US FDA OK with a bit of blue: Colorcon's Spirulina approved for pharma pills
The US regulator cleared Spirulina extract – a protein derived from blue-green algae – for pharmaceutical and dietary supplement pill coating last week in a decision Colorcon’s Film Coating General Manager, Kelly Boyer, said broadens manufacturers' colour pallets.
“Blue and green colors are difficult to achieve using previously approved “natural” colorants. Incorporating pigments that are more “natural” requires specialized formulation and extensive stability programs to obtain the best quality results, including acceptable shelf-life for the final coated tablets.”
Pill colour plays a key role in pharmaceutical branding. Pfizer’s erectile dysfunction blockbuster Viagra (sildenafil) is known colloquially as the little blue pill.
However, pill colour is also known to be important in patient compliance.
A recent study by Harvard Medical School found that patients whose doctors switched them to generic tablets that differed in shape and hue from their original meds were more likely to end their treatment early.
Earlier this year the US Food and Drug Administration (FDA) went further.
The agency told drugmakers that generic pills that differ too much from the branded products are a safety risk and urged developers to consider a pill’s physical characteristics earlier in the development process.
For generic drugmakers trying to make copycat versions of green or blue pills for the US market – including Viagra, which loses patent protection in 2020 – the availability of a new stable coating technology will be of interest.
