Capsules for Use in Dry Powder Inhalers (DPIs) in Early Phase Dev

Matt Richardson, Capsugel; Massimo Moratto, Aptuit; Mike Savill, Capsugel
Finding efficient drug delivery methods is becoming increasingly important as the pharmaceutical industry looks to improve the performance of its new compounds and extend the applications of existing drugs. One option that has long been used to successfully treat respiratory conditions and provide compounds with a fast-acting route into circulation is drug delivery via inhalation using a dry powder inhaler (DPI).

Capsugel’s Xcelodose technology is ideally suited to meet the specialized demand for filling capsules for DPI use, as it is proven to dispense very low weights repeatably with precision and accuracy. The technology is suitable for any dry powder, including micronized and cohesive powders, and fills the powder into the capsule without compressing or compacting the powder base, thereby facilitating evacuation on inhalation. Collaborative data shows that the action of filling does not give rise to segregation of blended products provided the constituents have similar particle size and density, nor will it degrade the bonds between API and carrier particles.

Matt Richardson, Pharmaceutical Business Development Manager, Capsugel
Matt has a BS in Chemistry (Wofford College) and Ph.D. (Wake Forest) in synthetic organic and organometallic chemistry. Prior to joining Capsugel in 2005, he worked in process development and scale up of pharmaceuticals.

Massimo Moratto, Senior Scientist Pharmaceutical Development, Aptuit
Massimo has worked in formulation development at Aptuit, formerly GSK, for ten years. He works with solid oral dosage forms, Dry Powder Inhaler formulations and is responsible for upgrading the Aptuit Verona facility for respiratory technologies, including the purchase of a new Xcelodose 600S.

Mike Savill, Pharmaceutical Technology Manager, Capsugel
Mike supports product and process development for Capsugel’s laboratory equipment. He has helped develop the Xcelodose technology and specialises in the automated precision dosing of dry powders.
Jun 28 2011
69 mins
Capsules for Use in Dry Powder Inhalers (DPIs) in Early Phase Dev
capsugel xcelodose dpi
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  • With scrutiny on lenders’ risk management policies intensifying, more and more community banks are writing their first policies or updating old ones. The OCC just raised the bar for the banks it regulates with the August release of expanded guidelines for environmental risk management that bring their policy requirements in line with those of the FDIC. What are the critical components that should be in every policy? What elements are common to most institution’s policies? How does your institution measure up to industry best practices? How is policy administered across organizations?

    Join us for this webinar as seasoned insiders selected from the ranks of a mid-sized bank and small community lender share their experiences in writing and updating environmental policies. Learn what these experts are doing to protect their institutions from environmental risk exposure, and the dangers that lenders face by not having adequate policies in place to protect them from financial and legal liability.
  • Do you have more questions than answers about the industry’s transition over to a new ASTM Phase I ESA protocol? You’re not alone.

    On August 15, 2013, the U.S. Environmental Protection Agency published a Direct Final Rule which proposes to reference the E 1527-13 standard as compliant with the agency’s All Appropriate Inquiries rule (40 CFR Part 312). The agency’s 30-day public comment period just closed and the ASTM standard moves one step closer to publication.

    Right now the #1 question in the industry is: When will ASTM E 1527-13 take effect?

    At this webinar, two of the experts closest to the ASTM process will share the latest status of the AAI rule amendment and publication of the new Phase I ESA standard.

    There are a number of moving pieces in play right now. Tune into this event to learn the latest on the ASTM front, the hot-button issues raised during the public comment period, what happens to E 1527-05 and more. It is an important time for the industry as it prepares to put a new standard into effect and this event will help keep environmental professionals abreast of the process as it unfolds.

