November 22nd 2024
The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.
November 21st 2024
There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
Manufacture and Dissolution Studies of Lipid Spheres: Part I
October 1st 2003Previous articles have presented a general review of the different types of spheres that can be obtained with a rotary fluidized bed process.1,2 This two-part study focusses on lipid spheres that can be prepared using hydrogenated castor oil, as well as examining the feasibility of the process and the main characteristics of the spheres obtained.
Defining the Similarity of Dissolution Profiles Using Hotelling's T2 Statistic
June 1st 2003This article describes a method for assessing the similarity of dissolution profiles using Hotelling's T2 statistic. The method applies a covariance structure that accounts for the heterogeneity of variance and correlation across time points. Comparing the method with the f2 criterion recommended in FDA's guidance on dissolution testing, the performance of the two methods was assessed on real examples, and simulation studies were also done to compare the method's performance with that of the f2 criterion.
Effervescent Dosage Manufacturing
April 1st 2003Oral dosage forms are the most popular way of taking medication, despite having some disadvantages compared with other methods. One such disadvantage is the risk of slow absorption of the active pharmaceutical ingredient (API), which can be overcome by administering the drug in liquid form and, therefore, possibly allowing the use of a lower dosage.
Design, Development and Optimization Using Computational Fluid Dynamics
March 1st 2003Interest in more advanced drug delivery systems has increased, with an acceleration in the discovery and development of novel therapeutic macromolecules for targeted applications. Computational fluid dynamics is a design tool that allows producers of these and other products to evaluate different models rapidly and cost-effectively.
Understanding and Implementing Efficient Analytical Methods Development and Validation
February 1st 2003Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.
Improving Dose Content Uniformity Testing for MDIs and DPIs
January 1st 2003It has been demonstrated that the existing FDA dose content uniformity test has very poor statistical relevance, which has resulted in the acceptance of poor quality batches and the rejection of good quality batches. By using Bayesian Inference, a much improved test has been produced that allows the quality of a batch of drug product to be determined accurately, using a suitable number of samples for the quality of the batch.
Selecting the Right Ultrafiltration Membrane for Biopharmaceutical Applications
December 1st 2002Ultrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.
An Alternative Spectroscopy Technique for Biopharmaceutical Applications
December 1st 2002Spectroscopy using light is a familiar technique and the electromagnetic spectrum from UV to IR is routinely employed. This article looks at the advantages and applications of spectroscopy using sound waves, with special reference to pharmaceutical research.
Formulation of Lactose for Inhaled Delivery Systems
November 1st 2002Dry powder inhalers (DPIs) contain a powder which, when required, is discharged and inhaled. The therapeutic drug is manufactured in powder form as small particles a few micrometres in diameter. In many DPIs, the drug is mixed with much larger sugar crystals, such as lactose, and the smaller drug particles attach to these excipient particles, improving entrainment of the drug upon inhalation. This article examines how the application and combination of versatile processes such as milling, micronizing, sieving and air classification can be used to manufacture dedicated lactose products for practically every possible combination of active and excipient blend in DPIs.
IMS Limit Test Improves Cleaning Verification and Method Development
October 1st 2002A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.
Validation Changes to the USP Assay Method for Ibuprofen Tablets
March 1st 2002This study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.
A Novel Mathematical Method for Quantitative Expression of Deviation from Zero-Order Drug Release
September 2nd 2001Because drug delivery at a zero-order rate provides uniform concentration of a drug for absorption, this study attempts to identify a simple mathematical method to quantitatively express the deviation from zero-order kinetics.