HOUSTON: March 8, 2012— Professional Compounding Centers of America (PCCA) has announced the results of a landmark study on Lipoderm transdermal bases. The first-of-its-kind study, performed by PRACS Institute/Cetero Research in North Dakota, confirmed that simultaneous delivery of up to four pharmaceutical medications can be achieved through a transdermal vehicle. Additional details, including links to study results, are available atwww.pccarx.com/lipoderm.
In the extensive, two-month study, Lipoderm was tested using the exacting Franz Skin Finite Dose Model, which utilized samples of human skin, in vitro, to evaluate the percutaneous absorption of four different drugs. The active pharmaceutical ingredients (APIs), selected because of their frequent use in topical pain formulations, were ketamine HCl, gabapentin, clonidine HCl and baclofen. In addition to proving Lipoderm’s effectiveness in carrying multiple APIs, the findings also verified that this base is highly resilient in the presence of a wide range of drugs and increases permeation of the APIs.
“For many years, pharmacists have wanted an effective and proven way to deliver multiple drugs via transdermal methods,” said Gus Bassani, PharmD, PCCA vice president of Consulting, R&D and Formulations. “The findings from this study confirm that PCCA’s Lipoderm can fill this need.”
The data signify a marked increase in the benefits that already come from the use of transdermal bases. For patients unable to take medication in more common forms – pills and injections among them – use of a transdermal cream can often mean the difference between treatment success or failure. Because they allow medications to successfully penetrate the skin, these transdermal creams show the potential to sidestep many common side-effects of drugs, such as upset stomach, and minimize the effects on other organs. This reduction of side effects is particularly significant in pain treatment, where the application of the cream can be localized to an area with relatively low blood-flow, meaning higher concentrations at the site of application and lower concentrations of the drug throughout the body.
“I routinely prescribe custom-compounded medications for my patients and specify the use of Lipoderm because I’ve seen the studies and I’ve seen the results in my patients,” said Dr. Chad Domangue, managing partner, Neuroscience & Pain Institute. “Before now, I was hesitant to prescribe APIs like ketamine due to concerns with systemic absorption and the lack of thorough studies from the other transdermals on the market. Now with Lipoderm, I can confidently target the peripheral nerve while systemic absorption remains typically low. It offers an easy, elegant alternative to taking multiple pills and my patients love it.”
The fact that Lipoderm can successfully deliver four medications at the same time brings additional benefits. Because a transdermal dosage-form has a more direct path to the bloodstream, the API can be administered in a lower concentration than the same medication in pill form. Depending on the site of application and formulation makeup, the transdermal method can provide optimal delivery either locally or systemically. Further, the study also showed that the four APIs maintained their individual identities after being absorbed, further reducing the likelihood that any of the drugs would mix and thereby impede the efficacy of any one medication.
Based on molecular size of the APIs, a majority of medications can be delivered through a transdermal base. And for patients who require multiple medications each day, having to apply just one cream – rather than having to keep up with four medicines in a variety of dosage forms – could further mean increased ease of compliance and a better treatment outcome as a result.
“These findings open the door for a variety of meaningful applications, such as in hospice utilization, with nausea control or pain management,” said Bassani. “There is also the potential to significantly impact the way other treatments are administered. The possibilities are many.”
In related studies, three Lipoderm derivatives were tested independently for ability to deliver four drugs at once, as well as for other qualities unique to each:
- Lipoderm ActiveMax™ for higher active concentrations without the separation or liquification typically seen in other transdermal bases;
- Anhydrous Lipoderm for API that are unstable in water or that require a soy-free base; and
- Lipoderm High Molecular Weight™ for drugs with high molecular weight, making it ideal for HCG delivery or autism, as it does not contain lecithin, phospholipids or eggs
Lipoderm is only available from PCCA, which offers more than 60 proprietary bases for use by member pharmacies. PCCA has spent almost $8 million throughout the past 10 years on formula and base development, and to ensure formula compatibility with APIs. Only FDA-registered and GMP-certified manufacturers are used for the purchase of APIs; 14 checks and analyses are performed on every chemical lot as it arrives and before it is shipped to pharmacies.