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Solid Dosage Drug Development and Manufacturing SUPPLEMENT TO THE APRIL 2020 ISSUE OF 2020 PharmTech.com Solid Dosage Drug Development and Manufacturing Development OTC Formulations Quality Excipient Regulations Manufacturing Tableting Factors Multi-Tip Tooling Operations OSD Production Challenges CONTRACT MANUFACTURING Biologics | ADCs | Potent | Drug Product | Fermentation Fill/Finish | Hot Melt Extrusion | APIs abbviecontractmfg.com Experience Drug Product Unrivaled When it comes to delivering drug product, you need a CMO with longstanding commercial expertise to ensure fast time to market and assurance of supply. 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. Challener, PhD [email protected] s10 Considering Excipient Regulations Correspondent Sean Milmo (Europe, [email protected]) 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Jennifer Markarian Tel. 732.596.0276, Fax 732.647.1235, PharmTech.com Address MANUFACTURING 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235 s14 A Little Thought Goes PharmTech.com a Long Way in Tableting SALES Publisher Mike Tracey [email protected] Felicity Thomas East Coast Sales Manager Joel Kern [email protected] Mid West, West Coast Sales Manager BJ Ghiglione [email protected] European Sales Manager Linda Hewitt [email protected] European Senior Sales Executive Stephen Cleland [email protected] s18 Considerations for Executive Assistant Barbara Sefchick [email protected] Tablet Compression C.A.S.T. Data and List Information Michael Kushner [email protected] VP/Managing Director, Pharm/Science Group Dave Esola with Multi-Tip Tooling International Licensing Alexa Rockenstein [email protected] Frederick Murray Audience Development Research Director Christine Shappell [email protected] OPERATIONS MJH LIFE SCIENCESTM Chairman and Founder Mike Hennessy, Sr Vice Chairman Jack Lepping s23 In Top Table Form President and CEO Mike Hennessy, Jr Felicity Thomas Chief Financial Officer Neil Glasser, CPA/CFE Executive Vice President, Operations Tom Tolvé Senior Vice President, Content Silas Inman Senior Vice President, I.T. & Enterprise Systems John Moricone Senior Vice President, Audience Generation & Product Fulfillment Joy Puzzo s26 PharmaCapsules Vice President, Human Resources & Administration Shari Lundenberg Vice President, Business Intelligence Chris Hennessy Pharma industry news and technology developments. Vice President, Corporate Branding & B2B Marketing Amy Erdman Executive Creative Director, Creative Services Jeff Brown s25 Ad Index © 2020 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For uses beyond those listed above, please direct your written request to Permission Dept. or email: [email protected] MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers name, addresses, phone num- bers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want MultiMedia Pharma Sciences LLC to make your contact information available to third parties for marketing purposes, simply email [email protected] and a customer service representative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. Pharmaceutical Technology does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. Pharmaceutical Technology welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. Reprints: Contact Mike Tracey, [email protected]. Display, Web, Classified, and Recruitment Advertising: Contact, tel. 732.346.3027. Permissions: Contact Alexa Rockenstein, tel. 732.346.3007, [email protected]. On the cover: smallsmiles - Stock.adobe.com To subscribe: [email protected] Art Direction: Maria Reyes Development Oral Dosage Form Innovation in OTC Pharmaceuticals Gerry McNally lthough both share a preference for use of oral sol- id-dosage forms, the business model for consumer pharmaceutical manufacturers—often called over- the-counter (OTC) manufacturers in the United AStates—differs significantly from that of prescription drug manufacturers. 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
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