FDA guidance on product design has driven demand by pharma for tailored designs for tablet colour, size and shape, specialist consultancy Colorcon told Outsourcing-Pharma.com.
Draft guidelines published in December 2012 urging the industry to think about pill formulation at the earliest stages of development motivated drug makers to consider prevention of consumer medication errors in their designs. But as well as patient safety, drug appearance is also driven by companies looking to develop their brand, add perceived value, branch into new markets, reduce lead times, and co-operate with government HIV and TB programmes, said MD Steve Facer told our reporter during a tour of Colorcon in Dartford, UK.
Heart shapes for your heart
Colorcon, headquartered in Philadelphia, is a private company specialising in speeding the journey to market for tablets, capsules, and other solid oral dosage products for pharmaceutical customers, both innovative and generic. They design and mock-up the medicine’s excipient formulation, including film coatings, to comply with customer requests and official regulations.
The company usually gets involved in drug design around Phase II in trials. “That’s when companies are making choices about how the product should be put together,” said Deborah Taylor, spokeswoman.
Until that point, Phase I trials usually use capsules, but most pharmaceutical companies prefer tablets once they scale up production, because they are cheaper and simpler to produce, and, most importantly for Colorcon’s work, the shape of tablets can be altered.
Configurations include the traditional oval, Viagra’s diamond, triangles, or even heart-shaped red pills for cardiac medicines. However, said Taylor, the last proved unpopular as cardiac patients disliked being reminded of their illness by the shape of the tablet.
The industry is increasingly recognising the gains behind differentiating their drugs by shape, said the company, pointing to GSK’s “tilt-tab”, a six-sided tablet with a pointed fulcrum which prevents it lying flat on a table surface. The pill was designed for Parkinson’s sufferers who often lack dexterity to pick up traditional pills easily.
Among Colorcon’s designs to aid patient safety and compliance are tablets printed with the words “once a day”, or with coatings designed to mask taste for paediatric patients.
The company’s Senior Manager, Customer and Technical Services, demonstrated to our reporter the lab equipment for matching pill colour to customer preferences. A revolving library of pill samples in 40,000 colours spans three floors in the company’s Dartford facility and replaces the previous massive manual system.
Marcel Cimpan said the lab allowed Colorcon to replicate customer requests for specific colours even while working from the other side of the world. Its spectrometry machine can analyse the make-up of a specific colour, so clients can give the lab a pill, or even a scrap of paper, and the company is able to quantify precisely the shade.
Pharmaceutical customers are increasingly aware of the need to differentiate their products from others on the market, and are moving away from the traditional “white, oval” tablet that is most common on the market, said Colorcon. “If Pfizer had developed Lipitor today it wouldn’t be a white tablet,” said Deborah Taylor.