ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Crystallization Process Development: Peptide Crystallization

  Whether performed during formation of an API or as a means to purify intermediates, achieving control of nucleation and crystal growth is critical to designing a successful peptide crystallization process.

• Addressing Glass Particulates In Injectable Drug Formulations

  Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

• Pharmaceutical Nanotechnology: What To Know

  Here is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.

• Sophisticated Formulation Approaches For Insoluble Drug Candidates

  A sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.

• Nanosuspension Dosage Forms: Product Development & Scale Up

  For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.

• Gamification: The Answer To Pharma's Non-Adherence Crisis?

  Digital connectivity is transforming the consumer experience and digital technology can now improve the patient experience too, in ways that were just not possible before.

• A Step Change In Pharmaceutical Glass Packaging Innovation

  Valor Glass represents a significant, and much needed, step forward for glass innovation. Review the findings and learn how an aluminosilicate formulation can lower your glass vials' extractables profile.

• De-Risking A Novel Valve Component For Use With Standard Syringe Systems

  A novel valve provides dual‑chamber functionality within standard syringes, keeping two liquid drugs separated until injection while reducing development risk through advanced modeling.

• Choosing A Formulation And Process Approach To OCR Products

  Do you want to develop an oral controlled release (OCR) product? Understand the options and their ramifications as the first step toward devising a plan.

• Decoding the FDA Guidance on Essential Drug Delivery Outputs

  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.