    Speakers:

    Julie Kilgore, President, Wasatch Environmental, Inc., Chair of ASTM E50 Committee on Environmental Assessment, Risk Management and Corrective Action and Chair of the E1527 Task Group

    William Weissman, attorney, member of ASTM E50 Executive Subcommittee, retired partner of Venable LLP, Washington, DC
  • Change is in the air on the vapor intrusion front. Literally and figuratively. On April 16, the U.S. Environmental Protection Agency released a draft document, the OSWER Final Guidance For Assessing And Mitigating The Vapor Intrusion Pathway From Subsurface Sources To Indoor Air — External Review Draft for public comment. The release of EPA’s guidance comes just months before ASTM is poised to release a revised version of E 1527 that adds definitions of migrate/migration to address the vapor pathway as a potential conduit for contamination.

    As attention being placed on vapor risk increases, environmental professionals need to stay abreast of the changes and their implications. With the long-awaited federal guidance now out for public comment, environmental due diligence professionals, lenders, as well as prospective purchasers of properties like drycleaners, gas stations, and other types of properties impacted by petroleum or solvents have a valuable resource for understanding VI risk, assessing it and ultimately, managing it as appropriate for their own risk tolerance. Join us at this webinar to hear the perspectives of three experts on:

    • The implications of the federal vapor guidance and an insiders’ unique take on hot button issues;
    • How one environmental professional talks to his clients about vapor risk and protects their liability exposure; and
    • How vapor risk is being mitigated and managed in today’s deals.
  • For lenders operating in the shadow of the Dodd-Frank Act, CFPB and other regulatory enforcement agencies are focusing their efforts on consumer protection, disclosure and transparency and deem these critical to all areas of an institution’s compliance and operation. A dizzying array of new rules and regulations, often disruptive to existing operations, are raining down upon the mortgage lending industry. Now, however, it’s not enough to simply be aware of emerging rules and regulations. Little known requirements and regulations which have been on the books for years without being enforced are now getting renewed attention from those agencies, likely opening up an entirely new front in the uphill battle to stay compliant. One of the greatest potential risks to lenders arises from requirements for residential property appraisals and evaluations. It is likely we will see stricter environmental underwriting and more regulatory scrutiny on lenders’ risk management policies. Discover now where lenders are most at risk, and learn about cost-effective measures that can be taken to stay out of the regulatory crosshairs.

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    • Identify existing rules and regulations, little-known and long unenforced, that are likely to be revitalized by regulatory enforcers;
    • Spell out the specific risks that residential property contamination, including vapor mitigation, will pose to a mortgage lender;
    • Explain how the gamut of new and existing requirements will impact traditional due diligence requirements; and
    • Predict the possible financial impact upon lenders, as well as offering potential solutions for risk mitigation.
  • For the first time since 2005, the ASTM E1527 standard has been revised. ASTM submitted the final version to the U.S. Environmental Protection Agency for formal approval of the revised ASTM E 1527 standard as “AAI-compliant.” According to industry insiders, this approval could come as early as this summer. Once the approval process is successfully completed, the E 1527-13 standard would be published by ASTM and take effect immediately upon publication. With the summer only a few months away, now is the time to start thinking about what you can be doing to prepare.

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    -Clarification on vapor migration and ASTM E2600-10
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    The EDR team has been tracking the revision process closely since it began in 2010. Over the past fall/winter season, we educated over 1,000 environmental professionals at our Due Diligence at Dawn (DDD) seminars around the country.

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  • Remember when the U.S. Environmental Protection Agency’s All Appropriate Inquiries rule was promulgated in 2005? For the first time since then, there will soon be a new revision to the ASTM E 1527 Standard and the time to begin preparing your staff and educating your clients is now.

    The E 1527-13 revision is the result of three years of discussion and debate among many dedicated stakeholders who spent countless hours at ASTM Phase I ESA Task Group meetings and on conference calls examining all parts of the standard and hammering out every word of the revision. The most significant revisions are in the areas of: REC definitions, agency file review, vapor migration/intrusion, user responsibilities and more.

    For this event, EDR Insight is fortunate to have the input of three professionals—an environmental professional, a commercial real estate lender and an attorney—who were active with the revision process and who each devoted significant time and expertise to shaping the new revisions.

    Join us for this important and timely event as the commercial lending and property risk management industry prepares to transition away from the -05 standard to E 1527-13.

