Issue link: http://www.e-digitaleditions.com/i/730359
6 OCTOBER2016 Inhalation The 2016 American Association of Pharmaceutical Sciences (AAPS) Annual Meeting is fast approaching and will be held November 13-17 in Denver, CO, US. This year's pro- gram promises to include a range of scientific topics and discussions rele- vant to pharmaceutical scientists, for- mulators, chemists and regulatory officials across the world. The AAPS Inhalation and Nasal Technology Focus Group (INTFG) is excited to be supporting three ses- sions that will be included within the meeting. A brief description of each session is provided below. Please mark your calendars and try to attend these presentations. The Lipinski rule of 5 for alternative routes of administration: Dialogue and debate The systemic absorption and distrib- ution of the drug substance from a dosage form is dependent primarily upon the physicochemical properties of the drug, the dose administered, and the permeability and pharmaco- kinetics associated with the route of administration. An approach for clas- sifying orally administered drugs based on a macroscopic assessment of gastrointestinal permeability and aqueous solubility was first intro- duced in the 1990s. Even though this Biopharmaceutical Classification System (BCS) has been revised over t h e e n s u i n g y e a r s , i t s g o a l h a s remained the same: to provide a basis for correlating in vitro drug product dissolution to in vivo bioavailability assuming that drug dissolution, drug dose and GI permeability are the attributes dictating the rate and extent of drug absorption via the oral route of administration. on oral drug delivery") and Chris Edwards ("Pulmonary drugs— Physicochemical properties"). The session will be held on Tuesday, Nov- ember 15, 10:00 AM - 12:00 PM. 3D-printed drug delivery systems The United States Food and Drug Administration (FDA) recently characterized personalized medicine as "the tailoring of medical treat- ment to the individual characteris- tics, needs and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up." Three dimensional (3D) printing has the potential to play a role in achieving this and is a growing technology. It has been used in the manufacture of the oral drug Spritam (levetirac- etam) (Aprecia Pharmaceuticals) for the treatment of epileptic seizures, recently approved by the FDA. This indicates that future, broader deployment within the pharmaceu- tical industry is possible. To provide a fundamental overview of the technology, a sunrise session titled "3D-printed drug delivery sys- tems" will be on held on November 17, 7:30-8:45 AM. Two speakers, Didier Lefebvre from Abbvie and Clive Roberts from The University of Nottingham, will give presenta- tions with specific emphasis on prin- ciples of 3D-printed dosage forms, commercial opportunities and hur- dles. This session couples with a symposium titled "A new chapter in pharmaceutical technology: 3D- printing for solid oral dosage forms" on the same day to give meeting attendees detailed insight into this exciting development in pharma- ceutical technology. In contrast, drugs delivered via inhalation devices are deposited within the complex and diverse architecture of the human lung, rather than being swallowed for absorption in and distribution from the gastrointestinal tract. Drug depo- sition within the lung and the dose to the lung are primarily influenced by the inhalation device design, aerody- namic particle size and distribution of the dispersed product, fluid mechanics and the way the patient interacts with the drug delivery device. Although an inhalation drug classification system has not been established to date, at least one paper has been published on this topic. For inhaled drug products, the develop- ment of a classification system that combines the physicochemical prop- erties of the drug, the critical quality attributes of the product and the biology of the lung is the first step in understanding the role of in vitro performance parameters on in vivo product performance. The session "Lipinski Rule of 5 for alternative routes of administration: Dialogue and debate" is a continua- tion of the inhalation BCS (iBCS) discussion initiated at the AAPS/ FDA/USP workshop held in Balti- more, MD, US in 2015 and is spon- sored by the AAPS Inhalation and Nasal Technology Focus Group (INTFG). The session is designed to be a scientific "point/counter-point" discussion focused on whether an inhalation classification system is more aligned with a BCS or Lipinski Rule of 5 approach. The findings at this session will further support devel- opment of a pulmonary drug classifi- cation model. The session will include two speakers: Gordon Ami- don ("Impact on ADME properties Jayne Hastedt and Philip Kuehl On behalf of the AAPS Inhalation and Nasal Technology Focus Group CROSS - I NDUSTRY orGANIzATIoNS INTFG to support three sessions at 2016 AAPS Annual Meeting