Drug Development

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation. 

Revamping the Citizen’s Petition Process for FDA

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.


Overcoming Bioavailability ‘Roadblocks’ with LBDDS

As the development pipeline becomes more saturated with complex molecules and patient experience becomes more important, developers are looking to outsourcing partners to provide more specialized expertise and solutions.

The Demands of the Perfect Dose

Dr. Jeremy Drummond is senior vice-president of business development for MedPharm.

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

Getting in Touch with New Guidance on Topical Products

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Establishing OEL data and ensuring appropriate engineering controls are crucial aspects of safe handling.

Best Practices in Handling HPAPIs

Chintan Patel is researcher at Cadila Healthcare Ltd.’s Zydus Research Center in Ahmedabad, Gujarat, India

Gayatri Patel is associate professor of pharmaceutics and pharmaceutical technology at Charotar University of Science and Technology, Changa, Gujarat, India

Sanjay Bandyopadhyay is vice president at Cadila Healthcare Ltd.’s Zydus Research Center in Ahmedabad, Gujarat, India;

Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.

Optimizing Manufacturing Based on the Storage Stability of Pegylated Products

Frank Romanski, PhD is head of Global Marketing, Pharma Solutions, BASF Corp, Florham Park, NJ, frank.romanski@basf.com.

High-throughput platforms can be used to develop tertiary phase diagrams, which can be leveraged to identify the most stable SEDDS formulations and excipients for lipid-based drug delivery systems.

How Excipient Type Influences Self-Emulsifying Drug Delivery

MattÂ Richardson is business development manager at Capsule Delivery Solutions, Lonza Pharma & Biotech.

Nicolas Madit is senior business development manager at Capsule Delivery Solutions, Lonza Pharma & Biotech

Technological advancements can address the formulation and dissolution challenges of HPMC polymers.

Advancements in Encapsulation Technology

john Hammond is Technical & Marketing Manager with Starna Scientific Limited, 52-54 Fowler Road, Hainault Business Park, Hainault, Essex, IG6 3UT, UK

Nancy Lewen is research fellow, CSD Analytical chemistry, Bristol-Myers Squibb.

Emmanuel Akala is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Anthony Hickey is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients.

Jolyon Mitchell is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

June Liang is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Timothy Shelbourn is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Katherine Tyner is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Eloise Welfare is a members of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Norbert Maurer is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Munir Hussain is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Lawrence Block is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Myke Scoggins is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Thomas Tice is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.


Perspectives on Quality Attributes of Drug Products Containing Nanomaterials

George Collins is vice president, Vanderbilt Chemicals LLC. 

Katherine Ulman is president, KLU Consulting.

Douglas G. Muse is consultant—Compendial Affairs, Eli Lilly & Co.

Joseph Zeleznik is chair, IPEC-Americas QbD Committee

Priscilla Zawislak is global regulatory affairs advocacy manager, DuPont Nutrition & Biosciences

Elizabeth Tocce is associate application development engineer, Dupont.

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

This article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.

Formulation and Drug Delivery