Lisa Tech Y081

March 2008
Lisapharma Confidential
Company Introduction
&
Proprietary Technologies
March 2008
LISAPHARMA at a glance
Fully owned by Italian capital
Family-ruled business from its foundation to today
Manufacturing plant of dosage forms in full GMP
compliance, including -lactam ceph derivatives dedicated
line
Driven to technological developments throughout strong
liaisons with different university bodies
Operative on the Italian and international markets through
a portfolio of proprietary medicines
March 2008
Milestones
1925: Lisapharma is established in Bologna
1949: HHQQ and plant moved to actual site of Erba (Co)
1968: first export business to Taiwan
1970: establishment of international production units in Nicaragua &
Costarica
1993: first manufacturing activity as toll manufacturer with Novartis
2000: start of phase-out of production of oral solid non-sterile products
2002: establishment of the j.-v. with Omicron for the manufacture of
oral solid non-sterile products
March 2008
Key facts & figures

Fully owned Italian manufacturing plant for sterile injection products,
non-sterile liquids, semisolids
J.-V. participation in Omicron plant (Italy) for oral solid non-sterile
production
148 total headcounts, out of which 80 reps
International customers portfolio of 81 accounts
International sales in 32 different countries worldwide
Intellectual property of 18 patents covering original technologies
Development & RA expenditure up to 5.60% of company revenues
March 2008
Goals
To consolidate the presence in the Italian market
To improve the penetration in existing countries outside
Italy and to expand to further new markets its business
partneriships
To enlarge the toll manufacturing activities for renowned
international companies
BY..
March 2008
Strategy
In-house development of generic registration dossiers focusing on
niche products (injectable class,)
Partnering and/or tightening strategic alliances allowing the best
exploitation of the in-house developed patented technologies
(Sucralfate Gel, Dome Matrix, Patch-non-Patch, Chimerical
Agglomerates)
Diversification of the product portfolio to include additional non-RX
compounds dedicated to specialists (food supplements, medical
devices,)
Strengthening the existing collaborations through the proven high
standard of quality and service provided, by doing so attracting new
potential customers too
March 2008
PROPRIETARY TECHNOLOGIES
March 2008
Proprietary technologies
Long-lasting cooperation between Lisapharma and well
reputable Universities in Italy
Focusing in the development of novel delivery systems,
due to the increased market demand for drug delivery
technology
Aiming to develop versatility in drug delivery, as much as
adaptability to different drugs to inhance patient
compliance
ALL THIS LED TO

March 2008
Proprietary technologies
FOUR PLATFORMS
Dome Matrix, oral platform

Patch-non-Patch, transdermal platform
Chimerical Agglomerates, inhalation nasal platform
Sucralfate Gel, as unti-ulcer for GI tract and skin wounds
The technologies are covered by patents and available for

discussions
March 2008
10
The Platform Concept in DDS

More than 15% of the total pharma market in excess of
U$ 80 billion - is covered by drug delivery technolgies
Future belongs to biotech drugs, to old drugs to be
revaluated, to new drugs offered with appropriate dds, and
to generics
The systems invented shall posses not only versatility in
delivery, but also adaptability to different drugs
The term platform indicates a delivery system capable to
be adapted to various drugs, strenghts, mechanisms of
delivery, in order to control not only the time but also the
site of delivery
March 2008
11
DOME MATRIX
March 2008
12
Dome Matrix
The system is based on tablets (modules) with a peculiar
shape made of swellable polymer for controlling the
release rate
The typical shape of the module is a cylindrical tablet
having one concave and one convex base designed to
allow the convex base to be inserted in the concave
The shape permits to put together several modules to
create different assembled release systems
March 2008
13
Dome Matrix
March 2008
14
Dome Matrix
A peculiar assembly can be obtained by fitting the concave
base of two modules allowing the construction of a floating
system able to keep the release of the substance into the
stomach
March 2008
15
Dome Matrix
Piled configurations can be obtained by staking the
modules convex face into concave face
March 2008
16
Dome Matrix
Dome Matrix finds its ideal application whenever there is
a need for:
a prolonged release of solid dosage forms and it may
represent an effective answer to the need to have
versatility in the substance release kinetics
modulation of dose administered
association of different substances in one modular
system
improving the efficacy of the substance delivered,
providing a time-and-space controlled release system
March 2008
17
Dome Matrix
Dome Matrix technology can be applied
To old products presented in innovative dosage forms
New compounds combined with an original and
innovative delivery route
Dome Matrix industrial development is in progress

