The Blurred Line Between "Topical" and "Transdermal", Part G

This week, we will look at some clinical implications of "topicals" and "transdermals";

"What drugs are delivered to and through the skin?"

For topical administration, a large variety of agents are used, both in broken skin and where the skin barrier is intact. Classes of agents include anesthetics, anti-acne agents, antibacterials, antifungals, antiparasitics, antiseptics/cleaners, antivirals, coal tar, corticosteroids, cytotoxic agents, dithranol, phototherapy drugs, retinoids, and vitamin D analogs.

For transdermal administration, generally the best candidates are those of low molecular-weight (300 to 500) potent lipophilic molecules with a relatively wide therapeutic window. The candidates also need to have suitable aqueous solubility (greater than 100 mcg/mL) and a log partition coefficient (octanol/water) in the range of 1 to 3.5. Generally, a reasonably good candidate will have a flux in the vicinity of 1 mg/cm²/day. As an example, if 10 cm² is covered, then about 10 mg of drug could be delivered per day. Using this value of 1 mg/cm²/day, one can get an approximation of the maximum achievable dose for the drug. It is also best to keep in mind that the first-pass effect is avoided, and a simple oral dose may not be required when the drug is delivered transdermally.

Next week we will look at "To occlude or not to occlude�."

Announcements

The FDA Pharmacy Compounding Advisory Committee first meeting report is available at the following website: http://www.pharmacist.com/new-fda-pharmacy-compounding-advisory-committee-convenes-first-time

USP is looking for candidates for membership on the USP Expert Committee on Pharmaceutical Dosage Forms for the period 2015-2020 with expertise in viscosity/rheology applied to pharmaceutical dosage forms. Find all the details and register at: https://callforcandidates.usp.org/

The deadline is May 15, 2015; be sure to select DOSAGE FORMS expert committee.

News

FDA Making it Difficult for Compounding Pharmacies
The enhanced oversight that bolstered FDA authority is a double-edged sword. Hospitals, doctors, and patients may eventually have more confidence in compounded medications, but, in the meantime, costs and red tape have increased. A new batch of proposed guidelines issued by the FDA last week has set off another round of anguish. While the FDA maintains the guidelines are "critical to protecting public health," a compounding pharmacist argues "the FDA is trying to punish success. These guidelines impose a lot of onerous restrictions, and limiting good compounding pharmacies only hurts patients and their access to medications."
http://blogs.wsj.com/pharmalot/2015/02/20/compound-pharmacies-complain-fda-is-compounding-their-problems/

Medical Company Indicted
The federal government has unsealed a 37-count indictment charging Med Prep Consulting Inc. with wire fraud and violations of the FDCA. Med Prep, based in Tinton Falls, New Jersey, together with its owner and president, Gerald Tighe, and pharmacist-in-charge, Stephen Kalinoski, allegedly introduced adulterated and misbranded drugs into commerce and misbranded drugs with the intent to defraud and mislead the FDA and Med Prep's customers, who consisted of hospitals and other healthcare providers.

The indictment states that Med Prep processed numerous drugs-including oncology and dialysis drugs, pain medications, anesthesia drugs, and operating room drugs-in "supposed" sterile conditions. To gain market share, Med Prep repeatedly misrepresented to its healthcare provider customers that it adhered to, and in some areas exceeded, industry standards and laws applicable to sterile-drug preparation. However, the facility fell far short of standards of cleanliness, creating a risk to the health of already ill patients, and lied to healthcare providers about their failures to comply with basic sterility practices. The report includes grotesque examples of a Med Prep employee with untreated eczema working in the cleanroom and a syringe sold to a Florida clinic containing "particles that looked like cottage cheese."
http://www.brooklyneagle.com/articles/2015/2/20/medical-company-indicted-charges-fraud-criminal-violations-food-and-drug-act

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Did You Know ...

�that pharmacists have been associated with cosmetics throughout history? IJPC has now began posting formulas for many types of cosmetics on www.CompoundingToday.com. When entering the "Formulas" area, there are now three options:

1. Regular Formulas (Documented)
2. Named Formulas (Undocumented)
3. Cosmetic Formulas

Tip of the Week

Pharmacists are receiving more and more requests to prepare cosmetics because of allergies or sensitivities to preservatives, dyes, and fragrances and for the purpose of incorporating active medications into commercially available cosmetics. Do your patients know they have this option?

Looking Back

The rough and tough,
From wind and wave,
Your cheek
Grows sleek with,
     Burma Shave