issues

April 2019

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COVER

AMORPHOUS SOLID DISPERSIONS – Increasing Solubility From API to Tablets

Paulo Lino, PhD, and João Henriques discuss the main development goals and present a framework for a streamlined development of amorphous solid dispersion formulations by spray drying.

FEATURES

AMORPHOUS SOLID DISPERSIONS – Increasing Solubility From API to Tablets

Paulo Lino, PhD, and João Henriques discuss the main development goals and present a framework for a streamlined development of amorphous solid dispersion formulations by spray drying.

SMART DEVICES – Add-On Connectivity Facilitates New Generation of Smart Inhalers

Contributor Cindy H. Dubin reviews how the addition of electronic and connectivity to inhalers may improve patient adherence and, consequently, treatment efficacy.

FORMULATION FORUM – Revitalization of Older Drug Products Using Innovative Formulation Technologies by 505(b)(2) Regulatory Pathway

Jim Huang, PhD, says more than 50% of approved drugs on the market contain poorly water soluble APIs, which typically are associated with poor bioavailability, suboptimal drug delivery, ineffective drug efficacy, and side effects, and this creates a huge opportunity in generating 505(b)(2) products.

DRUG DISCOVERY – Zebrafish in Preclinical Drug Development – A Small Fish With Big Returns

Rafael Miñana, PhD, explores the benefits of preclinical outsourcing, the value of zebrafish as an alternative model, as well as the challenges and opportunities of managing a highly diversified portfolio and providing customized solutions.

GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 2, Notable Product Drug Delivery and Formulation Approvals of 2018

In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on how the pharmaceutical industry has harnessed well validated drug delivery and formulation technologies to deliver important product approvals in 2018.

SPECIAL FEATURE – Excipients: Formulators Want Excipients for Solubility & Beyond

Contributor Cindy H. Dubin speaks with leading excipient companies to discuss the current role excipients are playing in continuous manufacturing, biopharma formulation, and controlled- and immediate-release delivery.

EXECUTIVE INTERVIEW – PCI Synthesis: Acquisition by Seqens Expands its Pharmaceutical Offerings

Ed Price, President and CEO of PCI Synthesis, reflects on the trends fostering the CDMO industry consolidation and the positive impact it augurs in addressing sponsors’ needs to enter the clinic more quickly and safely.

DRUG DEVELOPMENT – Rapid Preparation of Gadolinium & Protamine Complexes With Aurintricarboxylic Polysalicylates: Implications for Drug Development

Timothy J. Smith, RPh, PhD, reviews how derivatives of aurintricarboxylic acid (ATA), a commercial reagent for aluminum ion determination, are under consideration for drug development in view of ATA’s diverse pharmacological spectrum.

THERAPEUTIC FOCUS – Targeting the Novel LANCL2 Pathway Offers Potential for a Differentiated Treatment Paradigm for Autoimmune Diseases

Andrew Leber, PhD, Raquel Hontecillas, PhD, and Josep Bassaganya-Riera, PhD, say current IBD therapeutics have mediocre efficacy, poor maintenance of response, and damaging side effects, including cancer, infection, and death, resulting in an unmet clinical need for safer and more effective oral therapeutics.

REAL ESTATE – Four Ways Firms Are Advancing Innovation With Real Estate

Roger Humphrey, MBA, says as companies pursue various and unique collaborative platforms, their real estate needs are changing — with profound implications for how and where life sciences companies choose to operate.

RISK MANAGEMENT – FDA’s Quality Risk Management Approach to New Drug Applications

Kaiser J. Aziz, PhD, explains how the FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.

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