Hands-On Course in Tablet Technology

The Hands-on Course in Tablet Technology, a post-graduate educational program offered by the Pii Center for Pharmaceutical Technology at the University of Mississippi School of Pharmacy, provides an extensive overview of conventional and advanced manufacturing technologies, including hot-melt extrusion, that is used to develop a variety of novel dosage forms.

Experts from industry and academia present lectures and supervise laboratory assignments that provide an in-depth overview of the development, manufacturing, and quality control of solid oral dosage forms. Lectures explore the concepts involved in designing tablet formulations and manufacturing processes using QbD principles, from selecting excipients based on preformulation data to regulatory strategies for making post-approval changes to the formulation and/or manufacturing process for NDA/ANDA drug products.

The laboratory portion of the course is designed to provide attendees with practical, hands-on experience in unit operations discussed in lecture sessions. Laboratory sessions include hands-on experience conducting pre-formulation studies, preparing powder blends and granulations (e.g., hot-melt extrusion and high shear granulation), manufacturing tablets (e.g., instrumented tablet press, 3D printing, and tablet coating operations), and conducting in-process and quality control release tests.

The course, initiated in 1998, has trained over 2,000 attendees, including scientists and engineers working in formulation development, process development, manufacturing, analytical method development, and quality control, and sales and marketing professionals from the pharmaceutical, dietary supplement, animal health, and food industries. Other attendees have been from excipient and equipment suppliers and regulatory authorities, including the FDA and Health Canada.

LAB 1 – Preformulation

Evaluate properties of a pharmaceutical API, powders, and polymers utilizing:

• Particle surface area analysis
• Porosity analysis
• Particle size and shape analysis
• Density analysis
• Moisture adsorption/desorption isotherms
• Texture analysis
• Thermogravimetric analysis
• Differential scanning calorimetry

LAB 2 – Granulation and Extrusion/Spheronization

Processing of a pharmaceutical API and excipients to form granules and extrudates by:

• High shear mixing and wet granulation
• Low shear mixing and wet granulation
• Extrusion/Spheronization
• Fluid bed drying

LAB 3 – Tableting

Evaluate excipient/drug compressibility and compressibility of wet granulated vs. direct compression tablet formulations utilizing:

• Instrumented single punch tablet press
• Instrumented rotary tablet press
• Equipment to monitor weight, thickness, and breaking strength of tablet compacts
• Software to determine scalability from small to large-scale production presses

LAB 4 – Hot Melt Extrusion, 3D Printing and Tablet Evaluation

Evaluate processing of hot melt extruded forms using:

• Hot melt extruder
• 3D Printing

Perform tests to evaluate quality control attributes of tablets using:

• Tablet dissolution apparatus, real-time and interval drug release testing
• Tablet disintegration testing
• Tablet friability testing

LAB 5 – Fluid Bed Granulation/Particle Coating and Tablet Pan Coating

Evaluate granulation of an API/excipient blend and film coating of non-pareil particles using:

• Fluid bed granulator/Wurster particle coater

Pan coat tablets using:

• Side-vented tablet coating pan

Travel

Shuttles will be confirmed via e-mail. Please meet your shuttle driver inside the airport and nearby Baggage Claim, Area B escalator.

Lodging

*For discounted room rates, please click the links below.*

The Inn at Ole Miss
Courtyard Marriott Oxford

Participants are responsible for making their own room reservations. The Inn at Ole Miss and Courtyard Marriott in Oxford have reserved block rooms for Tablet Course participants. The Inn at Ole Miss is on campus, close to on-campus lecture and laboratory facilities. The Marriott is located adjacent to the University of Mississippi campus at 305 Jackson Avenue East, also close to campus facilities.

Reservations at either of the referenced hotels should be confirmed 2-3 weeks before the course to receive the reduced rates.

Area

Special Accommodations

Contact Le’Tosha James for special accommodations at the course
Email: ljjames@olemiss.edu
Phone: (662) 915-7341
Fax: (662) 915-1177

Tablet Course

Sateesh Kumar Vemula

Phone: (662) 915-1155

Fax: (662) 915-1177

tabcourse@olemiss.edu