02. October 2018
The formulation of amorphous solid dispersions (ASDs) is an effective way to improve the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs). The combination of an amorphous state of the drug and the presence of crystallization-inhibiting polymers retains a high amount of dissolved API over time. ASDs with ketoconazole and different polymers were manufactured by spray drying and their characteristics as well as performance were analyzed. Dissolution tests with a...
01. October 2018
The occurrence of protein aggregation during bioprocessing steps such as purification, formulation and fill-finish, impacts yield and production costs, and must be controlled throughout themanufacturing process. Understanding aggregation mechanisms and developing mitigating strategies are imperative to ensure the clinical efficacy of the protein drug product and to reduce costs. Thiscommentary reflects on recent progress made in the field of monoclonal antibody (mAb) aggregation with...
13. September 2018
The study aimed at investigating the potential of spray drying method for encapsulation of protein drugs into solid lipid microparticles (MP) and evaluating effects of excipients on encapsulation and release of protein from MP. After transformation of model protein insulin to insulin-phospholipid complex, it was dissolved together with lipid excipients in organic solvent, which was spray-dried to form solid lipid MP. Polymeric MP with D, L-lactic-co-glycolic acid (PLGA) were prepared similarly....
10. September 2018
Pharma Excipients has been nominated for the CPhI Pharma Awards in the category "Excellence in pharmaceutical Excipients." What offers Pharma Excipients? A unique and neutral digital platform accessible on various digital ways Completely focussed on excipients and new developments Exchange of information and access to scientific papers Online sampling and sourcing platform Systematic database in development and available in Q3 2018 New ideas to increase and promote the knowledge on...
10. September 2018
Of over 250 entries in 17 categories the finalists have been announced by CPhI. Here is the shortlist of excipients and formulation. Excellence in Pharma: Excipients Adwatis SA – Advanced Water S-100 Evonik Industries AG – EUDRAGIT® FL 30 D-55 Ideal Cures Pvt. Ltd. – INSTA COAT QD Lonza – Capsugel® Colorista™ Capsules Merck – Parteck® MXP Excipient Pharma Excipients International AG – Pharma Excipients Sudeep Pharma Pvt Ltd – Magnesium Stearate EXCiPACT Excellence in Pharma:...
05. September 2018
As Pfanstiehl approaches its 100th anniversary in 2019, the company has launched a new high purity, low endotoxin, and low metal L-Arginine (USP, EP, JP, ChP), manufactured in the United States under strict cGMP, ICH Q7 compliant conditions. This is the first amino acid Pfanstiehl has launched and they have others in development.
30. August 2018
LIVE WEBCAST Tuesday, October 2, 2018 at 11am EDT, 10am CDT, 4pm BST, 5pm CEST Can't make the live webcast? Register now and view it on-demand after the air date. Event Overview The Inactive Ingredient Database (IID) provides information on inactive ingredients present in FDA-approved drug products and is used by industry as an aid in developing drug products. How can sponsors gain a better understanding of the FDA requirements and avoid lengthy review cycles, unnecessary requests for...
24. August 2018
Granutools is delighted to present you the Powder Flow Course given on October 4th by experst in powder flow characterization. You will be immersed into physics of powders, measurements of powder flowing properties and including hand's on training. The course is geared towards applications and process on the additive manufacturing of metal powders. Contact us via martin.laloux@granutools.com
22. August 2018
The effects of excipients on the accuracy of tablet subdivision are severely underinvestigated. In this study, placebo tablets were prepared using a combined mixture design of fillers and binders to evaluate the effect of these excipients on subdivision accuracy. The responses assessed were mass loss, mass variation, tablet fragmentation, and increased friability. Dicalcium phosphate dihydrate (DCP) gave rise to more uniform and denser tablets than microcrystalline cellulose (MCC), thus...
22. August 2018
IPEC-Americas presents the Technically Unavoidable Particles in Excipients (TUPs) webinar on September 12, 11 a.m. to 1 p.m. (EDT) The webinar will discuss the relevance of TUPs in excipient products. The presenter, Ann Van Meter, will highlight the IPEC-Americas Technically Unavoidable Particle Profile Guide (TUPPs Guide), explain a risk-based approach for evaluating visible particles in excipients and encourage suitable diaglogue between excipient manufacturers with their pharmaceutical...