Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper: Surety LLC
Protect Your Scientific Intellectual Property for the Long Term
Can your electronic research IP records withstand a court challenge?
Sponsored By: Surety, LLC
As more pharmaceutical, bio-sciences and R&D-centric firms move to electronic lab environments, your digital scientific research, formulas and clinical findings are your scientific Intellectual Property. Protecting the integrity and legally defending the authenticity and ownership of such electronic data is critical to your organization’s long-term success. But if you are overlooking this protection in your lab management workflows, you risk losing patent ownership, revenue and consequently your business, if you can't prove authenticity and time of creation, hence your ownership, in a court of law.
This new whitepaper from IP Protection Leader, Surety, explores these concepts and requirements, and discusses how you can implement simple, cost-effective controls to achieve legally defensible scientific IP for the life of the research records. |
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Analysis of Drug Degradants by LC/MS
Sponsored By: Shimadzu
High-speed analysis of drug degradants by single-quad LC/MS using ultrafast scan rates and polarity switching in combination with Collision Induced Dissociation. MS/MS measurement was also performed to determine the likely composition of the degradants. |
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The Aclar advantage for blister packaging
Authors: David Barker, Charles Rowlands, Amy Morgan
Sponsored By: Honeywell International Inc.
This paper examines the strategic implications of packaging choice in the generics industry. It looks at how companies are leveraging ultra high barrier thermoform solutions like Aclar® to create new value propositions. |
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Hot Melt Extrusion (HME) - nano-scale compounding developments
Author: Charlie Martin
Sponsored By: Leistritz
Hot melt extrusion is emerging as a preferred manufacturing methodology for dosage forms. The high cost and limited availability of raw materials during the development phase has resulted in the need to process small amounts of APIs/excipients via extrusion to determine process viability. Experimental data is presented on a new twin screw extrusion device that can process as little as 20 to 100 gram micro-batches, as well as a scale-up path. |
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Aqueous Critical Cleaning: Applications in Pharmaceutical Manufacturing
Authors: Malcolm McLaughlin, Theresa Dowds
Sponsored By: Alconox
This Guide to Critical Cleaning places a concise overview of our half-century of experience at your fingertips. From tablet presses to mixing tanks, Alconox detergents handle tough critical cleaning jobs—like removing insoluble coatings residues. The benefits of employing aqueous cleaning in pharmaceutical manufacturing are numerous. |
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Development of an Enteric Coating Process and Stability Evaluation of PCcaps®
Authors: Balaji V. Kadri, Aran M. Johnson, Danica M. Cartwright, Ken Lo, Mark A. Cappucci, Paul F. Skultety
Sponsored By: Xcelience, LLC
Enteric coating of capsules enables innovators to overcome challenges of acidic degradation and dyspeptic side effects associated with some compounds. This whitepaper provides an evaluation of the ability of commercially available enteric, aqueous film-coating systems to confer their enteric release properties on gelatin capsules in support of pre-clinical rodent studies. |
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Cold Water Granulation Using Pregelatinized Starch
Sponsored By: Grain Processing Corporation
Quality granulations can be made using only cold water as the binding solution and fully pregelatinized corn starch as the binder. Using Spress® B825 Pregelatinized Corn Starch NF in the manner described eliminates solution preparation and simplifies the granulation process which accelerates production resulting in cost reduction. |
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Warning Letters Galore: Causes and Prevention
Author: Mr Martin Lush
Sponsored By: NSF-DBA (USA) LLC
With Warning Letters and other regulatory action hitting an all time high, let’s reflect, asking “What can we learn from the mistakes of others?” |
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Targeting PK and Patient Needs with Versatile, Timed-Based Oral Drug Delivery
Authors: Michael A. Gosselin, Ph.D. and Vincent Parrino, M.Sc., M.B.A
Sponsored By: Aptalis Pharma
Through the development of more favorable pharmacokinetic profiles to meet specific patient needs, industry has successfully leveraged various drug delivery technologies for oral modified-release products. Multiple challenges may arise during the development of these dosage forms, including poor drug stability, low aqueous or pH-dependent solubility, narrow therapeutic windows, and food effects. This paper focuses on the solutions provided by optimizing timed-based pulsatile and sustained delivery profiles using multi-layered particulate dosage forms, for both acidic and alkaline drugs. |
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