We are specialized in
TOPICAL DELIVERY OF PHARMACEUTICALS

Need help developing pharmaceutical products?

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.

Our role in the development process

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.

Our services

All products are unique and have their own special requirements and challenges. To succeed in developing a topical drug product you have to master the entire development process and to understand how to develop formulations. Zelmic has skilled and highly qualified staff in formulation development, analytical chemistry and handling intellectual properties, all aimed at strengthening your R&D capacity and to minimize risk.
We offer:

FORMULATION DEVELOPMENT

We solve your delivery problems

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:

 

Pre-formulation

Drug selection

Solubility studies/particle properties

Compatibility with standard and proprietary formulations

Reversed engineering

Formulation screening

Generation of preferred products properties

Selection of vehicle type

Formulation development - composition

Formulation compounding

Selection of formulation/formulation candidates

Stability studies (screening and accelerated studies)

In vitro release and penetration studies

Selection of lead candidate(s)

Formulation development - manufacturing

Manufacturing process/method

Upscaling to 8 kg

Regulatory

Generation of data for regulatory evaluation

Generation of documentation to the CMC part of the registration file

Manufacture

Generation of SUPAC-SS method

Robustness testing of manufacturing method

Tech transfer of manufacture to CMO

Intellectual property (IP)

Development of patentable compositions/products

Generation of patent applications

Investigation on patentability/potential infringement

PERFORMANCE TESTING

We ensure that your formulation performs

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.

 

Zelmic uses in vitro testing to support:

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

Zelmic offers:

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

ANALYTICAL CHEMISTRY

We manage your analytical challenges

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.

 

Analytical method development

Stability indicating methods

Biologics analytical expertise (protein, peptide)

Sample preparation (formulation dependent)

Stress studies of API and product

Monitoring of impurities and degradation products according to ICH requirements

Mass balance investigation

Analytical method verification/validation

Depending on the phase of development

Complementary assay for pharmaceutical products

Uniformity, appearance, water activity, pH, viscosity etc

Implementation of pharmacopoeias (USP/EP/JP)

Physical characterisation

Reversed engineering

Generation of documentation for CTX/NDA

Transfer to commercial site

Stability studies according to ICH guidelines

NEW IDEAS

We invent for you

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.

 

IP

Development of patentable compositions/products

Generation of patent applications and strategy for patent protection

Investigation on patentability/potential infringement

GMP MANUFACTURING

We take care of clinical supplies

Zelmic has close collaboration with several commercial GMP manufacturers for clinical trail manufacturing and performs tech transfer to a suitable site.

 

PROJECT MANAGEMENT

We coordinate internal and external activities

Zelmic has long experience of running pharmaceutical projects and we can therefore assit you with managing and planning your project.

 

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