Wet milling of active pharmaceutical ingredients

Sterile production no problem for the WAB-GROUP

The Comminution, grinding and dispersion of active pharmaceutical ingredients in a liquid environment are important process steps in pharmaceutical formulation development. These steps serve to increase the solubility of the active ingredients, ensure the homogeneity of the formulation and ultimately improve the efficacy and bioavailability of the drug

Better solubility and permeability

The active pharmaceutical ingredients can be divided into 4 classes. The active ingredients of the first class can be dissolved well and have good permeability. The active ingredients in the second class have good permeability but poor solubility. The active ingredients in the third class have good solubility but poor permeability. And finally, the active ingredients in the fourth class have poor solubility and also poor permeability.

A central influence on the solubility and permeability has the particle sizessdistribution of theof the active ingredients. At lowern particle sizesssen is the surface of the active ingredients enlargedssert. This increases efficiency, solubility and bioavailability.sibility. The active ingredients of the Class 2 have intrinsically good permeability, but are very difficult to bring into solution. In the wet grinding process the precise comminution and dispersionedispersion of theser Wirkstoffeto convert them into a wellsoluble form to form.

Active pharmaceutical ingredients find wide applications in the pharmaceutical industry. They are used in various sectors, including the field of ophthalmic agents, injectables, auricular agents, oral applications, veterinary medicine, dermal applications and, last but not least, in the field of cell disruption for vaccine production.

The active pharmaceutical ingredients are mixed with a carrier liquid and thenAtend with one agitator bead mill the WAB-GROUP grind. During this process process, all parameters, such as maximum process temperature, have to bemust be adhered to in order to achieve the desired particle properties.

It is important to note that Processing of the active pharmaceutical wirials must be carried out in strictly controlled environments and in compliance with all relevant regulatory requirements, as it is a critical step in the drug manufacturing process. Dhe WAB-GROUP has been providing the necessary process technologies for over 50 years. available, to accomplish this central step in processing and the active pharmaceutical ingredients. manage.

In the application areas of ophthalmic drugs, ear remedies and injectables, active pharmaceutical ingredients are produced in an aseptic environment. In order to comply with these criteria, agitator ball mills from WAB-GROUP are used, which meet the requirements of Cleaning in Place (CIP) and Sterilization in Place (SIP) and are qualified for these processes.

With the Cleaning in Place (CIP) process, we ensure that the operator of the plant does not come into contact with the active pharmaceutical ingredients. Complete cleaning of the agitator bead mill ensures that the hazards of the highly active pharmaceutical ingredients are always under control. Sterilization by means of steam at up to 135° makes the plant completely sterile and enables germ-free production to be ensured. The necessary technical solutions have been developed and perfected over decades by WAB-GROUP engineers. Parameters such as sterilization, always safe cleaning, validation and qualification, monitoring of temperatures, requirements for technical components in dealing with heat, sterilization times, integration in existing automation chains, requirements electronic records and electronic signatures, seamless tracking of production, assurance of material quality, certification of product contact parts and much more, are an absolute standard of WAB-GROUP in connection with the processing of active pharmaceutical ingredients.

Are you interested in the production of active pharmaceutical ingredients and would like to learn more about WAB-GROUP's solutions on this topic? Then contact us via the contact form and talk to one of our process experts worldwide.

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