Solid dosage forms are the most popular method of drug delivery and although tablets are widely established throughout the pharmaceutical industry, this doesn't mean it is an unmoving area. According to a recent Pharmaceutical Tehnology poll, manufacturers are seeking to reformulate or reinvent their currently marketed solid-dose products to both renew patents and improve efficacy (see Figure 1).
One possible way to achieve these goals is to reformulate tablets into more exotic forms such as multilayer tablets, fixed-dose combinations, and other innovative dosages.
Pharmaceutical Technology brought together experts in solid dosage for a special roundtable on the formulation and manufacture of multilayer tablets. We also spoke to researchers about fixed-dose combinations, an area that has raised controversy, regarding adverse effects. Participants in the roundtable include: Marcus Behrens, sales director at IMA Kilian; James Calvin, Elizabeth Companies; Doug Kirsch, Technical Service Manager at Natoli Engineering Company; and LakshmiDevi Ethirajan, Manager, Formulation Development at Tedor Pharma.
Figure 1: Demand for reformulation (PharmTech poll).
PharmTech: How has demand for multilayer tablets altered in recent years? What factors have influenced this trend?
Behrens (IMA Kilian): Fixed-dose combination drugs are becoming increasingly popular, particularly as life-cycle management strategies seek to extend intellectual property and minimize generic exposure by creating an innovative dosage form. The multilayer tablet is a viable way to combine different actives for a synergic therapeutic effect, or different formulations of the same active in order to achieve a specific release profile. Furthermore, multilayer tablets can help avoid interactions between different drugs and optimize each formulation in terms of pharmacokinetics and manufacturability.
From left to right: Marcus Behrens (IMA Kilian), James Calvin (Elizabeth Companies), Doug Kirsch (Natoli); LakshmiDevi Ethirajan (Tedor Pharma) is not shown.
Calvin (Elizabeth Companies): The growth of high-potency and combination drug products over the last decade has made multilayer and tablet in tablet (core tablet) hot topics in the pharma industry. These novel delivery systems have been essential not only in formulating new products, but also in helping pharmaceutical companies to extend patents.
Ethirajan (Tedor Pharma): Among other advantages, triple-combination therapy in a single-dosage form is being used to promote better treatment adherence by providing a convenient single tablet. As well as increasing patient compliance, multilayer tablets can help to reduce the cost of medication.