פורמולציה לכימאים Formulation for Chemists

מרצה: Dr. Malcolm Ross

תאריך: 9, 10 אפריל 2014
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 14312
שפת הקורס: עברית
על הקורס
To develop efficient and reliable analytical methods the pharmaceutical analyst needs to understand the influence of both physical and chemical aspects of the drug substance and the effect of the drug formulation matrix as it may affect analytical procedures. In addition, when things go wrong it is important to understand the impact that formulation design and production techniques can have on analytical data.
It will help understanding the requirement of ICHQ8 [Pharmaceutical Development], Quality by Design and Process Analytical Technology concepts
קהל היעד
This course is intended for:
  • analytical chemists involved in the development of analytical methods for the quality assessment of finished dosage forms,
  • regulatory staff involved in compiling applications for market authorisations
  • quality assurance involved in inspecting and approving processes
פורמולציה לכימאים       Formulation for Chemists
התועלת שתופק
The modern approach to quality involves understanding processes rather than just testing the products to see if they comply with specifications.
For quality assurance and QC and analytical development chemists this means that they need to look beyond what happens in the analytical laboratory.
This course will provide participants with the fundamental tools to look at a formulation from the aspect of the formulation development and production team. They will understand why different processes and excipients are selected and how these choices may affect both the development of analytical methods and affect the reliability of the results. They will be able to look beyond the “analytical” part of an investigation into “out of specification” and become involved in planning and executing such investigations with a fundamental understanding of how such simple processes as mixing can affect the product quality.
For regulatory staff, this course will provide an insight into the science behind the documentation that they prepare and show how changes in materials or processes are related to the requirements for the filing of variations.
Although this course is not designed for in-depth formulation development it may prove valuable to new formulators starting on their careers
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
SECTION 1 DOSAGE FORM DESIGN
Why do we need different dosage forms and what sort of analytical challenges do they present. Physical properties of the drug substance and the finished dosage form from an analytical viewpoint [particle size measurement issues, viscosity etc.]

SECTION 2 EXCIPIENTS
  • The structure and function of some of the more important excipients
  • Excipient variability and GMP issues
  • Excipients that can interfere with the drug substance
  • Physical interference
  • Chemical interference
  • Excipients that can interfere with the analytical procedure
  • Non specific interference
  • Specific interferences
  • Analysis of excipients
  • Functionality Related Characteristic Testing
SECTION 3 SAMPLING ISSUES
  • Obtaining representative samples from different formulations
  • Factors affecting sample homogeneity including blending and segregation
  • The influence of particle size and shape on homogeneity and segregation
  • Blend uniformity
SECTION 4 MANUFACTURING PROCESSES AND THEIR EFFECT ON RESULTS
  • A comparison of different processes used in the manufacture of solid dosage forms including direct compression and wet granulation and tablet coating processes.
  • Dosage forms covered will include instant release tablets, modified release formulations and hard gelatine capsules.
  • Process effects on performance attributes such as dissolution, stability or polymorphic content.
SECTION 5 ANALYTICAL ERROR
  • An examination of analytical error
  • How the formulation issues translate into analytical error such as reproducibility and accuracy
  • Adjustment of analytical methods to reduce identified error
  • Regulatory aspects of altering analytical procedures-filing variations
SECTION 6 MISCELLANEOUS
  • Challenges of some special dosage forms [a brief overview of some dosage forms that present special analytical challenges]
  • Packaging artefacts
אודות המרצה

Dr. Malcolm Ross

Dr. Malcolm Ross is a consultant specialising in training, project management and research and development in the pharmaceutical industry.
He holds a B.Pharm and Ph.D in medicinal chemistry from London University, was a lecturer at the Welsh School of Pharmacy, UWIST and a Visiting Senior Lecturer in the Dept. of Chemistry at Bar Ilan University and is a registered pharmacist in the State of Israel.
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