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Download the Evonik for More Information! ADVANCED APPROACHES THE PRESCRIPTION CAN WE ACHIEVE FOR DELAYED-RELEASE ABUSE EPIDEMIC: EFFECTIVE ORAL P04 FORMULATIONS P18 DESIGNING A SOLUTION P32 DELIVERY OF VACCINES? NOVEL ORAL DELIVERY SYSTEMS 77 O 2017 • ISSUE N 2017 TH JULY 17 JULY Contents o TH ONdrugDelivery Issue N 77, July 17 , 2017 Advanced Approaches for Delayed-Release Formulations Maria Montero Mirabet, Senior Project Manager, NOVEL ORAL DELIVERY SYSTEMS Drug Delivery Services, Business Line Health Care, and 4 - 9 Brigitte Skalsky, Senior Director, Scientific Communication, This edition is one in the ONdrugDelivery series Business Line Health Care of publications from Frederick Furness Publishing. Evonik Nutrition & Care Each issue focuses on a specific topic within the field of drug delivery, and is supported by industry Technologies & Clinical Studies for the Oral Delivery of Calcitonin Nozer Mehta, Principal leaders in that field. Peptide Technologies James P Gilligan, Chief Scientific Officer 12 MONTH EDITORIAL CALENDAR 10 - 16 Tarsa Therapeutics Sep Wearable Injectors William Stern, Consultant Peptide Drug Development Oct Prefilled Syringes Nov Pulmonary & Nasal Delivery The Prescription Abuse Epidemic: Designing a Solution Dec Connecting Drug Delivery Aia Malik, Healthcare Product Manager, and 18 - 20 Gemma Budd, Director of Technologies and Strategy Jan ‘18 Ophthalmic Delivery Lucideon Feb Prefilled Syringes Mar Skin Drug Delivery: Targeting the End Goal: Opportunities & Innovations in Colonic Drug Delivery Dermal, Transdermal & Microneedles Sejal R Ranmal, Director of Formulation, Apr Pulmonary & Nasal Drug Delivery 22 - 26 Vipul Yadav, Director of Product Development, and May Injectable Drug Delivery: Devices Focus Abdul W Basit, Founder Jun Connecting Drug Delivery Intract Pharma Jul Novel Oral Delivery Systems Single-Step Functional Coatings for Increased Efficiencies Nathan Dormer, Vice-President of Research & Development, and Cory Berkland, Co-Founder & Chief Scientific Officer SUBSCRIPTIONS: 28 - 31 Orbis Biosciences 9-10 issues of ONdrugDelivery Magazine published per year, in PRINT & PDF. Can We Achieve Effective Oral Delivery of Vaccines? Evaluating a New Microsphere Based Controlled-Release PDF subscription is always completely free. Delivery System PRINT subscription costs £189/year. S Mohan Mohanraj, Director of Technology Print subscription includes delivery of a printed copy 32 - 36 PolyMicrospheres of each issue to one address anywhere in the world. Meir Kende, Dept of Molecular Biology, Integrated Toxicology Division Your partner for oral One partner – multiple benefits: E: [email protected] US Army Medical Research Institute of Infectious Diseases z Specific release profiles tailored to your therapeutic Meeting the Challenges of Paediatric Dosing drug delivery services EDITORIAL AND ADVERTISING: Don Barbieri, Technical Products Manager needs based on versatile use of functional EUDRAGIT® 37 - 39 SPI Pharma polymers. Contact: Guy Furness, Proprietor & Publisher T: +44 (0) 1273 47 28 28 Orally Disintegrating Films for the Delivery of z Smart formulation designs and appropriate state-of- E: [email protected] Biotherapeutics & Nano / Microparticle Formulations Evonik Health Care 40 - 43 Carmen Popescu, Senior Project Co-ordinator the-art manufacturing techniques for your compounds. Roquette www.evonik.com/oraldrugdelivery MAILING ADDRESS: z Enabling EUDRATEC® drug delivery technologies to Frederick Furness Publishing Ltd protect your formulation and get you a step ahead of The Candlemakers, West Street, Lewes, the competition. East Sussex, BN7 2NZ, United Kingdom ONdrugDelivery Magazine is published by z Commercially viable formulations based on 60 years Frederick Furness Publishing Ltd. Registered Office: product and formulation know-how. The Candlemakers, West Street, Lewes, East Sussex, BN7 2NZ, United Kingdom. z Comprehensive development services from first Registered in England: No 8348388. feasibility trials, via formulation development and VAT Registration No: GB 153 0432 49. process optimization to clinical supply. ISSN 2049-145X print ISSN 2049-1468 pdf z Handling of small moelcules and biopharmaceuticals, including HPAPIs and controlled substances. Copyright © 2017 Frederick Furness Publishing Ltd All rights reserved The views and opinions expressed in this issue are those of the authors. Due care has been used in producing this publication, but the publisher makes no claim that it is free of error. Nor does the publisher accept liability for the consequences of any decision or action taken (or not taken) as a result of any information contained in this publication. 