Zelmic is a contract research organization dedicated to local delivery of small molecules, peptides and proteins. We offer innovative product design and development and have a good track record from development of pharmaceutical products. We can contribute to the success of your project by working with your organization.
Zelmic takes full responsibility for the entire development process and assists in defining the intended specific product properties, to find a patentable technical solution that meets the requirements and to transfer analytical and manufacturing methods to a commercial manufacturer.
In topical drug products the formulation has a high impact on the performance of the product. An effective drug in an unsuitable formulation can be less successful in the clinic than a less suitable drug in an optimised formulation. It is important to decide upon the final formulation at an early stage. If the final formulation is not used, preclinical and phase I studies risk having to be redone at high costs and time delay.
Zelmic offers a first class formulation development service involving the following steps:
Drug selection
Solubility studies/particle properties
Compatibility with standard and proprietary formulations
Reversed engineering
Generation of preferred products properties
Selection of vehicle type
Formulation compounding
Selection of formulation/formulation candidates
Stability studies (screening and accelerated studies)
In vitro release and penetration studies
Selection of lead candidate(s)
Manufacturing process/method
Upscaling to 8 kg
Generation of data for regulatory evaluation
Generation of documentation to the CMC part of the registration file
Generation of SUPAC-SS method
Robustness testing of manufacturing method
Tech transfer of manufacture to CMO
Development of patentable compositions/products
Generation of patent applications
Investigation on patentability/potential infringement
There are many good reasons for including formulation performance testing in the formulation development program. The three key parameters to be studied are formulation stability, the release of the drug from the formulation and drug permeation characteristics. A formulation optimised for drug release and penetration is often more efficacious and may require a lower concentration of drug. This may reduce the cost of the final product, drug irritation, and also maximize clinical efficacy.
Selection of formulation composition and API
Understanding mechanism of cutaneous API transport
Prediction of skin concentrations
Prediction of in vivo bioavailability and bioequivalence
Metabolic activity
Safety argumentation
Efficacy argumentation
Biowaiver argumentation
SUPAC-SS method
In vitro release studies in Franz diffusion cells or Bronuagh flow through cells
Typical membranes: Silicon sheets, Cellulose acetate, Molecular sieves, PTFE membranes, Strat M membranes
In vitro penetration in Franz diffusion cells or Bronuagh flow through cells
Typical membranes: Excised animal or human skin, viable animal or human skin, cultured skin, bovine hoof membranes, human nails, synthetic membranes as human skin surrogates
In product development it is essential to assure the quality of the analytical method, whether you monitor the drug, the properties of the product, impurities or excipients. The quality of the pharmaceutical product is set by the quality of the methods provided during the early phase of development.
Stability indicating methods
Biologics analytical expertise (protein, peptide)
Sample preparation (formulation dependent)
Monitoring of impurities and degradation products according to ICH requirements
Mass balance investigation
Depending on the phase of development
Uniformity, appearance, water activity, pH, viscosity etc
Implementation of pharmacopoeias (USP/EP/JP)
Zelmic is monitored by Läkemedelsverket (Medical Products Agency)
Zelmic has developed several techniques to be able to overcome problems arising during development of new drug products. Since problem solving generates new knowledge, creation of IP and strategy for patent protection has become one of our skills.
Development of patentable compositions/products
Generation of patent applications and strategy for patent protection
Investigation on patentability/potential infringement
Zelmic has close collaboration with several commercial GMP manufacturers for clinical trail manufacturing and performs tech transfer to a suitable site.
Zelmic has long experience of running pharmaceutical projects and we can therefore assit you with managing and planning your project.
