Present Your Delivery Technology as Part of Our Inaugural Drug Development and Delivery Consortium!

Are you a young life science technology company with a technology that could be a game-changer for the pharmaceutical industry?

Do you seek a forum to present your technology to the pharmaceutical companies you would normally only dream of meeting in the hope of partnering to develop your product further?

The Drug Development and Delivery Consortium helps makes these partnerships happen. It is a full day presentation and networking event that highlights cutting edge commercial life science centered innovation and technologies for a big Pharma audience. D3's mission is to provide a spotlight where startups with promising products can present to the pharmaceutical companies they would otherwise not get to meet. Presenting companies will not only be guaranteed private meeting time with pharmaceutical executives, but will have extended networking time with all D3 attendees.

Included in the cost of presenting, companies will receive a two-day pass to the 16th Annual Drug Delivery Partnerships meeting, the largest global drug delivery event where you uncover NEW partners, NEW drug delivery technologies, and NEW formulation development strategies to accelerate drugs to market and lengthen lifecycles for long term profitability.

We invite you to submit an application to be a part of this one of a kind, pharma driven event. Be among the spotlighted innovators. APPLY NOW to present your technologies.

As a reader of The Drug Delivery Blog, you get a 25% discount off the standard rate when using code XP1778BLOG. If you have any questions about the agenda or event, please contact Jennifer Pereira at jpereira@iirusa.com.

Drug Delivery Partnerships TV: An Interview with Dean Kamen - Part 4

This week, we conclude  Marc Dresner's interview with Dean Kamen from DDP 2011.  In this final segment, Dean Kamen discusses his FIRST (For Inspiration and Recognition of Science and Technology) organization.  It's goal is to champion science and technology to today's youth.  They position science and technology in the ways we see sports and entertainment now, but encourage thinking and problem solving to change the culture of this country to the innovation spirit that we once had.




How important is it for Pharma to work with organizations like First to foster the innovative culture with the children of today?

Circadian rhythms and the role of time-delayed controlled release systems

Today's guest post come from Dr Vivekanand Bhardwaj.

The effects of circadian rhythms on the body are quite fascinating, and are yet to be fully incorporated into dosage form design. Conventional extended release systems can be applied to many conditions where symptoms exhibit a circadian pattern. However, they may also deliver drug when the patient doesn’t need it. This presents an opportunity for the development of more sophisticated, reliable chronopharmaceuticals, which are synchronised with the appearance of these symptoms.

What exactly are circadian rhythms and how do they affect therapeutic needs?

Derived from the Latin circa (‘around’) and dies (‘day’), the term “circadian cycle” refers to a 24 hour rhythmical activity cycle exhibited by many organisms. It explains why certain tasks are more difficult during the afternoon, when you may not be feeling at your most alert. But there are also much wider implications, particularly in the occurrence of disease symptoms. For example, congestive heart failure and asthma symptoms worsen during the night, sudden cardiac death, rheumatoid pain and cold and flu symptoms are all more prevalent in the early hours of the morning, while stomach acid and cholesterol production tend to increase in the evening.1,2

How can pharmaceuticals be designed to address this?

To address this requires the development of reliable time-delayed systems, capable of delivering the drug only when patients need it, for example during the night when they are asleep. The system should allow for variable release profiles (e.g. single pulsed release or multiple pulses with controllable time lags), yet should be practical, commercially viable and scalable for mass manufacture.

Drug Delivery International (DDi) has developed formulations that meet these requirements in several therapeutic areas. These time-delayed tablets employ a unique method to prevent drug release for a pre-determined duration after administration. In one example, if taken before bed, this would prevent reawakening for those who suffer from sleep maintenance insomnia. Another example is a pain relief system which delivers two pulses of drug, one immediately post-dose, and one when the patient is likely to be waking up the next morning, potentially allowing those who suffer from pain and stiffness related to rheumatoid arthritis to get to sleep and wake up pain free as well. The pulsed release properties of these formulations have been demonstrated in clinical studies.

This technology can be used to incorporate almost any drug type, and as the effects of circadian rhythms become more widely appreciated, such time-delayed solutions will become necessities in optimising therapy for patients.

For further information on the design and development of time-delayed formulations, visit www.drugdeliveryinternational.com


1. Smolensky and Peppas, Advanced Drug Delivery Reviews 59 (2007) 828–851.
2. Smolensky, Lemmer and Reinberg, Advanced Drug Delivery Reviews 59 (2007) 852–882.

A New Nasal Delivery Method For the Masses?

Could this simple new nasal technology become more popular than the conventional nasal spray pump and even invasive injectibles for the delivery of numerous medications? The inventor says yes, mainly since the device has the natural ability to increase nasal residence time of a given medication or agent to such a large extent. It is well known that medications sprayed into the nasal cavity via conventional methods are rapidly cleared from the nasal cavity into the digestive tract where up to 90% of the medication is un-absorbed and wasted. This is highly inefficient and toxic to the digestive tract. Instead, this technology physically would hold a given medication or agent in place against the nasal mucosa for hours at a time. The inventor suggests the rate of delivery can be controlled in various ways and that it's elementary that this approach will allow for reduced dose size with increased drug bio-absorption. The technology also promises a number of other key safety and efficiency benefits.

