The increasing complexity of today’s novel compounds make drug development more challenging than ever. To be able to meet the growing needs of patients around the world, a company must have a strategy that can shepherd new biologic therapies throughout the development timeline.
If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. For these reasons, a company must be aware of any potential conditions that could occur at a small-scale that could create major issues during commercial scale-up.
Implementing a bioavailability enhancing formulation approach can positively impact safety, efficacy, and patient adherence, leading to successful clinical outcomes. An in-depth look at how lipid-based drug delivery systems (LBDDS) with softgel dosage form can be used as a bioavailability enhancing technology for successful clinical outcomes.
A Q&A session with formulation and bioavailability experts on addressing formulation challenges for pediatric populations.
The road to take a drug compound from discovery to commercialization is long, expensive and often fraught with unforeseen challenges. While every project will undoubtedly face some bumps along its path, far too many programs hit insurmountable obstacles that require innovators to backtrack and correct their course before proceeding, further extending timelines and adding costs.
Zydis® fast dissolve formulation for Zelapar® (Selegiline anti-Parkinson’s compound) had a positive impact on the patient compliance as compared to the Selegiline traditional tablets.
While the wider use of opioids has led to many benefits for patients in pain, it also has led to higher incidences of misuse, abuse, and development of opioid addiction. To address this issue without preventing legitimate patients from receiving their necessary medication, Grünenthal set out to create an abuse-deterrent formulation with a technology that creates a physico-chemical barrier to abuse and, as a result, safeguards patients from the battle of addiction.
Pharmaceutical ointments are engineered to have rheological properties important to the physical performance of the product when used by the consumer.
Moisturizing creams will be defined by their viscosity or thickness. Formulating moisturizing creams depends on the required end product consistency, influencing the choice of material to use.
Anton Paar's Generation M density meters and Abbemat refractometers deliver accurate and repeatable measurement results while providing system security for 21 CFR Part 11 compliance.
NuAire offers ventilated and refrigerated micro-centrifuges ideal for high and low speed applications for small sample volumes.
From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s twice as many as any other CMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.
The CP100WX is a general-purpose Ultracentrifuge with outstanding performance up to 100,000 rpm assisting in a wide range of separation protocols in involving proteins, DNA, RNA, metal nano-colloids, and more. Reliable and efficient the Hitachi CP100WX features a Rotor Life Management (RLM) system to automatically maintain rotor logging history maximizing rotor life.
NuAire benchtop centrifuges offer mono and multi functionality, refrigerated and non-refrigerated models. Technical innovations optimize productivity in your laboratory work to improve results, save time, while providing a greater relative centrifugal force (RFC).
The new CharpyCool is a mechanically refrigerated bench top bath that eliminates the need for costly consumables such as liquid nitrogen or dry ice. Compact and completely self-contained, the CharpyCool offers up to 8 liters of working fluid volume enabling up to 91 Charpy impact test specimens to be accommodated at temperatures between -80°C and +30°C. A powerful variable speed magnetic stirrer and vortex breaker provide excellent temperature uniformity and stability enabling superior results. PID control enables the CharpyCool to sustain precise temperature control to within ± 0.1°C. The CharpyCool includes a digital temperature display, and an optional Charpy Rack is available which allows multiple-specimen loading and easy access to monitor your testing.
Considering that 90% of drug candidates have bioavailability issues, making sure your program is prepared for all phases of clinical trials from the very start is the fast way forward. Patheon Solubility Enhancement Services approaches BCS II and IV drug substance solubility issues a fundamentally different way that identifies the solubility enhancement technologies most likely to work before you get started. That helps eliminate rework and worry later on.
NuAire benchtop centrifuges offer mono and multi functionality, refrigerated and non-refrigerated models. Technical innovations optimize productivity in your laboratory work to improve results, save time, while providing a greater relative centrifugal force (RFC).
NuAire is pleased to partner with the reputable brand Hitachi Koki to offer our customers sales and support of table top and floor standing Mirco Ultracentrifuges in the North American market.
