August 20th 2025
Survey responses indicate that bio/pharma faces tariff-driven rising costs and supply strain, with firms aiming to boost compliance and diversification and seeking stable trade and R&D support.
An Alternative to the USP Disintegration Test for Orally Disintegrating Tablets
The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply
August 1st 2008To meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. The author examines various methods of capsule filling, including binary blends.
Solid Microstructured Transdermal Delivery Highlighted at Controlled Release Society's Meeting
July 17th 20083M Drug Delivery Systems has successfully designed a proof of concept device using a solid microstructured transdermal system for the systemic delivery of high-potency pharmaceuticals. The technology was showcased at a poster session at the annual meeting of the Controlled Release Society held this week in New York City.
European Pharmacopeia Defines Policy for Potentially Genotoxic Impurities
July 10th 2008The European Pharmacopeia Commission has published the General Information chapter "Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use" in the July 2008 edition of PharmEuropa.
FDA Urges Early Switch to HFA-Propelled Albuterol Inhalers
June 5th 2008The US Food and Drug Administration advised patients, caregivers, and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers now because chlorofluorocarbon-propelled inhalers will not be available in the US after Dec. 31, 2008.
Developments in Scanning Electron Microscopy for Tablet and Granule Characterization
May 1st 2008Recent advances in SEM, particularly the incorporation of automation and software, have made simpler, lower-end SEM instruments easy to operate and have improved the capabilities of larger, sophisticated instruments.
Improving Tablet Quality with Compression to Equal Force Technology
May 1st 2008Traditional tablet presses do not measure tablets' tensile strength, yet this characteristic strongly influences tablet quality. The author describes a compression technique that accounts for tensile strength and produces tablets with consistent weight and disintegration time.
The role of analytical science in the debate over biosimilars
April 1st 2008As the US biopharmaceutical industry and regulators debate new requirements for biosimilars, industry leaders are turning to analytical science to define intellectual property and business development strategies. Emerging techniques are providing previously unseen protein characterization details, giving both innovator and generics companies new weapons in the battle for future market share.
20th Anniversary Special Feature: Outsourcing biologics manufacturing
April 1st 2008Biopharmaceuticals are the most rapidly growing segment of the pharmaceuticals market. Developing and marketing biopharmaceuticals are huge roles in almost every major pharmaceutical company's strategy. However, they are extremely complex molecules and are highly sensitive to the manufacturing processes used to produce them. These processes require exquisite control of living production systems, making, without a doubt, biopharmaceuticals one of the most challenging products of any type to manufacture.
Advances in Radio-Frequency Transdermal Drug Delivery
April 1st 2008A microelectronic system based on radio-frequency (RF) cell ablation addresses limitations of other transdermal drug-delivery methods. This system expands the transdermal spectrum to include the delivery of water-soluble molecules, peptides, proteins, and other macromolecules.
Dissolvable Films: Dissolvable Films for Flexible Product Format in Drug Delivery
April 1st 2008For pediatric and geriatric patients, fast-dissolving drug-delivery systems provide an easier way to take medications and vitamins. Oral thin films have evolved to provide systemic delivery of active pharmaceutical ingredients for over-the-counter and soon, prescription drugs. The authors review the practical benefits of dissolvable films, their manufacture, and their market potential.
Challenges in the Secondary Manufacture of Encapsulated High-Potency Drugs
April 1st 2008Liquid and semisolid encapsulation using two-piece hard capsules is an ideal drug delivery approach for highly potent compounds and poorly water-soluble drugs. The authors detail the factors to reduce risk when designing and operating a facility for secondary manufacturing of highly potent drugs.