ORAL DRUG DELIVERY ARTICLES
In Part 2 of a two-part series, Fran DeGrazio explains why best practices in particle testing and related risk-based approaches to product quality should not wait for official regulatory guidances and standards to catch up.
ORAL DRUG DELIVERY RESOURCES
-
This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
-
Examine the vital role formulation development plays in oncology outsourcing and how sponsors can increase their chances of success with the right CDMO partner.
-
A uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Explore how the right formulation approach can enhance drug delivery and improve patient outcomes.
-
The study was designed to assess the clinical performance of prototype formulations, assess food effect and dose linearity of a selected formulation, and the impact on exposure in subjects taking proton pump inhibitors (PPI).
-
As patient-centricity spurs innovation in drug delivery systems, examine the potential of FDCs to provide convenient dosing and how increased patient compliance is alleviating the cost of health care.
-
Gamma scintigraphy was used to evaluate GI transit and release from 3 capsule prototypes with different coating systems; data on pH, temperature and pressure during GI transit was obtained and correlated.
-
Thanks to insoluble drug delivery technologies, the practice of reformulating poorly soluble drug products to improve efficacy, patient compliance and safety has now been widely adopted.
ORAL DRUG DELIVERY SOLUTIONS
-
Can my product be NanoImproved? Find out at at-a-glance with a brand new Nanoform 4-page informational spread covering new molecules and reformulations, small molecules and biologics, technology details, and proof points.
-
AustinPx offers integrated GMP manufacturing services for oral dosage forms with a full complement of analytical development and testing capabilities.
-
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.