Since the device does the opposite of 'flooding' medications into the body, such as with injections and the common spray technologies, it can offer less risk to the patient. With vaccines and other pharmaceuticals, the technology would slowly administer these powerful medications over a much longer period of time. Thus, if there were any indications in the patient that the medication was causing irritation or an adverse reaction, further drug flow could instantly be halted in contrast to present technology. "With vaccines, why have your child play a game of roulette", says the inventor.

The technology offers applications as a general medical disposable using anti-microbial compounds like nano-colloidal silver or (CHG) that healthcare staff could arm themselves with in the healthcare environment. The FDA has classified the technology as a non-medical device exempt from regulation and the inventor is seeking U.S. partners in the medical field.

For more information visit the product website www.nasalinsert.com and contact Mr. Dave Foggia, also the author of this post.

Do biofuel cells have the potential to be the next big drug delivery device?

Many of today's problems faced by today's pace makers and other implants is that they require a battery for power.  Once that battery runs out, the patient has to go back into surgery to replace it with another.  BBC News reports that Joseph Fourier University of Grenoble has found a way to fuel cells by materials abundant in the blood stream - oxygen and glucose.  These biofuel cells can power those medical implants and also be a valuable tool in delivering drugs into the system.

According to the report, this is how it worked as implanted in a rat recently:
Their system is surprisingly straightforward. The electrodes are made by compressing a paste of carbon nanotubes mixed with glucose oxidase for one electrode, and glucose and polyphenol oxidase for the other.

The electrodes have a platinum wire inserted in them to carry the current to the circuit. Then the electrodes are wrapped in a special material that prevents any nanotubes or enzymes from escaping into the body.

Finally, the whole package is wrapped in a mesh that protects the electrodes from the body's immune system, while still allowing the free flow of glucose and oxygen to the electrodes. The whole package is then implanted in the rat.


At this year's Drug Delivery Partnerships event, Valeo Partners and Boehringer Ingelheim will be on hand to discuss innovative new strategies for biotech and Pharma to capitalize on opportunities such as the biofuel cell. For more information on this presentation and the entire Drug Delivery Partnerships agenda, download the brochure here.

What are some of the key advantages of having a drug delivery method that are self-powering through their enviornment?

Drug Delivery Partnerships TV: An Interview with Dean Kamen - Part 3

This week, we continue with Marc Dresner's interview with Dean Kamen at DDP 2011.  This week, Kamen looks at the heros today's youth look up to and why.  He points out that the children growing up today have sports stars and celebrities to focus on as a result of the wealth that previous innovation has brought the United States.  The education system has remained largely unchanged.  So how is he giving children their own innovation rock stars to look up to?

Could nanorobots be the next big breakthrough in drug delivery?

A team of researchers at the University of Texas at Dallas has devised an artificial muscle that make up a yarn of carbon nanotubes can rotate and propel tiny articles in the blood system.  According to The Engineer, the yarn is activated by a soak in a salt solution, and the deformation of the yarns are directly related to the number of ions inserted.

John Madden, of the UBC Department of Electrical and Computer Engineering, stated:
‘What’s amazing is that these barely visible yarns composed of fibres 10,000 times thinner than a human hair can move and rapidly rotate objects 2,000 times their own weight. This new generation of artificial muscles — which are simple and inexpensive to make — could be used to make tiny valves, positioners, pumps, stirrers and flagella for use in drug discovery, precision assembly and perhaps even to propel tiny objects inside the bloodstream.’

Here's a video demonstration of how this would work:





At Drug Delivery Partnerships 2012, there will be a half day symposium entitled "Nanotechnology and RNAi Use for Drug Formulation and Delivery: How Do We Move Closer to Success?". Thomas Landh, Director, Strategy and Sourcing, Diabetes Research Unit, Novo Nordisk and Mahesh Chaubal, Sr. Director, Drug Development, Medical Products, Baxter Healthcare will cover various aspects of drug delivery in the nano-partical form. For more information on this session and the entire agenda, download the brochure here.

The FDA vows to encourage innovation instead of hinder it

Image Source: FDA

In yesterday's DDP TV post, one of the main themes was how Dean Kamen faced a constant challenge of having the FDA approve many of his high-tech prosthetic limbs which could better the lives of our service men coming from the war in the Middle East.

FDA Commissioner Margaret Hamburg recently addressed this by vowing to make the pathway for new medical devices and technologies clearer.  To help, the FDA has begun to partner with the US Small Business Administration, working with entrepreneurs from start to finish so that they understand the the regulatory process of the FDA. The Venture Capitol Dispatch states there is also a new FDA commissioner to oversee the regulatory processes for drugs, biologics and cell-based therapies.

