Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.
To meet the requirements of the USP ^755& Minimum Fill and ^698& Deliverable Volume tests, target fill levels greater than 100% must be established.This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.
The authors argue that chlorine dioxide (CD) is a safe and effective decontaminating agent that can be used for challenging applications.The effectiveness of CD gas for sterilizing complex isolator systems is studied.
The authors study the effects of sweet potato and cocoyam starches on the compressional and mechanical characteristics of a paracetamol tablet formulation using cornstarch BP.
Innovators and generics makers are staking out positions on follow-on proteins and other manufacturing issues.
X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage. This article describes the basic principles of the technique and provides examples of its potential applications.
"Stable Liquid" Technology Permits Heptavalent Vaccine Against Botulism
UK MHRA Okays Chiron Flu Vaccine Plant; FDA Approval Still to Come
Big Pharma Companies Team Up to Develop Once-Daily, Triple-Combination HIV Drug
This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.
New fixed-dose combination drugs aim to enhance safety and efficacy, while regulators clear a path for more drug–device combination products.
The author points out some major obstacles to effective scale-up and describes methods available to pharmaceutical scientists for addressing scalability issues.
In the manufacture of many pharmaceutical products, dry-particle blending is a critical step that directly affects content uniformity.
Novartis to Expand Generics Hold
CBER Draft Guidance for Spore-Formers and Plasmid Vaccines
Extrusion-spheronization and pellet compression are effective means of developing first-order kinetic, controlled-release drug delivery systems of azithromycin (AZI). The authors prepared, evaluated, and optimized AZI formulations and assessed the stability of the selected formulation under accelerated storage conditions.
Pharmaceutical Science & Technology Innovations
Laser-Marking Technique Improves Tablet Branding
ISA-88 Automation Standard Gains IEC PAS Status
Albumin-Bound Nanoparticle Drug Nabs FDA Approval
MHRA to Reinspect Chiron Flu Vaccine Plant
Engineered Oilbodies Produce Vaccines and Adjuvants
Engineered Oilbodies Produce Vaccines and Adjuvants
The author reviews the effects of moisture on flow properties, tensile strength, Heckel plot, energies involved in compaction, and elastic recovery.
From solving complex formulation challenges to delivering full product-development programs, outsourcing services organizations provide valuable expertise, experience, and technical know-how.