Product development

Pre-formulation

Developing a new product/formulation for clinical trials starts with a physicochemical characterization of the active pharmaceutical ingredient (API), for example by determining particle size and distribution as well as density measurements, and conducting solubility and compatibility studies. Based on the results of these studies, we produce one or several composition proposals for preliminary stability studies.

Formulation of medicines and medical devices

Proposed formulations and manufacturing processes for medicine formulations and medical products are developed. The proposals are based on the results of the pre-formulation studies and the desired product characteristics.

Preparation forms

The dosage forms we develop include:

• Water solutions
• Suspensions
• Emulsions
• Injection medicines
• Topical gels
• Creams
• Capsules

Analytical methods

We develop and validate the physicochemical and microbiological analytical methods used to characterize products and conduct stability studies. We base these on the product’s characteristics and propose a suitable method before carrying out development and validation. All work is done according to ICH guidelines.

Techniques

We work using techniques such as UPLC, HPLC, GC-fid, GC-headspace, HPLC-MS, GC-MS, IR, UV/vis, DSC, TGA and release analyses. We also have very long experience in wet chemical analysis according to pharmacopeia.

Product durability

To determine product durability periods, we carry out stability studies to see how well products perform over time and in various conditions. We set up stability studies in climate rooms according to the ICH guidelines.

The scope of the stability studies is determined based on the required product durability.

Pre-formulations, products in clinical trials and commercial products can all go through stability studies.