Product Development: Initiatives and Experiences Rufinamide Paediatric formulation development Inception meeting 26 th Nov 2014 Dr Shital Mahindra Maru Chair and Senior lecturer Dept. Pharmaceutics and Pharmacy Practice
Outline 1. Scope 2. Drug delivery in Context 3. Technology drivers 4. Core Capabilities at SoP 5. Expertise available at SoP 6. Facilities 7. Collaborative Research, Consultancy and Knowledge transfer Partnerships 8. Postgraduate Studies 9. Conclusion
Scope ∗ Formulation, research and development of generic Rufinamide paediatric formulation for use in Lennox-Gastaut syndrome (LGS) ∗ Collaboration initiative between academia- industry and regulatory authorities ∗ Training of Postgraduate students in various areas of pharmaceutical sciences
Drug Delivery in Context ∗ Drug Delivery is the method or process of administering a pharmaceutical compound to achieve therapeutic benefit ∗ Right amount ∗ Right time Formulation Formulation and and Product Design Product Design ∗ Right tissue Dosage Form
Technology Drivers for Paediatric Drug Products Palatability Precise, accurate and flexible dosing Ease of preparation and administration Paediatric Appropriateness Controlled Product for wide Release range of ages Drivers PK and Biopharm Stability Challenging molecules
Core Capabilities-SOP Quality by design
Expertise Department of Pharmaceutics and Pharmacy Practice 1. Dr Nasser Nyambene Nyamweya PhD. Pharm.Sc. University of Maryland, USA, MSc. University of Arkansa USA 2. Dr Lucy Jemtai Tirop B.Pharm (UoN), PhD King � s College London 3. Dr Shital Mahindra Maru B.Pharm (Karnataka University, India), M.Pharm Pharmaceutics (RGHUS, India), PhD Pharmaceutics (UoN), MBA (Uni. Liverpool, UK) 4. Prof. K.A.M Kuria. BSc Pharm. (Sunderland, UK) MSc (UoN), PhD (Katholieke Uni., Belgium)
Expertise .. contd Dept. Pharmacology and Pharmacognosy 1. Dr Margaret Oluka, B.Pharm (UoN), MSc (UoN), PhD(UoN) 2. Dr. Eric Guantai B.Pharm (UoN), MSc (UoN), PhD (UCT, SA) 3. Prof. A.N. Guantai B.Pharm (UoN), MSc (UoN), PhD
Expertise at SoP. Contd. ∗ Dept. Pharmaceutical Chemistry 1. Dr John Ogeto BPharm, MSc Pharmaceutical Sciences (Bradford, Uk) 2. Dr B. Amugune B.Pharm (UoN), MPharm (UoN), PhD (UoN) 3. Dr K. Abuga B.Pharm (UoN), MPharm (Katholieke Uni, Belgium), PhD (UoN)
Facilities ∗ Stability Chamber (KBF720, Germany) ∗ HPLC (Shimadzu, Japan) ∗ GC-MS (Shimadzu, Japan) ∗ UV-VIS Spectrophotometer (Prestige-21) ∗ Infra- red (IR) Spectrophotometer ∗ Dissolution apparatus (Erweka DT6, Germany) ∗ Disintegration tester (Erweka V-110 HZ 60, Germany) ∗ Friability tester (Erweka, TA3 HZ 60, Germany) ∗ Automatic Single punch Tablet Press (Erweka, EP-1, Germany) ∗ Electronic Tablet Hardness Tester (Schleuniger-2E, Germany) ∗ Multipurpose motor drive with attachments (Erweka, AR 400, Germany
Contract Research Work ∗ Drug Analysis Research Unit (DARU): Quality control, Quality Assurance and Analytical method development, Process Analytical Technology (PAT) ∗ Pharmaceutical product Development Unit: Formulation and process technology development, Quality by design (QbD) concepts for product development ∗ Pharmacological studies : animal models, Clinical trials and Bioequivalence studies ∗ Pharmacovigilence studies: Post market surveillance studies ∗ Pharmcoepidemiology studies
Collaborative Research, Consultancy, Knowledge Transfer Partnerships We look forward for more work in the following areas - Continuous granulation - Continuous tableting - Solubility and Dissolution Improvements - Modified Release systems - Paediatric and geriatric formulation development - Taste making - Trans dermal and muco-adhesive films - Coating technology - Polymer science - PAT (In Line measurements)
Collaborative work .. Contd ∗ Industry sponsored Masters and PhD studentships ∗ Collaborate to generate new Intellectual Property (IP) - with option to exploit new IP through Joint Venture
Postgraduate Studies and Placement Schemes ∗ Opportunities for Masters and PhD students to do research in various areas like - M.Pharm Industrial Pharmacy student: Pre formulation studies on Rufinamide and excipients used for solid oral and liquid oral dosage forms - M.Pharm Pharmaceutical Analysis on analytical method development and validation for Rufinamide - PhD studies on how to improve solubility and permeability of Rufinamide and use novel drug delivery system like solid dispersion or nano particulate system - PhD Pharmacology on Clinical trials and bioequivalence studies of prepared formulation
Concluding Remarks ∗ Strong drivers for application of formulation development of Rufinamide for Paediatric patients ∗ Necessity for rapid and affordable access to Rufinamide paediatric formulation in East Africa increases the emphasis for adoption of flexible dosing platform technologies (age appropriate dosing) ∗ Potential to develop and scale up pharmaceutical production of generic Rufinamide paediatric formulation locally
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