FDA’s quality-by-design (QbD) initiative is a systematic approach to designing and developing pharmaceutical formulations and manufacturing processes to ensure predefined product quality. Understanding the critical quality attributes of the ingredients in a formulation, including excipients, and the critical process parameters in the manufacturing process of the finished drug product is crucial for successfully implementing QbD. Pharmaceutical Technology will be holding a live webcast on Thursday May 23 from 10:00 AM  to 11:00 AM EST to examine the regulatory and technical considerations in implementing QbD for coatings in modified-release formulations, including strategies to mitigate the risks associated with alcohol-induced dose-dumping and the application of alcohol-resistant coatings. Read more »

 Quality by Design (QbD) is changing drug development and manufacturing. The science- and risk-based approach inherent in a QbD paradigm increases process understanding and leads to better drug development and manufacturing. Sharing lessons learned and strategies for applying QbD in solid dosage development and manufacturing is valuable. Pharmaceutical Technology will address this topic in a webcast, “A Pragmatic Application of QbD: Turning Theory into Tangible Success” this Thursday May 2 from 11:00 to 12:00 PM EST.

Two industry experts will share their experience with QbD and offer insight into how the practical application of QbD contributed to the success of their projects. Through several case studies, these experts will provide lessons learned and advice on the measures they took that enabled the success of their projects; steps that can be universally applied to other projects.

Don Barbieri, associate director of formulation and process development at Patheon, will present case studies demonstrating different aspects of the QbD approach, including identifying CQAs (critical quality attributes) and CPPs (critical process parameters) as well as how to perform risk assessment, incorporate risk mitigation into a process, and how to develop a design of experiments (DoE).

David Smith, pharmaceutical specialist, formulation and process development at Patheon, will present a case study where the pragmatic application of QbD enabled a successful technology transfer of a film-coated tablet from Phase III to commercial scale.

Further information, including how to register for the complimentary webcast, may be found  here.

With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class. Read more »

Endo Pharmaceuticals, maker of the opioid medication Opana ER (oxymorphone HCl), is suing FDA to prevent generic manufacturers from entering the market with formulations of oxymorphone that are not abuse-resistant. Read more »

Last week, FDA deemed that a generic drug manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals USA was not therapeutically equivalent to its reference product. The drug in question, Budeprion XL 300 mg, was approved in the US in December 2006 as a generic form of GlaxoSmithKline’s antidepressent drug, Wellbutrin XL 300 mg. Read more »

Pharmaceutical Technology and Patheon are partnering to provide you—our readers—with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world. To get started, we need to know what plagues your CMC strategies and daily work. Email your questions directly to Editorial Director Angie Drakulich at adrakulich@advanstar.com. (*Note: We will keep your name and company affiliation anonymous.)

Answers will be provided by the Patheon Certified Consultants team beginning in the January 2013 print and online editions of PharmTech. These experts have collectively brought more than 200 pharmaceutical products to market, including some of the world’s largest blockbusters.

Sample questions:

• I have a BCS Class II compound for which amorphous solubility is easily sustained, but I can’t get the compound to rapidly dissolve. What are some solutions, particularly with respect to excipient selection?
• I have a compound that is non-ionizable and does not form a stable salt. Are co-crystals my best option and what are the key criteria in identifying a suitable co-crystal?
• I am having trouble maintaining product stability when scaling up a lyophilization process. What are the likely factors causing the problem?

Innovation is the cornerstone of the pharmaceutical industry. The challenge to innovation not only entails identifying drugs with clinical efficacy but also in being able to produce and deliver the desired drug compound. An upcoming Pharmaceutical Technology webcast, Omega-3 Innovations in Pharmaceutical and Diagnostic Markets, will examine the latest developments for omega-3 prescription drug products, their regulatory status, and recent advances in softgel drug-delivery technologies for omega-3 products. Read more »

An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines. PharmTech’s Asia correspondent, Jane Wan, reports that India has set a high bar for patent approval that Western drug manufacturers are finding frustrating.

Read more »

Improving bioavailability of poorly water-soluble drugs is an ongoing challenge for formulation scientists and is of crucial importance to advance clinically promising drug candidates. A Pharmaceutical Technology webcast, Bioavailability Enhancement through Lipid-Based Drug Delivery, will examine advances in lipid-based drug delivery systems for enhancing the bioavailability of absorption-limited small and large molecules. Read more »

A new year is often reason to reflect on what has occurred and to consider what the future may hold. And for 2012, Pharmaceutical Technology is doing just that. Next year will mark Pharmaceutical Technology’s 35th anniversary, and as part of a special issue to be published in July 2012, we are seeking to gain your input on what you feel have been the most noteworthy achievements in the pharmaceutical sciences and manufacturing and what future developments may shape the industry. Read more »