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Tablets & Capsules April 2020 36 Marketing advantages Multilayer tablets offer a unique product appearance, allowing manufacturers to design tablets with a distinct appearance for marketing to consumers or create a new look for an existing product. Manufacturers can also extend product patents by creating combinations or new forms of previously marketed products. By allowing for a multitude of API-matrix combinations, multilayer and core tableting technologies provide manufacturers with a broad range of cost-effective product possibilities that are also convenient and therapeutically beneficial for patients. Outsourcing In developing drug products that use multilayer and core tableting, you should employ an end-to-end plan- ning approach that can examine a broad spectrum of val- ue-added services and manufacturing capabilities. Such an approach takes a method or service from development through manufacturing, delivering a complete functional solution. Such solutions allow the incorporation of a broad spectrum of value-added services and product develop- ment and manufacturing capabilities that small to mid- sized pharmaceutical companies may not have in-house. They also allow the use of comprehensive strategies. For example, a CMO or CDMO that offers an end- to-end approach will have the ability to work with a company during the initial product development stage, involving clinical trials, and also have the ability to take the drug product through to manufacturing. T&C Jim Calvin is general manager of Elizabeth-Hata and Ryan Keefer is North American sales manager at The Elizabeth Com- panies, McKeesport, PA (412 751 3000, www.eliz.com). The company manufactures tablet tooling, tablet presses, blister-pack tooling, turrets, and press parts for the pharmaceutical industry. often produced finished tablets with misaligned or miss- ing core tablets. Newer core-tableting technology uses a punch-driven, core transfer chain, which is synchronized with the rotation of the tablet press turret to precisely position the inner core tablets in the center of the die cavity every time. The process also uses optical vision technology, in which a camera detects the inner-core tablets for positioning during production. These new developments allow the core to be positioned precisely at the top, bottom, side, or center of the tablet so formula- tors can more accurately anticipate the dissolution rate of the core coating and the API release. Multilayer and core tableting technologies can provide drug product manufacturers with multiple formulation, manufacturing, therapeutic, and marketing advantages. Formulation advantages Perhaps the most prominent advantage of a multilayer and core tableting versus conventional single-layer tablet- ing is that it allows for multiple incompatible APIs within a single tablet. Each API is compressed into a separate matrix separated by an inert barrier layer. This prevents problems such as instability that can occur when the APIs are compressed into a single matrix. Multilayer and core tableting both work well with extended and delayed API release. Many new formula- tions require API release into the lower stomach. Multi- layer or core tableting can provide a dependable, accurate, delayed-release delivery mechanism for such products. Multilayer tablets can also contain two or more lay- ers of the same API, with each layer having a different release profile. An extended-release product works by controlling the hydration or swelling rate of the core, which slows down the tablet's dissolution in a patient's body. When the tablet enters a patient's stomach, it swells and increases in volume, causing it to remain in the stomach and release the API over a longer period of time. Manufacturing advantages Multilayer and core tableting can provide substantial operational and capital cost savings by reducing concur- rent manufacturing activities. Because a formulation can include two APIs in a single tablet, only one manufactur- ing process is required rather than two. Therapeutic advantages Multilayer and core tablet products can reduce or eliminate the need for patients to take multiple tablets at one time or over time. This is ideal for elderly patients who may have difficulty remembering to take prescribed tablets throughout the day. Also, multilayer and core tableting allow you to create specialty drug products that combine treatments for multiple conditions into a sin- gle-dosage form. For example, the proprietary polypill is a multilayer tablet that contains a combination of medica- tions to treat both heart disease and high blood pressure. These types of products can be very beneficial to patients and open up additional opportunities for manufacturers. Photo 1: On a modern core-tableting press, push pins synchronized with the press' turret rotation insert the core tablets into the die cavity and assist with centering and alignment.