ACCU-BREAK aims to divide and rule with tabletting tech

ACCU-BREAK's technology, which was promoted through two posters at this week's American Society of Hypertension meeting in Chicago, incorporates a drug-free 'zone' or layer in each tablet that allows for more accurate, individualised dosage adjustment and titration. That in turn can lead to more consistent therapeutic effects, fewer side effects and better adherence to treatment plan, the company says. According to ACCU-BREAK, difficult and uneven tablet-splitting is a "longstanding clinical problem with potentially important implications for patient safety and drug efficacy". Organisations such as the American Medical Association and the American Pharmacists Association formally oppose mandatory pill-splitting, the company notes. Moreover, research has shown that many tablets are physically difficult for some patients to break and that actual dosages of hand-split tablets may deviate by more than 20 per cent from the expected half-dose. ACCU-BREAK's hook is that its tablets are "made to be broken", whether into equal half, third or quarter doses. They are also easy to swallow whole, the company says. With the ACCU-T tablet design, the scored middle section of the tablet is inactive, serving as a breaking point for the two tablet halves. The design can be formulated for combination products, maintaining "the cost and compliance advantages of conventional fixed-dose combination products, while adding the flexibility of individual dosage forms", ACCU-BREAK points out. The uniqueness of this format has been recognised by the US Food and Drug Administration, which has indicated that standard fixed-dose combination tablets will not be substitutable for ACCU-BREAK's tablet design, the company adds. A second option is the ACCU-B tablet, which comprises a scored top layer pre-divided into four equal segments, plus an inactive bottom layer, which serves as the breaking region. ACCU-BREAK says its reformulation techniques are low-risk, low-cost and suitable for "essentially any product that can be manufactured as a tablet", including micro-encapsulated and matrix formulations. Among the claimed advantages are product differentiation and life-cycle benefits, improved patient compliance, reduced tablet wastage and significant protection against counterfeiting. The company has 18 patent applications filed on its technology in the US and worldwide. It is seeking pharmaceutical licensees for the underlying intellectual property. However, a joint venture formed in June 2006 with India's Strides Arcolab Limited, which involved developing generic drugs based on ACCU-BREAK's technologies for the US and international markets, recently folded due to the evolution of ACCU-BREAK's business model to include "potential brand sales of bioequivalent products and out-licensing of certain products".