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By Jasmine Rowe, Keirnan LaMarche, and Vidya Swaminathan

ROWE_picKeirnanLaMarcheVidya SwaminathanIn recent years, fixed dose combination (FDC) products have become increasingly popular as forms of treatment for a wide range of therapeutic areas because they offer convenience, a reduced dosing burden, and cost savings for patients. Thus, FDC regimens often improve patient compliance. From a development perspective, FDCs prolong patent life of a drug product, making them highly attractive. Multilayer tablets are often utilized as cost-effective platforms for FDCs comprised of chemically incompatible active pharmaceutical ingredients (API) and matrix tablet formulations that deliver different API release profiles.

The manufacture of multilayer tablets is not trivial and subject to numerous production challenges, including difficulty in controlling dose accuracy within multiple layers, cross contamination between the layers, and delamination (layer separation) during manufacture or storage. Limited mechanistic understanding of the compaction process has led to difficulty in efficiently designing successful multilayer tablets without extensive experimentation.

To move away from the traditional trial-and-error approach and address the lack in guidance for multilayer tablet development, substantial efforts have been invested to develop materials science- and modeling-based approaches that provide insight and predictive capabilities to guide the development of high quality and robust multilayer tablet products.

The short course Fixed Dose Combination Tablets: Materials Science and Modeling Approaches for Robust Design will systematically examine experimental aspects important to the successful development of multilayer tablets by covering applications of material property knowledge toward formulation development, novel characterization techniques to assess the strength of layered tablets, modeling of the compaction process to understand dominant mechanisms for layer adhesion, and the use of small-scale experiments to provide early insight into risk assessment during the development of multilayer tablet formulations.

Here are our top reasons you should attend:

  • Understand what causes the layers to stay together and what causes them to come apart
  • Learn how to measure the former without breaking the tablet (that’s the difficult part)
  • Learn how to predict the latter from a renowned expert in fracture mechanics
  • Hear product quality and regulatory considerations for this class of dosage from an FDA expert
  • Learn how to leverage science of scale, that is “getting from bench-top to commercial scale”
  • Share your experiences and bring your questions to interactive and lively panel discussions
  • Meet scientists and engineers from both academia and industry with an interest in bilayer tablets, who put this program together for you
  • Expand your professional network (after all this is what AAPS is all about: fostering connections and promoting education)

monster_trucks_compiled-cropIf you have registered, please make sure you arrive on Saturday; class begins at 8:00 am on Sunday, November 2! If you have not registered, we urge you to do so and learn how to make bilayer tablets so robust that they crush the competition!

 

Jasmine Rowe is a senior research investigator at Bristol-Myers Squibb (BMS), working in the area of oral solid dosage formulation development. She earned her Ph.D. in chemical engineering from the University of Texas at Austin.
Keirnan LaMarche is a senior research investigator for the Drug Product Science and Technology department of BMS, working on innovative approaches to formulation and process development for solid dosage forms. Keirnan received his Ph.D. in chemical engineering from Rutgers University.
Vidya Swaminathan is director of technical operations at BMS and is the 2015 chair of the AAPS Manufacturing Science and Engineering section.