AAPS PharmSciTech^SM
Publishes First Issue

Orthogonal HPLC Methods For Quantitating Related Substances and Degradation Products of Pramlintide
By Richard A. Kenley, Wade Demond, James L. Italien, David Lokensgard, and G. Weilersbacher
Pramlintide is a 37-amino acid peptide under development for diabetes therapy. This investigation describes analytical test methods for assuring the purity of the drug. These methods may have general application for analysis of complex peptides intended for therapeutic use.

Sustained Activity and Release of Leuprolide Acetate from an In Situ Polymeric Implant
By Harish B. Ravivarapu, Katie L. Moyer, and Richard L. Dunn
This article describes the preclinical development of an injectable and in situ forming polymeric implant system for effective delivery and activity of leuprolide acetate over a period of 90 days in the treatment of prostate cancer.

The Stabilization and Release of Hirudin from Liposomes or Lipid-Assemblies Coated with Hydrophobically Modified Dextran
By Russell J. Mumper and Allan S. Hoffman
Hirudin is a peptide used to prevent deep-vein thrombosis following knee and hip replacement surgery. Palmitoyl dextran-coated liposomes were found to stabilize hirudin, thereby enhancing the peptide’s ability to inhibit thrombin.

Dynamic Changes in Size Distribution of Emulsion Droplets During Ethyl Acetate-Based Microencapsulation Process
By Yogita Bahl and Hongkee Sah
This study focuses on the dynamic process of the breakup and formation of emulsion droplets during an ethyl acetate-based emulsion microencapsulation process. The results reported provide invaluable insight into the effect of the onset of ethyl acetate quenching upon the size distribution of poly-d,l-lactide-co-glycolide microspheres.

Novel In Vitro Release Technique for Peptide Containing Biodegradable Microspheres
By Janusz W. Kostanski and Patrick P. DeLuca
This paper describes a novel in vitro release method, utilizing a dialysis technique for peptide-containing biodegradable microspheres, that is applicable to in vitro testing and in vivo correlation of various microsphere formulations. The method provides an expedient and reliable approach to drug release testing from microspheres, eliminating the need for frequent centrifugations and vehicle replacement.

Liposome-Based Formulations for the Antibiotic Nonapeptide Leucinostatin A: Fourier Transform Infrared Spectroscopy Characterization and In Vivo Toxicologic Study
By Maurizio Ricci, Paola Sassi, Claudio Nastruzzi, and Carlo Rossi
This study identifies liposome formulations (MLVs or LUVs) as carriers for Leucinostatin A, a nonapeptide with high antimycotic activity but with low DL50. The choice formulation that could provide the highest DL50 for the peptide was assessed and characterized utilizing FTIR spectrophotometry, which also allowed insight on the action mechanism of this interesting peptide.

Papers can be submitted at www.pharmscitech.com. To submit a manuscript for consideration, contact the AAPS PharmSciTech manuscript coordinator at pharmscitech-edoffice@aaps.org or Paul Clark at 703-518-8448.

AAPS PharmSciTech covers the basic and applied research on pharmaceutical dosage forms, both traditional and novel, including the emerging area of biopharmaceuticals. The goal of the journal is to disseminate scientific and technical information on drug product design, development, evaluation and processing worldwide, taking full advantage of web publishing.

* * *