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Oral Drug Delivery

Optimising the release profile and exposure of your molecule

Oral drug delivery is the preferred route of administration for the majority of medicines. 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 oral drug delivery 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
  • Complex Medicines
  • Paediatric Product Development
  • CMC Regulatory

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 Medicines
    • Paediatric Product Development
    • CMC Regulatory
    • 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
      • DMPK Consultancy and Dose Selection
      • Pharmacokinetic Modelling
      • Clinical Pharmacology

      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
        • Paediatric Product Development

        Shanoo Buhdheo

        BSc (Hons)

        Senior Principal Scientist

        Shanoo Buhdheo

        BSc (Hons)

        Senior 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
          • CMC Regulatory

          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.

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            Expect a reply typically within 48 hours.

            Expertise:

            • Oral Drug Delivery

            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.

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              Expect a reply typically within 48 hours.

              Expertise:

              • Complex Medicines
              • Oral Drug Delivery

              Paul Gellert

              BA DPhil

              Consultant - Complex Medicines

              Paul Gellert

              BA DPhil

              Consultant - Complex Medicines

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              Paul has 33+ years’ experience in Drug Discovery and Development at AstraZeneca, specialising in novel formulation, drug delivery and product design. He has led many projects and teams in identifying, evaluating and designing novel viable drug delivery-based products and new drug delivery technologies across a broad range of routes of administration and drug modalities including many complex medicines.

              From 2017 to 2021, in additional to his role as Senior Principal Scientist in Drug Delivery, Paul was the Science & Innovation Director for Drug Delivery and Product Design, accountable for driving and championing science and innovation in drug delivery and product design to create new implementable business opportunities. Paul started and led AstraZeneca’s Global Novel Drug Delivery Network for many years and is widely recognised outside AstraZeneca as an expert on drug delivery technologies and the external drug delivery environment, including patent and intellectual property aspects.

              Paul has collaborated extensively with academic groups and drug delivery companies and is the co-author and co-inventor of a number of publications and patent applications. He has been a member of a range of external groups including Editorial advisory board member for the Nanomedicine journal, Scientific Advisory Board member and Programme Chair for the Controlled Release Society Conference, Scientific Consultant to the Wellcome Trust and EPSRC programme External Advisory Board member.

               

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                Expect a reply typically within 48 hours.

                Expertise:

                • Oral Drug Delivery

                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.

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                  Expect a reply typically within 48 hours.

                  Expertise:

                  • Oral Drug Delivery
                  • CMC Regulatory
                  • Analytical Sciences

                  Arun Kamath

                  MChem (Hons)

                  Associate Principal Scientist – Analytical Sciences

                  Arun Kamath

                  MChem (Hons)

                  Associate Principal Scientist – Analytical Sciences

                  Arun Kamath is an Associate Principal Scientist in Analytical Sciences at Seda. He has a Master of Chemistry (MChem) from the University of Leeds, with over 14 years’ experience in the global pharmaceutical industry. His area of expertise is in analytical sciences for drug product development, which has involved working with a wide range of analytical techniques and developing a comprehensive understanding of drug project analytical strategy requirements and critical product quality attributes.

                  Expertise:

                  • Complex Medicines
                  • 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
                  • Analytical Sciences

                  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
                  • Complex Medicines

                  Lorraine Jones

                  BSc (Hons)

                  Scientist

                  Lorraine Jones

                  BSc (Hons)

                  Scientist

                  Lorraine has over 20 years’ high quality laboratory experience at a leading global pharmaceutical company and one of the world’s leading toxicology laboratories. She is experienced in most aspects of drug development and toxicology, ranging from pre-clinical toxicology through to human clinical trials.

                  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.