Services

Formulation and advanced re-formulation of APIs:

Formulation of APIs offers to  solubilize hydrophobic/polar IPIs using GRASS and/or custom made compounds with the aim to achieve the target concentration set by the user. This service is intended for the first time formulation of water insoluble compounds before the in vitro trials or compounds which were tested in vitro using DMSO/other organic solvents. This service expands availability and selection of therapeutic candidates, allows continuous transition from in vitro to in vivo trials and addresses stability, scale-up and manufacturing issues at early stages of drug candidate development.

Advanced re-formulation offers to employ advanced drug delivery techniques to improve bioavailability, biodistribution and toxicity profiles, to target specific organ or disease site while providing sustained and controlled release of therapeutic cargo.

For both formulation and advanced reformulation TrasnNanoForm offers the following services:

1. Formulation design: formulation development strategy, molecule structure analysis and carrier selection to fit the administration route and other specific formulation requirements.

2. Formulation preparation and characterization: optimization of drug loading, drug loading efficacy, physicochemical characterization (particles size and size distribution, z-potential, short and long term stability tests and drug release profiles for sustained release formulations.

3. Scale up of the formulation and protocol validation.

4. Training and transition of the protocol to the final user.