Formulation & Process Development

At Pensatech Pharma we use our extensive experience in formulation and process development to identify and solve different challenges. We create a tailored formulation and process development program using a broad range of capabilities to proactively manage our customers’ requests. Our services 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

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Our technologies include:

 

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

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Parenterals

  • Depot suspensions (micronized/milled API; Nano-suspensions)

  • Emulsions / Nano-emulsions

  • Microparticles

  • Implants (HME and in-situ forming)

  • Liposomes

  • Biodegradable polymeric and lipidic carriers

  • Lyophilization 

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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

  • Delivery of poorly water-soluble drugs

  • Microencapsulated products

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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

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Please click here to have a look at our processing capabilities. For further information on our formulation and process development services, please contact us.