THE FUTURE OF SMART PHARMA FORMULATION

 ADVANTAGES IN PHARMA

Pharma GMP & ISO certified industrial electrospinning and spraying.

Optimize drug performance:

  • Size reduction of particles and fibers → Dramatically increased surface area and controlled crystallinity → increase bioavailability.
  • Efficient encapsulation → Design of release profile.

Versatile, simple and low impact processing:

  • Drying and encapsulation in a single step at room temperature.
  • Excellent processability of a wide range of materials.
  • Robust and continuous processing.

SUPPORTS ALL ADMINISTRATION ROUTES

ELECTROSPINNING FIBER
NONWOVENS

Muco-adhesive buccal, sublingual, transdermal patch

Oral thin film (OTF)

Subcutaneous insert

Ophthalmic patch

Wound dressing

Soft tissue implant

ELECTROSPRAYING
PARTICLES

Oral

Parental

Inhalation

THINK IN TECHNOLOGY PLATFORMS

THINK IN FUTURE

Mucoadhesive
patch platform &
sublingual patch
platform

Instantly soluble
transdermal
patch
 
Oral Dissolving
Film (ODF/OTF)
 
 
Enteric
encapsulation
platform
 
Nanonized API in
microcapsule
(Nano-in-Micro)
 

Mucoadhesive patch platform & sublingual patch platform

Example of our unique mucoadhesive delivery platform for drugs

Rivelin® mucosal drug delivery patch  novel administration route with designed release profile

  • Developed for the treatment of mucosal lesions e.g. oral lichen planus (6 million patients in USA & Europe)
  • Dual-action patch technology that adheres to any mucosal surface
  • Provides controlled and efficient uni-directional drug delivery to target area
  • Provides soft protective shield that offers instant pain relief and efficient healing
  • Currently in Phase 2b clinical trial – 240 patients with oral lichen planus, across 20 site in EU and US

Barrier Layer

    • Facing mouth
    • Non-adhesive
    • Hydrophobic
    • Biodegradable
    • No drug-loss into mouth – uni-directional towards mucosa
    • Controllable adhesion and drug release time
    • Electrospun material intimately conforms to the wound
    • 100% pharma and food grade and safe to swallow

Drug-loaded Layer

    • Facing mucosa
    • Bio-adhesive
    • Hydrophilic
    • Biodegradable

Instantly soluble transdermal patch

Example: Rivelin® mucosal drug delivery patch -> novel administration route
with designed release profile.

 

    • Developed for te treatment of mucosal lesions (e.g oral lichen planus)
    • Dual-action patch technology that adheres to any mucosal surface.
      • Controlled, uni-directional drug delivery to target area.
      • Soft protectie shield for instant pain relief and improvedhealing
    • Currently in Phase 2b clinical trial – 240 patients with oral lichen planus

Oral Dissolving Film (ODF/OTF)

    • Immediate release in the mouth for oral mucosal or gastrointestinal absorption..
    • Combination of different APIs in monolayer or multilayer design..
    • Flavour masking.

Nanonized API in microcapsule (Nano-in-Micro)

    • Increased dissolution rate, permeability and hence bioavailability
    • API nanodispersed within excipient microparticles
    • High API content within the microparticles, e.g.. >80%
    • Prevents API aggregation, recrystallization and polymorphism
    • Safe handling during tabletting

 

Example BSC Class II API: Valsartan (high blood pressure & heart failure)

 Nanonized API in microcapsule (Nano-in-Micro)

Dissolution rate

Effect of formulation and electrospraying process on dissolution rate.

    • Nanonized valsartan within microparticles leads to near instantaneous dissolution

Permeability profile

Effect on permeation across caco-2 cell membrane

    • Nanonized valsartan showed over 6x increase in permeability compared with pure API

Plasma Concentration

Effect on bioavailability.

    • Nanonized valsartan showed a 4.7x increase in systemic exposure compared with pure API

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