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Course Description

This course is intended to provide an overview of the fundamental concepts of the technology for preparation of uncoated/coated tablet products including hot melt extrudates. Participants will work in teams to prepare uncoated/coated tablet dosage forms including hot melt extrudates and conduct selected relevant testing for evaluation and quality control.

Lectures will include topics in the tableting processes and hot melt extrusion, such as preformulation, extrusion, granulation, tableting, 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, hot-melt extrusion, granulation, tableting, coating, and tablet evaluation.

Course Dates

  • March 2-7, 2014
  • June 1-6, 2014
  • September 21-26, 2014

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 form processing with the introduction of hot melt extrusion to the course
  • 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 including hot melt extrudates
  • 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, which now includes hot melt extrusion. It emphasizes the industrial application of the development, processing, and quality control functions. It is suitable to introduce this course to technical personnel from research, development, production, and quality control, as well as administrators, FDA investigators, or other individuals such as educators who need an introduction to tableting.

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Course Outline

Registration, reception and orientation will be 6:00-7:30 pm on Sunday. The course will end at 12:00 pm Friday.

Lecture topics covered in the course Include:
  • Preformulation Techniques
  • Formulation Selection
  • Mixing and Blending
  • Hot-Melt Extrusion
  • Granulation and Drying Principles
  • Powder Compression and Compaction
  • Excipient Uses and Case Studies
  • Physical Evaluation of Tablets
  • Laboratory
  • 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

LAB 1 (Preformulation)
  • Particle Size Reduction and/or Analysis
  • Density (True)
  • Surface Area and Porosity Measurement
  • Moisture Adsorption/Desorption Isotherms
  • Determination of Particle Size Distribution by Sieve Analysis
  • Determination of Bulk and Tapped Densities
  • Determination of Dynamic Flow Rate
  • Texture Analysis
  • Thermogravimetric Analysis
  • Differential Scanning Calorimetry
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LAB 2 (Granulation, Extrusion/Spheronization)
  • High Shear Mixing and Wet Granulation
  • Hot-Melt Granulation
  • Roller Compaction Granulation
  • Extrusion – Spheronization
  • Fluid-Bed Drying
LAB 3 (Tabletting)
  • Excipient Compressibility/Loading CapacityEvaluation
  • Tablet Compression with Piccola Press
  • Generation of Hardness – Compression Profiles
LAB 4 (Hot Melt Extrusion, Quality Control
  • Hot-Melt Extrusion
  • Tablet Evaluation (Dissolution, Disintegration, Friability)
LAB 5 (Coating, Granulating)
  • Fluid-Bed Granulation
  • Particle and Tablet Coating Using Fluid-Bed
  • Tablet Coating Using a Pan Coater
laboratory

Laboratory Facilities

Participants will have the opportunity to use state-of-the-art equipment including:

  • Micromeritics Surface area analyzer, Particle size analyzer, Density analyzer, Particle Insight
  • Surface Measurement Systems DVS Intrinsic Moisture Sorption Analyzer
  • LCI Extrusion-Spheronizer
  • Vector High Shear Mixer
  • Fitzmill Comminutor
  • Mendel Fluid Bed Processor
  • Piccola Bench-Top Press
  • Vector TFC Labo Roller Compactor
  • Glatt Fluid bed dryer/coater
  • Vector pan coating coater
  • Sotax Disintegration Tester
  • pION Rainbow Dynamic Dissolution Monitor System
  • Distek USP Dissolution equipment
  • Hanson SR8 Dissolution Test Station
  • Thermo Scientific Genesys TM 6 UV Spectrophotometer
  • Retsch Ball-Milling/particle grinding equipment
  • Thermo Fisher Hot Melt Extruders
  • Sotax Disintegration Tester, Friability Tester, Flowability Tester, Hardness Tester and Tap Density Tester

Fee and Enrollment

The course fee is $3,000 and includes tuition, lab coats, laboratory supplies, daily refreshments, lunch, and a reception. Pre-registration for the course is highly recommended. Mail or fax the completed form to the Course Registrar.

Registration cancelled more than 30 days before the start of the course will be subject to a cancellation fee of $1,000, 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.

