Transcript Rufenamide-presentation-oluka-mod

Product Development:
Initiatives and Experiences
Rufinamide Paediatric formulation development Inception meeting 26th Nov 2014
Dr Shital Mahindra Maru
Chair and Senior lecturer
Dept. Pharmaceutics and Pharmacy Practice
Outline
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Scope
Drug delivery in Context
Technology drivers
Core Capabilities at SoP
Expertise available at SoP
Facilities
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 academiaindustry 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
and
Product Design
 Right tissue
Dosage Form
Technology Drivers for
Paediatric Drug Products
Palatability
Precise, accurate and
flexible dosing
Ease of preparation and
administration
Paediatric
Product
Drivers
Controlled
Release
Appropriateness
for wide
range of ages
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
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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