ORAL DRUG DELIVERY ARTICLES

frankly-fran-better The Key to Regulatory Innovation? Global Harmonization

Innovation in drug development and delivery is often thought of as purely a technical matter. In this article, Fran DeGrazio illustrates why innovation must also be applied to regulatory practices. 

ORAL DRUG DELIVERY VIDEOS

See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

For poorly soluble drugs, overcoming absorption hurdles can hinder development. KinetiSol™ Technology empowers researchers to overcome solubility limitations and accelerate drug development.

Our new, state-of-the-art compounding pharmacy supports the rapid and cost-effective preparation of dosage forms including oral solutions, suspensions, drug or powder in capsule or bottle, and sterile preparations.

Through case studies on modified release, poor solubility, and pediatrics, discover how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.

ORAL DRUG DELIVERY RESOURCES

ORAL DRUG DELIVERY SOLUTIONS

  • This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.

  • Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.

  • Nanoform’s award-winning Controlled Expansion of Supercritical Solutions (CESS®) technology is a bottom-up nanoparticle engineering approach that enables the creation of API nanoparticles and can unlock the full therapeutic potential of small molecule drugs.

  • Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."

  • August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.

  • Learn what oral modified-release (MR) dosage forms can offer and why they continue to rise in popularity.

  • With over 20 years of experience, PCI’s strength lies in our ability to manage products with unique challenges ranging from small molecules presenting with solubility issues or a labile molecule that is only stable as a liquid presentation for a short time.

  • As the number of poorly soluble compounds continues to increase in the industry development pipeline, conventional formulation strategies may not be sufficient to achieve acceptable levels of solubility in the gastrointestinal tract and hence absorption into the systemic circulation.

  • Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.

  • Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.