2. 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
3. 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
4. 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.
5. 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
6. Problems, Challenges and Opportunities
Ibuprofen (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
15. 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.
Ibuprofen
In pH2.3
NanoVil
16. Solubility in water
0
0.5
1
1.5
2
2.5
AxisTitle
Solubility in water
Series3
Series2
Series1
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
17. So What ?!
Size and solubility dictates
Bioavailability, Efficacy and Safety
18. Next Generation Only with us
Old equation of Nanomedicine
Hybrid Nanoengineering™
Double edge sword
Increase effect
Less side effect
Enhanced compatibility
New equation of Nanomedicine
Key Players:
American Pharmaceutical
Partners
CritiTech
Novax Inc
RTP Pharma
Sheffield Pharmaceuticals
Nanosphere
Eiffel Technologies
Biosante Pharmaceuticals
Advectus Life Sciences
Copernicus Therapeutics
One Player : Us
19. 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.
20. 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.
22. What next
• Needed a partner for product development
through bioequivalent and FDA approvals.
• Needed a strong marketing partner.
23. 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