Liquid Silicone Rubber The Answer to HIV Prevention

HIV/ AIDS has plagued mankind for decades now. It may not receive as much attention as cancer but the WHO has data which shows that about 34 million people around the globe have been exposed to this dangerous virus, out of which 1.7 million of them have lost their lives. This is an epidemic that is a true cause for concern. 

Luckily, our medical experts realized the graveness of the situation and have been making significant advancements towards HIV treatment. The US FDA has been clinically testing a tool that can possibly help combat the virus. This antiviral drug is mixed in a two component liquid silicone rubber that is injection moulded into a vaginal ring which discharges the drug. 

The combining process involved in the making of this drug is complex and was specifically customized to optimize production. The equipment involved such as the metering system and the mold were all produced to maintain the highest hygiene standards and must only be operated in clean rooms that adhere to the ISO 13485 and FDA’s ‘good manufacturing practices’. 

The vaginal ring was created in Malmo, Sweden by QPharma AB which is also the organization that molds the product. There are several other companies that are involved in the manufacturing process including Arburg ( Germany) that creates electric injections for the to – test production system, 2KM ( Germany ) which is responsible for the LSR metering system and Rico Elastomere which manufactures the mold. 

The vaginal ring weighs 8g and has 25mg of a microbicide Dapivirine, and 30 % silica. The Drug’s most active component is an LSR insoluble micropowder, and the dosage must be maintained between 22 to 27 mg for best results. To ensure uniform antiviral distribution in the ring, QPharma uses a special stereoscopic method in order to analyze every single component. 

The drug has also received a few quality upgrades even in the short time that it has been in production. Initially, it was premixed with a silicone gel which was added as a third stream during the molding process. But this led to a lower concentration of the active component as its reaction with the silicone gel caused it to separate. After refinement, the process was modified partially. The micro powder – silicone gel mixture was gradually added to the LSR components in equal proportions and then mixed further in the metering system. This change improved stability and also made the drug distribution more uniform. 

There are a lot of factors that influence the final quality of the product. These mainly include, the holding pressure and shot volume which are both key in keeping up the I.D of the vaginal ring and helps maintain the right weigh as well. Time also has a partial influence over the process as it affected the part quality. 

The product has been put through several rigorous tests and has even surpassed Sig Sigma standards. Even Though the real world impact of it may only be known with usage over time, the possibilities are very promising. The science of it checks out and the product is only in its early stages. So, there is no doubt that with more progress and research, the battle between mankind and this deadly virus will end in our victory!