To provide 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 will be returned.

REGISTER ONLINE

Location

The course will be held on the campus of the University of Mississippi, which is located one mile from downtown Oxford, Mississippi, and approximately 75 miles south of Memphis, Tennessee. Participants should use the Memphis International Airport for air travel. Lectures will be held in the E.F. Yerby Conference Center and the laboratory program will be held in nearby Faser Hall on the University of Mississippi campus.

laboratory

Accommodations

A block of rooms has been reserved at the conveniently located Inn at Ole Miss Hotel. The Inn at Ole Miss Hotel is located on campus at 120 Alumni Drive. Participants may contact the hotel by phone at (662) 234-2331 or (888) 486-7666 or by fax at (662) 236-4835. The group rate is $99 per night for standard accommodations, $119 for deluxe accommodations, and $159 for one-bedroom suites. Participants are responsible for making their own hotel reservations. Participants should ask for the Tablet Technology for Pharmacy Professionals Group room block when registering. Reservations by attendees must be received on or before February 16, 2014, to receive the special room block rate. These rates are valid for the 2014 courses.

Special Accommodations

Please call Barbara Thompson, Course Coordinator and Registrar at (662) 915-5811 or email her at bthompso@olemiss.edu, if you need special accommodations such as dietary, sight, hearing, or access at this course.

Transportation

Persons who plan to fly to the course should book their flights to and from Memphis (Tennessee) International Airport. The University will provide a shuttle service for course participants who arrive at the Memphis International Airport (approximately 75 miles or 1 hour and 15 minutes drive). The cost of the shuttle is $135 round trip or $85 one-way. Shuttle reservations must be made and paid for in advance of travel by check (made payable to the University of Mississippi) or by Visa or MasterCard. If you would like to use the shuttle service, please contact Drew Pruitt, Project Administrator at 662-915-5132 or email: appruitt@olemiss.edu. Shuttles will be confirmed via e-mail. Please meet your shuttle driver inside the airport and nearby Baggage Claim, Area B escalator. (AMTRAK shuttle cost is $135 round trip or $85 one-way.)

Pharmaceutical Research, Development and Training Laboratories: Tablet Technology

Course Directors

Faculty
  • Dr. S. N. Murthy
  • Dr. Walter Chambliss
  • Dr. Nigel Langley
  • Mr. Mike Yelvigi
Graduate Students/Post-Doctoral Scientists
  • Hemlata Patil
  • Joe Morott
  • Naresh Modepalli
  • Nagendra S. Punyamurthula
  • Xin Feng
  • Manjeet Pimparade
  • Dr. Vijay Kulkarni
External Course Faculty
  • Mr. John F. Addison, Consultant
  • Dr. Firouz Asgarzadeh, Evonik Corporation
  • Mr. Brad Beissner (Ashland)
  • Dr. Brian Carlin, FMC
  • Mr. Dave Ellis, Glatt Air
  • Dr. Jean-Marie Geoffrey, Takeda Pharm
  • Mr. Edward Godek, Glatt Air
  • Mr. Samer Habash, LCI
  • Dr. Munir Hussain, Bristol-Myers Squibb Co.
  • Dr. Kerry Johanson, Material Flow Solutions, Inc.
  • Mr. Adam Keith, Micromeritics, Inc.
  • Mr. Gus LaBella, Colorcon Corp.
  • Mr. Ronald Levans, Merck Consumer Care
  • Mr. Darvin Martin , Sotax
  • Dr. William McLaughlin, Merck Consumer Care
  • Dr. Tom McNabb, Merck Consumer Care
  • Mr. Benjamin Murugesu, Quadro Engineering
  • Dr. Carmen Popescu, Roquette, Inc.
  • Dr. Stuart Porter, Ashland
  • Dr. M. Gerald Rajan, Merck Consumer Care
  • Dr. Manesh Rane, Colorcon
  • Mr. Jeff Schiavoni, Sotax
  • Mr. Robert Sedlock, SMI
  • Mr. Timothy Smith, Vector Corp.
  • Dr. Art Straughn, Consultant
  • Ms. Lana Terzian, Ashland
  • Dr. Gerard Thone, FMC
  • Dr. Shilpa Thosar, Takeda Pharm.
  • Mr. De Wood, Micromeritics, Inc.
  • Ms. Lauren Wood, LCI

Tablet Technology: Acknowledgements

The faculty and staff of the Department of Pharmaceutics and the Pii Center for Pharmaceutical Technology in the Department of Pharmaceutics, School of Pharmacy at The University of Mississippi, Oxford, gratefully acknowledge the following corporations for their sponsorship, gracious donation of equipment and supplies, and providing instructors for this comprehensive course.

