Archive for the 'Drug Delivery' Category

Delivering Complex Parenteral Formulations

Patricia Van Arnum PharmTech editorProgress in delivery science, manufacturing technologies, and commercialization are playing critical roles in advancing the development of complex parenteral drug formulations for new drug substances having a variety of formulation challenges. Unique formulation strategies and solutions are being investigated to extend the release of target peptides, proteins, nucleic acids, and small molecules for systemic, local, or cellular delivery. Pharmaceutical Technology will hold a live educational webcast, “Complex Parenteral Formulations for the Delivery of Peptides, Proteins, Nucleic Acids and Small Molecules,” on Thursday Nov. 21 from 10:00 to 11:00 AM EST, to examine the delivery science and product development of complex parenteral formulations. Read more »

FDA Offers Insight on QbD for Modified-Release Products

Patricia Van Arnum PharmTech editor 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 »

Improving Inhaled-Product Testing

The challenge of developing orally inhaled nasal drug products (OINDPs) is complicated by the interplay between drug-delivery devices and formulation. An article in the February 2013 issues of Pharmaceutical Technology and Pharmaceutical Technology Europe, “Improving Inhaled Product Testing: Methods for obtaining better in vitro-in vivo relationships,” discussed testing equipment and techniques. PharmTech recently interviewed the author, Mark Copley, sales director at Copley Scientific, to gain further insight into the importance of this topic. Read more »

Hot Melt Extrusion Research Continues

markarian online portraitResearch into hot melt extrusion (HME) as a solution to improve solubility continues to expand with a partnership between Encap Drug Delivery, a contract development and manufacturing organization in the UK, and the School of Pharmacy at the Queen’s University Belfast (QUB), announced in a press release this week. Read more »

CMC Troubles? Send Us Your Questions

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?

Researchers Investigate Raw Materials for Drug-Delivery Polymers

Researchers are trying to find better, cheaper ways to produce biodegradable and bio-based polymers.  Although one of the main drivers for this research is to compete with fossil-fuel-based polymers in large-volume, consumer plastics applications, medical applications, such as microcapsules for drug delivery, may also benefit.  While it seems odd, the researchers found that waste oil from cooking fried food can be used as a raw material in the polymer production process.  Read more »

Omega-3s Prescription Products: A Case Study of Innovation

Patricia Van Arnum PharmTech editor 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 »

Silk Protein Preserves Drugs Without Refrigeration

Tufts University research shows that silk protein can be used to stabilize and maintain the potency of vaccines and other drugs that would otherwise need refrigeration. “Silk stabilization has the potential to significantly change the way we store and deliver pharmaceuticals, especially in the developing world,” said research-paper author and Tufts doctoral student, Jeney Zhang, in a press release. Read more »

Bioavailability Enhancement through Lipid-Based Drug Delivery

Patricia Van Arnum PharmTech editor 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 »

Thirty-Five Years in the Pharmaceutical Sciences and Counting

Patricia Van Arnum PharmTech editor 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 »

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