FORMULATION FORUM - Rational Design of Oral Nanosuspensions for Insoluble Drugs
Jim Huang, PhD, explains how nanosuspensions are an important class of pharmaceutical dosage forms, particularly for pharmaceutical compounds with solubility and bioavailability challenges.
EXECUTIVE INTERVIEW - Adare Pharmaceuticals: A Virtual Acquisition is Possible
Ajay Damani, VP of Pharmaceutical Technologies Business Unit, Adare, and Maria Flynn, President and CEO, Orbis, discuss how both companies will benefit from the acquisition, future product development, and the challenges of a virtual acquisition.
GLOBAL REPORT - 2019 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery and Formulation Pipeline
In part 4 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, analyzes the pipeline with an emphasis on clinical-stage products for which there is more product-related information.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions
Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.
SUPPLY CHAIN SOLUTIONS - Storage and Distribution Support for Clinical Trials Worldwide
Patient centricity has moved to the forefront of clinical trials. Direct-to-patient (DTP) services provide convenience, and lead to greater participation and retention, addressing two key challenges that face study sponsors Yourway has.
DRUG DISCOVERY - Disrupting Drug Discovery From Assay Development to Lead Compound
Zack Gurard-Levin, PhD, says with new innovations in assay methodologies, scientists no longer have to make sacrifices to do quality drug discovery research.
ANALYTICAL SERVICES - Applying Innovative Thinking & Techniques to Reduce Time-to-Market
Ramesh Jagadeesan, PhD, says that while CDMOs have the capacity to support pharmaceutical companies with their analytical requirements for both small and large-scale projects, the opportunity exists to increase speed to market with innovative thinking.
RISK-BASED MONITORING - Making the Move to RBM: Improving Patient Safety & Data Quality With Real-Time Insights
Crystal Stone and Amanda Coogan indicate that in an era in which the time- and resource-intensive business model of developing blockbuster drugs has been supplanted by a push to move drug candidates through the pipeline with greater speed, accuracy, and quality, RBM and real-time data analytics are becoming a must-have for clinical trials.
LYOPHILIZATION - Process Monitoring During Freeze-Drying
Gregory A. Sacha, PhD, describes the devices used for process monitoring and how they can be used to detect end points during the process.
FORMULATION FORUM - Application of Nano-Emulsion Technology to Address Unmet Medical Needs: A Case Study of Clopidogrel IV by 505(b)(2) Pathway
Jim Huang, PhD, presents a case study on how the EmulSol technology produces stable, optically clear nano-emulsions without the use of organic solvents and with minimal use of surfactants using a high-pressure or microfluidic homogenization process.
EXECUTIVE INTERVIEW - FSD Pharma Inc.: Is Ultra Micro-PEA the Best Untold Story in Pharma?
Raza Bokhari, MD, CEO of FSD Pharma, discusses how acquiring Prismic will benefit FSD, what makes the ultra-micronized platform unique, and how ultramicro-PEA could be the answer to ending the opioid epidemic.
GLOBAL REPORT - 2019 Global Drug Delivery & Formulation Report: Part 3, Notable Drug Delivery & Formulation Transactions & Technologies of 2019
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on several notable drug delivery and formulation transactions and technologies.
SPECIAL FEATURE - Excipients: Matching Ingredients to Molecules Improves Functionality
Contributor Cindy Dubin speaks with several leading excipient manufacturers on how their excipient offerings are improving drug release, solubility, taste, physical characteristics, viscosity, and more for a range of molecules.
FORMULATION FORUM - Rational Design & Development of Lipid-Filled Hard Capsules
Jim Huang, PhD, says with ever increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based delivery systems, together with other main delivery technologies, have become an important tool for the development of those compounds.
THERAPEUTIC PEPTIDES - Continuous Manufacturing of Peptides Could Speed Up Development, Reduce Costs & Improve Quality
Jens Bukrinski, PhD, MSc, says the high-quality, high-process consistency between manufacturing runs and the in-line PAT analytics of the μLOT platform will enable unprecedented robustness of the manufacturing process, significantly retiring the risk of failure to supply due to non-scalability of the manufacturing process.
CANNABINOID THERAPY - NeuroDirect Effects(TM) CBD: Non-Systemic Cannabidiol for Autism Spectrum Disorder
Ronald Aung-Din, MD, says NeuroDirect Effects Technology CBD is particularly attractive in this population as it utilizes the body’s own ECS, and in utilizing a non-systemic therapeutic mechanism, there is less likelihood for long-term negative effects in developing brains of children.
ORAL THIN FILMS - Misconceptions, Advantages & Limitations About an Emerging Drug Delivery System
Srinivasan Shanmugam, PhD, says due to advancements in the science behind OTF design, as well as the predicted increase in OTF market valuation, this drug delivery system is becoming increasingly popular.
EXECUTIVE INTERVIEW - Tedor Pharma, Inc.: A Strategy Shift to Serve Both Generic & Branded Companies
Doug Drysdale, President & CEO of Tedor Pharma, Inc., discusses the FLEXITAB technology, his strategy for managing a shift in business model, and how Tedor is addressing the needs of small- and medium-size companies developing innovative and repurposed small molecules for unmet medical needs.
NATURAL LANGUAGE PROCESSING - How Life Sciences Companies Are Leveraging NLP From Molecule to Market
Jane Z. Reed, PhD, MA, discusses some of the challenges facing pharma researchers and executives; the benefit NLP can bring; and some specific customer-use cases (covering patent landscaping, gene disease associations, access to safety silos, and more).
DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 3
Josef Bossart, PhD, analyzes the development and review times of the US FDA’s new drug approvals (NDA and BLA) for the period of 2010 through 2018.