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    • Environmental due diligence professionals
    • Environmental risk managers at financial institutions

    Benefits to attendees:
    • Insights into specific areas of revision and a deeper understanding of what drove the changes
    • More clarity on REC-HREC-CREC definitions
    • More clarity on agency file review
    • An end user perspective from the lending sector
    • An attorney’s take on what the changes mean in the construct of CERCLA liability and commercial property transactions
    • Advice on how EPs and lenders should be preparing for E 1527-13
    • Potential changes that end users may see in their Phase I ESA reports when E 1527-13 takes effect
  • A number of recent developments, including 2013’s revisions to ASTM E 1527 Phase I environmental site assessment standard, make it more difficult—and risky—to ignore vapor migration during environmental due diligence. EDR Insight has assembled a panel of the most knowledgeable attorneys in the field to help environmental professionals and risk managers at financial institutions answer a common question:
    What can happen if vapor-related issues are missed?

    This team of experts, with decades of experience advising commercial real estate deals, will share real-world cases of “due diligence gone wrong” from vapor migration-related lawsuits filed as a result of inadequate property investigations and poor lender oversight. This one-time event is an important learning opportunity for any environmental professional who participates in environmental investigations, as well as commercial real estate lenders who extend credit on properties that may be impacted by vapor migration.

    Attendees of this webinar will learn:
    • Recent developments that have brought vapor migration front and center.
    • Why environmental due diligence policies should expressly address vapor migration.
    • How federal and state authorities are responding to vapor intrusion concerns—and the implications for buyers, lenders and sellers.
    • Steps that environmental professionals and commercial real estate lenders can take to avoid liability related to vapor migration.
    • Real-world examples of what can happen if vapor issues are ignored during environmental due diligence.
  • For the first time since 2005, the ASTM E1527 standard is going through a significant revision. Now is the time to start preparing your staff and your clients! The changes to the standard will go into effect immediately once the new version is published in 2013. At this complimentary webinar you will learn about:
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    -Clarification on vapor migration and ASTM E2600-10
    -Changes to User Responsibilities and important news about environmental liens
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    The EDR team has been tracking the revision process closely since it began in 2010. This fall, we have educated over 1,000 environmental professionals at our Due Diligence at Dawn (DDD) seminars around the country.

    Join EDR and Anthony J. Buonicore, former E1527 Task Group leader, for this webinar and learn all you need to know to comply with the forthcoming edition of the ASTM E1527 Standard.
  • Vapor intrusion, the migration of volatile chemicals from the subsurface into overlying buildings, presents potential health risks and environmental liability at properties with current or past contamination. The U.S. EPA is preparing its final Vapor Intrusion Guidance for evaluating and assessing risk from VI. The release of EPA’s guidance is scheduled for release a few months before ASTM is expected to publish a revised Phase I environmental site assessment protocol (ASTM E 1527). Among the changes to ASTM E 1527-05 is the addition of new language throughout the standard to include the assessment of vapor migration risk.

    EDR is extremely fortunate to offer you a webinar with three speakers who have been performing successful VI investigations for many years, and have been working with ASTM and the U.S. EPA to provide comments on draft documents. With the scheduled release of EPA’s final VI guidance—followed by a revised ASTM E 1527 standard to include vapor intrusion—now is the time to prepare and ensure that due diligence policies include VI and that appropriate science is used to minimize the impact of VI on property deals, including brownfield redevelopment.

    It is critical that risk managers understand what these two documents mean in terms of the standard of care and how it might affect their own liability—or that of their borrowers.

