Check out this commented presentation by Anne Linnet Skelbæk-Pedersen
Pharmaceutics (ISSN 1999-4923, click here) is an open access journal which provides an advanced forum for the science and technology of pharmaceutics and biopharmaceutics. It publishes reviews, regular research papers and communications. Covered topics include drug delivery and controlled release; pharmaceutical technology, manufacturing and devices; physical pharmacy and formulation; nanomedicine and nanotechnology; pharmacokinetics and pharmacodynamics; biopharmaceutics; drug targeting and design; gene and cell therapy; biologics and biosimilars; clinical pharmaceutics. Pharmaceutics is indexed by SCIE (IF 4.773, ranks 26/267 (Q1) in the category of Pharmacology & Pharmacy), PubMed and Scopus; it also is a member of DOAJ.
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Cryomilling as manufacturing technique to produce ASDs, a technique as gentle as generally assumed or rather not?Written by Timothy Pas
In this short communication, on current hot topics in the drug delivery and disposition lab, a chemical (and physical) evaluation of cryogenic milling to manufacture amorphous solid dispersions (ASDs) is provided to support novel mechanistic insights in the cryomilling process. Cryogenic milling devices are being considered as reactors in which both physical transitions (reduction in crystallite size, polymorphic transformations, accumulation of crystallite defects and partial or complete amorphization) and chemical reactions (chemical decomposition, …) can be mechanically triggered. Degradation of both APIs (Cinnarizine, Fenofibrate, Indomethacin and Naproxen) and polymers (HPMC, PVP, PVPVA, BSA and Gelatin 50PS) was observed and hence further characterized in depth by means of different analytical tools. Results demonstrated APIs to be more prone to chemical degradation in case of presence of polymer. A significant reduction of the polymer chain length was observed and in case of BSA denaturation/aggregation occurred. Hence, mechanochemical activation process(es) for amorphization and ASD-manufacturing cannot be regarded as a mild technique, as generally put forward, and one needs to be aware of potential chemical degradation of both API and polymer.
a word from one of our "Best Presentation Award" winners:
Anne Linnet Skelbæk-Pedersen
STAR PhD student
Oral Pilot and Process Development
Novo Nordisk A/S
Spray drying is widely used in pharmaceutical manufacturing to produce microspheres from solutions or suspensions. The mechanical properties of the microspheres are reflected by the morphology formed in the drying process. In suspension drying, solids dissolved in the carrier liquid may form bridges between the suspended primary particles, producing a microsphere structure which is resistant against mechanical loads. Experiments with individual, acoustically levitated droplets were performed to simulate the drying of suspension droplets in a spray drying process.
One of the biggest problems in the manufacturing of high-quality low-dose inhalation products, is dose uniformity of filled capsules . Our approach towards a scientific qualification of dosator nozzles for low-fill weight (1–45 mg) capsule filling comprises a decoupling of the filling process in dynamic and static mode tests, whereas the latter was carried out using a novel filling system, i.e. stand-alone static test tool, developed by us.
Cold compaction of powder is important for many industrial processes, e.g., for the production of green bodies before sintering of metallic or ceramic parts in mechanical engineering, pellets for mineral or animal food industry or the production of tablets in the pharmaceutical industry. The final powder compact requires a minimum strength as otherwise it would disintegrate during processing, transportation or storage. Experiments can be used to adjust the process to get the desired compact strength. This is time-consuming, as process parameters change often, e.g., the geometry of the machine tools or the powder properties. Hence, reliable numerical models to predict the properties of compacts with simulations are crucial.
Controlled expansion of supercritical solutions: an alternative method for producing nanoparticles with supercritical carbon dioxideWritten by Jenni Pessi
Poly(lactic-co-glycolic acid) (PLGA)-based microparticles offer a great potential as parenteral controlled drug delivery systems . Different types of drug release patterns can be obtained from PLGA microparticles, in particular mono-, bi-, or tri-phasic drug release kinetics. Interestingly, yet the underlying mass transport mechanisms in PLGA microparticles are not fully understood, despite their great practical importance. This can be attributed to the complexity of the involved mass transport mechanisms. The aim of this study was to better understand the mass transport mechanisms controlling drug release from PLGA microparticles. Importantly, new insight was gained based on the experimental monitoring of the swelling kinetics of single microparticles.
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Ensuring thermodynamic stability of amorphous solid dispersions by predicting drug-polymer solubilityWritten by Matthias Manne Knopp, Rene Holm and Thomas Rades
The potential of amorphous solid dispersions to improve the solubility, dissolution rate and bioavailability of poorly water soluble drugs is well known. However, the number of formulations that have made it through to the market is limited because of the unstable nature of the amorphous form, which often results in recrystallization of the drug with the subsequent loss of the solubility and dissolution advantages. Thus, ensuring the stability constitutes a major challenge in the development of amorphous solid dispersions.
For the first time, an appropriate solid dosage form was developed for a co-amorphous drug-amino acid formulation, demonstrating the high physical stability for the particular system during further processing to tablets and during long-term storage thereof.
We have developed a new technique to better understand what happens to the microstructure inside a tablet during rapid disintegration.