הנושאים שמעניינים אותי
(אפשר לבחור מספר נושאים)
This course is intended for scientists who are responsible for the development of film-coated oral solid dosage forms, and the design of film-coating processes. In addition, it will be suitable for scientist and engineers who have responsibility for providing technical support to manufacturing operations with respect to film-coated products, and potentially to coating process operators and supervisors.
Formulation Design: General formulation overview
Provides a general introduction to film coating, and overview of the different types of ingredients used in film-coating formulations, and explanation of their purpose.
Formulation Design: Film-coating formulations for IR (Immediate Release) applications
Provides an overview of materials (primarily polymer classes) that are used in immediate-release film-coating formulations and describes the various properties of film coatings that can be achieved with their use.
Formulation Design: Film-coating formulations for modified release applications
Provides a general introduction to modified-release film coating, differentiating between delayed-release (enteric) film coatings and extended-release (sustained release) film coatings. Describes the various approaches that can be used for designing modified-release products, and the likely factors (from a coating formulation standpoint) that are likely to influence product performance.
Process Design: Overview of processing equipment
Provides a general introduction to the different types of coating equipment that can be used, differentiating between pan-coating and fluid-bed-coating processes. Also describes some equipment maintenance issues.
Process Design: Introduction to continuous coating processes
Introduces both large-scale continuous processes that are currently being used as stand-alone processes, as well as smaller-scale processes that are being considered as a key element of overall continuous manufacturing processes (i.e. powders in one end, packaged product out the other).
Process Design: General processing considerations
Provides a general overview of film-coating processes, and describes how the critical process parameters can influence the outcome of the process
Process Design: Overview of process thermodynamics
Focuses on a key aspect of film-coating processes, namely the drying process, and explains this in terms of process thermodynamics. Also reviews the impact of the drying process on coated product quality.
Process Design: Designing optimized processes
Introduces the concept of process optimization, using application of statistical design of experiments (D.o.E.) techniques and provides examples of how these may be used to gain a better understanding of the film-coating process.
Process Scale-up & Technology Transfer: Overview of scale-up process
Provides an overview of those factors that are critical to the successful scale-up of film-coating processes.
Discusses how to predict scale-up factors and describes the many challenges to be faced during process scale-up.
Provides case studies depicting the successful scale-up of both pan-coating and fluid-bed coating processes.
Process Scale-up & Technology Transfer: Understanding process control
Describes the scale-up process in terms of process control issues that are critical to achieving success. Also provides a brief introduction to the implementation of PAT (Process Analytical Technology) initiatives in film coating and describes some of the challenges to be faced.
Process Scale-up & Technology Transfer
Film coating on the manufacturing scale Describes several issues that are to be faced when film coating on the manufacturing scale, describing how they may impact final coated product quality. Also introduces the concept of SUPAC (Scale-Up and Post Approval Changes), an initiative introduced by the FDA to help to deal with changes that may be required once a product has received initial approval.
Troubleshooting in Film Coating
Provides a logical approach to identifying common problems that impact film-coated products, and a systematic way of dealing with such problems. Recognizes that while troubleshooting is often a production-scale issue, the answer to problem resolution may fall outside the scope of what can be achieved in the production setting. Presents several case studies.
Having completed the seminar, the participants will:
• Understand the classes of ingredients that are used to prepare film-coating formulations, including becoming familiar with the impact that each can have on the functionality of the coating.
• Become conversant with how the different types of film coatings can influence the behaviour of the final dosage form, especially when dealing with coatings that are intended to improve product stability or modify drug release.
• Gain familiarity with the different types of equipment that can be used to film coat pharmaceutical dosage forms, understand how to identify important processing parameters, become familiar with process thermodynamics, and achieve an understanding of approaches that may be used to facilitate process optimization.
• Understand the important issues involved in scaling up film-coating processes, particularly with respect those parameters that are critical to achieving effective control of the process.
• Gain a good understanding of those issues involved in troubleshooting film-coating processes, and be able to recognize those that can be handled within the scope of existing regulatory constraints, and those that might require greater intervention than just attempting to make minor processing adjustments.
הנושאים שמעניינים אותי
(אפשר לבחור מספר נושאים)