    Benefits to Lenders:
    •Recent regulatory history surrounding vapor intrusion
    •Myths about vapor intrusion and mitigation alternatives
    •Available data that can be used to evaluate VI risk
    •Implications of the new federal guidance document
    •What the vapor-related revisions to ASTM E 1527 mean in terms of lenders’ environmental due diligence policies

    Benefits to EPs:
    •A better understanding of why vapor migration presents a risk to your clients
    •A way to begin thinking about how the new guidance and revised ASTM E 1527 standard may necessitate changes to your Phase I ESA process
  • To help you meet the challenge of staying up to speed on the forces driving demand for property assessments, EDR Insight invites you to a complimentary web event on the state of the market in the third quarter of 2012—and a look to 2013. Attendees of this 60-minute webinar will learn:

    • The status of commercial property transactions and the asset classes attracting the most attention
    • Commercial real estate lending volume
    • Key players in the deal-making and lending worlds
    • Where to focus business development efforts for 2013 and beyond
    • EDR Insight’s near-term forecast for Phase I ESA volume and major market risks

    Join us for a look at the forces driving demand for your services so that you can position your firm for growth.
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  • Capsules for Use in Dry Powder Inhalers (DPIs) in Early Phase Dev Recorded: Jun 28 2011 69 mins
    Finding efficient drug delivery methods is becoming increasingly important as the pharmaceutical industry looks to improve the performance of its new compounds and extend the applications of existing drugs. One option that has long been used to successfully treat respiratory conditions and provide compounds with a fast-acting route into circulation is drug delivery via inhalation using a dry powder inhaler (DPI).

    Capsugel’s Xcelodose technology is ideally suited to meet the specialized demand for filling capsules for DPI use, as it is proven to dispense very low weights repeatably with precision and accuracy. The technology is suitable for any dry powder, including micronized and cohesive powders, and fills the powder into the capsule without compressing or compacting the powder base, thereby facilitating evacuation on inhalation. Collaborative data shows that the action of filling does not give rise to segregation of blended products provided the constituents have similar particle size and density, nor will it degrade the bonds between API and carrier particles.

    Matt Richardson, Pharmaceutical Business Development Manager, Capsugel
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    Massimo Moratto, Senior Scientist Pharmaceutical Development, Aptuit
    Massimo has worked in formulation development at Aptuit, formerly GSK, for ten years. He works with solid oral dosage forms, Dry Powder Inhaler formulations and is responsible for upgrading the Aptuit Verona facility for respiratory technologies, including the purchase of a new Xcelodose 600S.

    Mike Savill, Pharmaceutical Technology Manager, Capsugel
    Mike supports product and process development for Capsugel’s laboratory equipment. He has helped develop the Xcelodose technology and specialises in the automated precision dosing of dry powders.
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    Chris joined Waters in 2001 after earning his Ph.D. in Analytical Chemistry and Mass Spectrometry from Purdue University in 2000, and held a post doctoral position at the University of Cincinnati Medical School conducting proteomics research. During his doctorate and post-doctorate education, he became keenly interested in informatics solutions to manage and mine analytical data
  • A Complete Moisture Analysis Recorded: Jan 13 2010 85 mins
    This seminar will highlight the importance of a complete moisture analysis consisting of both water activity and moisture content. Definitions for water activity and moisture content will be established with a particular focus on their differences. Methods for measuring water activity and moisture content as well as techniques for obtaining accurate measurements will be highlighted. The relationship between water activity and moisture content, referred to as a moisture sorption isotherm, will be described. Practical applications for water activity, moisture content, and moisture sorption isotherms will be detailed. These applications will cover both product safety and quality including: microbial safety, shelf life, ingredient mixing, temperature abuse, product formulation, caking and clumping, and package performance.

    5 Major Learning Objectives:

    1) What is water activity and moisture content?

    2) How are water activity and moisture content different?

    3) How are water activity and moisture content measured?

    4) What is a moisture sorption isotherm?

    5) How do water activity and moisture content influence product safety and quality?

    6) How can the relationships between moisture content and water activity be used to improve product formulation?
  • The Science of Food Profiling Recorded: Nov 10 2009 55 mins
    The Science of Food Profiling: Determining the Adulteration, Authenticity and Origin of Foods

    With reports of 5 to 10% of global food trade involving counterfeit goods, regulatory agencies and food manufacturers are compelled to employ programs that help ensure consumer safety, protect trade markets, maintain product quality and preserve brand image.

