Download Pharmacological Class Active, Strength

3100 Cote Vertu, Suite 240, St- Laurent, QC, CANADA Tel: 514-360-8737 Fax : 514-221-4311
www.findlayventures.com
Executive Summary
Differentiated/value-added products with barriers to competition
 An advanced Orally-Dissolving-Film (ODF) platform that has circumvented many of the
technology’s previous limitations availing significantly more product possibilities.
 A biopharma company; leader in the R&D and manufacture (GMP and certified by
Health Canada) of ODF and Gels; utilizes a pharmaceutical approach.
 ODF products offer enhanced consumer benefits; convenience,
ease of use, increased compliance, and overall patient experience.
 Appropriate for many applications and a wide variety of active ingredients.
(Dietary supplements, nutraceuticals, pharmaceuticals, over-the-counter
medications, veterinary).
portability,
The Technology
A delivery system designed to accommodate a wide variety of
ingredients for immediate release upon administration to the oral cavity

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


Thin films (50 to 150 microns)
High loading (~60% of active) ≤150 mg total
Actives can be liquid or solid
Small surface area (4 to 15 cm2)
Fast release (<15 sec)
Multiple materials capability for wider array of product
options:



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Pullulan (bacterial polysaccharide polymer)
Cellulose-based
Aliginates
Pectin
3
Application / Administration
1. Targeted molecules
incorporated in a
highly soluble and
fast-dissolving
polymeric film strip
2. Film placed on or under
tongue, or in buccal
cavity
3. Film dissolves
in 2-15
seconds
4. API can be
absorbed under
tongue, in buccal
cavity, or via
digestive tract
An intra-oral delivery system
May offer clinical advantages
 Intra-oral products are administered either on the tongue,
sublingually, or via the buccal cavity.
 These highly vascularized mucosal areas allow some substances
more direct access to blood circulation, providing direct
systemic administration.
 This could potentially allow a faster onset of action and a
reduction of side effects as the product bypasses the stomach
and liver.
 While not all substances are permeable and accessible to the
buccal mucosa, ODF prototypes have demonstrated some
characteristics that may enable them to be buccally absorbed.
Take anytime and anywhere
“40% of consumers have difficulties taking pills and capsules”*
 Does not require water, spoon or any device to take.
 Immediate dissolution, drug/active ingredient delivery, and onset of action.
 Easy and convenient to take and administer - dissolves in mouth in 3-20 seconds.
 Portable and discreet.
 Can be dissolved in liquid (i.e.; tea, juice, water, baby’s feed-bottle, etc.).
 Particularly convenient for infants, children, the elderly, and anyone who may
have difficulties in swallowing tablets.
*Source: Pill-Swallowing Problems in America: a National Survey of Adults, by Harris Interactive, 2003
Technology Limitations Reducing
Product possibilities significantly increased
Previous Limitations
Limitations Reduced
 Low loading of ingredients < 20mg
 Higher loading ~ 100mg
 Careful ingredients selection
 Most all ingredients categories now possible,
e.g.,
all natural , pure extracts, microencapsulation,
etc.
Examples:
Electrolyte Replacement:
Sodium 50mg , Potassium 15mg
PharmaGABA:
75mg
CoQ10:
60mg
Key features and Benefits of Technology
Attributes
Features
2-10 cm² (small)
 100 μm (thin)

Size
Technology Attributes

Absorption
Mechanism
Dose range
possibilities up to 100
mg API
Via blood vessels
under tongue or in
buccal cavity.

Manufacturing
Development
Status
Fast dissolution.

Convenient to take “anytime, anywhere”.

Can take/administer without
water.

Product works fast.


Immediate absorption in
circulatory system.
Appropriate for patients who can’t or won’t take
pills.
Flexible.
Can be used to deliver many active
ingredients/drugs
 Appropriate for may applications; dietary
supplements, nutraceuticals, pharmaceuticals, etc.
Potential for reduced sideeffects, faster onset of action.
 Immediate absorption in
circulatory system.
Products can work better, faster, and with less side
effects.


 Turnkey product; from
GMP, Health Canada
development to market.
- Certified
 Fast product development
manufacturing
turnaround.
facility.
 Pharmaceutical-like controls.
Products ready for
market.
 Other prototypes
developed.

Benefits

2-20 seconds (fast)
Dissolution
Platform
technology
Advantages

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Products fast to market.

Meets and exceeds regulatory requirements.

