Solity 3p-applications

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Solity 3p™*
Stabicon Life Sciences’ Innovative Solity 3p™* proprietary product technology platform. It
enables a wide set of industry and function specific solutions that allows our customers to
elevate productivity and create value.
Innovation
Novel Idea
Efficient
Capable of Integration of
incompatible actives of
varying solubility to
accomplish significantly
enhanced synergistic
action or effect
Transforming non-soluble
/ sparingly soluble mix of
compounds, molecules,
biomolecules to water
soluble formulations with
significantly enhanced
bioavailability
Augmented
Absorption
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Business Confidential Document of Stabicon Life Sciences
(www.stabicon.com)
Validated Research
Tested and validated on
in vitro and clinical
models
Market Opportunities
Improved products,
Novel, reduced toxicities
, dose reductions, at par
or superior efficacies

Solity 3p™* Technology Platform
Application Layer
Solity™*
Technology Platform
 Highly versatile delivery platform using Nano
technology for insoluble and poorly soluble
compounds
 Improved potency at lower dose and less
toxicity
 Significant increases in solubility
 Manifold increase in bioavailability for health
products
 Potential to create highly potent formulations
with reduced side effects while retaining
effectiveness
 RT stability demonstrated for 2 years
 Simple and straightforward manufacturing
 Patent issued
 Companies can gain market exclusivity and
patent protection for their products.
Great Products
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Environment
Herbal
Agriculture
Cosmeceuticals
Biotech Industry
Nutraceuticals
Food & Beverages
Specialty Chemicals
Animal Nutrition
Pharmaceutical
Solity 3p™* Technology- Enabler Industry Wide Solutions
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Solity 3p™* Technology Application Solution
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 Superior optimisation of biological activity
 Significantly improve handling and application
 Maximise long term stability
 Modification of persistence on target
 Safety in manufacture and use
 Tremendous cost reduction for user
 Radical reduction of dose of active ingredient applied by up
to 90%
 Dramatic reduction of waste and effluent of all kinds
(environment)
 Extend patent life of active ingredient
 Provide a competitive and leading edge for products
Better Formulations
Better Bio-Availability
Better Stability
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Pharmaceutical
Enhance product bioavailability
Potent forms of products
Reduce side effects
Improve palatability of bitter
tasting drug
Enhance product solubility
Dose can be reduced to nearly
1/100th of conventional regular
dose
Solity 3p™*
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Nutraceutical
Enhancing Bioavailability
Reduction in undesirable side
effects, while retaining
Efficacy
Enhancing solubility
Improved taste masking
Solity 3p™*
Protection from degradation during
manufacturing and throughout shelf
life
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Cellular Activities of Curcumin and Molecular MoA
Ref.: Jack Vanden Heuvel, PennState College of Agricultural Sciences, http://nrresource.org/nuclear_ receptors/peroxisome-proliferator-activated-receptor-gamma-pparg-nr1c3/
Role in metabolic disorder

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However, its efficacy is limited due to low bioavailability…
Short Half-Life
Blood Concentrations
Tissue Distribution
• Oral admin. of 400mg showed that only traces
of unchanged drug was found in the liver & kid
ney and 90% was found in the stomach after 30
min which was reduced to 1% after 1h
• IP route showed max. amount of curcumin in th
e intestine after 1h; spleen, liver & kidney show
ed moderate amounts
• ORAL: Admin. of 1.0g/kg showed low plasma
levels (0.13µg/mL) after 15min, max. plasma l
evel (0.22µg/mL) after 1h, which then declin
ed below detection limit by 6h
• I.V/I.P: Plasma levels peaked (2.25µg/mL)
within 15min of admin. & declined rapidly
within 1h
• Study shows that when 1g/kg curcumin was given or
ally to rats, 75% of it was excreted in feces & ne
gligible amounts were found in urine
• The absorption & elimination half-lives of orally ad
ministered curcumin in rats was found to be 0.31 &
1.7h respectively
• Half-lives in humans were not found since the serum
levels were below the detection limits

