Ian C. Ellul

When it comes to the armamentarium of medicines available locally, recently we have made great advances, mainly heralded by innovator pharmaceutical companies. These are represented locally by PRIMA (Pharmaceutical Researchbased Industry Maltese Association), which was established in 2006. On the other side of the coin, one must also not underestimate the essential contribution of generic companies. Of the most reputable generic companies operating locally is Actavis which manufactures a phletoria of products.

Innovative products logically include combination medicines. Although we are mainly accustomed to seeing combinations of active ingredients to treat acute conditions, the advent of combination products to treat chronic conditions is quite recent. These include Eucreas® (Novartis) which contains vildagliptin and metformin, the Coveram® range (Servier) which contains perindopril and amlodipine and Symbicort® Turbohaler® (AstraZeneca) which contains budesonide and formoterol. Interestingly, the latter has also received the Good design award (Japan, 2010). However, we are now also seeing triple combination products, i.e. Exforge HCT®(Novartis), which contains amlodipine, valsartan and hydrochlorothiazide in a single tablet. Advantages obviously include increased compliance by patients.

A different albeit equally innovative formulation is Diamicron MR® 60mg (Servier), containing gliclazide. When I had a fuller head of hair, I was taught that modified release formulations could not be divided. Well, this product is an exception since its product literature specifically states that the tablets can be broken into two equal halves. Another recently launched range of products, marketed under the brand name Tricef® (Bial), containing cefixime, offering a once daily posology; obviously this increases patient compliance, especially in children

Other newer generation products worth mentioning include Xarelto® tablets (Bayer), containing rivaroxaban, which are the first orally available active direct factor Xa inhibitor; Onbrez® Breezhaler®(Novartis), containing  indacaterol, which is the only ultra-long-acting beta-adrenoceptor agonist; Exelon® patches (Novartis), containing rivastigmine for the treatment of mild to moderately severe dementia; and Resolor® (Shire), containing prucalopride, which is a selective, high affinity serotonin receptor agonist indicated for chronic constipation in women.

At times, an already existing product can be improved simply by reformulating it. Taking Panadol® Advance (GSK) as an example, this product contains Optizorb® technology which allows the tablets to disintegrate in the stomach up to five times faster than standard paracetamol tablets.

Obviously, increasing the availability of the medicines for a population of 400,000 has also been made possible following an adaptation of our registration system. In fact in 2005, the previous administration implemented the provisions of article 126(a) of Directive 2001/83/EC. A medicinal product which has been introduced in this manner is Solupred®tablets (Sanofi Aventis) which offer a fast-dissolving oral prednisone formulation. This has filled up a lacuna in our healthcare system which is created each time rectal prednisolone is out of stock. Another unique formulation which has been marketed via an article 126(a) authorisation with a view to increase compliance, is Forcid® tablets (Astellas), containing co-amoxiclav, which offer the versatility of either swallowing the tablet whole or dissolving it in water prior to intake.