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Featured Whitepaper: Vaisala
USP Guidance Chapters for Temperature-Controlled Supply Chains
Sponsored By: Vaisala
This paper looks at the five general chapters of the updated and revised United States Pharmacopeia and The National Formulary (USP 33–NF 28) that touch upon the temperature-sensitive supply chain.
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WORKING WITH A CDMO TO IDENTIFY OPTIMAL PACKAGING OPTIONS
Sponsored By: DPT Laboratories
There are many factors to take into consideration when selecting or designing a packaging component. Working with a contract development and manufacturing organization early in the process helps eliminate packaging problems that may arise after the development stage. |
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Topical Product Development for Dermatology Products
Author: Barry Calvarese
Sponsored By: Dow Pharmaceutical Sciences
Dermatology drug development presents distinctive and sometimes peculiar challenges that demand creative solutions. What differentiates dermatological drug development from oral or parenteral drug development? |
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Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin; Feng Zhang, Ph.D.; James C. DiNunzio, Ph.D.
Sponsored By: Leistritz
Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides. |
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THE APPLICATION OF TABLETTING SCIENCE TO DEVELOP ADVANCED TABLET TOOLING COATINGS
Author: Rob Blanchard
Sponsored By: I Holland Limited
This paper contains an overview of the evolution of tablet coating technology and how I Holland’s Tabletting Science program is using many advanced analytical techniques to help improve the performance of its punch and die coatings. |
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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: KIMBERLY-CLARK PROFESSIONAL* – (Damon Larkin)
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination. |
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Process Analytical Technology as Key Enabler of QbD
Authors: David W. Humphrey / Dr. Brandye Smith-Goettler
Sponsored By: Siemens AG
The Food and Drug Administration (FDA) has championed one initiative, known as Quality by Design (QbD), with the goal of improving productivity and reducing manufacturing costs. Process analytical technology (PAT) is an enabling technology for QbD. Siemens offers a comprehensive, well-integrated solution for process analytical technology (PAT) called SIPAT. |
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Analysis of Multi-Component Engineered Particles for Inhalation
Author: Dr. Oksana Olkhovyk
Sponsored By: Gateway Analytical
This white paper discusses using Raman Chemical Imaging as method for spatially resolved, chemically-specific analysis of particles that contain multiple active ingredients in order to verify the composition of the particles, which is critical for process optimization, and regulatory requirements. Reviews method used for determining the ratio of drug components. |
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Q&A Dissolution Enhancement and Controlled Release
Authors: Ashish Sarode, Catherine Cote, Peng Wang, David Worthen
Sponsored By: Nisso America Inc.
Processing techniques for low viscosity hydroxypropylcellulose polymers. Low viscosity HPC-SL and SSL can be employed to produce chemically stable SDs of poorly- as well as highly water-soluble drugs using various pharmaceutical processes in order to control API dissolution. |
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