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Ingredients Physicochemical Properties
Mol. Ma
ss (g/m
ol)
Melting P
oint (°C)
Solubility in H
exane or Eth
er
Solubility i
n Alcohol
or Acetone
Curcumin 368.4 183.0-186
.0
Insoluble Soluble
Demethoxycu
rcumin
338.0 172.5-174
.5
Insoluble Soluble
Bisdemethoxy
curcumin
308.1 224.0 Insoluble Soluble
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%
3%
77
%
Non-ionic oil-in-water emulsifier
Multistep Mfg. & Son
ification process
Indian Patent Application No.:201
841039937 and PCT Application N
o. PCT/IN2019/050780
Commercial Grade Curcuminoids And Non-Curcuminoids
Curcumin/Turmeric
Extract
+
TO/CRTO
Mother liquor after isolation of
curcumin from oleoresin
This complex could be either diluted
with pharmaceutically acceptable so
lvents to make liquid products or wit
h water soluble solid excipients to m
ake solid dosage, semi solid dosag
e forms. The end product derived is
water soluble.
To be repla
ced with ph
oto of actua
l bottle

Herbal
Extract/Powder/Oil/SCFE
extracts in water
Improved palatability of
bitter tasting herbs
Improved compliance
Develop product of your choice
Enhance solubility of Herbal
Solity 3p™
*
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Agriculture
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 A large number of agrochemical products are insoluble in water OR have very low solubility and quite toxic
 Currently marketed in quite high concentrations, “overdosing” to guarantee that the substance reaches all plants
 Solity 3p™* can reduce “overdosing” problem, allow use at lower concentration, reduce toxicity, maintaining
effectiveness or improving it further.
 Such a soluble and low concentration product will rapidly gain market leadership in its segment either by
regulatory limitation on the existing products that are now considered toxic or by a huge cost advantage due
to a much reduced quantity of active substance per application (up to 90%).
 Functional food
 Nutritional food
 Herbicides
 Pesticides
 Fungicides
 Fertilizers
(www.stabicon.com)

Nanocosmeceuticals
Cosmeceuticals are chasm between pharmaceuticals and personal care products. Cosmetic manufacturers use
nanoscale versions of ingredients to provide better UV protection, deeper skin penetration, long-lasting effects,
increased color and finish quality etc. The use of nanomaterials such as metal oxide nanoparticles, nanospheres, nano
capsules, nanoemulsions, functionalized niosomes and liposomes among others in formulations containing active
ingredients such as UV-filters, vitamins or anti-oxidants, has become increasingly common.
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Moisturizers with improved hydration
Fragrances
Shampoo Hair conditioner & treatments
Lipstick, eye shadow and nail varnish
UV-filters in suncare products
Cosmetics with improved transparency
Anti-aging formulations
Global nanotechnology market is expected to
exceed US$ 125 Billion mark by 2024
Top 10 beauty companies in terms of number of nano-related patents
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Solity 3p™* Advantage
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Controlled Release
Increased Efficacy
Occlusive Properties
Physical Stability
Improved Shelf Life
Site Specific Targeting
Active Transporter of Active
Ingredient
High Entrapment Efficiency
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Future of Cosmeceutical With Solity™*
Natural products for skin health
care applications, with increased
efficiency and cost benefits
Formulations with vitamins and
antioxidants
Green Formulations – Eco
friendly and less toxicity
Specialized natural active ingredients
such as organic, herbal and ayurvedic
products as part of cosmetic products
Formulations with anti bacterial
and anti microbial activity
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NASAL VACCINE DELIVERY TECHNOLOGY
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Introduction
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• Most pathogens gain access to the human body through mucosal sites and initiate
systemic infections.
• Parenterally administered vaccines induce strong systemic immunity and almost
no mucosal immunity.
• Administration of drug through nasal route is referred as Nasal Drug Delivery
System.
• Nasal Mucosa has been considered as a potential administration route to achieve
faster and higher level of drug absorption.
• It is an ideal alternative to the parenterals for systemic drug delivery.
• Delivering the vaccine to the nasal cavity, stimulates the production of local
secretory IgA antibody as well as IgG, providing first line of defense, which helps
to eliminate the pathogens.
(www.stabicon.com)