    This webinar will demonstrate how the latest analytical instrumentation and data analysis software can assist food testing laboratories in the determination of food adulteration, authenticity and origin.

    • Liquid chromatography and mass spectrometry are key analytical technologies for food profiling. The application and advantages of these techniques will be discussed.

    • Employing chemometrics software for automated data analyses can yield critical information for food testing laboratories. The approach facilitates the identification of differences or similarities between brands or manufacturing batches. This methodology will be examined.

    • Examples of edible oil, tea and fruit juice food profiling applications will be shown.

    Presenter

    Dr. Tim Jenkins is part of Waters Chemical Analysis Market Development group where he leads the Business Operations team. This group has particular expertise in food testing and environmental applications and addresses global market development issues. Prior to joining Waters Dr. Jenkins gained over 15 years experience of practical mass spectrometry and technical management in a variety of environments including academia, corporate R&D and contract analysis laboratories.
  • Innovative 3rd Generation Coating: BASF’s Kollicoat Recorded: Nov 2 2009 56 mins
    Innovative key features of the new patented PEG-PVA graft polymers are the low viscosity of the polymer solution, outstanding flexibility of the film and extremely rapid dissolution of coating. In terms of viscosity alone this new technology offers significant advantages over cellulose derivatives. Sprayable dispersions at high solids concentrations which are not sticky and fast drying ensures gains in productivity and process costs. You will gain an in-depth knowledge about these new PEG-PVA graft polymers as coatings and the proper formulation and the best process parameters for excellent performance in finished solid dosage forms. Ms. Vaishali Tawde, Technical Services Manager, South Asia, BASF India Dr. Eric Liu, Senior Technical Marketing Manager, BASF China
  • Food Safety Certification: Get the Abridged Version Recorded: Oct 8 2009 87 mins
    How do I get started with Food Safety Certification? What's the process?
    What are the GFSI benchmarked standards and which is best for my organization?

    Do these questions sound familiar? Do you have even more? Attend this information-packed webinar to get the answers to your questions and valuable details you need about Food Safety Certification.

    Catherine Francois, Consumer Goods Forum (CIES/CFSI)

    Kathleen Wybourn, DNV

    Case Study Speaker: Robert Haydu, Wm. Wrigley Jr. Company

    Attendees to the webinar that are interested in pursuing certification and using the IFS standard, will receive a free copy of the standard (a $57 value) and one free license to “auditXpress”, the IFS internal auditor software (a $290 value). To obtain these items, you must attend the webinar! (Restrictions apply, limited quantities available)
  • Hot Melt Extrusion for Poorly Soluble Drugs Recorded: Oct 6 2009 77 mins
    Hot Melt Extrusion (HME) is becoming an important technology within the Pharmaceutical Industry as a means for formulating poorly water-soluble active pharmaceutical ingredients (API’s). Additionally, HME provides greater drug bioavailability. This Webinar will cover:

    • A review of Hot Melt Extrusion Technology.
    • Modification to the traditional extrusion system for pharmaceutical needs.
    • An economically-feasible continuous process and solvent-free manufacture.
    • The role of polymers and plasticizers.
    • The use of low temperatures to minimize API degradation.
    • Optimization of HME Formulation and Process.

    Scott T. Martin, Senior Application Specialist, Thermo Fisher Scientific

    Dr. Karl Kolter, Ph.D., Head of Global R&D Project Management Excipients
    BASF SE, Germany, Pharma Ingredients and Services

    BASF reserves the right to limit access to this event.
Trends and Developments
This channel will provide webinars that focus on the unique niche of post-discovery development and validation as well as webinars that examine current products, technologies. and philosophies used in laboratories; tracks the deployment of tools that processors and the food service industry professionals use to ensure safe and consistent products.

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  • Title: Capsules for Use in Dry Powder Inhalers (DPIs) in Early Phase Dev
  • Live at: Jun 28 2011 3:00 pm
  • Presented by: Matt Richardson, Capsugel; Massimo Moratto, Aptuit; Mike Savill, Capsugel
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