SLIDE 1 Product Development: Initiatives and Experiences
Dr Shital Mahindra Maru Chair and Senior lecturer
- Dept. Pharmaceutics and Pharmacy Practice
Rufinamide Paediatric formulation development Inception meeting 26th Nov 2014
SLIDE 2 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
Outline
SLIDE 3
∗ 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
Scope
SLIDE 4 Drug Delivery in Context
∗ Drug Delivery is the method or process
- f administering a pharmaceutical
compound to achieve therapeutic benefit
∗ Right amount ∗ Right time ∗ Right tissue
Formulation Formulation and and Product Design Product Design
Dosage Form
SLIDE 5 Technology Drivers for Paediatric Drug Products
Paediatric Product Drivers
Palatability Appropriateness for wide range of ages Challenging molecules Controlled Release PK and Biopharm Ease of preparation and administration Stability Precise, accurate and flexible dosing
SLIDE 6 Core Capabilities-SOP
Quality by design
SLIDE 7 Department of Pharmaceutics and Pharmacy Practice 1. Dr Nasser Nyambene Nyamweya PhD. Pharm.Sc. University
- f Maryland, USA, MSc. University of Arkansa USA
- 2. Dr Lucy Jemtai Tirop B.Pharm (UoN), PhD Kings 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
SLIDE 8
- 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 .. contd
SLIDE 9 ∗ 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)
Expertise at SoP. Contd.
SLIDE 10
∗ 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
Facilities
SLIDE 11
∗ 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
Contract Research Work
SLIDE 12 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 Research, Consultancy, Knowledge Transfer Partnerships
SLIDE 13 ∗ Industry sponsored Masters and PhD studentships ∗ Collaborate to generate new Intellectual Property (IP)
- with option to exploit new IP through Joint Venture
Collaborative work .. Contd
SLIDE 14 ∗ Opportunities for Masters and PhD students to do research in various areas like
- M.Pharm Industrial Pharmacy student: Pre formulation studies
- n 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
- f prepared formulation
Postgraduate Studies and Placement Schemes
SLIDE 15
∗ 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
Concluding Remarks
SLIDE 16
