Lipoderm® Topical Vehicle Used in USP Compounded Preparation Monograph
HOUSTON--(BUSINESS WIRE)--Aug 8, 2018--Lipoderm® – developed and produced by PCCA, and the first proprietary permeation enhancing vehicle in the compounding industry – is now included in the official USP Compounded Preparation Monograph for Ondansetron Compounded Topical Gel (20 mg/ml).
“The monograph represents a significant investment of time and resources by the USP to create meaningful standards for compounding – and to ensure that patients have access to the quality compounded medicine they need,” said Gus Bassani, PharmD, Vice President of Consulting, R&D and Formulations for PCCA.
Published in the USP–NF and in the USP Compounding Compendium, the monograph for Ondansetron Compounded Topical Gel includes information such as: The formula, ingredients (including PCCA’s Lipoderm®), quantities of ingredients, directions on how to correctly compound the preparation and the 90-day beyond-use date (BUD), which is the date after which the preparation must not be used. The BUD was determined by a study conducted by USP that utilized a validated stability indicating methodology.
Since 1820, USP Compounded Preparation Monographs have provided quality standards for specific preparations to assist practitioners in compounding formulations for which there is no suitable commercially available product for human and animal patients. As of July 2018, there are nearly 200 official USP Compounded Preparation Monographs. After identifying a public health need, USP initiates the creation of the data and evidence necessary to create a Compounded Preparation Monograph. USP has invested more than $1.8 million since 2012 in the development of monographs to meet public health needs, as reported on its website ( www.usp.org ).
Scientifically proven to deliver APIs through the skin, Lipoderm is the ideal base in deep-penetrating topical formulations for local absorption of APIs, as well as formulas for systemic absorption of APIs. It’s supported by an ever-growing portfolio of peer-reviewed journal publications and FormulaPlus™ BUD-studied formulas. These FormulaPlus BUD studies determine the physicochemical stability of a formula utilizing a stability-indicating method. Lipoderm is also non-comedogenic and doesn’t separate with refrigeration, resulting in cosmetically elegant and stable preparations of deep-penetrating topical formulations. The patented Lipoderm core technology has also led to the development of an entire line of permeation enhancing bases. For more information about Lipoderm, contact PCCA at 800.331.2498.
PCCA helps pharmacists and prescribers create personalized medicine that makes a difference in patients’ lives. As a complete resource for independent compounding pharmacists, PCCA provides high-quality products, education and support to more than 3,500 pharmacy members throughout the United States, Canada, Australia and other countries around the world. Incorporated in 1981 by a network of pharmacists, PCCA has supported pharmacy compounding for more than 37 years. Learn more at www.pccarx.com.
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Kim Speairs, APR, MBA, 281.709.8277
Director of Communications and Engagement
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PUB: 08/08/2018 11:49 AM/DISC: 08/08/2018 11:49 AM