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Figure1: Routes of mucosal vaccination within the mucosa-associated
lymphoid tissue (MALT), with several subcompartments including:
the nasopharynx-associated lymphoid tissue (NALT), bronchus-
associated lymphoid tissue (BALT), gut-associated lymphoid tissue
(GALT) and genital tract-associated lymphoid tissue, reproduced
from Lycke et al, 2012.
Routes Of Mucosal Vaccination: Nose To Brain Delivery:
Figure 2. Human head representation, a) general structure
of nasal passage, b) location of the nasal associated
lymphoid structures (Waldeyer’s ring) and connections
between nerves from the central nervous system and nasal
cavity, c) schematic representation of the Waldeyer’s ring.
(www.stabicon.com)

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1. Simplicity and ease of administration
2. Improved access and compliance
3. Better nasal bioavailability for smaller drug molecules
4. Drugs which cannot be absorbed orally may be delivered to the systemic circulation
through nasal drug delivery system
5. Convenient route when compared with parenteral route for long term therapy
6. A non invasive route: Avoidance of infection from inappropriate re-use of needles
7. Hepatic first-pass metabolism is absent
8. Rapid drug absorption
9. Quick onset of action
10. The bioavailability of larger drug molecules can be improved by means of absorption
enhancer or other approach
11. Reduction of logistic cost
Advantages Of Nasal Delivery
(www.stabicon.com)

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Table:2 Current marketed/approved mucosal vaccine
Vaccine name Target Route of
administration
Sabin OPV*
Dukoral / Shanchol / Euvichol
Rotateq / Rotarix / Rotavac / RotaSiil
Vivotif
FluMist
HeberNasvac**
Poliovirus
Vibrio cholerae
Rotavirus
Salmonella typhi
Ty21a
Influenza
Chronic HBV
Oral
Oral
Oral
Oral
Nasal
nasal / subcutaneous
Relevant recent mucosal vaccine's clinical trials
NCT01385215 / NCT02755948 /
NCT04034290
NCT01473810 / NCT01084343
NCT03541499 / NCT04036526
NCT02034500
NCT03017378
NCT02718443
Influenza
HIV
Bordetella pertussis
Shigella Sonnei
BCG (tuberculosis)
Tumor
Nasal
Nasal / mucosalparenteral
combinations
Nasal
Nasal
nasal / sublingual
oral
(www.stabicon.com)

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Figure 3. The particulate antigens are actively taken up by M cells (A) or permeate passively through epithelial junctions (B). Alternatively, antigens are take
n up by DCs extensions into the lumen (C). Once antigens are captured by DCs, they migrate to nearest lymphoid follicles or lymph node to present antigens
to CD4+ T cells. DCs-stimulated CD4+ T cells activate naive B cells and undergo isotype switching to form antigen-specific IgA+ committed B cells (D). These
IgA+ B cells migrate from lymph node to the blood circulations (E). Finally, IgA+ B cells exit the blood and enter toward the effector site. They undergo final
differentiation and maturations producing IgA+ plasma cells (process enhanced by IL-5 and IL-6, a subset of Th2 cells) and ultimately form dimeric or
polymeric IgA (F). The dimeric or polymeric IgA binds with pIgR in the basolateral region to form sIgA (G) and further transcytosed toward the apical side of
luminal surface (H).
DC: Dendritic cell; IL: Interleukin; M-cell: Microfold cell; pIgR: Polymeric immunoglobulin receptor; sIgA: Secretory IgA; Th: T-helper cell.
(www.stabicon.com)

