Advil Vs. NanoVilSolubility/Bioavailability

A new Nanomedicine Technology Platform

For Ibuprofen

AdvilNanoAdvil

Nano Advil LLc. has the capability to use our own proprietary nano-technology platform to make an inventory of nano-technology based consumer products that will provide any Pharmaceutical company with a major advantage in the market place. In addition, we are looking to partner with an established Pharmaceutical company to propose solutions and create a suite of patented OTC and Rx products in line with our nano-technology competency and expertise.

NanoAdvil

Dr. Mewa Singh

Dr. Mewa Singh has 18 years of experience in product development in the field of biotechnology. He is currently working on a process for discovery of new nano-medicines in various therapeutic areas. Dr. Mewa is specialized in various fields including new labs setup, manufacture of biopharmaceuticals and project management / leadership associated with product development. He has already delivered 23 products in the biopharmaceutical market including a nano-medicine for arthritis, Neisseria meningitides vaccine, and a compound formulated to treat acid reflux.

Principals

WHO Report• Based on the Biopharmaceutics Classification System (BCS), about 30% of the

drugs that are currently on the World Health Organization (WHO) Essential Drug List are reported to be poorly water-soluble and need to be improved.

• Over 40% of newly developed pharmaceutically active substances have solubility

issues and are looking for a technology to improve their clinical development.

• The poor dissolution and/or permeability of these drugs often result in low and

highly variable bioavailability.

• The major obstacle to successful commercialization or improvement of

these compounds is the difficulty of enhancing their dissolution rate and extent of dissolution.

• Advil (Ibuprofen) is one of those compounds that attracted our attention towards improvement of the dissolution rate.

What is new It will provide more than a nano-medicine

• New concept and new approach• Two active molecules have never been used before to develop a nano-

medicine. • A hybrid nano-medicine has never been developed until now.• An active molecule to developed a water soluble drug formulation has never

been used until now• Two water insoluble drugs have never been used before to developed a water

soluble formulation, at least without changing the chemistry• Chemistry of individual drugs remains unchanged• But IT IS NOT JUST SOLUBILITY; IT IS A BETTER TREATMENT

Problems, Challenges and OpportunitiesIbuprofen (advil etc.) is one of the most commonly used pain relievers due to its effectiveness and high tolerability in doses of 200 mg and 400 mg. Based on the amounts of ibuprofen produced globally, a consumption of around 30 billion tablets per year can be assumed. The available dosage forms mostly contain ibuprofen in the acid form in view of the lower costs . Ibuprofen, however, has a poor and highly pH-dependent solubility. As the solubility increases above a pH of 6.5, the active ingredient is dissolved and absorbed only in the intestinal tract but not in the stomach. Depending on the pH conditions in the intestinal tract, absorption may be further delayed due to physiological reasons. This is confirmed by numerous blood level tests which show a maximum blood level 1.5 to 2 hours after ingestion. This delay is a great disadvantage because patients expect a fast onset of the analgesic effect when taking a pain reliever and tend to unnecessarily raise the dosage when the effect is delayed.A clear improvement was, however, achieved through the use of ibuprofen salts with good water solubility such as ibuprofen lysinate, ibuprofen arginate and ibuprofen sodium salt. The distinct acceleration of absorption is astounding, since the ibuprofen salts are usually released under acidic conditions in the stomach which leads to precipitation of ibuprofen.

Our NanoAdil has all the requirements to have an optimal IBUPROFEN.

Results are shown in the following sections.MOST IMPORTANT IS THAT WE KEEP THE ORIGINAL MOLECULE INTACT

Nano IbuprofenTons of Raw MaterialReady to Formulate

Multiple Batches of Nano Ibuprofen

Advil and NanoVil

AdvilAdvil NanoAdil

NanoVil

Dry Crystal Structure

Advil Nanovil

Advil Solubility in water

After 1 minute After 5 minute

After 30 minute After 15 minute

After 10 minute

Comparative Solubility in water

NanoVil solubility after One minute Advil solubility after One minute

Solubility

Advil

NanoVil

Solubility After 3 hours

AdvilNanoVil

NanoAdvil

Resolved acidic environment(pH2.3) precipitation of Ibuprofen

• Our NanoVil beat the problem of all ibuprofen formulations and added value in fast relief of pain and fever, independent of pH in all parts of the system.

IbuprofenIn pH2.3

NanoVil

Solubility in water

0

0.5

1

1.5

2

2.5

Solubility in water

Series3Series2Series1Axis Title

0

0.2

0.4

0.6

0.8

1

1.2

1.4

Series1

Nano 5mg/ml

Advil 20mg/ml

Ibuprofen salt 20mg/ml

0.32mg/ml

0.64mg/ml

1.25mg/ml 2.5mg/ml

5mg/ml

Ibuprofen curve in ethanol

5 10 20 30 Time

So What ?!

Size and solubility dictates Bioavailability, Efficacy and Safety

Next Generation Only with us

Old equation of Nanomedicine

Hybrid Nanoengineering™

Double edge swordIncrease effectLess side effectEnhanced compatibility

New equation of Nanomedicine

Key Players:American Pharmaceutical PartnersCritiTech Novax Inc RTP Pharma Sheffield PharmaceuticalsNanosphereEiffel TechnologiesBiosante PharmaceuticalsAdvectus Life SciencesCopernicus Therapeutics

One Player : Us

Conclusion

• Preliminary in vitro data show that NanoVil is a superior fast release, improved NSAID formulation of Ibuprofen compared with some brands.

• We suggest joint collaboration with GAP, LLC to proceed with in-vitro and in-vivo trials with NanoVil.

• Furthermore, we suggest joint collaboration to allow us to introduce the platform of our technology to explore further opportunities for use of fast release improved bioavailability technology with other OTC/Rx drugs in your portfolio.

Established For NanoAdvil• Three pilot scale batches of 5 kg each have been processed to establish

batch-to batch consistency.• Stability established.• Drug release at different pH established.• Formulation established.• Raw material vendors established• Manufacturing SOPs established.

Double edge action Of our Nano :

ILs and inflammations

What next

• Needed a partner for product development through bioequivalent and FDA approvals.

• Needed a strong marketing partner.

Nano science and technology are advancing quickly; therefore, the status of nano technology commercialization is rapidly changing. Meda Biotech LLC believes that a successful development program using this technology is possible, but it will require an open and honest collaborative relationship with a partner and with a clear understanding of the goals. 

We are looking forward to a joint development program with a major partner that will bring ideas, compatibility, aligned interests, complementary experience and skills. The ideal partner would be an industry leader who will give us the opportunity to apply our novel nanotechnology to provide innovative new products to consumers and patients.

You can contact us to discuss ways to work together to pursue current and/or future development opportunities using our new nanotechnology.

Proposal: Joint Development Program

Questions?

Please contact Mewa Singh PhD via:

mewasinghsandhu@hotmail.com

www.nanomeda.com

Tele#: 609-902-7128