Topicals

Processes

Ever since, Nordmark`s portfolio comprises demanding dosage forms for the application on intact or damaged skin. We have developed a large variety of ointmens, creams and gels with different bases, excipients and drug substances. We can produce topicals under controlled and reproducible conditions in lab- as well as pilot-scale. Our specialty is a technology platform that allows us to formulate complex and sensitive biotechnological substances like proteins or living cells.

Services for the production of topicals:

• Production of topicals in a lab reactor
• Production of topicals in pilot scale
• Tube filling
• Production of sterile topicals
• Scale-up and transfer to production

Analytics

Challenges in the development of semi-solid dosage forms are the physical and microbiological stability of the base and  the drug substance. In case of suspensions, particle size, their distribution and alterations over time, have to be taken into account. Concerning processability, batch-to-batch comparability and up-scaling, it is necessary to gain knowledge about the rheological characteristics. In all mentioned analytical fields, we have established methods at our disposition. In addition to that, we can offer a broad range of particle analytics in different dispersion media or solid bases. After all, we have longstanding expertise in the activity measurement of complex biotechnological drug substances in topical dosage forms.

To get the full picture, we are equipped to apply orthogonal methods in many cases.

Services for the analytics of topicals:

• Pharmacopoeial microbiological methods
• Rheological measurements
• particle analysis
• Activity measurements
• Concentration measurements
• Characterisation of the drug substance