24. September 2017
Abstract Thermoresponsive polymers are a class of smart materials that exhibit change in their physical properties with temperature, which make them unique and useful materials in a wide range of biomedical applications. Soluplus®, a thermoresponsive block graft copolymer with poly(vinyl acetate) PVAc and poly(vinyl caprolactam) PVCL block grafted on a poly(ethelyne glycol) PEG backbone in a ratio of 30:57:13 respectively, is marketed by BASF Corporation, it aids in solubilizing and increasing...
18. November 2016
The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy. The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy. The IID is intended to be a definitive searchable catalogue of every excipient that has ever been used in a US Food and Drug Administration (FDA) approved drug. The...
17. November 2016
Whitepaper Enhancing Ingredients Owing to their product-enhancing functions and wide range of application possibilities, fluidized and spouted bed technologies have become established as important formulation processes in the food and beverage industry. Product optimization is key to success, and choosing the right combination of process type and parameters is critical. Knowing the benefits of spray agglomeration, which process parameters influence formulation or reformulation, how to improve...
12. October 2016
FDA and the excipient industry are giving more thought to how the inactive ingredient database (IID) can be improved to better support the development of emerging dosage forms, including drug delivery devices such as transdermal patches, metered dose inhalers, nasal sprays, and implants. A session was held at the 2016 IPEC-Americas/ExcipientFest Conference, held in late April in Baltimore, Maryland, to explore the regulatory issues encountered in formulating emerging dosage forms and how the...
15. June 2016
Abstract In this study, terahertz time-domain spectroscopic (THz-TDS) technique has been used to ascertain the change in the optical properties, as a function of changing porosity and mass fraction of active pharmaceutical ingredient (API), of training sets of pharmaceutical tablets. Four training sets of pharmaceutical tablets were compressed with microcrystalline cellulose (MCC) excipient and indomethacin API by varying either the porosity, height, and API mass fraction or all three tablet...
05. June 2016
Background: In previous work, we built the Drug Ontology (DrOn) to support comparative effectiveness research use cases. Here, we have updated our representation of ingredients to include both active ingredients (and their strengths) and excipients. Our update had three primary lines of work: 1) analysing and extracting excipients, 2) analysing and extracting strength information for active ingredients, and 3) representing the binding of active ingredients to cytochrome P450 isoenzymes as...
29. May 2016
Abstract Excipients represent diverse classes of molecules, small molecules or macromolecules, with versatile structures within a given class and are from natural, semi-synthetic and synthetic sources. They are essential ingredients in drug products independently of the route of administration where both traditional and non-traditional uses are present. Beyond their traditional use as formulation and manufacturing aids, certain excipients exhibit biological effects and thus can be used either...
14. April 2016
Phenol, chemically known as carbolic acid, is a white, volatile crystal solid. It is a mildly acidic, water-soluble chemical that requires safe handling due its ability to cause chemical burns. Phenol is produced both “naturally” as well as synthetically. In its natural form, phenol was initially found in coal tar. It is also present naturally in human and animal wastes as well as in some foods. Chemical companies manufacture phenol on a large scale from petroleum and sell it commercially...
30. January 2016
April 25 - 27, 2016 Renaissance Harborplace Hotel, Baltimore - MD ExcipientFest attracts Pharmaceutical Scientists from the Americas and around the world to a unique two day forum for cutting-edge scientific developments. ExcipientFest features in-depth technical talks on Excipient Technology, New Drug Applications and Regulatory Issues from industry’s top-pharmaceutical experts. The seminar is designed to have a total science focus and to be true to the role of functionality of pharma...