  • Agilent, Santa Clara, CA
  • Ashland Aqualon, Wilmington, DE
  • BASF Pharma Ingredients and Services, Tarrytown, NY
  • Chris Hansen, Inc., Mahwah, NJ
  • Colorcon, West Point, PA
  • Distek Inc., North Brunswick, NJ
  • Dow Chemical U.S.A., Midland, MI
  • Evonik, Inc., Piscataway, NJ
  • Fitzpatrick Corporation, Elmhurst, IL
  • FMC Corporation, Princeton, NJ
  • Foremost USA, Baraboo, WI
  • Gattefossé USA, Paramus, NJ
  • Glatt Air Techniques, Inc., Ramsey, NJ
  • Hanson Research Corporation, Chatsworth, CA
  • Hercules Inc., Wilmington, DE
  • LCI Corporation, Charlotte, NC
  • Mallinkrodt Specialty Chemicals Corporation, West Orange, NJ
  • Merck Consumer Care, Memphis, TN
  • Mettler Instrument Corporation., Hightstown, NJ
  • Micromeritics, Norcross, GA
  • Moreflex, Inc., Greensboro, NC
  • Mutchler, Inc., Harrington Park, N
  • pION, Woburn, MA
  • Quest International, Hoffman Estates, IL
  • Robot-Coupe USA, Inc., Jackson, MS
  • Sartorius Corporation, Edgewood, NY
  • SMI, Specialty Measurements Inc., Lebanon, NJ
  • Sotax, Hopkinton, MA
  • SPI Polyols, Inc., Wilmington, DE
  • Surface Measurement Systems, Allentown, PA
  • Vector Corporation, Marion, IA
Tribute to Dr. Atul Shukla and Dr. James R. Johnson, founders of the Hands-on Course in Tablet Technology:

15 years ago, Dr. Atul Shukla and Dr. Jim Johnson initiated the first Hands-on Course in Tablet Technology as a continuing education opportunity for the pharmaceutical industry and regulatory agencies, and as a means to help support the graduate student program at the University of Tennessee. At that time no Hands-on post graduate industrial course existed. Little did Dr. Shukla and Dr. Johnson know that their efforts would result in a course that is still one of a kind and is well accepted by the pharmaceutical industry and related fields today. This course has withstood the test of time due to the assistance of experienced and knowledgeable personnel from the industry. Its focus was initially on the domestic pharmaceutical industry. However, it has transitioned since its inception to a course attended by participants from not only the USA, but Canada, Australia, Singapore, Malaysia, Bangladesh, Japan, Italy, Germany, Belgium, Brazil, Mexico, Venezuela and New Zealand. Attendees have represented various related fields of expertise – pharmaceutical, FDA, Health Canada, biotech, food, equipment, excipients, etc. Unfortunately, Dr. Shukla succumbed to lung cancer in 2009 and was unable to participate in the course as was his custom prior to his passing. However, Dr. Johnson capably directed and maintained the course going forward. It is with great pleasure that this tribute is being given to Dr. Shukla and Dr. Johnson -- two true pioneers in the area of promoting and fostering continuing education in the realm of pharmaceutical technology. The Hands-on Course in Tablet Technology is changing venue this fall from the University of Tennessee to the University of Mississippi, Oxford, MS under the direction of Dr. Jim Johnson and Mr. Ed Brunson in collaboration with Dr. Michael Repka, Chairman, Department of Pharmaceutics, School of Pharmacy and Dr. Soumyajit Majumdar. The vision initiated 15 years ago by Dr. Shukla and Dr. Johnson continues on at the Ole Miss School of Pharmacy.