Oral Salmon Calcitonin The Lead in Product Development

SCT is approved for the treatment of OP and other diseases that are involved in the acceleration of bone turnover. Preliminary evidence suggested that sCT might provide therapeutic benefits that could translate into chondroprotective effects in progressive degenerative joint diseases, such as OA and rheumatoid arthritis (38). Novartis is applying the Eligen technology to develop an oral dosage form of sCT for OP and OA indications. Clinical developments of these products are currently in phase...

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Hinton PR, Xiong JM, Johlfs MG, et al. An engineered human IgG1 antibody with longer serum half-life. J Immunol 2006 176(1) 346-356. Bitonti AJ, Dumont JA. Pulmonary administration of therapeutic proteins using an immunoglobulin transport pathway. Adv Drug Deliv Rev 2006 58(9-10) 1106-1118. Roopenian DC, Akilesh S. FcRn the neonatal Fc receptor comes of age. Nat Rev Immunol 2007 7(9) 715-725. Gunraj CA, Fernandes BJ, Denomme GA. Synonymous nucleotide substitutions in the neonatal Fc receptor....

Target Mediated Elimination Pathways

Protein therapeutics that act on cell surface receptors often show target-dependent PK behavior. The fate of the target (endocytosis, degradation, etc.) and the consequences of target engagement (gene induction, modulation, posttranslational modifications) will influence both exposure and response kinetics. Immunostimulatory cytokines may be subject to receptor-mediated endocytosis, as is the case for interleukin (IL)-2, IL-15, and type 1 interferons (IFNs). Ligand engagement triggers receptor...

References

Alterations in insulin absorption and in blood glucose control associated with varying insulin injection sites in diabetic patients. Ann Intern Med 1980 92(1) 59-61. 2. Calara F, Taylor K, Han J, et al. A randomized, open-label, crossover study examining the effect of injection site on bioavailability of exenatide (synthetic exendin-4). Clin Ther 2005 27(2) 210-215. 3. Vaag A, Handberg A, Lauritzen M, et al. Variation in absorption of NPH insulin due to intramuscular...

Etanercept

Etanercept is a dimeric fusion protein that is indicated for the treatment of RA, juvenile RA, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Drug interaction studies of etanercept have been conducted with several drugs. The summary of these drug-drug interaction studies is as follows. Administration of paclitaxel in combination with etanercept resulted in a twofold decrease in etanercept clearance in a nonhuman primate study and in a 1.5-fold increase in etanercept serum levels in...