• Login
    View Item 
    •   Home
    • The Christie Research Publications Repository
    • All Christie Publications
    • View Item
    •   Home
    • The Christie Research Publications Repository
    • All Christie Publications
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of ChristieCommunitiesTitleAuthorsIssue DateSubmit DateSubjectsThis CollectionTitleAuthorsIssue DateSubmit DateSubjectsProfilesView

    My Account

    LoginRegister

    Local Links

    The Christie WebsiteChristie Library and Knowledge Service

    Statistics

    Display statistics

    A new sustained-release preparation of human growth hormone and its pharmacokinetic, pharmacodynamic and safety profile.

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Authors
    Jostel, Andreas
    Mukherjee, Annice
    Alenfall, Jan
    Smethurst, Linda E
    Shalet, Stephen M
    Affiliation
    Department of Endocrinology, Christie Hospital, Manchester, UK. andreas.jostel@christie-tr.nwest.nhs.uk
    Issue Date
    2005-05
    
    Metadata
    Show full item record
    Abstract
    OBJECTIVE: Adult GH replacement is currently given by daily subcutaneous (sc) injections. Recently, sustained-release (SR) preparations of GH have been developed, the preparations being characterized by a dominant early release, resulting in supraphysiological early GH peaks, and a rapid decline thereafter. We present data on a new SR GH preparation. DESIGN: Phase I/II study of hGH-Biosphere(R) (SkyePharma AB, Malmo, Sweden), a new SR preparation of recombinant human GH in amylopectin microspheres coated with polylactide-coglycolide. PATIENTS: Eight adults with severe, untreated GH deficiency (stimulated GH peaks between < 1 and 1.7 microg/l), aged 36.1 years (range 22-49 years) in good general health. MEASUREMENTS: Pharmacokinetic (PK), pharmacodynamic (PD) and safety data over a period of 28 days. RESULTS: The systemic and local tolerability of the drug was satisfactory, and no serious adverse events occurred. PK analysis showed a smaller early serum hGH peak followed by a broad sustained second peak of hGH (C(max) 1.20 microg/l at 7.2 days), and hGH levels were maintained above baseline for at least 14 days. The mean GH level never exceeded 1.1 microg/l, making the GH fluctuations comparable to continuous sc infusion. Resultant IGF-I concentrations were characterized by sustained elevation at a level near C(max) of 103 microg/l (at t(max) of 9.7 days), equal to an SD score of +0.8. IGF-I generation per administered GH was more efficient compared with reports of other SR preparations. CONCLUSION: hGH-Biosphere(R) is a well-tolerated SR GH preparation with superior efficacy in achieving target IGF-I levels without causing supraphysiological GH concentrations. Our data suggest the suitability of this preparation for longer-term trials in adults with injection frequencies of no more than once every 2-3 weeks.
    Citation
    A new sustained-release preparation of human growth hormone and its pharmacokinetic, pharmacodynamic and safety profile. 2005, 62 (5):623-7 Clin. Endocrinol.
    Journal
    Clinical Endocrinology
    URI
    http://hdl.handle.net/10541/74882
    DOI
    10.1111/j.1365-2265.2005.02271.x
    PubMed ID
    15853836
    Type
    Article
    Language
    en
    ISSN
    0300-0664
    ae974a485f413a2113503eed53cd6c53
    10.1111/j.1365-2265.2005.02271.x
    Scopus Count
    Collections
    All Christie Publications

    entitlement

    Related articles

    • Safety and efficacy of growth hormone (GH) during extended treatment of adult Japanese patients with GH deficiency (GHD).
    • Authors: Chihara K, Kato Y, Kohno H, Takano K, Tanaka T, Teramoto A, Shimatsu A
    • Issue date: 2008 Aug
    • Development of a novel sustained release formulation of recombinant human growth hormone using sodium hyaluronate microparticles.
    • Authors: Kim SJ, Hahn SK, Kim MJ, Kim DH, Lee YP
    • Issue date: 2005 May 18
    • A pharmacokinetic/pharmacodynamic model for recombinant human growth hormone effects on induction of insulin-like growth factor I in monkeys.
    • Authors: Sun YN, Lee HJ, Almon RR, Jusko WJ
    • Issue date: 1999 Jun
    • Development of a sustained-release recombinant human growth hormone formulation.
    • Authors: Kwak HH, Shim WS, Choi MK, Son MK, Kim YJ, Yang HC, Kim TH, Lee GI, Kim BM, Kang SH, Shim CK
    • Issue date: 2009 Jul 20
    • Growth hormone deficiency (GHD) in adult thalassaemic patients.
    • Authors: Scacchi M, Danesi L, Cattaneo A, Valassi E, Pecori Giraldi F, Argento C, D'Angelo E, Mirra N, Carnelli V, Zanaboni L, Cappellini MD, Cavagnini F
    • Issue date: 2007 Nov
    DSpace software (copyright © 2002 - 2025)  DuraSpace
    Quick Guide | Contact Us
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.