EXCIPIENT NORTH. technology forum. A technical event specifically designed for the Canadian Pharmaceutical formulation community.

Transcription

1 EXCIPIENT NORTH technology forum THURSDAY OCT 1st 2015 A technical event specifically designed for the Canadian Pharmaceutical formulation community. Presented By

2 EXCIPIENT NORTH 2015 WHAT IS IT? A technical forum aimed at the Canadian Pharmaceutical Formulation community. Presentations from seven global excipient suppliers on new products, studies and formulation technologies that offer technical insights on today s excipient formulation technologies and processing options. A USB with all presentations and a certificate of participation is provided. There is no cost if you register prior to the event. WHEN IS IT? WHERE IS IT? HOW DO I REGISTER? Thursday, October 1st, :00 a.m. 5:00 p.m. Event Check in starts at 8:30am Terrebonne Room Sheraton Laval Hotel 2440 Autoroute des Laurentides Laval, Quebec, H7T 1X5 Tel: Contact Jamie Elliott of Chemroy with the following: Your Name, Company, Title Telephone number, address jelliott@chemroy.ca :30am AGENDA AT A GLANCE Event Check-in Begins 9:00am Welcome to Excipient North :10am 10:00am 10:50am 11:10am 12:00pm 1:10pm 2:00pm 2:50pm 3:10pm 4:00pm 4:50pm High Productivity, Sustained Release Pharmaceutical Dosage Forms: Evaluation of Rotor process and Dry Powder Coatings of Ethylcellulose - Nick Grasman, DOW Evolution of Excipient Co-processing - Joseph Zeleznik, MEGGLE BREAK - Coffee, Tea, Snacks Provided The Effect of Excipients on the Performance and Physical Properties of Semi-Solids Anna Vladimirova, BASF LUNCH - Buffet Provided at La Piazza Restaurant, Sheraton Laval Formulation/ Process Development: From Steel to Scale up and everything in between - Fazal Mohideen, NATOLI Alginates: The right chemistry for pharmaceutical applications - Rina Choskhi, FMC BREAK - Coffee, Tea, Snacks Provided Introduction of Acryl-EZE II and Opadry amb II - Gus LaBella, COLORCON The Advantages of Special Low Viscosity Hydroxypropyl Cellulose (HPC-SSL) in Pharmaceutical Formulation Applications - Ryan Cheng, NISSO Closing Remarks

3 9:10am High Productivity, Sustained Release Pharmaceutical Dosage Forms: Evaluation of Rotor Process and Dry Powder Coatings of Ethylcellulose - Nick Grasman, DOW Spray coatings of ethylcellulose for sustained drug release on multi-particulate dosage forms is common in the pharmaceutical industry, but can be disadvantageous because of long process times, need for organic solvent capabilities, and particulate agglomeration. Using a rotor process technology, ethylcellulose can be applied to drug layered beads as a dry powder; enabling the user to achieve high levels of weight gain in a short period of time while still demonstrating sustained release. Information will be presented comparing performance and productivity to traditional solvent-based Wurster coating and aqueous-based Wurster coating. Dow Pharma and Food Solutions Overview: Dow Pharma & Food Solutions designs differentiated solutions that enable pharmaceutical delivery & nutritional benefits to customers around the world. A business of Dow Consumer Care portfolio, Dow Pharma & Food Solutions offers a single interface to all Dow technologies and expertise focused on solutions serving the pharmaceutical and food manufacturing markets. We provide functional excipients, active pharmaceutical ingredients (APIs) and highly functional food ingredients to help consumers live healthier, more convenient and enjoyable lives. 10:00am Evolution of Excipient Co-processing - Joseph Zeleznik, MEGGLE Excipient co-processing is no longer a new concept or practice, nor is it limited to binary ingredient compositions. Excipient co-processing has been performed for several decades and for many reasons, the primary focus of which has been enhancing functional performance. As a result, co-processing has helped to transition the excipient industry from fit-for-use to designed - for - purpose ingredients which overcome many of the limitations possessed by traditionally used formulation ingredients. The speaker will discuss the advent of excipient co- processing and its evolution to creating high-performance ingredients for pharmaceutical dosage form development and manufacture. Meggle: Excipient and Technology Overview: Excipient and Technology is a business group within 122 years old Meggle Holding and dedicated to pharmaceutical excipients, exclusively. From its beginnings production covered milled and sieved lactose grades, followed by the development of the first agglomerated (e.g. Tablettose 70/80100) and subsequently spray-dried (FlowLac 90/100) lactose type. For all kind of pharmaceutical granulation processes a broad variety of so called co-processed materials, as Cellactose80, Microcellac 100 or Starlac is available, as well. Since 2000 inhaler grade lactose types can be found in the product portfolio. Meggle is constantly working to develop hightech, functional products for implementation in customer applications, where they can deliver maximum performance. Even with advances in innovation, Meggle remains what they always have been: a family business with strict values and high standards. Performance and partnership with customers is at the core of Meggle s success.

