Breaking News

Juniper Pharma To Reformulate Phase II PharmAust Drug

February 1, 2016

Will reformulate monepantel due to unpleasant taste

Juniper Pharma Services has been selected by PharmAust Ltd. to reformulate monepantel (MPL) for its Phase II studies. PharmAust will also manufacture 20,000 capsules of the reformulated MPL solution for Juniper under GMP, ensuring that the Phase II data are admissible to regulators as part of any subsequent submissions.
MPL needs to be reformulated because of the unpleasant taste. While the Phase I study showed significant activity of MPL on tumor markers such as p70S6K and p-4E-BP1, compliance was poor due to nausea associated with its exceptionally poor palatability.
Dr. Roger Aston, chairman at PharmAust, said, “We expect the reformulation process to take about 12 to 14 weeks, which gives us time to prepare clinical trial submissions to regulatory bodies based on the capsule format. 
Dr. Nikin Patel, president at Juniper Pharma Services, said, “We are very pleased to have secured this project with PharmAust as it further demonstrates our specific expertise in assisting companies from across the globe in reformulating and manufacturing products such as capsules for clinical trials.”

Related Packaging:

  • Predictive Analytics and the Future of RBM

    Rajneesh Patil, Senior Director, RBM and Analytics, QuintilesIMS||January 23, 2017
    How advances in Risk-Based Monitoring will enable a more proactive approach to identify and mitigate potential risks

  • The Growing Realm of Real-World Data

    Kristin Brooks, Contract Pharma||November 8, 2016
    PPD's Evidera acquisition aims to help clients address the growing demand for evidence from regulators and payers

  • Mastering Immunotherapy Clinical Trials: Dosing and Response

    Mastering Immunotherapy Clinical Trials: Dosing and Response

    Kristin Brooks, Contract Pharma||August 1, 2016
    Andrew Zupnick of Novella Clinical provides insights into dosing and measuring response in immunotherapy clinical trials

  • CROs and Today’s  R&D Landscape

    CROs and Today’s R&D Landscape

    Kristin Brooks, Associate Editor, Contract Pharma||November 9, 2016
    John Lewis of ACRO discusses opportunities, challenges, and the future CRO

  • Choosing Oral Formulations for First-in-man Clinical Trials

    Choosing Oral Formulations for First-in-man Clinical Trials

    Jon Sutch, Senior Manager of Formulation Development, Patheon||October 11, 2016
    Early formulations should be simple, but selecting a simple formulation isn’t as easy as it seems

  • Robust Assay Designs

    Robust Assay Designs

    Tim Wright, Editor, Contract Pharma||October 11, 2016
    Easing the transition from preclinical to clinical research