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Our Rapid Advancement Process utilizes a number of tools to accelerate feasibility and early development studies while conserving precious API. Integrated capability from rapid feasibility assessments through clinical and commercial manufacture ensures an overall rapid-to-product solution for Capsugel clients.
Powder-in-capsule (PIC) studies, utilizing Capsugel’s proprietary Xcelodose® Precision Powder Micro-Dosing Systems – the industry standard for micro-dosing with unparalleled speed, low dose fills to 100 mcg, and fill accuracy of
1-2% RSD - have been shown to reduce early development time by 13-17 weeks. By eliminating the need for excipient compatibility and dissolution studies for phase I clinical trials, faster API screening is achieved. Capsugel has isolation equipment and protocols in place for handling highly potent compounds.
In-house micronization capability at all phases of drug development - from non-GMP feasibility assessments through GMP development, clinical and commercial supply – is an additional tool for rapid advancement. A full range of jet milling equipment, as well as nano-milling capability, is utilized for optimized API particle size distribution. High containment capability is in place for both development and commercial scale micronization.
Models and reference maps, based on key physicochemical properties that have been identified for choosing an enabling technology based on our experience and investigation of hundreds of challenging compounds, have been developed. Specialized equipment, e.g. lab scale particle spray dryers, and micro-testing methods have also been developed for feasibility studies. These tools enable Capsugel Dosage Form Solutions scientist to conduct feasibility studies in as little as 2 weeks. Typically our feasibility screening requires 200 mg or less of API - a critical consideration for many clients working with early-stage new chemical entities. Formulation optimization and scale-up is performed only after demonstration of feasibility.
Clinical trial manufacture is available across a full range of solid oral dosage forms including tablets, multiparticulates and encapsulation. Primary and secondary packaging is available for clinical and small scale commercial material. Clinical trial services include all kitting, distribution and logistics.