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Featured Whitepaper: Vaisala
To Wire or Not to Wire
Sponsored By: Jon Aldous, Vaisala
To Wire or Not to Wire: Learn how to evaluate your environmental monitoring applications to find the ideal connectivity to your network. There are times that wireless is a panacea, and times when a hybridized “wired-plus-wireless” system is a better solution.
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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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WORKING WITH A CDMO TO IDENTIFY OPTIMAL PACKAGING OPTIONS
Author: 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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Dissolution of a Phosphate Prodrug from Hard Gelatin Capsules: A Case Study
Authors: Thomas B. Gold, Jennifer G. Warren, and David R. Collier
Sponsored By: Metrics, Inc.
This case study demonstrates how smart formulation during over-encapsulation – a process some might consider trivial – is critical to drug efficacy. It describes how a promising prodrug tablet over-encapsulated in gelatin failed to dissolve properly after stressed stability storage. After identifying the problem, scientists proposed two alternative capsule shells as solutions. |
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Using Raman Chemical Imaging to Analyze Inhaled Combination Therapies
Author: Dr. Oksana Olkhovyk
Sponsored By: Gateway Analytical
This white paper discusses using Raman Chemical Imaging as method to analyze dry powder formulations containing multiple active ingredients in order to obtain important data about the aerosolization behavior that was previously unavailable. This analysis offers developers new opportunities to optimize the formulations and the delivery devices for combination therapies. |
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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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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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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: 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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How in-line sensors are affecting the pharmaceutical process and validation
Author: Dr. Jorg Pochert
Sponsored By: Hamilton Company
Pharmaceutical Technology conducted an interview with Dr. Jorg Pochert, on a discussion about intelligent vs. in-line sensors. In pharmaceutical processes, in-line sensors generally offer a real-time view of the relevant parameters. In-line sensors make sure processing is done under validated conditions at all times, to obtain the expected product. |
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Blisterpack Integrity Testing Using Sepha VisionScan
Author: Dr. Dorian Dixon, University of Ulster
Sponsored By: Sepha Ltd.
An overview of Sepha's VisionScan technology in detecting integrity breaches in a range of pharmaceutical blister package types using non-destructive methods compared to traditional blue-dye testing. |
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Drastically reduced isolator decontamination cycles
Author: Felix Henning
Sponsored By: Optima Packaging Group GmbH
With the use of catalytic aeration, M + P is able to reduce the duration of the aeration phase in isolators by about 50%. Those reduced and shortened isolator decontamination cycles have multiple advantages for the pharmaceutical industry. |
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Ultra-high Speed HPLC Analysis of Ibuprofen within USP <621> Allowed Limits
Author: Shimadzu
In the recent revision of USP <621>, the modification of parameters is allowed only when the chromatogram improvement is still within the stated system suitability factors. This note shows an example of Ibuprofen analysis from the USP-NF with a conventional column and a core-shell column. |
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Life Sciences Guidebook on Best Practice Compliance Solutions
Author: Tim Lozier.
Sponsored By: EtQ, Inc
This paper provides you with a basic overview for selecting, implementing and using FDA Compliance and Quality Management solutions. Learn the importance of QMS, best practices for FDA Compliance and Quality systems, and tips and tricks for finding the solution best suited for your company. |
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Q&A Dissolution Enhancement and Controlled Release
Authors: Ashish Sarode, Catherine Cote, Peng Wang, David Worthen
Sponsored By: Nisso America
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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