Featured Articles
LIPOSOME PREPARATION TECHNOLOGY - Freeze Fracture Electron Microscopic (ff EM) Examination & Analysis of Liposomes Produced by Covaris AFA Technology
Srikanth Kakumanu, PhD, and Rajeev A. Jain, PhD, explain how an alternative ultrasonic processing technology allows manufacturing of liposomes of predetermined sizes and offers an efficient, isothermal, and non-contact process.
MANAGEMENT INSIGHT - Digital Soup
Derek G. Hennecke continues with part 5 on a new 6-part series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
MARKET BRIEF - Controlled Release Technologies: Advancing Toward Targeting Therapeutics
Frost & Sullivan Analyst Cecilia Van Cauwenberghe, MS, reviews a few recent innovative approaches to controlled release technologies with a focus on some of the therapeutic areas most relevant to the current pharmaceuticals market.
ORALLY DISINTEGRATING TABLETS - Novel Controlled Release Formulation for Orally Disintegrating Tablets Using Ion Exchange Resins
Abhijit Gokhale, PhD, and Praba Sundararajan indicate that drugs not typically amenable to ODT formulations include those that present taste-masking difficulties or require controlled or sustained release. However, as the demand for ODTs continues to grow, formulation scientists are exploring ways to adapt ODT formulations for drugs that require controlled or sustained release for optimal therapeutic benefits.
THERAPEUTIC FOCUS - Evaluation of a Needleless Injection Technique for Treatment of Peyronie’s Disease: a Feasibility Case Study
Jeffrey Marotte, MD, FACS, presents a proof of concept that the Madajet may be a suitable instrument to inject medication into Peyronie’s plaques.
ADVANCED DELIVERY DEVICES - Tackling Traditional Usability Issues With Innovative Device Design
George Perkins believes that by addressing the stigma and usability issues of self-administered injections, it is possible to make them the more attractive method for the administration of drugs in various scenarios.
BIOAVAILABILITY ENHANCEMENT - Out of the Shadows: Excipients Take the Spotlight; Part 1 of 2
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
BUSINESS DEVELOPMENT- The Performance Report
John A. Bermingham says a performance report should be a document in which you and the person you are reviewing take the opportunity to talk about that person’s job performance not just from your perspective but from the reviewee’s perspective.
CELL CULTURE MEDIA - Addressing Variability in Dry Powder Mammalian Cell Culture Media
Jörg von Hagen, PhD, believes it is critical for media manufacturers to have a process in place that can consistently deliver raw material and process quality to be able to deliver batch-to-batch consistent dry powder cell culture media that are scalable from kilograms to tons.
SPECIAL REPORT - Prefilled Syringes & Parenteral Contract Manufacturing: Improving for Flexibility & Customization
Special Feature: Contributor Cindy H. Dubin speaks with prefilled syringe manufacturers as well as contract parenteral manufacturers who share their thoughts about the delivery challenges associated with high-viscous, high-volume formulations.
ADVANCED DELIVERY DEVICES - Important Considerations in the Delivery of Large-Volume & Viscous Drugs
Kevin Cancelliere, MS, believes that as the trend toward self-administration continues, the need for careful consideration of primary container design, interaction with the drug product, method of administration, and end-user needs becomes even more critical.
AUTOLOGOUS CELL THERAPIES - Development of Autologous Cell Therapies: Keys to Clinical & Commercial Success
Ronnda L. Bartel, PhD, Tod Borton, and Brian S. Hampson review how Aastrom Biosciences has developed the innovative processes necessary to reduce risk throughout the manufacturing process. The company is now preparing for future commercialization for its investigational therapy derived from a patient’s own bone marrow stem cells.
EXCIPIENT UPDATE - Delivering Gastric-Resistant Functionality Via a Colorless Top Coat
Philip J. Butler and Thorsten Cech investigate the gastric-resistant functionality obtained by applying a clear, two-component MAE coating formulation onto a tablet sub-coated with a pigmented instant-release coating and investigate the impact of hydrophilic and lipophilic plasticizers on the film characteristics of MAE-based coating formulations.
EXECUTIVE INTERVIEW - SNBL, Ltd.: Innovation in Drug Delivery Enabled Through a Unique Business Model
Drug Development Executive: Dr. Shunji Haruta, Founder of NDS (Nasal Delivery Systems) Division and Executive Officer, SNBL, Ltd., discusses how NDS Division and its powder nasal delivery platform, µco System, fit into a new paradigm.
FORMULATION DEVELOPMENT - A Call for Collaboration to Meet the Bioavailability Challenge
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., begins his multiple-part series discussing today’s most challenging issues in solubility.
FORMULATION DEVELOPMENT - Trends & Opportunities in Particle Design Technologies - Life Sciences & Biopharma in the Spotlight
Frost & Sullivan Analyst, Cecilia Van Cauwenberghe, MS, examines the observed trends in particle design and engineering technologies, as well as the main factors and opportunities driving the principal technological advances in the biopharmaceutical industry.
M*A*S*H
John A. Bermingham explains how it is incumbent upon CEOs and their management teams to triage all functional areas of the company when in times of trouble and the investors are looking for a quick fix to stop the bleeding.
MANAGEMENT INSIGHT - Rook to D7: Game Theory in the Pharma Industry
Derek G. Hennecke continues with part 4 of a new 6-part series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
MARKET FORECASTING - Monte Carlo-Based Forecasting: How to Deal With Uncertainty
Jemma Lampkin and Gerard Loosschilder, PhD, show how Monte Carlo-based forecasts are better at handling uncertainties, turning them into valuable tools for product managers and marketers engaged in strategic business planning.
TRANSDERMAL DELIVERY - New Frontiers in Transdermal Drug Delivery
Kenneth B. Kirby and Chandan A.S. Alam, MD, are part of a team at Transdermal Delivery Solutions Corp. (TDSC) that has been leveraging its patented technology to develop a unique patchless, metered pump, spray-on drug delivery system and products.
