30. August 2016
Abstract In situ -gelling systems has the great potential in the wide areas of drug delivery. The application areas of such systems are broad and these systems can be formulated not only as gels but also as in situ gelling nanospheres, microspheres and liposomes. To overcome the drawbacks associated with conventional drug delivery systems and take advantages of both solutions and gels, such as accurate dosing, ease of administration of the former and longer precorneal residence of the latter, a...
30. August 2016
Abstract Pharmacopoeias, as standard references for pharmaceutical drug specifi cations and reference standards in the form of monographs, play a pivotal role to assure drug quality and safety. With emphasis on the activities concerning non-biological complex drugs (NBCDs), the mechanisms by which new monographs are introduced into the European and the US pharmacopoeias are presented. Introduction Over the last decades we came to realize that high molecular weight drugs of biological origin,...
30. August 2016
Abstract Personalized medicine aims to tailor drug combination and dosage manufacturing to the specific needs of a patient by taking into consideration its genetic profile, phenotypic response, and pathophysiology. New technologies are needed to enable the rapid manufacturing of custom pharmaceutical tablets in a scalable manner, while meeting quality assurance regulatory standards. 3D Pharming, the use of 3D Printing to directly fabricate personalized pharmaceutical tablets, is under intense...
30. August 2016
The Board of EXCiPACT asbl is pleased to announce that the IPEC Association (China) limited has recently become the fifth member of EXCiPACT asbl - the independent, voluntary 3rd party GMP/GDP certification program for manufacturers and distributors of pharmaceutical excipients - joining the four founding members – IPEC Europe, IPEC Americas, FECC, and PQG (UK). IPEC Association (China) was inaugurated in July 2008 to be the voice for the manufacturers, distributors and users of...
29. August 2016
A string of new guidance documents have made it clear that data integrity (DI) remains high on the agenda of regulatory authorities around the world and this has become a global issue. DI in the context of pharma manufacturing has led to a rising number of regulatory enforcement actions citing failures in the recording and review of manufacturing data. In some cases violations have led to written warning letters and even bans on imports from some manufacturing facilities. The extent of draft...
29. August 2016
Abstract Although process analytical technology (PAT) guidance has been introduced to the pharmaceutical industry just a decade ago, this innovative approach has already become an important part of efficient pharmaceutical development, manufacturing, and quality assurance. PAT tools are especially important in technologically complex operations which require strict control of critical process parameters and have significant effect on final product quality. Manufacturing of prolonged release...
29. August 2016
Introduction Over the last three decades industrial adaptability has allowed hot-melt extrusion (HME) to gain wide acceptance where it has established its place in the broad spectrum of manufacturing operations and pharmaceutical formulation development. HME has been demonstrated as a robust, novel technique to make solid dispersions in order to provide 1.) time-controlled, 2.) modified, 3.) extended, or 4.) targeted drug delivery, resulting in improved bioavailability as well as taste masking...
28. August 2016
Abstract: The aim of the present work was to prepare and evaluate sublingual fast dissolving lms containing metoprolol tartrate-loaded niosomes. Niosomes were utilized to allow for pro- longed release of the drug, whereas the lms were used to increase the drug’s bioavailability via the sublingual route. Niosomes were prepared using span 60 and cholesterol at different drug to surfactant ratios. The niosomes were characterized for size, zeta-potential, and entrapment ef ciency. The selected...
26. August 2016
BIOGRUND’s tabletting Agent CompactCel® TC provides an easy to use and homogeneous compound of several sugar alcohols and cellulose fibers, which acts as a perfect taste masking dry binder.
26. August 2016
Brussels, 23rd August 2016 EXCiPACT asbl is delighted to announce that the Armor ProtéinesS.A.S. –Armor Pharma™ site has recently been awarded an EXCiPACT Certificate from SGS, one of EXCIPACT’s internationally-recognised Certification Bodies. See also