BACKGROUND Needlestick injury has been identified as a major cause of exposure to blood and body fluids. The heparin-lock intermittent intravenous procedure was implicated in the largest number of needlestick-related exposures (26%) at this 1100-bed tertiary care hospital, and replacement of this system was imperative. Cost concerns, however, necessitated that replacement products not increase ...

In 2006, the Product Quality Research Institute’s (PQRI) Leachables and Extractables Working Group released a comprehensive and detailed recommendation document related to leachables and extractables for inhalation drug products. The document includes best pharmaceutical development practice recommendations regarding container closure/delivery system component composition and selection, control...

Bacterial endotoxins, also known as lipopolysaccharides, are a fever-producing by-product of gram-negative bacteria commonly known as pyrogens. It is essential to remove endotoxins from parenteral preparations since they have multiple injurious biological activities. Because of their strong heat resistance (e.g., requiring dry-heat sterilization at 250 degrees C for 30 min) and the formation of...

conducted involving a wide range of protein therapeutics for various conditions. Most of the proteins have been successfully applied in therapy, mainly as parenterals. An oral dosage form is the preferred form of delivery because of ease of administration, patient compliance, and cost. Major hurdles must be overcome before the oral delivery of a protein becomes a reality. Among the proteins, or...

There have been only a dozen parenteral extended release formulations that are designed to deliver drugs from a week up to 6 months since the first introduction of Lupron Depot® made of poly(lactic-coglycolic acid) (PLGA) microspheres in 1989. All parenteral extended release formulations are made of PLGA in the form of microspheres, solid implants, and in situ forming implants. Over the past fe...

Sterility means the absence of all viable microorganisms including viruses. At present, a sterility assurance level (SAL) of 10(-6) is generally accepted for pharmacopoeial sterilization procedures, i.e., a probability of not more than one viable microorganism in an amount of one million sterilised items of the final product. By extrapolating the reduction rates following extreme artificial ini...

The healthcare industry is challenged with meeting stringent quality requirements regarding the manufacturing of drug products. Packaging components are critical to this operation. Because of these requirements, each final container processed for parenteral preparation must be inspected thoroughly for the presence of visible particulates. According to USP 32-NF 27, “Each final container of all ...

INTRODUCTION The special nature of Blood Transfusion Services has been very well described by Wolf' who states that "unlike other clinical laboratories the blood bank provides a parenteral therapeutic agent. Unlike the pharmacy's primarily synthetic parenterals, blood and its components resemble tissue or organ transplants. They require individual patientdonor matching. The unique aspects of tr...

We have used stably transfected CHO cell lines to characterize the pathway of intracellular transport of the 1gp120 (lgp--A) to lysosomes . Using several surface labeling and internalization assays, our results suggest that 1gp120 can reach its final destination with or without prior appearance on the plasma membrane . The extent to which lgp120 was transported via the cell surface was determin...

The purpose of these studies was to examine the pharmacokinetics, oral bioavailability, and systemic side effects of aminolevulinic acid (ALA) in beagle dogs after oral and i.v. administration. Oral and i.v. doses of ALA (128 mg of ALA hydrochloride, equivalent to 100 mg of ALA) were administered to four animals using a crossover design. Animals were allowed a 2-week washout period between dose...