Apparatus and method for transdermal delivery of parathyroid hormone agents

• US 7,556,821 B2
• Filed: 03/18/2005
• Issued: 07/07/2009
• Est. Priority Date: 05/13/2004
• Status: Active Grant

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Cormier, Michel J. N., Maa, Yuh-Fun, Kamberi, Marika, Ameri, Mahmoud, Daddona, Peter
• Primary Examiner(s): Kosar; Andrew D
• Application Number:
  US11/084,634
• Publication Number:
  US 20050256045A1
• Time in Patent Office: 1,572 Days
• Field of Search: 604 20- 22, 604 46- 48, 604/173, 424/400, 424/422, 424/423, 424/426, 424/428, 4351734-1763
• US Class Current: 424/423
• CPC Class Codes: A61K 38/29 Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 5/18 of the parathyroid hormones

Abstract

An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the PTH-based agent is contained in a biocompatible coating that is applied to the microprojection member.

Claims

1. A device for transdermally delivering a PTH-based agent to a patient, comprising:

a microprojection member having a plurality of microprojections that are adapted to pierce the stratum corneum of the patient; and

a biocompatible coating disposed on said microprojection member, said coating comprising a hPTH acetate, hydrochloric acid, Tween, sucrose, and EDTA.

2. A device for transdermally delivering a PTH-based agent to a patient, comprising:

a microprojection member having a plurality of microprojections that are adapted to pierce the stratum corneum of the patient; and

a biocompatible coating disposed on said microprojection member, said coating being formed from a coating formulation comprising 20% hPTH(1-34) or salts thereof, 20% sucrose, 0.6% HCl, 0.2% Tween 20, and 0.03% EDTA and is at a dose of approximately 10-1000 μ

g that results in a plasma C_max of at least 50 pg/ml after a single application.