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Hands-On Course In Tablet Technology: September 13-18, 2009

COURSE DESCRIPTION

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.

COURSE OBJECTIVES

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.

COURSE OUTLINE

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

LABORATORY CONTENT

The laboratory will cover the following topics:

• Particle Size Analysis, Density, Porosity, Dynamic Flow Determination, Surface Area Measurement and Moisture Sorption/Desorption
• High Shear Mixing; Wet, Hot-Melt and Fluid Bed Granulation; Extrusion-Spheronization
• Tablet and Particle Coating, and Tensile Strength Testing
• Instrumented Tablet Compression, Tablet Evaluation, Disintegration and Dissolution
• Spray Drying
• Near Infrared Spectroscopy
• Determination of drug content in tablets and purity of raw materials using LC/MS/MS

ENROLLMENT INFORMATION

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.

Enrollment Forms

Online Enrollment Form

ACCOMMODATIONS

A block of rooms has been reserved at a nearby hotel. Participants are responsible for making their own hotel reservations. Hotel information will be sent to preregistrants so that direct confirmation with the hotel can be made. 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.

For a brochure and enrollment form please contact:

COURSE FACULTY

Mr. John F. Addison (Consultant)
Mr. Eddie L. Brunson (Univ of TN)
Mr. Dave Ellis (Glatt Air)
Dr. Isaac Donkor (Univ of TN)
Mr. Shawn Engels (Vector Corp.)
Mr. Donald Foltz (Vector Corp.)
Dr. Reba A. Forbess (Consultant)
Dr. Rajeev Gokhale (Abbott)
Dr. Munir Hussain (Brystol-Myers Squibb Co.)
Dr. Gerald Rajan (Schering Plough Healthcare)
Dr. James R. Johnson (Univ of TN)
Dr. Casey Laizure (Univ of TN)
Ms. Courtney Magee (LCI Corporation)
Ms. Lana Terzian (ISP)
Dr. William McLaughlin (Schering Plough)
Mr. Robert Mattes (Foss NIRSystems)
Dr. Yingxu Peng (AstraZeneca)
Dr. Stuart Porter (ISP, Inc.)
Dr. Wen Qu (Univ of TN)
Dr. Umang Shah (Solvay)
Mr. Timothy Smith (Vector Corp.)
Dr. Arthur Straughn (Univ of TN)
Dr. Shilpa Thosar (Takeda Pharm)
Mr. Dirk Vanderroost (Collette, N.V)
Mr. Tomas Vermeire, (Collette, N.V)
Mr. De Wood (Micromeritics, Inc.)
Dr. Rohit Ghan (Glatt Air)
Dr. Murti Vemuri (Aventis)