Drug Delivery

It's time for the pharmaceutical industry to consider electronic innovations as part of their life cycle management strategies.

Using the Bergum Method and the MS Excel software program, the author determines the probability of passing the USP dissolution test.

FDA Sees Hike in Combination Product Applications

Novartis Pharma and Ono Pharmaceutical have signed an agreement to codevelop and co market...

Researchers at Johns Hopkins University (Baltimore, MD, USA) have devised a self-assembling cube-shaped perforated container...

SEC Loosens Revenue-Recognition Rules for Vaccine Stockpile Participants

NIAID Boosts Vaccine Innovation but Draws Controversy

FDA Warns Consumers Against Unapproved, Contaminated 'Miracle II Neutralizer'

The attraction of nasal administered therapeutic agents is obvious, including faster onset of action, increased compliance and avoiding degradation during first pass metabolism.

Solid oral drug products are one of the oldest of all manufactured dosage forms (1). Today, the development of an appropriate formulation of drug and excipients and of an effective manufacturing process to create a tablet or capsule is slowly transforming from a practice of applied art to one of applied science. The US Food and Drug Administration supports this change by expecting sponsors of new drug applications to understand, describe, and control materials and processes as well as the risks associated with drug product manufacturing (2). These steps will ensure the consistent production of products that meet their specifications and remain safe and effective during their shelf life.

Formulators currently face numerous challenges in nanosuspension development in terms of ensuring safety, efficacy, and stability. Presenters at Wednesday's AAPS symposium offered strategies for addressing these challenges, including setting meaningful particle-size specifications, selecting the method to measure particles in nanosuspensions (especially for nonspherical particles), gaining a meaningful particle-size distribution, and determining the particle size from such distributions.

The International Organization for Standardization (ISO, www.iso.org) has approved the use of the photometric method for liquid delivery performance verification. Artel (Westbrook, ME, www.artel-usa.com), a manufacturer of precision testing and calibration systems for liquid handling instruments, uses the photometric method to calibrate pipettes and automated liquid handlers.

Extending the life cycle of a drug product has paved the way for "the new pharmaceutical industry" according a Tuesday AAPS Annual Meeting session, "Formulation Approaches to Life Cycle Management."

Generally, tablet and capsule film coatings are applied as aqueous or organic-based polymer solutions or dispersions, graduate student Sagarika Bose (University of Connecticut) explained during her Tuesday AAPS Graduate Student Symposium presentation, "Development and Evaluation of Solventless Photocurable Pharmaceutical Film Coating." However, organic film coatings can be flammable, toxic, and must comply with strict environmental regulations. Aqueous film coating can lead to the degradation of certain drugs by heat and water.

At the plenary session at the AAPS Annual Meeting, two researchers presented studies targeting completely different areas of stem cell research, but their work focused on the same ultimate goal: finding new therapies.

Roche Puts Hold on Tamiflu in US

Recent advances in transdermal technologies challenge the paradigm that only a few drugs can be delivered transdermally.

A radiotracer technique is a simple, fast, and sensitive technique for analyzing the integrity of clinical supply packages to water.

Although agitation improves drying efficiency and ensures uniformity of the final dry material, it can also affect the physical properties of the product as it dries. This study evaluates the effect of scale up and equipment selection on an active ingredient undergoing granulation during the drying process.

Eli Lilly and Alkermes’ rival formulation to Pfizer’s inhaled insulin, Exubera, has cleared a Phase II clinical trial.

Poly(ethylene oxide) is gaining the attention of research and development organizations and its application is extending into a wide range of drug delivery systems.

Pharmaceutical science and technology innovation

IAdvances in pressurized metered-dose inhalers (pMDIs) in terms of formulation capability and the performance of the container closure system enable products to be developed faster and with less technical risk. Despite new delivery devices for new molecules breaking into the pMDI market, pMDIs have the ability to gain regulatory approval significantly faster than a novel device, which could save a company many hundreds of millions of pounds.

Being the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence-the most critical development area.

First Contraceptive Spray Offers Advantages over the Pill

Can macromolecular processes learn from small-molecule experience? Burdened by exploding bioreactor productivity, architects of downstream bioseparation technology are looking into the drug industry's past for inspiration, while small-molecule companies adopt techniques pioneered by biotechnology. (The first of three articles on the current state of separations.)

Genentech Anticipates Full-Capacity Manufacturing

Development Collaboration for Ophthalmic Drugs Could Eliminate Injections

Self-Assembly Nanotechnology Improves Microencapsulation

Once considered mainly an afterthought in a company's lifecycle-management strategy, controlled-release dosage forms are now positioned at the forefront of many formulation strategies. In contrast to drug discovery, formulation work focuses not only on the intricacies of the active pharmaceutical ingredient (API), but also on fine-tuning the excipients, the release profile, and the delivery mechanism to provide optimal therapeutic benefit. Because of their wide range of applications and functionalities, especially in controlled-release therapies, polymers are among the most widely used excipients.