2. What’s in the name and logo.?
AT A GLANCE
“Aizant” is derived from the name “Aizan”, Caribbean goddess of healing
Arrow head represents GROWTH
Bird in flight signifies FREEDOM
Four circular walls – four values
Innovation, People, Learning
and Quality
Blue arc – our POSITIVE attitude
Our logo – GLOBAL experience and standards
CONFIDENTIAL 2
3. Vision and Mission
AIZANT DRUG RESEARCH SOLUTIONS PVT LTD
So Little Done, So Much To Do - Cecil Rhodes
Aizant Vision
To be a global leader for science based integrated drug development solutions
Our Mission
Pursuit of excellence through science and technology
Agile team with open communication and honoring deliverables
Environmentally and socially responsible research
Aizant Core Values
Innovation
People
Learning
Quality
CONFIDENTIAL 3
4. Overview
Overview
AT A GLANCE
Established by individuals with global pharmaceutical industry experience
(USA/India/Europe/Australia)
No. of Employees: 290+ full time
Close to 90% of staff dedicated to pursuing career in R&D
16 Ph.D’s (current and pursuing), 3 physicians & 60 Master’s degree holders
Core competencies
◦ Dosage form development
◦ cGMP scale-up and clinical supplies
◦ Clinical Research
◦ Bioanalytical
CONFIDENTIAL 4
5. CONTENT
Overview
Technology Evolution
Opportunities
Market Potential
Current Scenario
Future Trends
QbD in Controlled Release Technology
Indian Scenario
5
6. OVERVIEW
Controlled Release Technology- What, Why & How ?
Delivery of drug at a predetermined rate for an extended period of time while
maintaining blood concentration within therapeutic limits .
Drug Delivery Technology
V
A
L
Enable
New Drug New Drug U
+
• NME
+
New DDS
E
Proven DDS
&
Enhance
R
Proven Drug Proven Drug
+ + I
• LCMs
New DDS Proven DDS S
K
6
7. OVERVIEW
Controlled Release Technology- What, Why & How ?
Meet Clinical Patent/Exclu
sivity Competitive
Reduce Side needs
advantage
Effect
Market
Optimize Pk
Scintific Strategic Penetration
Profile
New brand
Delivery by
Conventional route Improve New Patient
Compliance population
7
12. OPPORTUNITIES
Regulatory
FDA Approvals : NCE Vs Reformulation 1.NCE like status with minimal R&D
REFORMULATION NCE
77
expense (2% of NCE Research) .
75
73
69 2.Minimal regulatory risk ( Pk / PD
64
55 goals are well defined.
49 50
3.New indication accessed through
31
505 (b) 2 route increase increases
25 26
21
18 18
patient pool.
17 16
4.Low cost clinical study Clinical end
point – typically bioavailability &
2002 2003 2004 2005 2006 2007 2008 2009
non inferiority.
5.Time to approval ~ time to market
is short in comparison to NDA.
12
13. OPPORTUNITIES
Commercial & Strategic
Life cycle Management -Cardizem Story
$1,200.00
$1,000.00
Sales [In $ 000s]
$800.00
$600.00 Cardizem CO
$400.00 Cardizem SR
$200.00 Cardizem IR
$-
1988 1989 1990 1991 1992 1993 1994 1995 1996
Year
Cardizem hcl has been reformulated and launched twice to maintain and
enhance its market share in the same therapeutic segment and helped
Aventis to protect it’s block buster
13
15. Market Driver
MARKET POTENTIAL
R&D Spend Vs NME Approved Cost/NME
R&D
productivity
Sales Loss
due to
Patent expiry
Revenue Loss due to patent expiry
Global pharmaceutical companies are desperately looking at
15
alternative strategy to increase profitability
16. MARKET POTENTIAL
Key Statistics
Global Sales Of Drug Delivery Product [2007 – 2014] [In $ billion] Market Share –Dosage form
Oral, 52%
Liposomes, 2% Transdermal, 1
2%
Injectable, 8%
Pulmunory, 19
%
Nasal, 7%
Ocular &
Buccal, 1%
• Global pharmaceutical market size - $555.5 billion in 2006
• Drugs incorporating NDDS ~ $72 billion (~13%)
• NDDS market has a CAGR of ~15% v/s ~6% CAGR
• There are 700 NDDS companies with more than 1700technologies
• Worldwide NDDS market ten times Indian Pharma market
BCC Research http://www.bccresearch.com/report/drug-delivery-systems-phm006g.html
GBI Research
16
17. MARKET POTENTIAL
Key Statistics
Drug delivery project [1999 to 2004]
Growing drug delivery segment : Oral drug delivery systems
Preferred business model : JV/Partnership
17
18. CONTENT
Overview
Technology Evolution
Opportunities
Market Potential
Present Scenario
Future Trends
QbD in Controlled Release Technology
Indian Scenario
18
19. PRESENT SCENARIO
Oral delivery system - OROS Technology (ALZA corporation)
Products in market:
Sudafed 24
hours (Pseudoephedrine)
Volmax (Salbutamol
• Single layer tablet: Drug core (water soluble drug with or without excipients)
• Semi permeable membrane with a drilled orifice
• Water imbibitions by the core because of osmotic action results in drug
dissolution, which is released at a controlled rate through the orifice
19
20. PRESENT SCENARIO
Oral delivery system - Geomatrix® (SKY Parma)
Products in market:
Cordicant -uno®
Madopar-DR
Sular-ER
•This technology Controls amount, timing and location of release in body.
•Formulation with predictable and reproducible drug release profile.
• Controls rate of drug diffusion throughout release process, ensuring 100% release
20
21. PRESENT SCENARIO
Transdermal delivery system - MicroCor™ (Corium company)
• Has an array of microstructures that mechanically creates reversible “micro-pores” in the
outer skin barrier to facilitate transdermal delivery.