Do you think these new steps by the FDA will help the approval process for new drug delivery technologies?

Drug Delivery Partnerships TV: An Interview with Dean Kamen - Part 2

This week, we continue with Marc Dresner's interview with Dean Kamen at DDP 2011.  This week, Dean discusses how DEKA was tasked with the challenge to create prosthetic arm for service men who had lost their limbs in Iraq.  The government wanted an arm that could pick up a grape from the table and move it to the mouth without crushing the grape.  However, since the success of this invention, they've been challenged with the policies that are in place tho regulate the industry.



Kamen states that his company moves at the speed of technology, not regulation.  Should the government make exceptions in cases like this as well?

See Who Is Speaking at the 16th Annual Drug Delivery Partnerships

Who can you hear from at this year’s Drug Delivery Partnerships event taking place January 25-27, 2011? DDP is where you hear from 80+ senior level speakers, including 40+ NEW speakers.


You will hear from:

• Mark McClellan, Director, ENGLEBERG CENTER FOR HEALTHCARE REFORM, BROOKINGS INSTITUTE,
• G. Steven Burrill, CEO, BURRILL & COMPANY
• Marc Koska, Inventor and Award Winning Humanitarian
• David Nicholson, SVP and Head, Worldwide Licensing & Knowledge Management, MERCK
• John Baldoni, SVP, Platform Technology & Science, GLAXOSMITHKLINE
• Christopher Seaton, SVP, Global Licensing, BAYER PHARMACEUTICALS
• Uros Urleb, Chief Scientific Officer, SANDOZ INTERNATIONAL GMBH
• Chris Jones, VP and Global Head, Pharmaceutical Development, ASTRAZENECA
• Michael Kaufman, VP, Pharmaceutical Sciences, MILLENNIUM PHARMACUETICALS
• Sesha Neervannan , VP, Pharmaceutical Development, ALLERGAN

To find out about what these speakers will be presenting about, and the rest of the agenda, download the brochure.

As a reader of the Drug Delivery Partnerships blog, you get a 25% discount off the standard rate when using code XP1778BLOG. If you have any questions about the agenda or event, please contact Jennifer Pereira at jpereira@iirusa.com.

Scintigraphic imaging -- visualising the behaviour of drug delivery systems in man

by Vicki Ronaldson

Strategic formulation development requires reliable early stage in vivo data. Traditional early phase trials on new formulations provide pharmacokinetic data on the drug – but how do we know what the formulation is doing once inside the body? When do oral formulations empty from the stomach? When and in which precise area of the GI tract do they start to break up and what effect does food have on their performance?

Scintigraphy is used to answer all these questions and many more. It is a nuclear imaging technique that allows non-invasive in vivo assessment of the behaviour of oral, nasal, pulmonary and ophthalmic dosage forms, as well as gastric emptying of food.

How does it work?

Formulations are radiolabelled with a low dose of a gamma emitter (commonly 99mTc or 111In) and sequential images of the volunteer or patient are acquired with a gamma camera, allowing visualisation of the dispersion of the radiolabelled formulation in vivo. Prior to the clinical phase, in vitro testing is carried out in order to determine the optimal radiolabelling method for the dosage form in question. This may involve USP dissolution testing, in the case of oral dosage forms, to confirm that the labelling procedure doesn’t alter the physical properties of the system.


What information does it provide?

The radioactive counts within a particular region of interest can be recorded over sequential images, allowing quantification of thedispersion of the radiolabel. The graph below shows quantification of gastric emptying of a radiolabelled meal.

What makes scintigraphy even more powerful is that it can be conducted in parallel with blood sampling to facilitate correlation of PK data with formulation behaviour. The PK data can be interpreted more fully when accompanied by evidence of where the dosage form was located at a given moment and whether it underwent any physical change.

Why is this useful?

The data produced from clinical scintigraphic studies allows informed decision making at the crucial early stages of the formulation development pipeline, as well as supporting claims on formulation performance for marketing or regulatory purposes. Scintigraphy can be used to test the performance of drug delivery systems without the need to incorporate an API. Being able to see how the formulation behaves in the body allows go-no go decisions to be made at an early stage, saving money and reducing the time to market for successful drug delivery systems.

For further information on scintigraphic imaging of drug delivery systems, visit www.bio-images.co.uk

Drug Delivery Partnerships TV: An Interview with Dean Kamen

Last year, DDP's Marc Dresner was on site to sit down with a few of the key speakers from DDP's 2011 event. Leading up to the 2011 event, we'll be releasing segments to the interviews weekly.  This week, we begin with Dean Kamen.  In this week's segment Dean looks at how a company like Coca Cola could become one of the biggest healthcare companies in the world because they have a bigger global distribution than any Pharmaceutical company.  If Kamen's DEKA Research and Coca Cola combine, could it be possible to deliver clean water to nearly the entire world's population?




Come back next week for DDP's second part of Marc Dresner's interview with Dean Kamen.