Eyedrops processing is quite literally a sight for sore eyes. There is no shortage of eye care products, from eyewashes to anesthetics to antibiotics. But formulating eyedrops is a complex affair with multiple safety checkpoints. Technological advances bring a pair of fresh eyes to manufacturing, ensuring higher-quality products for specialized applications.
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Formulate eyedrops with a thickening agent to increase contact time
Vehicles for eyedrops are prepared from aqueous media, making them thin solutions. A runny product is less effective because it reduces contact time with the cornea. Formulate the solution with a viscolizer such as hyaluronic acid or polyvinyl alcohol to address this challenge.
These adjuvants increase the product’s viscosity so that it has a longer period in the eye and produces higher bioavailability.
Incubate the eyedrops solution in a microbial medium to test its sterility
Eyedrop solutions must pass the sterility test before they can be deposited into containers for shipping. The procedure involves inoculating the sample with a microbiological environment like a soy-bean casein digest medium.
The samples are deemed sterile if no growth is observed after 5 days of direct incubation. In the case of indirect incubation using a membrane filtration method, the testing period must run for 14 days.
Eyedrops processing using alternative preservatives
Multi-use eye drop products contain preservatives to prevent microbial growth. The most common agent used in manufacturing is benzalkonium chloride (BAK). But this substance raises health issues, especially in cases of dry eye disease.
A special polymer named PQ-1 (Polyquaternium-1) is used as an alternative preservative for both dry eye preparations and glaucoma medications. An anti-bacterial, PQ-1 keeps the product free from pathogens. But because of its larger molecular size, it does not penetrate human cells and drastically lowers the toxic risks compared to BAK.
Print the vital information directly on the packaging
The eyes are delicate organs, and packaging for ophthalmic drugs must adhere to stricter safety parameters than other dosage forms.
Bottle openings have to be sealed to protect the solution and ensure the validity of the use-by date. Besides the expiry information, the packaging must include the date of manufacture and storage recommendations.