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Tablets & Capsules March 2020 17 additional benefit of increased patient or consumer com- pliance, especially for brands that require daily use (such as vitamins and fiber supplements). For any given brand, the optimal use of drug delivery can involve a variety of improvements over time to help achieve increased com- pliance. The most common improvements include forms that make the product longer-acting, faster-acting, more palatable, or more consumer friendly. Longer-acting products. In the early days of self-se- lection therapies, oral tablets often had fast-release prop- erties, which provided immediate therapeutic benefits (typically 4 to 6 hours) but required more frequent dos- ing. Over time, manufacturers developed longer-acting or sustained-relief therapies with existing compounds, effectively delivering medicament over a longer time period (up to 12 hours). The switch to OTC of formerly Rx therapies expanded on the long-acting therapy model. For example, Aleve was first offered as a 12-hour OTC pain reliever in the mid tic agents" [1]. Drug delivery systems can take many forms, such as oral solids, oral liquids, topical, nasal, transdermal, drug/device combinations, and more. This article will focus on oral delivery, including both imme- diate- and controlled-release tablets, capsules, and soft- gels; orally disintegrating tablets (ODTs) and thin films (ODFs); and confectioneries. The advantages of these oral forms can include accurate dosing, portability, ease of use, and extended shelf life. US consumer healthcare market Consumer healthcare products represent a large and growing business. According to the Nicholas Hall 2019 DB6 database [2], global sales of OTC and VMS prod- ucts in 2018 were $135.4 billion, up 4 percent versus the prior year. The US is the largest market, representing nearly 25 percent ($33.6 billion) of all worldwide sales in 2018. This was a 3 percent increase versus the prior year. In the US, key therapy areas in the consumer health- care market include cough /cold /allerg y products (21 percent), analgesics (12 percent), gastrointestinals (11 percent), VMS products (36 percent), dermatologicals (12 percent), and lifestyle OTCs (9 percent), as shown in Figure 1 [2]. Other than for dermatologicals, the vast majority of brands use oral delivery forms, especially tab- lets, capsules, ODTs, and confectioneries. Each of the top 10 US OTC brands for 2018 exceeded $300 million in sales, as shown in Table 1 [2]. With the exception of Flonase (GlaxoSmithKline), which uses nasal delivery, each of these top 10 brands uses oral delivery forms for many individual products. Using drug delivery in lifecycle management To effectively use drug delivery in lifecycle manage- ment, you must understand consumer needs, know the delivery technology alternatives, and implement a sound development and manufacturing process. Developing a checklist of all the critical steps, with expected outcomes and due dates, will give you a clear plan to execute. Understanding consumer needs Understanding a brand's existing and prospective con- sumers can provide great value when assessing appropri- ate delivery forms. For existing products, is current busi- ness declining, flat, or growing? Determine the profile of the brand's current users, especially heavy users, depend- ing upon the type of product. Companies often use traditional qualitative and quan- titative market research to measure how individuals will react to new delivery systems and how the delivery sys- tem can impact brand purchases. Be sure to include the cost investment when analyzing whether a new delivery system can improve a product or formulation and its ulti- mate effect on the business model. Selecting the right delivery technology The objective of expanding a brand via drug delivery is often to appeal to a broader user group with a better and bigger range of choices. In the long run, this has the Table 1 2018 Top 10 US OTC brands (in millions of US dollars) 1 Nature Made 769.283 2 Tylenol 765.442 3 Mucinex 662.794 4 Advil 646.667 5 Vicks 614.909 6 Nature's Bounty 470.144 7 Claritin 409.092 8 Zyrtec 372.657 9 Aleve 349.257 10 Flonase 300.746 Total US Market 33,594.542 Figure 1 2018 US OTC sales (in millions of US dollars) Vitamins, minerals, & supplements 11,966.758 Lifestyle OTCs 3,189.861 Gastrointestinals 3,603.393 Analgesics 3,931.813 Dermatologicals 4,003.296 Cough, cold, & allergy 6,899.422