Product quality and consistency ensured.
Late stage of development.
May require PK; only for
marketing.
Regulatory
Considered an oral dosage form by FDA and Health Canada
 Food, vitamins/dietary supplements, over-the-counter, and prescription ODF products
are regulated as an alternative oral dosage forms to chewable tablets and orally
disintegrating tablets. This requires that they comply to the regulations that apply to the
underlying product`s/active`s regulatory pathway.
 The exception occurs when claims of alternative routes of administration, other than
the oral route, are made, e.g., sublingual, buccal, and/or direct circulatory absorption.
Examples of Consumer Accepted Products
Consumer Acceptance
100%
80%
60%
40%
20%
0%
Source: CIMA Labs
Would Ask
for ODT
Would
Purchase
ODT
Would
Prefer ODT
(40%) of adults experience difficulty swallowing pills
People are trying alternative forms of medication, such as orally dissolving
technology (chewable tablets, rapidly-dissolving tablets or film). The greatest
importance underlying their decision are;
Ease of transporting their pills (80%)
1.Ease of administration (78%)
2.No need for preparation (76%)
3.No need for water when swallowing pills (65%)
4.Better taste of the pill (61%)
Culverhouse Center for Swallowing Disorders, University of South Florida College of Medicine
"Never before has there been a broad, comprehensive study of this under-recognized problem, and the
findings are disturbing," - Worth Boyce, Jr., M.D., Professor of Medicine, Hugh F. Culverhouse Chair in
Esophagology,
"It is alarming that so many Americans are challenged to swallow needed medications, and many are not
adhering to the medication treatment recommended by their doctor”. , - Joy McCann , Director
Source: 2004 PR Newswire Association LLC , 2004 Gale, Cengage Learning. All rights reserved. Harris Interactive(R) (http://www.harrisinteractive.com/)
Clinical Evidence of Consumer Acceptance
85% prefer Vitamin-D Fast-Dissolving Film Strips over Vit.-D Drops
Film strip improved compliance over solution, and resulted in fewer repeated dosages.
A Randomized, open-label, Cross-over study comparing two Vitamin D Supplements for infants” Liquid versus fast-dissolving
ThinsolTM film strip, Dr. Rodd and Dr. Weiler, McGill University, December 2009
41 patients with mean gestational age of 39 weeks, 6-week study.
Number of responses
Reasons for preferring strips
30
25
20
15
10
5
0
Easier to
administer
No mess
No spit out
Main reasons
Full dose
consummed
Blue Type - Products on market
Green Type Ready for market
Red Type- Products developed - "close to market".
Black Type - Products in advanced development ; proof-of-concept, prototype & samples completed.
Product list - Dietary Supplements
Pharmacological Class
Active, Strength
Sleep aid
Melatonin, 3mg (all natural)
Anemia, fatigue
Vitamin B12, 1 mg
Cough and Throat
Menthol, 5mg and Oil Eucalyptus, 3 mg
Cold and Flu
Thyme oil, 5mg
Maintain cardiovascular health
Resveratrol, 25mg
Vitamin (Infants, Toddlers)
Vitamin D3 400 IU
Vitamin (Adult)
Vitamin D3 1000 IU
Anti-Anxiety
PharmaGABA 75mg
Anti-oxidant, maintain cardiovascular health
Coenzyme Q10, 60mg
Maintain cardiovascular health
Omega 3, 30mg
Multi-vitamin
Various vitamins
Product list - Over-the-counter
Pharmacological Class
Active, Strength
Teeth-whitening
Hydrogen peroxide
Energizing
Caffeine 40mg
Energizing, sexual dysfunction, well
being
Caffeine 25mg / Ginseng (ginsenosides
1mg)
Appetite suppressant
Crocus 20mg
Laxative
Senna- Sennoside, 5, 15 mg
Nicotine Replacement Therapy
Nicotine, 2mg
Electrolyte replacement
Electrolyte, 50mg Na et 15mg K
Tissue reparation, Immune system
Vitamin C 30 mg
The facilities
Health Canada Certified Manufacturing for Natural Products
 Facilitiy located within a concentration of Bio/Pharma/Vet industries in St. Hyacinthe, Quebec,
Canada
 15,000 sq ft manufacturing and R&D facilities
 Quality Control and R&D laboratory
 40ft. casting and drying ovens
 Pilot R&D casting/drying oven
 Automated cutting & packaging equipment
 Cartoning and shrink wrapping equipment
Key business benefits
 Differentiate, add-value to Product Category
 Take Competitors’ Sales
 Increase Barriers to Competition
Film packaging – Portability & Flexibility
Single carton
 Can contain 1 or 2 aluminium pouches
 Carton can have a flap with peg hole