Dome Matrix is covered by patent, license or transfer
could be considered
March 2008
18
Patch-non-Patch
March 2008
19
Patch-non-Patch
Patches vs. Traditional Systemic Formulations
Constant plasma levels
Lower incidence of side effects
vs Injection
vs Oral
Non invasive
Increased bioavailability
More acceptable
Reduced dosing frequency
No need of specialized
No drug interaction
personnel
Limitation
Low skin permeability (daily dosing < 10 mg)
March 2008
20
Patch-non-Patch
Patches vs. Traditional Systemic Formulations
Topical formulations (solutions, creams, gels,) can:
Be accidentally removed contact time
Applied at the wrong dose
Stick to cloths
Patches guarantee control in:

Dose applied
Area of application
Contact time
Release kinetics
March 2008
21
Patch-non-Patch
The Typical Structure of a Patch
Multi-layer structures composed of:
Backing
Deposit of the active (solid/liquid)
(Membrane)
Adhesive
Release liner
Backing
Deposit
Membrane
Adhesive
Liner
Minitran
March 2008
22
Patch-non-Patch
The Typical Structure of a Patch
Lidoderm
Plasters
Backing (woven-non-woven)
Thick adhesive hydrogel
containing the active
Liner
Gauzes soaked in gel/oil formulations
March 2008
Medicell Patch
23
Patch-non-Patch: the Novelty
Patch-non-Patch
SEM Image
March 2008
24
Patch-non-Patch: Characteristics
Dry
Not self-adhesive
Flexible, transparent
Water permeable
Electrically conductive
Organic solvents not required
Adhesive only on wet skin
Washeable with water
March 2008
25
Patch-non-Patch
March 2008
26
Patch-non-Patch: Case Studies

Lidocaine
Estradiol
Hydrocortisone
Caffeine
Nitroglycerin
Herbal extracts
Thiocolchicoside
Progesterone
Ibuprofen lysine Nicotine&Bupropion

Diclofenac
Sumatripan
Rutin derivatives
Ketoconazole
Clindamycin
Acyclovir
Clorexidine
Nicotinamide&Salicylic ac.
Thyroxine
March 2008
27
Patch-non-Patch: Production
Solution (suspension) of all components in water
Lamination on the release liner at predetermined time
Oven drying (60-80C)
Cutting
Thickness of 40-200 m
Different shapes/patterns possible
March 2008
28
Patch-non-Patch: The Cosmetic difference
March 2008
29
Patch-non-Patch: The Cosmetic advantage
March 2008
30
Patch-non-Patch: Advantages vs
Competitors
Feature
P-n-P
Patch Plaster Gel
% of active released
High
Low
Low
Low
Time lag
No
Yes
Yes
No
Duration of activity
Long
Long
Long
Short
Adaptation to skin surf.
Yes
No
No
Occlusive
No
Yes
Yes/No No
Water soluble
Yes
No
Yes
Electrically conductive
Yes
No
Yes/No
Cosmetically acceptable
Yes
Yes/No No
Easy to be removed
Yes
No
March 2008
Yes/No Yes
31
Patch-non-Patch: Advantages vs
Competitors
Feature
P-n-P
Patch Plaster Gel
Preservatives needed
No
No
Yes
Organic solvents requ.
No
Yes
Yes/No No
Drying step critical
No
Yes
Yes
Active crystalliz.critical No
Yes
Yes
Yes
Cost of production
++++ +++
March 2008
++
Yes
++
32
Patch-non-Patch
Patch-non-Patch is meant for pharmaceutical, cosmetic,
medical device and medical industries
Patch-non-Patch feasibility studies with different
actives/prototypes are available and further can be added
Patch-non-Patch allows several potential applications
including smoking cessation products, analgesic patches,
caffeine-based cellulite treatments, among the others
Patch-non-Patch is covered by patent, license or transfer
can be considered
March 2008
33
Chimerical Agglomerates
March 2008
34
Inhalation nasal platform
A new nasal form as powder able to satisfy different
technological requirements related to preparation and
administration of powders through non-invasive routes
such as oral, buccal and nasal ones
The powder is made of agglomerates of micro-particles
obtained by spray-drying process of an aqueous or hydroalcoholic solution containing the substance and excipients
March 2008
35
In case of insufflation, the agglomerates dimension are
useful for the dose metering of the powder into the
insufflation device
After insufflation, due to turbolence of air flow,
agglomerates are broken into fragments of appropriate
dimension for nasal or buccal administration which are
rapidly deaggreagated in the primary micro-particles by
water
March 2008
36
March 2008
37
Chimerical Agglomerates is very versatile system since
it is possible to prepare formulations of different
substances by varying the composition of the microparticles
Chimerical Agglomerates scale of development is

