Efficient Recombinant Human Growth Hormone Delivery with a Transdermal Microneedle Patch System: Patch Stability, Efficient Delivery and Dose Dependent Delivery Comparable to SC Injection

Presentation Number: MON-0150
Date of Presentation: June 23rd, 2014

Mahmoud Ameri*, Miryam Kadkhodayan, Joe Nguyen, Joseph A Bravo, Rebeca Su, Kenneth Chan, Ahmad Samiee and Peter E Daddona
Zosano Pharma, Fremont, CA

Abstract

There is a major unmet need for safe, convenient, and cost effective alternatives to conventional injectable forms of biopharmaceuticals. Recombinant human growth hormone (rhGH) is currently administered by daily subcutaneous (SC) injection for the treatment of pediatric patients with short stature due to hGH deficiency.  Treatment requires years of good compliance to attain its therapeutic effect, thus a patient-friendly and needle-free delivery would be a desirable alternative. We describe the development of a novel rhGH transdermal microneedle patch demonstrating 6 months at 40 oC packaged storage stability and a simple, one step press-and-apply application. Preclinical in vivo delivery and pharmacokinetic compared the rhGH microneedle patch to Norditropin® at 0.5 and 1mg doses in a hairless guinea pig model. Patch wear time was 1 hour. Results showed that the rhGH microneedle patch delivered with high efficiency (70 % of the patch loaded dose) with a linear dose response and  tmax of 30 minutes. The bioavailability of the rhGH microneedle patch was similar to the comparable subcutaneous injected dose. These results suggest that transdermal microneedle patch delivery of rhGH is feasible and warrants further development as a patient-friendly alternative to current subcutaneous injection.

 

Nothing to Disclose: MA, MK, JN, JAB, RS, KC, AS, PED