈíÑÇ
> IT IS THE NEW MEDICATION OF DIABETES BUT IT IS INHALATION... PLS
IF U HEARD MORE ABOUT THIS MEDICINE CAN U JUST TELL ME PLS.
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