12:00- 13:00 Shinji YAMASHITA (Setsunan University)

2016-10-05

Cutting edge Seminar

 

Speaker:

Shinji YAMASHITA, Ph.D. (Professor, Laboratory of Biopharmaceutics, Faculty of Pharmaceutical Sciences, Setsunan University)

Title: Ambition or just a dream?  History and future perspective of oral delivery of biologics

 

Date&Time:  5 Oct. (Wed.) 2016, 12:00- 13:00
Venue: Conference Room(1F), IMEG

Abstract:

Recent trend in drug development toward bio-molecules rather than small compounds has increased the demand for oral delivery of biologics, especially of therapeutic peptides and proteins. Since major factors limiting oral absorption of peptides/proteins are 1) the pre-systemic degradation by enzymes and 2) the poor penetration of the intestinal mucosa and epithelium, various systems which can bypass those barriers have been proposed so far. However, despite extensive research efforts by industrial and academic laboratories, no major breakthrough in the effective oral delivery of peptides/proteins has been accomplished. Much of those researches have been characterized by early promise with the system showing positive results in animal studies, whereas success in human has proven more elusive. For clinical use, in addition to enough abilities to enhance the absorption, oral products of biologics are required to guarantee the short- and long-term safety, the reproducibility in the therapeutic effect and the uniformity of product’s quality. At present, several products of biologics including oral insulin and GLP-1 peptide are on the stage of clinical trial. If they succeed the trial and are approved for marketing, it might trigger further development of oral biological products. In the presentation, different types of oral delivery system of biologics, such as absorption enhancers, particulate carrier systems or chemical/physical conjugation with other molecules, will be introduced and discussed for their potential to be developed as a market product.

 

References:

Tsume T. et al., Biol Pharm Bull. 19:1332-1337 (1996)

Morishita M, Pepass NA. Drug Discovery Today. 11: 905-910 (2006)

Gradauer K. et al., Mol Pharm. 12:2245-2253 (2015)

 

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