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Solid Dosage Drug Development and Manufacturing 2020 EDITORIAL DEVELOPMENT Editorial Director Rita Peters [email protected] Senior Editor Agnes Shanley [email protected] Managing Editor Susan Haigney [email protected] s4 Oral Dosage Form Innovation European Editor Felicity Thomas [email protected] in OTC Pharmaceuticals Manufacturing Editor Jennifer Markarian [email protected] Science Editor Feliza Mirasol [email protected] Gerry McNally Assistant Editor Lauren Lavelle [email protected] Senior Art Director Marie Maresco; Graphic Designer Maria Reyes Contributing Editors Jill Wechsler [email protected]; Hallie Forcinio [email protected]; QUALITY/REGULATIONS Susan J. Schniepp [email protected]; Eric Langer [email protected]; and Cynthia A. 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However, both types of companies have been responding to market changes by focusing on formulation and delivery changes that increase convenience to the patient/con- sumer. Figure 1 summarizes recent trends in consumer-directed innovation in the OTC pharmaceutical market. Differences between prescription and OTC products first became pronounced in the mid-1980s, when OTC manufac- turers began to introduce increasingly diverse consumer-ori- ented products, and to change their approach to marketing, PHAT1978 - STOCK.ADOBE.COMPHAT1978 promotion, and packaging. The OTC marketing approach became more like that used in other fast-moving consumer A quick look at the history of OTC dosage packaged goods (FMCG) industries (e.g., foods, beverages, form development shows the importance and personal care products). Packaging and advertising were of patient-centered innovation. increasingly directed to the consumer, rather than the health- care provider or pharmacist. Emphasis on form and sensory attributes During the 1990s, the marketing of dosage formats and features such as form and sensory attributes (e.g.,colors, ap- pearance, and flavors) became part of the product promotion mix. Recently, a major growth driver for OTC pharmaceuticals, particularly in the US, has been new products that resulted from prescription-to-OTC switches. These products were predomi- nantly standard tablets or capsules with relatively few new de- livery formats other than some modified-release products, the most unique being a slow-release nicotine chewing gum. Introduction of more competitive and higher quality pri- vate-label or store-brand products in the 1990s underscored the need for branded OTC manufacturers to differentiate their offerings. The pressure to innovate with dosage form and pack- aging design has remained constant, driven by competing OTC Gerry P. McNally is principal of McNally Consulting brands as well as generic-pharmaceutical companies that supply Group, LLC. With more than 25 years of experience, drug stores and supermarkets with copies of branded products. he earned a BS and PhD in chemistry from University Retailer consolidation has also driven increased competition, College, Dublin, Ireland and holds more than 25 patents and dosage form innovation has become a crucial way for com- in drug delivery and formulation. He can be reached at [email protected]. panies to differentiate products (1). s4 Pharmaceutical Technology SOLID DOSAGE DRUG DEVELOPMENT AND MANUFACTURING 2020 PharmTech.com Anthrax Perfecting Your Forula Ebola Since 1998, Emergent BioSolutions has been the go-to source for solutions to some of the most dangerous threats to public health. SARS No matter the challenge, Emergent is ready to navigate uncharted waters and help bring life-saving therapies to the world. COVID-19 Learn more at emergentcdmo.com. Development that consumers became familiar with once- or twice-daily dos- Figure 1. Innovation in over-the-counter oral solid dosage ing. Thus, Delsym and other legacy long-acting brands expe- delivery forms (1990 - 2020) rienced something of a renaissance in the late 1990s and early 2000s. Johnson & Johnson’s Tylenol analgesic brand maintained a strong market presence over several decades, due to continu- ous form innovation, which included introducing novel gela- tin-coated, capsule-shaped tablets called gelcaps, with a later addition of gelatin-coated round tablets called geltabs. In the mid 2000s, Tylenol gelcaps were replaced by rapid-release gels, gelatin-coated caplets with laser-drilled holes that enabled faster disintegration and dissolution. Other innovations included im- proving the taste of pediatric