4 11:10am The Effect of Excipients on the Performance and Physical Properties of Semi-Solids - Anna Vladimirova, BASF This talk will cover the oldest of the currently available skin delivery systems, medicated semi-solids, which continue to retain consumer attractiveness due to ease of application, absence of first pass metabolism, and localized drug delivery. Although formulations of semi-solids may seem empirical, subtle differences in the physico-chemical framework associated with these systems may have a large effect on the performance and bioavailability of the drug agents. Specifically, these frameworks are composed of numerous possible microstructures including API polymorphs, surfactant phases, crystalline lipophiles, polymer networks and lipophile-surfactant gel or liquid crystalline phases. Thus, the selection of excipients in topical semi-solids will determine the structure of the microscopic phases during and after processing, and fundamentally alter the performance of the formulation; this is ultimately important for both our customers as well as the FDA. In this work, the complexity of PEG ointment formulations and o/w emulsions are investigated using BASF excipients. The influence of these ingredients on the physical properties of the formulations was observed by measuring viscosity and observing microstructure. Exemplary data will demonstrate how specific excipients were used to modify formulation performance, correct formulations that exhibited phase separation, and improve stability BASF Pharmaceutical Ingredients and Services Overview: The BASF Tarrytown, NY site is the home of the Global Skin Delivery Laboratory for the Pharma Ingredients & Services group, where our mission is to best service the pharmaceutical industry and our global customers with a deep technical understanding of dermatological products. Anna received her B.S. in Chemistry from Texas A&M University-Commerce in Anna specialized in mechanistic enzymology and obtained her Ph.D. in Chemistry from Texas A&M University in She joined BASF and the Global Skin Delivery Laboratory under Pharm Ingredients & Services in March, 2015 as a member of the Professional Development Program (PDP). Besides her molecular biology and enzymology background, she is progressively gaining valuable experience in medicated semi-solid formulations and understanding the importance of excipients on drug bioavailability. Anna hopes to further explore possibilities for biocatalysis in the productions of biologics. 1:10pm Formulation/ Process Development: From Steel to Scale Up and Everything in Between - Fazal Mohideen, NATOLI This presentation will cover key parameters in tablet production: Grades of Steels Offered, Characteristics of API and Binary Studies (Pre Formulation), Excipient Choices, Direct Mixing/Analytical Issues, Wet granulation/roller Compaction, How Particle Size Influences Tableting, Troubleshooting Tableting Issues, Dissolution and Blend Uniformity Problems, Scale Up and Range Studies of Final Formulas. Natoli Engineering Company Inc. Overview: Founded in 1973 and considered a leader in manufacturing, Natoli Engineering has over 40 years of experience in delivering tablet compression products and services to pharmaceutical, nutritional, confectionery, industrial and veterinary industries around the globe. Our commitment to innovation and excellence has earned us an International reputation for high quality and reliability. Mr. Mohideen has 19 years in the formulation development business within the pharmaceutical industry, including 3 years as Senior Scientist at Merck Generics; 2 years as Manager of Formulation Development at Teva Canada; and 3 years as Manager, Technical Sales for Natoli Engineering in Canada. Fazal has patents within the US, Canada and EU within his 19 years in the pharma business, and has developed over 400 molecules for Canadian, EU and US markets. He has many years of experience in product development, scale up processing, analytical troubleshooting, dry/wet granulation, roller compaction, tableting, coating, and encapsulation.

