A lot of pharmaceutical products are light sensitive those degrade when directly exposed to the light. Some impurities may develop during this degradation and product may fail during the quality control analysis. These impurities may harm the patient’s health.
These light sensitive APIs and pharmaceutical products should be protected from light during processing and distribution. Light sensitive products may be affected by sunlight or artificial light. Light induces the interaction between the molecules of the compound that leads to the formation of new compound known as impurity. Light has energy that can activate the molecules of drug. Photo degradation usually occurs due to absorption of short wavelength light between 500 and 300 nm. Visible blue, violet and ultraviolet light cause this degradation. For example ofloxacin remains 80% when exposed to direct light for a period of 240 hours.
List of light sensitive products:
Some drugs are affected by light of a special wavelength that should be studied before developing the formulation and product should be protected from that light. Excipients added in formulation can also reduce the effect of light on a light sensitive drug. Formulation should be tested for photostability to determine the effect of light on formulated product and to develop the protective measures.
During manufacturing process these product should be protected from these light degradation. Lights having long wave length (more than 500 nm) are used in granulation, compression and packing areas. Brown colored light having wavelength between 500 nm and 800 nm is the best option for this purpose.
Tablets containing light sensitive products should be coated with colored film coating. It will protect the sensitive drug from degradation due to the light. These tablets should be packed in alu-alu packing or in amber colored blisters. Injections containing light sensitive drugs should be filled in amber colored vials or containers.
Analysis of light sensitive products should be done carefully because light may cause error in the analytical results. Sample preparation should be done in amber colored glassware and also wrapped with aluminum foil when stored. Analysis should be done in dark or brown colored light.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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