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Company Introduction

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Family-ruled business from its foundation to today ... analgesic patches, caffeine-based cellulite treatments, among the others ... – PowerPoint PPT presentation

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Title: Company Introduction


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Company Introduction Proprietary Technologies
3
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 ß-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

4
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

5
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

6
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..

7
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

8
  • PROPRIETARY TECHNOLOGIES

9
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

10
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
11
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

12
  • DOME MATRIX

13
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

14
Dome Matrix
15
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

16
Dome Matrix
  • Piled configurations can be obtained by staking
    the modules convex face into concave face

17
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

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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

19
  • Patch-non-Patch

20
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 lt 10 mg)

21
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

22
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

23
Patch-non-Patch
  • The Typical Structure of a Patch
  • Plasters
  • Backing (woven-non-woven)
  • Thick adhesive hydrogel
  • containing the active
  • Liner
  • Gauzes soaked in gel/oil formulations

24
Patch-non-Patch the Novelty
Patch-non-Patch
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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

26
Patch-non-Patch
27
Patch-non-Patch Case Studies
  • Lidocaine Estradiol Hydrocortisone
  • Caffeine Nitroglycerin Herbal extracts
  • Thiocolchicoside Progesterone Rutin derivatives
  • Ibuprofen lysine NicotineBupropion Ketoconazole
  • Diclofenac Sumatripan Clindamycin
  • Acyclovir
  • Clorexidine NicotinamideSa
    licylic ac.
  • Thyroxine

28
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 µm
  • Different shapes/patterns possible

29
Patch-non-Patch The Cosmetic difference
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Patch-non-Patch The Cosmetic advantage
31
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 Yes/No Yes

32
Patch-non-Patch Advantages vs Competitors
  • Feature P-n-P Patch Plaster Gel
  • Preservatives needed No No Yes 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

33
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

34
  • Chimerical Agglomerates

35
Chimerical Agglomerates
  • 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 hydro-alcoholic solution
    containing the substance and excipients

36
Chimerical Agglomerates
  • 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

37
Chimerical Agglomerates
38
Chimerical Agglomerates
  • Chimerical Agglomerates is very versatile system
    since it is possible to prepare formulations of
    different substances by varying the composition
    of the micro-particles
  • Chimerical Agglomerates scale of development is
    laboratory tested scale up phase
  • Chimerical Agglomerates is covered by patent,
    license or transfer could be considered

39
Chimerical Agglomerates
  • 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

40
Chimerical Agglomerates
  • Highly respirable insulin case study
  • 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 µm, 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

41
Chimerical Agglomerates
  • Highly respirable insulin case study
  • 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

42
  • Sucralfate Gel

43
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

44
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

45
Sucralfate Gel
46
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

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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
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