Formulation/Delivery
The Lead
Needle-Free Injection: Has its Time Finally Arrived?
June 4, 2013 1:39 pm | by John J. Turanin, Vice President and General Manager; Zogenix Technologies, San Diego, Calif. | Articles | Comments
There have been significant advancements in needle-free injection technology, which aim to increase adoption of self-injectable therapies and adherence. Patients often lack the confidence to self-inject or are put off by the complexity, impacting their ability to incorporate these therapies into their lifestyle.
Nanotech Improving Tumor Targeting
June 13, 2013 11:31 am | News | Comments
Nanotechnology opens up a portal into living tissue that allows scientists to watch cancers...
Needle-Free Injection: Has its Time Finally Arrived?
June 4, 2013 1:39 pm | by John J. Turanin, Vice President and General Manager; Zogenix Technologies, San Diego, Calif. | Articles | Comments
There have been significant advancements in needle-...
Novel Use of Silica for Drug Delivery
October 15, 2012 5:21 pm | News | Comments
W. R. Grace & Co. and Formac Pharmaceuticals NV will present positive data from initial...
Dermal Delivery of Large-molecule Drugs
April 11, 2013 4:31 pm | by Bob Bruno, Principal; R.P. Bruno and Associates | Articles | CommentsScientists recently demonstrated that biphasic vesicles can deliver large-molecule or macromolecule drugs into the skin. Success with biphasic vesicles offers the potential for needle-free administration of many pharmaceuticals that could previously only be administered by injection.
A New HPMC Capsule for Optimum Formulation of Pharmaceutical Dosage Forms
March 7, 2013 3:19 pm | White Papers | CommentsCapsugel’s Vcaps Plus capsules are produced without a gelling agent that can delay dissolution and lead to unwanted issues during product development.
Testing Drug Stability for Long-Term Storage
October 5, 2012 3:57 pm | by Mike May, Contributing Editor | Articles | CommentsAlthough drug discovery gets much of the attention in the pharmaceutical industry, stability plays an equally fundamental role. A drug must remain potent and safe long after it leaves a manufacturing facility. Ensuring this safety requires a range of technologies and applications.
Using SEM/EDX for Particle Characterization in the Drug Manufacturing Process
October 4, 2012 3:29 pm | by Sue Benes, Product Marketing Manager, and Marie Vicéns, PhD, Manager of Analytical Services, ASPEX Corporation, Delmont, Pennsylvania | Articles | CommentsDrug manufacturing processes―especially production of drugs delivered through inhalation―must have strict control over contaminate particles. Numerous methodologies allow companies to monitor these particles, the challenge is gathering the information quickly enough in order to be able to detect manufacturing problems.
Selexis Technology Aids in LUB-13-04 Production
June 28, 2012 12:00 pm | News | CommentsSelexis SA announced that its US-based customer, Lubris LLC, has achieved over 1 g/L per liter yield in manufacturing production runs of LUB-13-04.
Quotient, Capsugel Begin Formulation Partnership
June 26, 2012 11:17 am | News | CommentsQuotient Clinical and Capsugel have announced a collaboration to enable the rapid development and clinical assessment of lipid-based formulations.
Ambrx and Merck in $300M Collaboration
June 18, 2012 11:41 am | News | CommentsAmbrx Inc. said that it will receive $15 million and could receive more than $300 million from a partnership with Merck & Co. to develop drugs using its technology.
Drug Studies In Small Doses
June 13, 2012 3:21 pm | by Iain Shaw, Director of 14C Enabled Drug Development; Lloyd Stevens, Senior Research Fellow; Quotient Clinical, Nottingham, U.K. | Articles | CommentsWhile exploratory clinical trials have been proposed for years,interest has boomed since the publication of the ICH M3 R2 guidelines in 2008.
Quotient Receives Enterion Approval
May 2, 2012 11:42 am | News | CommentsQuotient Clinical has received approval of the final patent for its Enterion technology. This completes a portfolio of eight granted patents across North America and Europe.
A New Picture of Particles
April 12, 2012 2:34 pm | by Marie C. Vicéns, PhD, Manager of Analytical Services; ASPEX Corp., Delmont, Pa. | Articles | CommentsBased on the recommendations and requirements of regulatory agencies, many pharmaceutical companies and contract manufacturers are developing particle characterization programs.
Particle Analyzers
April 2, 2012 10:45 am | Product Releases | CommentsThe FlowCAM PV Series imaging particle analysis system from Fluid Imaging Technologies automatically takes high-resolution, digital images of individual particles of encapsulated Paclitaxel.
Atomic Force Microscopy and Drug Research
March 9, 2012 12:50 pm | by Sophia Hohlbauch, Biological Applications Scientist; Nicholas Geisse, Biological Applications Scientist; Irene Revenko Biological Applications Scientist; Asylum Research, Santa Barbara, Calif. | Articles | CommentsAtomic force microscopy is part of a broad class of scanning probe microscopes that were originally developed in the 1980s. AFMs physically track samples with a microfabricated probe to generate 3D topographical images.