• Microstructures are integrated into a patch which contains both the drug and adhesive
• Drug candidates cross all major therapeutic areas
• The microstructure array is integrated into custom designed delivery systems for
painless administration of small and large molecular weight molecules through the skin.
• Delivery directly to the viable epidermis (20 to 200 µ)
http://www.coriumgroup.com
21
22. PRESENT SCENARIO
Parenteral
Depot or reservoir preparations
Parental administration prolonged by using insoluble
salts or suspensions in non-aqueous vehicles.
E.G Boldenone oil depo 1s a week inj, Testosterone
cypionate oil solution IM inj 1s a week.
Implants
Drug delivery systems implanted under skin from which
the drug is released slowly over a period of 1-5 years.
Norplant : Levonorgestrol subdermally implanted in
upper arm Provides contraceptive protection for ~5yrs.
Microspher
Small spheres made of any material and sized from
about .1-1000µm
E.G Risperdal consta
22
23. CONTENT
Overview
Technology Evolution
Opportunities
Market Potential
Current Scenario
Future Trends
QbD in Controlled Release Technology
Indian Scenario
23
24. FUTURE TREND
Polymer based delivery system
Hydrogels
•Polymers that swell without dissolving in an
aqueous environment releasing entrapped
drug
Ringcap Technology
•Tablet coated with water insoluble coat and
drug release is controlled based on count,
position & thickness of ring
Pulsincap Technology
•Capsule made of water soluble cap
•Drug is released when the hydro gel plug
swells and oozes the drug out of the shell
24
25. FUTURE TRENDS
Transdermal - Nano MAP
•For painless delivery of nanostructured large molecule drug or hormone.
•Delivery by topologically undulating patch.
•Proof of concept test for NanoMAPs has been demonstrated in rodent with
naoparticulate insulin
25
26. FUTURE TRENDS
Parenteral
Parenteral, especially biotechnology drugs, are ideal candidates for drug delivery technologies.
The success of next generation biotechnology molecules, including DNA-based drugs as well as
small interfering RNA molecules, depends on the effectiveness by which such molecules are
delivered to the desired site of action.
Needle less injection
Autoinjector
ProLease®, Medisorb® …..
These technologies enable delivery of complex macromolecules and small molecules to enhance drug
formulations, creating valuable medical and commercial benefits.
26
27. FUTURE TRENDS
Targeted Delivery System
Quantum dots
A quantum dot is a semiconductor nanostructure that confines the motion of
conduction band electrons, valence band holes, or exactions(bound pairs of
conduction band electrons and valence band holes) in all three spatial
directions. QDs can function as 'light beacons' by conjugating them to
chemotherapeutic drugs, such as doxorubicin. The QDs can be specifically
designed to fluoresce once the drug has been delivered and released
27
intracellularly.
28. FUTURE TRENDS
Targeted Delivery System
Folate Targeting
Folate targeting is a method utilized in biotechnology for drug delivery purposes.It
involves the attachment of the vitamin, folate(folic acid), to a molecule/drug to
form a "folateconjugate". Based on the natural high affinity of folate for the folate
receptor protein (FR), which is commonly expressed on the surface of many human
cancers, folate-drug conjugates also bind tightly to the FR and trigger cellular
28
uptake via endocytosis.
29. FUTURE TRENDS
Targeted Delivery System
Liposomes
These are vesicular concentric structures, range in size from a nanometer to several
micrometers, containing a phospholipids bilayer and are biocompatible, biodegradable
and no immunogenic.
E.G Allovectin-7 of Vical for delivery of antisense rNA
Oncolipin of Oncotheraputics Inc. for delivery of interlukins-1
Duanosome & Ambisome of Nextar Inc. for delivery of Doxorubicin & Amphotericin
29
30. Fabricated Delivery System
FUTURE TRENDS
The use of electronics opens up new possibilities in the era of drug delivery
•Active feedback system
•Implantable Device
•Programmable drug release profile
•Improved ease of use
•Great clinical and patient feedback
30
31. FUTURE TRENDS
Advance Delivery System
Molecular Gate
• pH sensitive gel
• Swells and deliver drug when pH
increases .
Nano robots
• Based on demand drug delivery
31
32. FUTURE TRENDS
Advance Delivery System
Nano robots
The device consist of a tiny nickel drum, attached to the ATP-powered biological
motor, which is coated with antibodies that adsorb the target molecules, whereupon
an electric field pulls the molecules to a storage chamber and holds them in place.
E.G Respirocytes : The artificial red blood cell
32
33. CONTENT
Overview
Technology Evolution
Opportunities
Market Potential
Current Scenario
Future Trends
QbD in Controlled Release Technology
Indian Scenario
33
34. QbD
Quality By Design
MOHEB NASR, FDA QUALITY INITIATIVES WORKSHOP, FEBRUARY 28, 2007
Empirical to mechanistic transition
34
35. QbD
Systematic Approach
• Target the product profile (TPP)
• Determine the critical quality attributes
(CQAs)
• Link input material attributes and process
parameters to CQAs and perform risk
assessment
• Develop a design space
• Design and implement a control strategy
• Manage product lifecycle, including
continual improvement
CHI-WAN CHEN AT 2007 AAPS ANNUAL MEETING, ROUND TABLE ON CHALLENGES AND OPPORTUNITIES FOR IMPLEMENTATION OF QUALITY BY DESIGN (QBD), SAN DIEGO, CA., NOV 13, 2007
35
37. INDIAN SCENARIO
Controlled Release Technology
Technology
Human resources
Regulatory
NDDS Scenario in India: Vital Role of Pharma Professionals-Pharmainfo.net
International journal of pharmatech research vol-2 (www.sphingsai.com) 37
