Robustness Study for Hydrophilic Matrix Tablets of METOLOSE® SR using QbD Sample Kit
Author: Sakae Obara
Sponsored By: Shin-Etsu Chemical Co., Ltd.
A sample kit of Hypromellose having different viscosity levels, hydroxypropoxy content and particle size was applied to a robustness study of a hydrophylic matrix tablet of dipyridamole.

Stability Evaluation of Amorphous Solid Dispersions (ASDs) of Felodipine (FLD) during Storage and Biphasic Dissolution
Author: L. Sarode, S. Malekar, C. Cote, and D. R. Worthen
Sponsored By: Nisso America
The purpose: to compare HPC-SSL versus PVP-VA as pharmaceutical formulation excipients for the production of hot melt mixed ASDs of FLD.

Tableting Performance of Sorbitol Excipient
Author: Marjorie Lejeune
Sponsored By: Tereos Syral
Tereos Syral has conducted a formulation study to assess the tableting performance of sorbitol excipient (spray-dried and crystalline) against lactose when associated with ascorbic acid at 25%. It shows that sorbitol ensures high quality, while providing competitive advantages in terms of hardness, friability, color stability, dilution potential, and dissolution profile.

QbD Based Formulation Services — The DPT Labs Approach
Sponsored By: DPT Laboratories
This paper describes the approach and benefits of using DPT Labs’ QbD Formulation service and follows the previous paper in our Thought Leadership Series, “What is QbD and Why Should You Care?”

Differentiation of Drug Particle Agglomeration in OINDPs
Authors: Oksana Olkhovyk, Diem Ngo, and William H. Doub
Sponsored By: Gateway Analytical
This whitepaper presents the results of a collaborative study with FDA that reviewed the effects that can occur in aqueous nasal spray suspensions during long term shipping or storage conditions. Having the knowledge of the environmental conditions and their effects on OINDPs may benefit developers of formulations containing multiple APIs and/or excipients such as nasal suspensions, dry powder inhalers, and metered dose inhalers.

Functional Surfaces To Control Surface-Biomolecule Interaction
Authors: Dr. Heinrich Jehle
Sponsored By: Greiner Bio-One GmbH
The toolbox material science containing several pathways for selective surface functionalization enables the development of novel biological assays and applications. These new functional materials give the chance to overcome existing limitations in biotechnology. Cell-based assays, microarrays as well as optimized protein crystallization platforms are exemplified.

Selecting a Dosage Form for Drug Delivery to the Lungs
Authors: Dr. Jay T. Holt
Sponsored By: Cirrus, a KEMWELL company
When initiating a development program for drug delivery to the lungs, selection of the dosage form warrants careful consideration. Metered-dose inhalers (pMDIs), dry powder inhalers (DPIs), and nebulized solutions and suspensions each have relative advantages, disadvantages, and challenges.  Other factors for consideration include the target patient population, biopharmaceutics, physic-chemical characteristics of the active (API), intellectual property, marketing, competitive landscape, and timeline and budget for the development program.

Improving Product Quality with Risk Assessment Tools
Author: Brenda Percy
Sponsored By: EtQ Inc.
With the product lifecycle moving so fast, many organizations may ask the question, "How can we effectively measure quality?" The answer is risk management. Learn the elements of risk management and how they help to identify, prevent, and mitigate risk throughout an organization.

Three Steps to USP H₂O Success
Author: Dr. Geoff Sheffrin
Sponsored By: OBK Technology Ltd.
USP water systems are highly specific in their requirements. To get there successfully is relatively easy BUT you are dealing with a large number of detailed requirements that MUST work in harmony to produce reliable Purified Water or Water for Injection, cost effectively and with minimum maintenance. Here's how.

Devolatilization/Solvent Extraction via Twin Screw Extrusion
Author: Charlie Martin
Sponsored By: Leistritz
Devolatilization (DV) is the process by which various amounts of unreacted monomer, solvent, water, or other undesirable volatile contaminants are removed from a polymer melt.  A twin-screw extruder (TSE) is a device that is commonly utilized to compound polymer formulations to facilitate specific end-product performance. Oftentimes, there are chase impurities in the polymeric system that needs to be cleansed, sometimes as a result of tighter governmental or commercial standards, or due to the deleterious effects the residuals may have on final product properties.

Gut Microbes and Medicines: How the GI environment impacts drug metabolism
Author: Oliver Grundmann, PhD
Sponsored By: University of Florida Pharmaceutical Chemistry
A wide range of factors determines the safety and efficacy of a drug. For example, microorganisms in the gastrointestinal tract impact how a drug gets metabolized. Topics in this discussion include: How variable is the microbial composition in the human gut? What models are being used to study the gut microbiome and its influences on drug metabolism? What role does pre-systemic drug metabolism play in the effectiveness or also in the toxicity of a drug (and impact on drug formulation)?.

Cleaning Validation for Pharmaceutical Manufacturing
Sponsored By: Alconox
Cleaning validation is a necessary and time consuming part of manufacturing pharmaceuticals. The validation process can be expedited and cost of validation can be lowered if the cleaning supplier can provide support, allowing for pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation, as well as discussing the kinds of support services you should seek from your supplier of critical cleaning products in order to optimize your cleaning validation process.

Keeping Relative Humidity Calibrated
Sponsored By: Rotronic
Many processes in pharmaceutical science require controlled humidity to produce the desired product and preserve the necessary quality control. To maintain a humidity-controlled environment, manufacturers must keep instruments calibrated. Here, Pharmaceutical Technology talked with David Love, Vice President of Rotronic Instrument Corporation, to answer the question: Do you really know your relative humidity calibration vendor?.

Quantifying Economic Benefits of Automated Rapid Detection
Author: Rapid Micro BioSystems
Most pharmaceutical manufacturers have adopted lean initiatives within their production areas in order to survive and thrive in an increasingly competitive economy. But an often-overlooked area, quality control, has been left untouched by lean initiatives. Pharmaceutical companies can achieve maximum efficiency by evaluating and streamlining microbial quality control procedures using lean principles to automate and accelerate the work microbiologists have traditionally done manually with a rapid microbial method. Learn key components to include in a business case.