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Oral Drug Delivery

Optimising the release profile and exposure of your molecule

Large numbers of molecules in the discovery and development pipelines of biotech companies demonstrate properties which have the potential to limit drug absorption from the gastro-intestinal tract and their subsequent systemic availability. At Seda, we have experience of working in a wide range of projects with lead molecules demonstrating low aqueous solubility, low gastrointestinal permeability and a propensity for other exposure limiting factors such as pre-systemic metabolism or short half-life. In this regard, we have worked extensively in our laboratories to develop enabling formulations suitable for use in preclinical and clinical studies which address these issues and include:

  • Solubilised formulations containing complexing agents and lipidic surfactants
  • Amorphous solid dispersions
  • Salts and rapidly dissolving solid forms
  • Lipidic formulations
  • Micronised and sub-micron particulates
  • Controlled release dosage forms
  • Permeation enhancement

Why choose Seda?

We have significant experience of developing products and authoring regulatory submissions in these areas and so can support companies on their journey to first time in human studies and marketing authorisation. This includes significant expertise in developing clinically relevant in vitro and in vivo tests to support the evaluation, development and testing of these products and design of studies in humans and animal models to assess product performance.

Related Publication

Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products

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Expertise:

  • Oral Drug Delivery
  • DMPK and Dose Selection
  • Pharmacokinetic Modelling

Linette Ruston

BSc (Hons) PhD

Senior Principal Scientist: ADME

Linette Ruston

BSc (Hons) PhD

Senior Principal Scientist: ADME

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Linette is a Senior Principal Scientist at Seda with a BSc (Hons) and PhD in Chemistry from Universities of Glasgow and Edinburgh, respectively.  She is an experienced Biopharmaceutics and DMPK scientist having spent 17+ years with AstraZeneca where she held roles in Discovery and Early Pharmaceutical Development, providing expert physicochemical, ADME and Biopharmaceutics input into compound design and selection, and applied knowledge of in vitro, in silico and in vivo models to enable material choice and project progression from discovery to early clinical development.  Her current focus is on translation of DMPK/PD and biopharmaceutics understanding into meaningful product and clinical study design within Seda.

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    Expect a reply typically within 48 hours.

    Expertise:

    • Oral Drug Delivery
    • Complex Parenterals
    • Paediatric Product Development
    • Regulatory CMC

    Paul W Stott

    BPharm (Hons) PhD

    Director & CEO

    Paul W Stott

    BPharm (Hons) PhD

    Director & CEO

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    Paul is an established pharma executive with extensive global experience. Prior to joining Seda he was Vice President, Global Product Development at AstraZeneca, leading a group of over 350 scientists and engineers in the development of all products, manufacturing processes and analytical methods for the AstraZeneca small molecule portfolio.

    AstraZeneca Global Product Development has centres in the UK, Sweden, US and China and a network of partnerships with colleagues all over the world and under Paul’s stewardship registered 10 global products.

    At AstraZeneca Paul was accountable for the Drug Product CMC component of all Due Diligence assessments and was CMC lead on several multibillion dollar acquisitions. In addition, Paul is a visiting Professor of Pharmaceutics at the University of Manchester, UK and founder of the North West Centre for Drug Delivery (NoWCADD) at the University.

    He is a proven senior manager and strategic leader in Pharmaceutical Development with experience across geographical boundaries. Passionate about the development of individual and group capabilities and the application of innovation and scientific rigour to bring new medicinal products to market.

    He is recognised within the Industry and with Regulatory Agencies as a driving force in the establishment and realisation of best practice in CMC Quality by Design.

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      Expect a reply typically within 48 hours.

      Expertise:

      • Oral Drug Delivery
      • Complex Parenterals
      • Paediatric Product Development
      • Regulatory CMC
      • Analytical Sciences

      Marcel de Matas

      BSc (Hons) PhD FRSC CChem

      Director & Co-Founder

      Marcel de Matas

      BSc (Hons) PhD FRSC CChem

      Director & Co-Founder

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      Marcel has a track record in a range of management and senior scientific positions in industry and academia. Most recently he was a Principal Scientist in Product Design and Innovation at AstraZeneca, where he was responsible for introducing the latest science, new technologies (advanced drug delivery and manufacturing) and product design thinking into the Product Development group.

      Marcel has led technical activities, provided project leadership and has managed product development teams responsible for the delivery of drug projects from initial concept design through late stage development, regulatory submission and launch (including advanced drug delivery systems). He has led teams at the drug discovery-development interface, assessing the level of chemistry manufacturing and controls (CMC) technical risk and defining product design strategies in early development. Project experience has covered projects across a range of disease and therapy areas with substantial experience in the oncology field.

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        Expect a reply typically within 48 hours.

        Expertise:

        • Oral Drug Delivery
        • Paediatric Product Development
        • Complex Parenterals

        Shanoo Buhdheo

        BSc (Hons)

        Principal Scientist

        Shanoo Buhdheo

        BSc (Hons)

        Principal Scientist

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        Shanoo is an experienced pharmaceutical development scientist with many years’ experience in large pharma and the biotech sector. She has a particular interest in biopharmaceutics, development of clinically relevant in vitro tests and the development of products for paediatrics.

