Hands-on Course in Tablet Technology
This course is intended to provide an overview of the fundamental concepts of the technology for preparation of uncoated / coated tablet products. Participants will work in teams to prepare uncoated / coated tablet dosage forms and conduct selected relevant testing for evaluation and quality control. Appropriate techniques and state of the art equipment will be utilized for manufacturing, data acquisition and quality control.
Lectures will include topics in the tabletting process, such as preformulation, granulation, tabletting and coating, as well as stability, validation, product evaluation, FDA regulatory requirements and SUPAC guidelines.
Laboratory will consist of "20 hours of hands-on training" and include preformulation, granulation, tabletting, coating, and tablet evaluation.
Through laboratory practice and lectures, the course is designed to allow participants to:
- Develop an overall understanding of the science and technology of solid dosage forms processing
- Explore concepts of scale up, process validation, product evaluation and FDA regulatory requirements
- Learn or review principles in the technologies of development, production and quality control including QbD and PAT
- Gain hands-on experience in planning, processing and testing uncoated / coated tablets
- Work and exchange ideas with faculty and other participants
WHO SHOULD ATTEND
This course presents an in-depth study of tablet processing including an extensive laboratory program. It emphasizes the industrial application of the development, processing and quality control functions. It is suitable to introduce this operation to technical personnel from research, development, production and quality control, as well as administrators, FDA investigators or other individuals who need an introduction to tabletting.
Registration for the course will be 6-7 p.m. on Sunday. The course will end at 12:00 p.m. on Friday.
The topics to be covered in the lecture portion of the course include:
- Preformulation techniques
- Formulation Selection
- Near Infrared Spectroscopy
- Mixing and Blending
- Granulation and Drying Principles
- Powder Compression and Compaction
- Excipient Uses and Case Studies
- Physical Evaluation of Tablets
- Introduction to Coating and Sugar Coating
- Film Coating
- Scale up Considerations for Granules and Tablets
- Process Validation
- SUPAC Guidelines
- Stability and Expiration Dating - FDA Requirements
- Bioequivalence - FDA Requirements
LAB 1 (Preformulation)
- Particle Size Reduction & Analysis
- Density (true)
- Surface Area and Porosity Measurement
- Moisture Adsorption/Desorption Isotherms
- Spray-Drying of Potent Drug
- Determination of Particle Size Distribution by Sieve Analysis
- Determination of Bulk and Tapped Densities
- Determination of Dynamic Flow Rate
LAB 2 (Granulation)
- High Shear Mixing and Wet Granulation
- Hot-melt Granulation
- Roller Compaction Granulation
- Extrusion – Spheronization
- Fluid-Bed Drying
LAB 3 (Tabletting)
- Tablet Compression with Hata Press
- Generation of Hardness – Compression Profiles
- Tablet Compression with Piccola Press
LAB 4 (Coating)
- Fluid-Bed Granulation
- Particle and Tablet Coating Using Fluid-Bed
- Tablet Coating Using a Pan Coater
LAB 5 (Quality Control)
- Near Infrared Spectroscopy
- Tablet Evaluation (Dissolution, Disintegration, Friability)
Participants will have the opportunity to use state-of-the-art equipments including:
- Micromeritics Surface area analyzer, Particle size analyzer, Density analyzer, Particle Insight
- VTI Corporation Moisture Sorption Analyzer
- Surface Measurement Systems DVS Intrinsic Moisture Sorption Analyzer
- Buchi Mini Spray Dryer
- Gilson Autosiever
- LCI Extrusion-Spheronizer
- Vector High Shear Mixer
- Retsch Ball-milling/particle grinding equipment
- Fitzmill Comminutor
- Niro Fluid bed dryer/coater
- Piccola Bench-Top Press
- Elizabeth-Hata Tablet press and Tester
- Vector TFC Labo Roller Compactor
- Glatt Fluid bed dryer/coater
- Vector pan coating coater
- Hanson Disintegration Tester
- pION Rainbow Dynamic Dissolution Monitor System
- Distek and Hanson Corporation USP Dissolution equipment
- PerkinElmer Lambda 20 UV Spectrophotometer
- Foss NIRSystems NIR equipment
The course fee is $3000, and MUST accompany the registration form. The course fee includes tuition, lab coats, laboratory supplies, daily refreshment breaks and a reception. Preregistration for the course is highly recommended. This can be done by submitting the online registration form to the course coordinator.
Registration cancelled more than 30 days before the start of the course will be subject to a registration fee of $1000, and the balance will be refunded. There will be no refund of fees if registration is cancelled 30 days or less before the start of the course. Substitution of another person from your company will be accepted.
Advance registration is required. To provide for an informal atmosphere and allow for individualized instruction, enrollment is limited. Registrations received after the maximum enrollment is reached will be offered priority in the next scheduled course or the entire enrollment fee returned.
The course will be held on the campus of The University of Tennessee, Memphis, located 1 mile from downtown Memphis. The laboratory program will be held in the Feurt Building, College of Pharmacy.
Spring Hill Suites, which is located at 21 N. Main Street, Memphis, TN 38103 (Tel: 901-522-2100), has been chosen for the course, the group rate is $115 per night plus tax. Hotel reservation links will be sent to the registrants via email, participants are responsible for making their own hotel reservations. The hotel will hold the rooms until 21 days before the beginning of the course. Therefore, room reservations should be confirmed no later than 21 days before the beginning of the course.