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1
• To improve the nasal residence time.
2
• To enhance nasal absorption.
3
• To modify drug structure to change physiochemical
properties.
Strategies To Improve Nasal Absorption
(www.stabicon.com)

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Strategies To Improve Nasal Absorption
Figure 4. Different methods of antigen incorporation to nanoparticles. (A)
Amphiphilic antigens can self assembled itself to form nanoparticles, (B)
antigens are encapsulated into the nanoparticles, (C) antigens are adsorbed
on the surface and encapsulated into the nanoparticles, (D) antigens are
adsorbed on the surface of nanoparticles, (E) antigens are conjugated onto
the surface of the nanoparticles and (F) physical mixture of antigens and
nanoparticles.
(www.stabicon.com)

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Can Stabicon Bypass The Challenges?
S.No. Limitations
Can Stabicon
Overcome the
limitation?
1. Nasal Irritation √
2. Risk of Local Side Effects or damage of the cilia
on the nasal mucosa
√
3.
Histological toxicity due to absorption enhancers
√
4. Less surface area √
5. Inadequate immune response √
6. Addition of preservatives √
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Solity™* Technology Timeline
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Physical Stability
2012
Natural /
Plant based
Complementary
Formulations
2015
Formulation
Research
2017
POC
Intellectual
Property
Clinical Studies
Patent Filing
2018 2019 -20
Product Registration / Product
Extensions
Ongoing Research on expansion /
new Product pipeline
Completed In Progress
Global Patent on the Technology
2014
Technology
Development
(www.stabicon.com)

Business Confidential Property of Lyrus Life Sciences
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02 03
04
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07
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Increasing
Prevalence
Increasing
Consumerism
Increasing Formats
& New Launches
Fragmented
Market Few
Targeted
Products
Growing
Demand for
Natural
Ingredients
Supply
Demand
Market
Commoditi-
zation
Convergence
of HCP
Channel with
Nutra
High probability of Success
for Stabicon’s product if
strategically positioned
with evidence-backed
claims
Market Belief/ Product Vision
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Experienced Team
₋ 200+Scientists
₋ 5 Vertically Integrated Teams (Ideation,
Formulation Development, Analytical
Development, Pilot and Exhibit Manufacturing &
Regulatory team)
Innovation
NDDS, platform technologies and innovative
solutions such as Nano, Solubility & Bio
availability enhancement, Drug-Layering
One-stop Shop
Formulation development of niche generics, new
fixed dose combinations, nutrition & nutraceuticals
and providing end to end solutions- from
development until dossier submission, including
Bioequivalence/ Bioavailability, proof of concept
studies.
R&D Capability
In-house process development capabilities
(Skilled R&D)
Ultramodern Infrastructure
₋ Modern Infrastructure spread over 75,000 sq. ft.
₋ Equipment's for NDDS & complex developments
₋ Capacity to develop over 30 challenging products every year
₋ Plant as per EU GMP guidelines
Strong Product/ Services Portfolio
₋ Capability to develop Nutraceutical and OTC
₋ Has 50+ products, where either the Marketing
Authorization has been granted or are in various stages
of approval
Stabicon Advantage
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Our Milestones
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Stabicon Life Sciences Pvt. Ltd.
Corporate Office
#4M-413, 1st Floor, 3rd Block, Kammanahalli Main Road, HRBR, Bengaluru – 560043, Karnataka, India
Phone: +91 80 41250324
E mail: bd@stabicon.com , info@stabicon.com
© 2020, Stabicon Life Sciences Pvt. Ltd. All Rights Reserved.
Stabicon, Stabicon logo, Solity 3p™* are applied trademarks of Stabicon Life Sciences in India.
The content of this document are confidential and are meant for the review by the recipient of the same. This material
was used during an oral presentation; it is not a complete record of the discussion. This work may not be used, sold,
transferred, adapted, abridged, copied or reproduced in whole on or in part in any manner or form or in any media
without the prior written consent. All product names and company names and logos mentioned herein are the
trademarks or registered trademarks of their respective owners.
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