Improving the Solubility of Benzoyl Peroxide: A Review

Jul 1, 2011 | Contact Author | By: James Ziming Sun, PhD, Diversapack of California; and Alex Wang Sun, Tufts University
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Title: Improving the Solubility of Benzoyl Peroxide: A Review
solubilized benzoyl peroxide (BPO)x acne treatmentx P. acnesx powder suspensionx
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Keywords: solubilized benzoyl peroxide (BPO) | acne treatment | P. acnes | powder suspension

Abstract: In this review, the authors examine studies relating to the solubility of BPO. The clinical trials discussed show that compared with suspended BPO, BPO solubilized by dimethyl isosorbide reduced P. acnes and decreased both inflammatory lesions/irritation and the emergence of antibiotic-resistant P. acnes strains. This reveals the importance of solubilizing BPO for improved efficacy and safety.

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JZ Sun and AW Sun, Improving the Solubility of Benzoyl Peroxide: A Review, Cosm &Toil 126(7) (2011)

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Benzoyl peroxide (BPO) has been used as an anti-acne treatment for several decades. Its unique activity is based on the ability to not only reduce Propionibacterium acnes, but also to decrease inflammatory lesions. As is well-known, P. acnes is the bacteria responsible for acne breakouts and it cannot live in an aerobic (i.e., oxygen-rich) environment. Benzoyl peroxide works by introducing oxygen into the pore, thereby killing the bacteria and, in turn, reducing the number of breakouts on the skin. And since BPO acts as a toxin on P. acnes rather than an antibiotic, resistance to BPO does not occur and has not been reported. Another factor that makes benzoyl peroxide so effective is its ability to help rid the follicle of excess dead skin cells since clearing the pore of cellular debris lessens the chances of pore blockages, or comedones. In this way, benzoyl peroxide helps to prevent breakouts before they start.

Regarding its regulation, the final Federal Register monograph of the US Food and Drug Administration (FDA), published on March 4, 2010, classified BPO as a safe and effective over-the-counter (OTC) topical acne drug product. This monograph went into effect on March 4, 2011, having taken more than 20 years to establish due to safety precautions. The monograph permits the use of BPO at levels between 2.5% and 10.0%; common commercial drug products, such as wash-off or leave-on gels or creams, typically use concentrations of 2.5% and 5.0%, up to 10.0%.

BPO commonly causes initial dryness and sometimes irritation, although skin tolerance usually occurs after a week or so.2, 8 However, a small percentage of individuals are much more sensitive to it and can suffer burning, itching, peeling and possibly swelling. It therefore is sensible to apply the lowest concentration to build up skin’s tolerance, as appropriate. Once tolerance is achieved, increasing the quantity or concentration a second time and gaining tolerance at a higher level usually gives better subsequent acne clearance.2, 9

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Table 1. BPO Formula Ingredients Comparison

Table 1. BPO Formula Ingredients Comparison

A comparison of a traditional BPO crystalline powder suspensionc and two solublized BPO formulations is shown in Table 1.

Figure 1. Structure of benzoyl peroxide

Figure 1. Structure of benzoyl peroxide

The structure of BPO, shown in Figure 1, is nearly symmetrical and non-polar, and is poorly soluble in water.

Figure 2. Solvents that can dissolve BPO

Figure 2. Solvents that can dissolve BPO

Reviewing the structures of benzyl benzoate and dimethyl isosorbide—the only solvents known to successfully solubilize BPO—they are similar to BPO (see Figure 2), which follows the rule of “like dissolves like.”

Footnote (CT1107 Sun)

a Brevoxyl-4 and Brevoxyl-8 are registered trademarks of Steifel, a GSK Co.
b The CLENZIderm M.D. product line is manufactured by Obagi Medical Products.
c Clean & Clear is a registered trademark of Johnson & Johnson Consumer Companies, Inc.

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