5 2:00pm Alginates: The Right Chemistry for Pharmaceutical Applications - Rina Choskhi Ph.D. FMC Alginate is a biocompatible and biodegradable polysaccharide from brown seaweed, which can be manufactured with a wide range of viscosity and gelling characteristics. The versatility of alginate enables a diverse range of pharmaceutical, biomedical and nutraceutical applications. This presentation will cover detail understanding of alginate synthesis and chemistry with particular focus on critical material attributes such as molecular weight/viscosity, Mannuronic/Guluronic acid ratio, effect counterions and batch to batch consistency. Alginate offers primarily two functionality viscosity and gelation, which will be discussed with clear understanding of mechanism of action. This presentation will provide overview of various alginate applications correlating to material attributes such as antireflux, controlled release, solid dispersion, enteric coating, satiety/weight control, macoencapsulation, cell encapsulation and cardiology. FMC BioPolymer Overview: FMC BioPolymer provides oral dose form drug delivery solutions, assisting our customers in bringing drugs to market faster and making their operations more cost effective. FMC s ability to help with customer formulation challenges is unrivaled due to our well-controlled products, decades of formulation and manufacturing experience and staff dedicated to our customer s success. 3:10pm Introduction of Acryl-EZE II and Opadry amb II - Gus LaBella, COLORCON Acryl-EZE II - Delayed release oral solid dosage forms are widely used to protect the gastric mucosa from irritating actives or to protect drugs sensitive to gastric fluids. Delayed release products are also utilized for drug delivery to local sites in the intestine, promoting absorption and increasing the bioavailability of the active ingredients at the site of action. Acryl-EZE II, optimized aqueous acrylic enteric system is a fully formulated, high performance coating that offers reliable enteric protection at lower weight gains compared to existing Acryl-EZE systems. The formulations are suitable for use on multiparticulates or tablets including proton pump inhibitor (PPI) applications. Opadry amb II High Performance Moisture Barrier Film Coating - This is the first fully formulated Opadry PVA-based immediate release system without polyethylene glycol (PEG) that delivers the three-fold advantage of high productivity, low impurity levels and a superior tablet finish. Tablets coated with Opadry amb II exhibit a high-gloss, quality appearance with well-defined logos. The Perfect Balance Protection, Time Savings, Ease-of-Use. Colorcon Overview: Gus LaBella, Formulation Technologies Manager at Colorcon, has more than 27 years of experience in solid oral dosage form development. He is responsible for providing customer support and generating applications data for core formulation excipients and modified release products offered by Colorcon. His prior experience includes various positions within Research and Development, including Product Development, Investigational Supplies, Support to Marketed Products, and R&D Technologies. His skills range from pre-formulation of novel dosage forms to post launch support of marketed products. His areas of interest are wet granulation, compression instrumentation and design of experiments. Gus holds a BS in Materials Engineering from Drexel University in Philadelphia, Pennsylvania. 4:00pm The Advantages of Special Low Viscosity Hydroxypropyl Cellulose (HPC-SSL) in Pharmaceutical Formulation Applications - Ryan Cheng, NISSO Special low viscosity hydroxypropyl cellulose (HPC-SSL) is a unique polymer which can provide excellent tablet properties at low usage level. In this study, we evaluate the performance of HPC-SSL and its super fine powder analogue (HPC-SSL-SFP) in a number of formulation methods for solid dosage forms: (1) high shear mixer granulation, (2) fluidized bed granulation, and (3) direct compression. In general, special low viscosity HPC improved a variety of tablet properties via high shear mixer granulation, fluidized bed granulation, and direct compression. Nisso America Inc. Overview: Nisso America Inc. is the U.S. subsidiary of Nippon Soda Co. Ltd., Tokyo, Japan. Nisso America imports and markets chemicals in the pharmaceutical, agricultural, paper and other industries. Pharmaceutical excipient products include Nisso HPC, a high quality Hydroxypropyl Cellulose, available in a wide range of viscosities in regular, fine powder, and super fine powder types.