laboratory tested scale up phase
Chimerical Agglomerates is covered by patent, license
or transfer could be considered
March 2008
38
Highly respirable insulin case study
Dry insulin powders have been prepared by using spray-drying
process starting from suspensions or aqueous solutions of the
active ingredient in acetic acid
As metering device has been used a commercial device able to
administer 2 mg of insulin powder when activated by an air flow of
60 l/min
Stability study has been carried out for 12 months during which the
powders have been kept in two different conditions: 25C-60% RU
and 2-8C
March 2008
39
Powders obtained form insulin suspensions showed lower values
of FPF (10-30%) compared to those obtained by drying of solutions
of insulin (60-80%)
Particles obtained applying this latter option have corrugated
surface characteristics, when examined through SEM analysis
All powders showed a median volume diameter below 5 m,
therefore suitable for inhalatory administration
The chemical and physical stabilities of powders obtained starting
from acetic acid solutions were the best one and the hydrolytic
degradation products, the related substances as well as the
covalent aggregation products remain within the spec limits
described in EP, also when the powders were stored at 25C up to
24 months
March 2008
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By spray-drying process therefore is possible to obtain dry insulin
powders characterized by high stability and suitable particle shape
able to make the powders highly breathable and manageable for
manufacturing
These powders show good flow properties which allow them to be
easily charged in a adevice for insufflation
By this approach insulin crystals are transformed in micro-particles
The product does not contain excipients, so reducing the potential
side effects associated to them
The room temperature stability of these pwders allows the product
to be stored in non-refrigerated conditions
March 2008
41
Sucralfate Gel
March 2008
42
Sucralfate Gel
Sucralfate is a safe and active antiulcer drug
A new physical form of Sucralfate, named Sucralfate Gel,
has been patented and developed and possesses colloidal
properties due to the reduced particle size
The material is a humid solid since the drying of the
sucralfate gel causes the lost of the gel properties
It has been demonstrated that sucralfate gel superior
activity is due to a demonstrated strong bio-adhesion
towards the oral and gastrointestinal mucosa, which allows
the product to persist in contact with the tissue to be
healed
March 2008
43
Sucralfate Gel
Other than the development of Sucralfate Gel as oral suspension for
the treatment of GI ulcers, the peculiarity of this new material has
suggested a series of further development.
One of this has been the topical use of Sucralfate Gel for the
treatment of the skin ulcers of various origin, which has got the CE
approval as Medical Device
This was made possible again by the bio-adhesion properties of the
Sucralfate humid gel that allowed the preparation of a simplified and
self-adherent topical preparation
The topical preparation can be used also as a carrier for topical
substances and it is patented
March 2008
44
Sucralfate Gel
March 2008
45
Sucralfate Gel
There are already on the market in many countries various products
based on the Sucralfate Gel technology including:
Sucralfate gel topical 25% for the treatment of skin ulcers of various
origin (Medical Device)
Sucralfate gel oral suspension 1g/5ml sachet
Sucralfate gel oral suspension 2g/10ml sachet
Dried sucralfate gel tablets 1g (under registration)
Dried sucralfate gel sequential tablets + ketoprofen
Dried Sucralfate gel sequential tablets + aspirin
March 2008
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Good tips to partnering with Lisapharma

Small though efficient and dedicated team group allowing quick
decision process
Flexibility combined to first class service
Quick adaptation to market changes
Fast reacting to customers demands and needs
Commitment to innovation
Very promising tech package portfolio
Excellent expertise and know how in manufacturing of injection
products
Independent company not belonging to any group
March 2008
47

Lisa Tech Y081

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Lisa Tech Y081

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March 2008

Key facts & figures

ALL THIS LED TO

Dome Matrix, oral platform

The technologies are covered by patents and available for

The Platform Concept in DDS

Dome Matrix industrial development is in progress

Reduced dosing frequency

Patches guarantee control in:

Gauzes soaked in gel/oil formulations

Patch-non-Patch: the Novelty

Patch-non-Patch: Case Studies

Ibuprofen lysine Nicotine&Bupropion

Patch-non-Patch: The Cosmetic difference

Patch-non-Patch: The Cosmetic advantage

Patch Plaster Gel

Adaptation to skin surf.

Patch Plaster Gel

Organic solvents requ.

Drying step critical

Chimerical Agglomerates scale of development is

Good tips to partnering with Lisapharma

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