Issue link: https://www.e-digitaleditions.com/i/1000772
Tablets & Capsules July 2018 19 revenue anticipated to rise from an estimated $11.4 billion in 2017 to about $27 billion in 2025 [2]. Table 1 lists some examples of the more than 450 over-the- counter (OTC) and prescription ODT products currently available on the market. The world's aging population has increased the demand for geriatric drug products, and this trend is expected to continue. Also, evidence shows that children are not just small-sized adults when it comes to medication. For example, a child's metabolism differs significantly from that of an adult, so pediatric medicines may require not only different dosages but also different API release profiles than adult medicines. In fact, since 2007 the European Medicines Agency has required pharmaceutical companies to submit a pediatric investigation plan to the agency's pediatrics committee at the end of the first phase of testing a new drug in adults [1]. Th e need to develop age-appropriate formulations targeting pediatric and elderly patients is clear. ODTs can help improve compliance for these two populations because ODT tablets are usually smaller than traditional tablets and capsules, they disintegrate rapidly in the patient's mouth, and they have a pleasant mouthfeel and flavor. In the combined regions of the US, the European Union, and Japan, the ODT market has doubled in the last four years. A 2017 study by Persistence Market Research predicted that the global ODT market will grow at a significant pace in coming years, with annual Figure 1 Key DC ODT platform performance attributes and formulation challenges Hardness dependency Stability over time Disintegration time Flow and compactability Organoleptic properties Chemical stability Flowability Dilution potential Lubricant sensitivity Mouthfeel Taste Texture Impurity content Hygroscopicity Inertness Stability Figure 2 a. Placebo tablets (99 percent ODT platform, 1 percent magnesium stearate) Compression force versus tablet hardness b. Caffeine tablets (89 percent ODT platform, 10 percent caffeine 1 percent magnesium stearate) 1 4 7 10 13 16 1 4 7 10 13 16 150 130 110 90 70 50 30 10 150 130 110 90 70 50 30 10 Hardness (N) Hardness (N) Compression force (kN) Compression force (kN) Platform 1 Platform 2 Platform 3 Platform 4 Platform 5 Platform 1 Platform 2 Platform 3 Platform 4 Platform 5 Table 1 Examples of currently marketed ODTs [4] Active ingredient Brand name Category Technology Loratadine Claritin Antihistaminic Lyophilization Mirtazapine Remeron Antidepressant Compressed tablets Olanzapine Zyprexa Antipsychotic; serotonin-dopamine antagonist Lyophilization Ondansetron Zofran ODT Nootropic; antiemetic; serotonin receptor antagonist Lyophilization Risperidone Risperdal Antipsychotic; dopamine receptor antagonist; serotonin-dopamine antagonist Lyophilization Rizatriptan Maxalt Antimigraine; serotonin receptor agonist Lyophilization Tramadol Ultram Analgesic (non-narcotic) Cotton candy process Zolmitriptan Zomig Antimigraine; serotonin receptor agonist Compressed tablets Zolpidem Ambien Sedative/hypnotic Cotton candy process