2 www.ondrugdelivery.com Copyright © 2017 Frederick Furness Publishing Ltd 17-01-198 AZ Oral drug delivery services, A4, engl.indd 1 14.06.17 17:36 Your partner for oral One partner – multiple benefits: z Specific release profiles tailored to your therapeutic drug delivery services needs based on versatile use of functional EUDRAGIT® polymers. Evonik Health Care z Smart formulation designs and appropriate state-of- www.evonik.com/oraldrugdelivery the-art manufacturing techniques for your compounds. z Enabling EUDRATEC® drug delivery technologies to protect your formulation and get you a step ahead of the competition. z Commercially viable formulations based on 60 years product and formulation know-how. z Comprehensive development services from first feasibility trials, via formulation development and process optimization to clinical supply. z Handling of small moelcules and biopharmaceuticals, including HPAPIs and controlled substances. 17-01-198 AZ Oral drug delivery services, A4, engl.indd 1 14.06.17 17:36 Evonik ADVANCED APPROACHES FOR DELAYED-RELEASE FORMULATIONS There is growing awareness of the potential for delayed-release formulations to improve patient compliance and increase therapeutic effect. Maria Montero Mirabet, PhD, Senior Project Manager, Drug Delivery Services, and Brigitte Skalsky, PhD, Senior Director, Scientific Communication, both of Evonik Health Care, review advances in delayed-release technology including advances in enteric-coating applications and the use of pulsatile technology to provide tailored lag times. Delayed-release formulations continue to be a highly “New modified-release products, relevant formulation approach. Traditionally, the main focuses either as extended or delayed have been to protect acid- release, can lead to better patient sensitive drugs against gastric compliance or to improved fluid and to safeguard gastric mucosa against aggressive treatment of diseases with actives. In the future, specific therapeutic needs.” however, targeted drug delivery will be the major motivator Dr Maria Montero Mirabet for formulating drugs with delayed-release ago as an IR tablet. Although the drug Senior Project Manager, Drug Delivery characteristics. itself is powerful, when administered Services, Business Line Health Care The potential of delayed-release in the evening, the IR tablet does not T: +49 6151 18 6513 formulations to improve therapeutic achieve therapeutic plasma concentration E: maria.montero-mirabet effects is reflected in the number of market to treat the high level of pro-inflammatory @evonik.com authorisations in this area, as listed by cytokine excretion in the early morning. the US FDA. Although immediate-release Several scientific communications reported (IR) dosage forms strongly dominate the the efficacy of a delayed-release prednisone pharmaceutical market, manufacturers formulation, targeting the circadian increasingly select modified-release pattern of inflammatory mediators and approaches to improve their products. thus relieving the morning stiffness of New modified-release products, either as rheumatic patients.3 extended or delayed release, can lead to However, not until 2012 did the first better patient compliance or to improved commercial prednisone delayed-released Dr Brigitte Skalsky treatment of diseases with specific product gain approval by the FDA Senior Director, Scientific therapeutic needs. (RAYOS® Delayed-Release Tablets; Communication, Business Line As an example, rheumatic arthritis (RA) Horizon Pharma, Dublin, Ireland). Health Care is associated with high cytokines levels, According to packaging information, T: +49 6151 18 4389 E: [email protected] especially in the early morning.1 Patients with RAYOS® releases the active approximately RA can be treated with the glucocorticoid four hours after intake. Administration prednisone. This therapy is highly efficient in the evening therefore leads to an Evonik Nutrition & Care GmbH if the drug plasma concentration matches optimal therapeutic plasma level in the Kirschenallee 64293 Darmstadt the circadian rhythm of RA patients.2 early morning hours. As a result, both Germany The first commercial product of patient compliance and therapeutic effect prednisone was launched several decades have been improved. www.evonik.com/healthcare 4 www.ondrugdelivery.com Copyright © 2017 Frederick Furness Publishing Ltd Evonik ENTERIC COATING TECHNOLOGY Still, for most drugs a release within infection and inflammation are substrates 30 minutes in buffer medium should be of this transporter which goes along with Delayed drug release is commonly achieved fast enough to ensure therapeutic plasma reduced absorption and permeation of the by the application of an enteric coating on concentrations. However, there are other drugs. Examples reported are aldosterone, dosage forms such as tablets, capsules and active pharmaceutical
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