• API Characterisation

    • MedPharm supports customers at the very start of the development process to quickly evaluate any likely risks that might lie ahead in the development process.
    • MedPharm characterises the API using a variety of physio-chemical methods to help advise the customer on the best formulation development strategy for their product.
    • Information obtained can be used directly in regulatory submissions.


  • In Silico Prediction and In Vitro Assessment

    • MedPharm are experts in dermatology and have computer/in silico models, some proprietary, which rank the ability of compounds to penetrate the skin based on key physio-chemical information.
    • Different models are tested in parallel to support further ranking.
    • In silico investigations with API characterisation helps clients make sound decisions on compound selection very early in the development pathway.
    • In vitro assessment can be carried out to rank permeability of the compounds experimentally using ex vivo human skin. Allows compounds to be selected on activity and skin permeability.


  • Preformulation

    • MedPharm selects potential excipients based on the API characteristics, the target product profile agreed with the client and MedPharm’s extensive experience.
    • Excipient selection and likely use levels are carefully matched to any regional requirements where the final formulation may be marketed.
    • Solubility of client’s compound(s) in excipients are assessed.
    • Non-solvents are identified to help achieve appropriate saturation levels where necessary.
    • Short term stability studies of the compound in excipients/solvent systems are performed to identify any likely risks once full formulation development is undertaken.
    • Rigorous approach to understanding the likely interactions between API’s and excipients reduces time and risks associated with formulation development.


  • Formulation Development

    • MedPharm develops formulations based on pre-formulation data and the target product profile following close consultation with the client.
    • Formulation development is typically performed in conjunction with the most appropriate performance testing depending on the stage in the development process.
    • Development strategy will cover:
      • Dosage forms which are most appropriate
      • Dose-allowable concentrations expected
      • Thermodynamic activity of the drug
      • Patient compliance considerations
      • Relevant regulatory status of excipients
      • The need for penetration enhancers
      • Chemical and physical stability
    • MedPharm will typically develop multiple formulation types in parallel to aid selection of the most appropriate form.
    • MedPharm can keep development on a small scale to preserve valuable APIs if necessary.


  • Analytical and Bioanalytical Methods

    • As with any development, the data MedPharm supplies to clients is the output of defined analytical methods.
    • MedPharm is equipped to deliver all modern analytical and bio-analytical methods required for topical and transdermal development.
    • MedPharm regularly develops new methods for customers.
    • MedPharm’s analytical capability includes HPLC, UPLC, GC, and LC-MS/MS.
    • MedPharm will develop all necessary analytical methods applicable to the API, experimental matrix, formulation type and presentation.
    • Analytical Method Development & Formulation Development
      • API in formulation
      • Formulation physical and chemical stability
      • Rheometric and particle sizing methods for physical characterisation
      • DSC, microscopy and other spectroscopic techniques for physical stability and polymorph detection
    • Bioanalysis & Performance Testing:
      • Drug and/or excipients in tissue or receiving fluid
      • Pharmacokinetic and pharmacodynamic parameters
      • Methods can be developed to detect tissue drug concentrations down to low picogram per ml levels.
      • Bioanlytical expertise with tissue extraction and systemic fluid include calculations and interpretation of key pharmacokinetic parameters
    • MedPharm can conduct forced degradation studies and develop stability-indicating methods to establish and predict product shelf lives.
    • Methods used to predict long term physical stability of multi-phase formulations.
    • Methods are developed to the appropriate level of validation to satisfy regulatory requirements.
    • Methods are validated to ICH guidelines where required by the customer.
    • Where available, MedPharm use client methods to facilitate method development or support method transfer to streamline the development process where applicable.


  • Lead Formulation Selection

    • MedPharm’s development strategy will typically identify products often based on different formulation types that meet all the key goals set by the client.
    • Lead candidate selection will always be done in close consultation with client. Development goals set at the start of the project are regularly reviewed and risk-assessed to confirm they are still valid.
    • There is often more than one lead formulation and MedPharm will typically recommend taking forward one lead formulation and one back up to minimise risk and retain options.