Dosage Forms

Articles

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

Using the Bergum Method and MS Excel to Determine The Probability of Passing the USP Dissolution Test

The survival of Bacillus subtilis spores in dicalcium phosphate, lactose, and corn starch and in their binary mixtures depends on the compressional properties of these materials and on parameters involved during the tableting process, including compression speed.

The Survival of B. Subtilis Spores in Dicalcium Phosphate, Lactose, and Corn Starch and Their Binary Mixtures during Tableting

Fernando J. Muzzio, PhD, is a professor and the director of the pharmaceutical engineering program at the Department of Chemical and Biochemical Engineering, Rutgers University, 98 Brett Road, Piscataway, NJ 08854-8058, tel. 732.445.3357.

Almost all pharmaceutical manufacturing processes require handling and processing cohesive powders. The application of sufficient shear (i.e., the total deformation that the bulk of granular material undergoes under applied shear stress) is an essential factor in such processes. Sufficient shear is required to mill and de-lump materials, achieve sufficient flow, and homogenize cohesive ingredients. Shear mixing plays a critical role in the blending of dry powders, particularly for those that contain a minor cohesive component such as a solid lubricant or a drug. This mechanism is necessary to achieve a satisfactory homogeneity and disintegrate possible agglomerates. Excessive shear can be disadvantageous, however, and can lead to electrostatic buildup, attrition, and overlubrication.

The Effect of Shear Mixing on the Blending of Cohesive Lubricants and Drugs

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.

The Importance of Fundamental Data Gathering and Planning for Solid Oral Drug Product Manufacturing

Control Development's (South Bend, IN, www.controldevelopment.com) blend uniformity and dryer monitor consists of a NIR spectrometer, a sampling head, computer, and software.

New dryer monitor released

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.

Solventless Photocurable Film Coating

The common crystal form of ibuprofen was changed to optimize processing and manufacturing properties. Six modified crystal forms were prepared and assessed for dissolution, morphology, particle size, density, thermal characteristics, powder x-ray diffractometry, flow properties, and tabletability.

Improving the Physical and Chemical Properties of Ibuprofen

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

A Rapid, Sensitive, Radiotracer Technique

This review article discusses orally disintegrating tablets and their manufacturing technologies, development issues, and future trends.

Orally Disintegrating Tablets

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.

Solid/Semi-Solid Dosage