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          Expect a reply typically within 48 hours.

          Expertise:

          • Oral Drug Delivery
          • Complex Parenterals
          • Regulatory CMC

          Nicola Parisi

          MSc PhD

          Principal Scientist

          Nicola Parisi

          MSc PhD

          Principal Scientist

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          Nicola holds a MSc in Pharmaceutical Chemistry from the University of Messina and a PhD in Pharmaceutics from UCL School of Pharmacy. He is an accomplished Formulation Scientist with 9+ years’ experience in the field and roles at AstraZeneca and GlaxoSmithKline. He additionally holds a qualification from the Association for Project Management (PFQ). He is expert in planning, leading and managing clinical drug product development projects and has a deep understanding of change control, risk and stakeholder management processes.

          Ask me a question

            Expect a reply typically within 48 hours.

            Expertise:

            • DMPK and Dose Selection
            • Oral Drug Delivery
            • Complex Parenterals
            • Pharmacokinetic Modelling
            • Clinical Pharmacology

            Wang Wang Lee

            MPharm (Hons) PhD GPhC

            Principal Scientist

            Wang Wang Lee

            MPharm (Hons) PhD GPhC

            Principal Scientist

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            Wang Wang Lee is a GPhC registered pharmacist with a PhD in Pharmaceutical Sciences and MBA from the University of Strathclyde. She has deep industry and academic experience particularly in the areas of biopharmaceutics and product development. Her expertise in early and late stage development, risk assessing and mitigating the development challenges has helped clients transition compounds into the clinic from discovery. Most recently, she is interested in DMPK and clinical pharmacology projects for poorly solubles and complex parenterals.

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              Expect a reply typically within 48 hours.

              Expertise:

              • Oral Drug Delivery
              • Complex Parenterals

              Talbir Austin

              BSc (Hons) PhD CChem MRSC

              Consultant - Material Sciences

              Talbir Austin

              BSc (Hons) PhD CChem MRSC

              Consultant - Material Sciences

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              Dr Talbir (Tal) Austin is a consultant providing expertise in solid state, material design and characterisation, and development with particular focus on the early development phase.

              Dr Austin is a structural organic chemist who has worked within the pharmaceutical industry for nearly three decades. Her previous positions involved complex problem solving and troubleshooting of projects – overseeing material design, selection and development, from the Preclinical phase through to Early Development at AstraZeneca. She also led the design and implementation of AstraZeneca’s material selection strategy at the discovery and development interface. Dr Austin has extensive experience in optimising material properties for different therapy areas (Respiratory, Inflammation, CNS, CV, GI and Oncology) and modes of administration; oral, inhalation, parenteral, topical.

              Ask me a question

                Expect a reply typically within 48 hours.

                Expertise:

                • Complex Parenterals
                • Oral Drug Delivery

                Alexander Clout

                BSc (Hons) PhD

                Senior Scientist

                Alexander Clout

                BSc (Hons) PhD

                Senior Scientist

                Alex has a background in chemistry and holds a PhD in pharmaceutics from University College London, during which he gained extensive experience in the solid-state characterisation of pharmaceutical materials, including polymorphism and co-crystallisation, combining both thermal and structural analyses to develop a full picture of the changes occurring when materials undergo phase transitions. More recently he has worked on projects in formulation development with a particular focus on the microfluidic manufacture of nanomaterials for administration of sustained release parenterals. He also has valuable experience in the development and manufacture of oral solid dosage forms.

                Expertise:

                • Oral Drug Delivery
                • Complex Parenterals

                Elen Roberts

                BSc (Hons)

                Scientist

                Elen Roberts

                BSc (Hons)

                Scientist

                First class Medical Science graduate with 1.5 years experience working in the pharmaceutical industry. Areas of focus include formulation development for both preclinical and clinical studies across a range of administrative routes and indications, including the use of amorphous solid dispersions to enhance the solubility of poorly soluble compounds.

                Expertise:

                • Oral Drug Delivery
                • Analytical Sciences

                Sin Nee Teoh

                BSc (Hons) MRes

                Scientist

                Sin Nee Teoh

                BSc (Hons) MRes

                Scientist

                Sin Nee has a Medicine and tissue engineering background with 1.5 years’ experience working in the pharmaceutical industry. Areas of experience include formulation development for preclinical and clinical studies as well as analytical development for Client specific compounds. Responsible for method development and upkeep of LC systems in Seda.

                Expertise:

                • Oral Drug Delivery
                • Analytical Sciences

                Vivien Lin

                BSc (Hons) MRes

                Scientist

                Vivien Lin

                BSc (Hons) MRes

                Scientist

                Biomaterial and tissue engineering graduate with a MRes in regenerative medicine. Working in the pharmaceutical industry for 1 year. Focus on analytical and formulation development for both preclinical and clinical studies.