One of the causes of crimp variation that can lead to integrity failures due to poorly sealed vials has been reported to be component dimensional variation. Critical dimensions of the components of a vial system (vial, stopper, and cap) can vary within manufacturing tolerances, but these ranges of variation may require adjustments to the capper settings to ensure a proper package seal.
In this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.
Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
Prior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.
The authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
Scientific breakthroughs, operational innovation, and cultural shifts are driving tomorrow’s medicines.
The potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.
A new approach to testing water content in biologics is needed that will give a more accurate determination of actual water content in the biologic.
The purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations.
Attendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.
A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
The way in which a suspension nasal spray product interacts with the body depends not only on the droplet size of the delivered droplet, but also on the particle size of the suspended API.
Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.
This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.
This position paper describes a model for the future that would provide appropriate standardization, facilitate drug registration and support regulatory agencies.
The emerging markets represent an attractive investment opportunity for the pharmaceutical industry because of the countries' growing economies and unmet medical needs.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
In this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.
The choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.
Regulatory, analytical, and process concerns must be taken into account.
This article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
Challenges in fermentation can be addressed through equipment changes, facility design, and process development.
Was FDA's decision to issue a draft guidance on of-label information, amidst Congressional scrutiny, the right thing to do?
Needle-free injection technologies have been developed for injecting liquid formulations, as well as injecting drugs and vaccines in a solid dosage form.
The authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
Kindeva’s microneedle array patch platforms for solid and liquid APIs have the potential to deliver far-reaching clinical, environmental, and usability benefits.