Through the blend of polymer science and capsule engineering, Capsugel has developed a line of functional capsules that provides the industry with a viable alternative to achieve enteric protection and delayed release without functional (enteric) coating.
Capsugel® Vcaps® Plus capsules represent a unique and valuable contribution: they perform like gelatin but offer additional advantages, particularly a lower moisture content, which makes them excellent for hygroscopic and moisture-sensitive drugs and manufacturing processes. HPMC capsules are inert and robust against cross-linking or the effects of extreme storage conditions. Furthermore, Vcaps® Plus capsules have equivalent performance and appearance to that of gelatin capsules, offering new possibilities to product developers around the world.
Catalent combines decades of projects with all pulmonary dosage forms including pMDIs, DPIs, nasal sprays and solutions/suspensions for inhalation. Speed is delivered by workflows that have been continuously refined and applied to programs at all stages of development. For global pharmaceutical companies with inhaled drug pipelines, Catalent is your service solutions partner that enables you to enhance the value of your treatment and improve your product’s speed to market.
This short animation, featuring the Andersen Cascade Impactor (ACI) [a commonly used cascade impactor and features in both the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.)] demonstrates how cascade impactors separate particles in an aerosol sample based on aerodynamic particle size.
This video shows how DecaVertus®, a 10-way automated shake and fire to waste system for MDIs, is highly advantageous from the perspective of conserving analyst time, eliminating the risk of RSI, and maximising the repeatability of test data.
This video shows how EnviroMate™ from Copley, a benchtop environmental chamber, has been designed specifically to improve the repeatability and integrity of orally inhaled and nasal drug product (OINDP) testing data.
This short animation shows how a realistic patient breath profile can be generated through the inhaler, whilst a constant flow rate can be maintained through the cascade impactor. Such a system enables the acquisition of more patient relevant data, in-vitro, which may have particular value when undertaking bioequivalence testing for generic products. The animation also features the Alberta Idealised Throat (AIT), which is an improved representation of the human throat geometry. This replaces the simplified, right-angled induction port used in traditional test methods.
This video shows how the Vertus® fully automated shake and fire benchtop range has been designed to enhance the sensitivity of OINDP testing, and more broadly, boost data integrity by eliminating firing errors, controlling air flow speed and automating leak testing.
This short animation shows how our purpose-built data analysis software, Inhalytix®, can be used for the entry, analysis and reporting of the APSD of drug output from all OINDPs. Flexible and fully validated, Inhalytix® also serves as a database for laboratory-based cascade impactor inventory and for the setting up and running of detailed test methods. User-configurable, the software will accept data from both standard and customised cascade impactors.
As a combination drug product development project moves from the laboratory into production to generate supplies for clinical research, it is necessary to involve multiple functions including manufacturing, engineering, and analytical support to make and release these materials. This is especially true for inhalation and nasally administered powders. The complexity of transferring a drug product is increased when the product involves a drug-device combination. Watch the webinar to learn about critical steps to transfer the development process, sponsor and service provider responsibilities, and accelerate timelines on your pathway to the clinic.
A robust approach for combination drug product development requires an understanding of the drug product characteristics, the effects of processing and device design, and how they impact product performance. Risk management connects the dots and interactions of these critical factors. Watch the webinar to understand more about drug product characteristics, effects of processing and device design, and how risk management can help minimize delays and accelerate timelines on your pathway to the clinic.
Dry powder inhalation (DPI) drug products are rightfully developed for patients with efficacy and safety in mind. However, as products move forward in the drug development process to clinical development, the ability to efficiently manufacture these products becomes critical in order to determine if a process is commercially feasible. In this webinar, DPI product formulation characteristics, including rheology, density and cohesiveness, will be examined as sources of potential process risk and a case study will demonstrate the impact drug product characteristics can have on processing.
A novel and unique dissolution and absorption test method for inhalation drugs, either New Chemical Entities or generic formulations: designed to be close to the underlying physiologic process. Would you like to know more?
High-precision instrument that precisely automates shaking and actuation of up to 10 devices (PMDIs or canisters) simultaneously, ensuring uniform dose delivery for every shot through the life of the devices.
Flexible actuation platforms, which can be used in conjunction with other systems, keep the actuation parameters of orally inhaled and nasal drug products consistent throughout different analytical tests and reduce variability.
With outstanding properties in terms of puncturing that favor for an uninterrupted airstream and reduced particle shed, Quali-V®-I capsules offer a low moisture content in the range of 4.5%-6.5%, and a controlled lubricated internal shell surface, enabling superior powder emptying, delivery, and aerosolization. These characteristics, along with strict microbiological process controls, allow for the use of Quali-V®-I in an inhalation device with exceptional constant (reproducible) performance.
Qualicaps®, a Mitsubishi Chemical Holding Corporation company, has +125 years of experience as a company dedicated to the supply of two-piece hard capsules and related services. We deliver pharmaceutical-grade hard-two-piece capsules to the pharmaceutical and consumer healthcare industries, together with a comprehensive service along the product life cycle through our global team of commercial, scientific, and technical experts. We are a responsible company that takes pride in producing each capsule with the aim of offering specific and optimal solutions for drug delivery and overall health and wellbeing challenges.