Almac Adds Encapsulation Equipment
February 28, 2012 4:21 pm | News | CommentsAlmac, a provider of contract services to the pharmaceutical and biotech industries, has acquired encapsulation equipment for their North American headquarters in Souderton, Pa.
Sol-Gel Signs Deal for Dermatology Drug Delivery
February 27, 2012 4:32 pm | News | CommentsSol-Gel Technologies Ltd. has entered into a second development and licensing agreement with a leading U.S. pharmaceutical company for the development and commercialization of a major dermatologic drug.
Daiichi Sankyo, Terumo to Co-develop Intradermal Vaccine
February 27, 2012 9:50 am | News | CommentsDaiichi Sankyo Co. Ltd. and Terumo Corporation announced an agreement to co-develop a new vaccine for the prevention of infectious diseases, utilizing Terumo’s intradermal injection device.
Issues in the Characterization of Sub-Visible Particulates in Biologics
February 24, 2012 12:06 pm | Webinars | CommentsThis webinar discusses the methodologies used to characterize sub-visible particulates in parenterals, Dynamic Image Analysis for particulate characterization and orthogonal instrument methodologies.
Easier to Swallow
February 21, 2012 10:36 am | by Jeff Shimizu, Chief Technical Officer; Medimetrics, Briarcliff Manor, N.Y.; Lee Ann Hodges, Chief Operating Officer; Bio-Images Research Ltd., Glasgow, U.K. | Articles | CommentsThe concept of an electronic pill has been around for decades. Many have imagined and even pursued a swallowed capsule with electronic function on board to measure, intervene, and/or deliver a drug while passing through the gastrointestinal tract.
Therapy Dose Management During Clinical Development of Oncology Products
January 24, 2012 5:47 am | by Salvatore J. Salamone, PhD, Founder & Chief Scientific Officer; Edward L. Erickson, President & Chief Executive Officer; Saladax Biomedical Inc., Bethlehem, Pa.; Jack DeForrest, PhD, President; JDF PharmaConsulting LLC, Wycombe, Pa. | Product Releases | CommentsBody surface area (BSA) has long been the gold standard for determining the appropriate dose of chemotherapeutic agents. Numerous studies, however, have shown that this results in large patient variability due to variations in drug biodistribution, genetic variation, metabolism, and clearance.
On Target Delivery
December 6, 2011 5:24 am | by Robert Shorr, PhD, DIC, Chief Executive Officer; Cornerstone Pharmaceuticals, Cranbury, N.J. | Articles | CommentsAdvances in nanotechnology—the discovery of materials with new compositions and performance properties—as well as advances in manufacturing processes and scale are having a revolutionary impact on the diagnosis, treatment, monitoring, and prevention of disease.
Chiral Metal Surfaces May Help Manufacture Drugs
October 26, 2011 12:26 pm | News | CommentsNew research shows how metal surfaces that lack mirror symmetry could provide a novel approach towards manufacturing pharmaceuticals.
Improving Peptide Performance
October 7, 2011 1:18 pm | by Baosheng Liu, PhD, Vice President, Research and Manufacturing, American Peptide | Articles | CommentsThe advent of stable isotopes have allowed the relative or even absolute quantification of proteins by mass spectrometric techniques based upon their well-characterized increase in molecular mass compared to the native protein or peptide of interest.
When the Well Runs Dry
October 7, 2011 12:33 pm | by Ted Agres, Contributing Editor | Articles | CommentsThe Food and Drug Administration, lawmakers, and industry officials are attempting to curtail an impending crisis in the availability of critical drugs. Legislation is pending that would require pharmaceutical manufacturers to give the FDA advance notice of possible shortages.
R & D for Drug R & D
October 7, 2011 12:00 pm | by Rita C. Peters, Editorial Director | Articles | CommentsA sister publication—R&D Magazine—will present the 49th Annual R&D 100 Awards this month. Among the top technologies and processes introduced in 2010 are many with direct applications in life sciences and drug research.
Determining the First Dose
September 9, 2011 11:38 am | by Rob Harris, PhD, Director, Early Development; Molecular Profiles, Nottingham, U.K. | Articles | CommentsThe objective of a Phase 1, first-time-in-man clinical trial is to provide information on drug pharmacokinetics and pharmacodynamics in humans and to determine the appropriate dose to be taken into further clinical studies.
Biobetter Collaboration
September 9, 2011 11:09 am | by Mike May, PhD, Contributing Editor | Articles | CommentsBiobetter drugs offer unique opportunities and challenges. These drugs aim at similar targets and indications as existing biologic products, but provide some improvement other than price, such as efficacy, safety, or dosing regimens.
