Q: I am compounding a preparation intended to administer testosterone and dehydroepiandrosterone transdermally, but the gel keeps "breaking."I am using a carbomer/alcohol/water gel that is preserved and a small amount of ethanol as the levigating agent.
A: Compounding hormones and/or other active ingredients into gel basis for transdermal administration is a widely accepted pharmaceutical practice and is well-documented in the literature. Clinical observation and monitoring of appropriate markers during this therapy can be beneficial to the patientthe goal of extemporaneously compounded therapy is individual outcome. A key component of transdermal gels is of a penetration enhancer such as isopropyl palmitate/lecithin (50/50 w/w; Lipoil). In this combination, phospholipids/micelles are liberated from the solubilized lecithin. Phospholipids are well-known to aid the transport of active ingredients into the skin for absorption. The penetration enhancer usually is incorporated as 22% to 24% of the formulation and probably should be included here.
As to the "broken"gel, carbomer gels are pH-sensitive and also can break when overloaded with ingredients. Literature references point to the use of a poloxamer gel at 20% to 30% concentration in water (Pluronic F127 NF or Polox), a clear solution at refrigerated temperatures that becomes a semisolid at room-to-body temperatures. This behavior allows the material to remain in place where applied to the skin, instead of running off as a carbomer or methylcellulose gel might.
Mr. Erickson is director of professional affairs at Gallipot Inc.
One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
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