Extensive Experience in Formulation and Process Development

At Pensatech Pharma we use our extensive expertise in formulation and process development to provide solutions for challenging API or drug delivery objectives through science- and data-driven formulation, drug delivery and dosage form developments. We create a tailored formulation and process development program using a broad range of capabilities to proactively manage our customers’ requests.

The benefits for our customers include:

  • Contract formulation development services, which offer tailor-made formulation solutions to the specific needs of our clients
    • Solution of complex formulation challenges
  • Formulation design and DDS technology selection: Rationale selection of dosage form, formulation and processes based on expertise in drug delivery and biopharmaceutics
    • Defining target release profile based on PK-analysis
    • Risk-based approach to decision making within a Quality-by-Design (QbD) framework
  • Formulation and process development:
    • Feasibility studies
    • Formulation concept studies to support in vivo assessment (PK-study)
    • Development of enabling formulations for rapid evaluation in the clinic
    • Development of commercialisable formulations
    • Full development
  • Product transfer and industrial scale up with partnering contract manufacturers

Our Technologies

Modified release systems

  • Extended release drug delivery systems
    • Multiparticulates (granules, pellets)
    • Minitablets
    • Single unit tablets
    • Osmotic tablets
    • Matrix and coated systems
    • Hydrophilic and lipophilic polymeric matrix and coating materials
  • High dose extended release drug delivery systems
  • Fixed dose combinations with independent release adjustment for each API
  • Dual release systems (immediate + extended release combination)
  • Reduced food effect (robustness against intestinal forces and fluids and food / food degradation products)
  • Enteric/ colonic delivery dosage forms
  • Pulsatile drug delivery

Parenterals

  • Depot suspensions (micronized/milled API; nano-suspensions)
  • Emulsions / Nano-emulsions
  • Biodegradable microparticles
  • Implants (hot melt extrusion and in-situ forming)
  • Liposomes
  • Biodegradable (PLGA) and nondegradable (PEVA) polymeric and lipidic carriers
  • Lyophilization

 

Delivery of poorly water-soluble drugs

  • Micronization, nano-milling
  • Spray-drying
  • Hot melt extrusion
  • Polymeric and lipidic carriers
  • Smart excipient selection (co-solvents, surfactants, pH-adjustment)
  • Cyclodextrin complexation

Specialized drug delivery techniques

  • Paediatric and geriatric dosage forms (multiparticulates, taste masking)
  • Orally disintegrating tablets (ODT) or fast dissolving/disintegrating dosage forms (FDDF) (tablets, lyophilized products)
  • Delivery of unstable drugs
  • Microencapsulated products
  • Taste-masking (coatings, tablets, ganules, ODTs)

Classical pharmaceutical dosage forms

  • Solid oral dosage forms
    • Granules, pellets, tablets and capsules
  • Coating systems (aqueous- and solvent-based)
    • Modified release, taste masking and moisture protection
  • Liquid and semisolid formulations
    • Aqueous and oily solutions, emulsions, suspensions and gels

Processing Capabilities

The experimental work is conducted in well-equipped laboratories. For many processes, miniaturized equipment is available allowing us to screen optimal formulations with a minimum of drug required. Our processing capabilities include:

Oral solid dosage forms

  • Micronisation, milling (dry and wet), blending, sizing
  • Granulation (aqueous and organic)
    • Fluidized bed
    • High shear
    • Rotor granulator
    • Extrusion / cutting (dry and wet, 20x L/D)
    • Mixer torque rheometer
    • Dry granulation (roller compaction)
  • Pelletisation
    • Extrusion / spheronisation
    • Layering technologies
  • Tableting
    • Fully instrumented single punch press
    • Rotary presses
    • Compaction simulator (Huxley Bertram)
  • Coating (aqueous and organic)
    • Fluidized bed
    • Perforated pan
  • Hot melt extrusion
  • Lyophilisation

Suspensions/emulsions dosage forms

  • Milling (dry and wet milling, micro- and nanonisation)
  • High pressure homogenizer
  • Lyophilisation / spray-drying
  • Sterilisation (gamma-irradiation, steam, dry heat)

Biodegradable microparticles and Implants

  • Polymeric carriers:
    • Solvent evaporation/ extraction techniques
    • Phase separation / coacervation
    • Spray drying
    • Hot melt extrusion
  • Lipidic carriers
    • Spray congealing
    • Melt emulsification
    • Solid lipid extrusion

Liposomes

  • High pressure homogenisation
  • Solvent injection system
  • Lyophilization
  • Tangential flow filtration
  • Sterile filtration

Please get in touch to discuss your next pharmaceutical project with Pensatech Pharma

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