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Pharmaceutics 2014, 6(2), 220-234; doi:10.3390/pharmaceutics6020220

Human Growth Hormone Delivery with a Microneedle Transdermal System: Preclinical Formulation, Stability, Delivery and PK of Therapeutically Relevant Doses

Zosano Pharma, 34790 Ardentech Court, Fremont, CA 94555, USA
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Received: 14 February 2014 / Revised: 21 April 2014 / Accepted: 25 April 2014 / Published: 15 May 2014
(This article belongs to the Special Issue Advanced Transdermal Drug Delivery)
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Abstract

This study evaluated the feasibility of coating formulated recombinant human growth hormone (rhGH) on a titanium microneedle transdermal delivery system, Zosano Pharma (ZP)-hGH, and assessed preclinical patch delivery performance. Formulation rheology and surface activity were assessed by viscometry and contact angle measurement. rhGH liquid formulation was coated onto titanium microneedles by dip-coating and drying. The stability of coated rhGH was determined by size exclusion chromatography-high performance liquid chromatography (SEC-HPLC). Preclinical delivery and pharmacokinetic studies were conducted in female hairless guinea pigs (HGP) using rhGH coated microneedle patches at 0.5 and 1 mg doses and compared to Norditropin® a commercially approved rhGH subcutaneous injection. Studies demonstrated successful rhGH formulation development and coating on microneedle arrays. The ZP-hGH patches remained stable at 40 °C for six months with no significant change in % aggregates. Pharmacokinetic studies showed that the rhGH-coated microneedle patches, delivered with high efficiency and the doses delivered indicated linearity with average Tmax of 30 min. The absolute bioavailability of the microneedle rhGH patches was similar to subcutaneous Norditropin® injections. These results suggest that ZP-transdermal microneedle patch delivery of rhGH is feasible and may offer an effective and patient-friendly alternative to currently marketed rhGH injectables. View Full-Text
Keywords: human growth hormone; rhGH; stability; transdermal microneedle patch; pharmacokinetics human growth hormone; rhGH; stability; transdermal microneedle patch; pharmacokinetics
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This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

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MDPI and ACS Style

Ameri, M.; Kadkhodayan, M.; Nguyen, J.; Bravo, J.A.; Su, R.; Chan, K.; Samiee, A.; Daddona, P.E. Human Growth Hormone Delivery with a Microneedle Transdermal System: Preclinical Formulation, Stability, Delivery and PK of Therapeutically Relevant Doses. Pharmaceutics 2014, 6, 220-234.

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