BDD is a specialist drug formulation company providing expertise across all areas of drug delivery. We offer a full-service package to fit individual needs from troubleshooting, formulation development, in vitro and in vivo testing and full technology transfer. Our patented time release technology OralogiK provides unrivaled control of drug release at the right place and time. OralogiK has been validated in numerous clinical studies in man and enables the oral delivery of single, multi-dose or combination drugs at pre-determined times from one to 12 hours after dosing.
This bring benefits such as:
• Night time dosing of a drug to be delivered pre-wakeup
• Multi-phased delivery of one or more drugs (immediate and delayed) to allow once-a-day dosing or for pre-treatment by one drug before the delivery of a second
• Delivery of drugs to a specific regions of the G.I.T BDD also specialize in gamma scintigraphy, a powerful and versatile technology used to investigate the in vivo behavior of your formulation.
Coupled with pharmacokinetic data, this technique can be used to provide information on time /site of disintegration, gastric emptying, GI transit and intra/ inter individual differences. Our clinical division provides a full clinical package, including protocol development, study documentation design and regulatory authority submission, through to close out and production of ICH GCP-compliant clinical study report.
Gattefossé provides innovative excipients and drug delivery solutions to health industries worldwide. Simplifying formulation decisions and shortening the drug development path are at the heart of the Gattefossé product offer. The product list includes solubilizers, emulsifiers, bioavailability enhancers, sustained-release matrix formers, and penetration enhancers for oral, topical, injectable, vaginal, and other routes of administration. Each excipient is fully characterized by physico-chemical properties and safety profile. Guidance documents for formulation design in preclinical as well as late development stages are also available. Through a network of over 60 subsidiaries and highly trained technical staff, Gattefossé ensures timely technical support to its customers.
BioDuro is a full-service provider for integrated drug discovery and development, including discovery support, API synthesis and optimization, formulation development and cGMP manufacture of drug products. From drug substance to drug product, discovery to development, small molecule or biologics, BioDuro is your partner for accelerating drug discovery and development and improving efficiency in establishing drug candidate success.
BioDuro provides integrated drug development services from preformulation to clinical trial material (CTM) manufacturing. Our formulation services cover delivery systems and formulation technologies from simple API-in-capsule to enabled, solubilizing formulations utilizing approaches such as hot-melt extrusion and spray-dried dispersion. Our analytical expertise drives sound formulation and process development decisions. We provide phase-appropriate method development, validation, in-process, release and stability testing. BioDuro provides GMP-compliant manufacturing for solids, liquids and semi-solids, up to Phase III.
Fluid Air’s patent-pending PolarDryTM Spray Dryers utilizes revolutionary Electrostatic Technology, provides low temperature spray drying, near perfect encapsulation and selective agglomeration in the creation of particles. Years of development have proven that PolarDryTM technology has many advantages that include superior morphology, higher bulk density, longer shelf life, non-reactive processing, minimal emissions and low energy consumption. This new Technology will provide the means to make your formulation ideas a reality. Applications include API production where high temperature is a limiting factor, new avenues for drug delivery where perfect encapsulation is a must. Visit www.fluidairinc.com.
ProMed Pharma specializes in the molding of drug-loaded silicones and thermoplastics and leverages this expertise to manufacture long-term implants and combination devices under cGMP. Working with established and early stage companies, we utilize robust manufacturing processes for controlled release of drugs utilizing a variety of materials. From clinical trial materials to commercial products, ProMed supports pharmaceutical and medical device companies developing controlled release formulations including subcutaneous, orthopedic, cardiovascular, and ophthalmic implants, intravaginal rings, and steroid-eluting components.
Foster Delivery Science focuses solely on Hot Melt Extrusion to blend client’s API’s into polymers for the purpose of enhancing solubility and bioavailability, or creating local delivery solutions. For over 10 years, Foster has provided clients formulation development, scale-up, clinical trial material and has expanded into a new 32,000 square foot GMP facility producing oral formulations, implants, films, and single strand fibers. We can offer our expertise to create co-extrusions where more than one release rate is required, or blending more than one API into a single formulation. Our facilities are located in Putnam, CT, just west of Boston for a short 75 minute drive.
Pion is a scientific instrumentation company. We help customers who find themselves wondering how to keep up with the ever-changing world of dissolution, customers who may struggle to match in vitro data with observed in vivo behavior of their development molecules or formulations and customers who require accurate, measured PhysChem data to enable them to make better decisions. Pion has the capabilities and expertise to exceed customers’ expectations.
Our mandating system focuses on two main aspects. First, the accurate respect of the contents and time-plan; second, it aims at constantly observing the specific needs, in a welcoming and dedicated atmosphere.
MUNIT daily operates for the pharmaceutical sector, which is one of the most process-improvement oriented markets, for example with the creation of guidelines that allows managing the complexity of the various production processes. These guidelines are also the core of some dedicated abilities in order to profile the production quality’s value also in the form of activities that have to be part of the planning of the process itself.
Therefore, MUNIT can support with its own know-how, within the sphere of the micronization service, those customers using the DoE/QbD approach for their processes.
Visit us at www.munit.com