In the world of pharmacology, the efficacy and safety of drugs are closely linked to manufacturing and sterilization processes. Some drugs, particularly fat-soluble drugs, present unique challenges during manufacturing due to their poor solubility in water.
Fortunately, advanced technologies such as LAST Technology’s TS ROTO are revolutionizing the way these drugs are sterilized, ensuring superior quality and safety.
The challenge of fat-soluble drugs
Many medicinal compounds are fat-soluble, which means they do not easily dissolve in water, blood or other body fluids. This characteristic makes their effective administration difficult, as the human body is composed mainly of water.
Recently, the pharmaceutical industry has explored the use of mixtures of water and hydrogels as a simpler and more efficient alternative. Hydrogels offer a structure that can accommodate fat-soluble molecules while being compatible with body fluids, reducing potential side effects and simplifying the manufacturing process.
The rotary sterilization process
Despite advances in formulations, sterilization of these preparations remains a challenge. Solutions containing hydrogels or oil mixtures tend to separate when they remain static and are heated during the sterilization process. Maintaining product homogeneity is essential to ensure the correct dose and therapeutic efficacy.
TS ROTO uses nozzles to distribute a jet of superheated water throughout the sterilization chamber, ensuring internal temperature uniformity. This is especially important to avoid container rupture due to pressure imbalances between the inside and outside of the product during critical heating and cooling phases.
Unlike conventional sterilization systems that require the removal of air from the chamber to establish a direct correlation between pressure and temperature, TS ROTO accurately adjusts the backpressure air pressure in the initial heating and final cooling stages. This controlled process prevents damage to the containers and ensures that the drug maintains its integrity.
Major leap forward in sterilization
TS ROTO’s innovation represents a significant step forward in the sterilization of complex drugs. It ensures that drugs that require complex mixtures to be effective can be sterilized safely and efficiently, without compromising their quality. This system not only improves the safety and efficacy of drugs, but also reduces the complexity of the manufacturing process, making sterilization of innovative and complex drugs more affordable.
With technologies like TS ROTO, the future of pharmaceutical sterilization promises to be safer, more efficient, and capable of meeting the increasingly complex needs of the pharmaceutical industry.
