Dr. Jacobs has over twenty years of experience in the fields of controlled release and microencapsulation. He was formerly the Director of Drug Delivery Technology for KV Pharmaceutical in St. Louis, Missouri and previous to that was the Director of R & D at Particle and Coating Technologies. He was also a member of the research faculty at Washington University in the Chemical Engineering Department working with Prof. Robert Sparks. Dr. Jacobs has developed several products that are on the market in the U.S. and around the world including several generics and specialty pharmaceuticals, a nutritional supplement, a veterinary controlled release parenteral injection and a pharmaceutical excipient. He also developed several products in various stages of clinical testing. He has numerous patents in the area of controlled release technology and has authored or co-authored a variety of published papers and symposium presentations on controlled release techniques including pharmaceutical bioavailability enhancement, spray drying, taste-masking, and process scale-up. He has co-authored three book chapters on subjects such as pharmaceutical processing, microencapsulation in pesticides, and microencapsulation processing and formulations for the food industry. He has been an invited speaker at technical symposia in the U.S., Australia, Europe, and Asia and a course director for the Center for Professional Advancement.

Dr. Jacobs has demonstrated a career path across a number of areas of formulation development mostly concentrated around controlled release. He has also consulted in areas of formulation development, strategic planning, evaluation of current process technologies, and project team leadership. He has performed tasks related to expert witness testimony in a number of patent litigation cases. He has consistently met goals, objectives and deadlines with outstanding performance ratings. He has excellent teaching ability providing strong presentations and demonstrating outstanding communication and interpersonal skills.

• Assessment of project goals to begin dosage form design and formulation development
• Analytical needs assessed and any contract analytical work or inside biopharmaceutics work defined and assigned
• Existing patents researched. Technical articles, books, or other references researched to provide background to the development effort
• Experimental design: formulations to prepare, processes defined, any process development work described; assign to contract research organizations if needed
• Review any problems encountered during formulation development, review results; design follow on studies as needed

• Bioavailability enhancement: amorphous matrix, nanoparticle preparation by nanoprecipitation and nanodispersion techniques
• Taste masking: examination of solubility and existing particle morphologies available and design of formulation techniques including granulation / particle coating using fluid bed techniques or matrix particle preparation using lipid matrix. This includes use of specific flavors and sweetener combinations and other additives which can greatly effect taste profiles. Other recent techniques used for taste masking include melt based coatings with various additives to adjust release kinetics and coacervation techniques. New techniques using ion exchange resins have been developed and a great deal of experience has been gained in this area.
• Buccal delivery devices: use of multilayering systems for delivery of active ingredient in controlled manner as well as proper use of adhesives
• Aqueous suspensions: experience includes use of ion exchange resins and use of varying wetting agents and viscosifiers for maintaining dosage uniformity. The balanced use of flavors and sweeteners has been developed.
• Use of various additives in high shear granulation to provide extended release
• Use of various additives in multiparticulate coating to control release kinetics but also to prevent any ingredient interaction with coating chemistry

• Improved techniques for spray drying especially when organic solvents may be necessary
• Particle engineering during spray drying operations
• Fluid bed coating techniques for fine particles to prevent agglomeration
• Fluid bed coating techniques with molten coatings
• Rotary atomizer design and particle coating techniques especially where narrow size distributions may be required

• Set project timelines
• Coordinate activities of outside contract research organizations
• Define analytical requirements including biopharm studies as well as design of experiments to assess pharmacokinetics of candidate formulations

• Proper writing of batch records
• Auditing of raw material suppliers as well as other vendors in supply chain
• Auditing of contract manufacturers, review of SOP's
• In-process and finished product analysis techniques and documentation

• Dosage form design for special needs patients: the elderly, the very young
• Included new taste masked dosage forms providing flexibility in dosage size
• Formulation of large dosage forms for improved compliance and use in managed care facilities