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

This week, we will look at the "dilution of creams and gels" issue.

Numerous topical and transdermal products are available in different strengths and formulations. Corticosteroids are formulated in lotions, pastes, gels, creams, and ointments in various strengths. It is sometimes necessary to reduce the dose used by either diluting the formulation or applying less to the involved area. Normally, dilution of creams and gels is not recommended since the stability of the formulation may be compromised, and there may be a risk of microbial contamination that may need to be considered if the formulations are applied to broken skin. Even though many creams and gels contain preservatives, the dilution of these may reduce the concentration of the preservative to less than that needed to be effective.

Despite these considerations, it is sometimes necessary to dilute a cream or gel. If so, one may consider limiting the dilution to no more than 1 in 10 and to not use any heat or not use excessive heat (keep less than ~50�C) in the process. If dilution is required, the "diluent" should be a similar cream or gel (or ointment vehicle as appropriate for ointment products) that is easily miscible with the formulation and one that is preserved, etc. Diluents may include oil-in-water creams, water-in-oil creams, gels, PEG-based semisolids, etc., as appropriate. Patient characteristics should be considered for allergies, etc. in selecting the diluent.

In summary, dilution of topicals and transdermals is not recommended but sometimes is necessary, and in those cases it should be done appropriately with due consideration to the diluent characteristics and patient requirements.

News

South Carolina College of Pharmacy—USC Campus Wins First Place at SPCC
The winner of the Fifth Annual National Student Pharmacist Compounding Competition held March 21-22 at the University of Florida, Gainesville, and sponsored by Medisca, was the South Carolina College of Pharmacy—USC Campus. The overall results are as follows:

Twenty colleges of pharmacy (the maximum number that can compete) participated in this year's event. Congratulations to all who participated, and we can't wait until next year!

Drugs Approved in Europe May Become Available in U.S. Faster
Legislation has been introduced to require the FDA to expedite the review and approval of pharmaceutical products already approved in Europe. The bill, Speeding Access to Already Approved Pharmaceutical Act, targets "drug lag"-the difference between when one product is approved and marketed in one country and when it is finally approved and marketed in subsequent countries. The FDA does approve between 66% and 74% of drugs before anywhere else in the world; however, a handful of drugs are approved elsewhere—including Europe—first. Elias Zerhouni, the former head of the National Institutes of Health (NIH) and now the head of research and development at Sanofi, stated in remarks made at the European Medicines Agency (EMA) on 18 March 2015, that a lack of regulatory consistency between regulatory bodies, including the FDA and the EMA, was baffling. "In my short experience of five years, I have not seen a single regulatory decision that was fully consistent across regulatory agencies," he said.
http://www.raps.org/Regulatory-Focus/News/2015/03/20/21778/Bill-Wants
-Drugs-Approved-in-Europe-to-be-Available-More-Quickly-to-US-Patients/

13 Observations Result from the FDA's Visit to a U.S. Sterile Manufacturer
In January, after 10 days at the contract manufacturer Pyramid Laboratories' Costa Mesa, California plant, the FDA issued 13 observations in a 483 related to the manufacturer's aseptic filling operations. The FDA posted the Form 483 publicly on its website last week. The problems included: a nonviable particle excursion which occurred in November in the company's Class 10,000 component preparation room; not properly training employees on visual inspection of injectable drugs and sterile biologics (new inspectors were held to a lower standard than experienced inspectors); failure to require a supplier to provide test results on endotoxin specifications for sodium acetate trihydrate crystals; and inspectors criticized Pyramid for failing to conduct some particulate monitoring during a shift. The Form 483 can be viewed at:
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobal
RegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom
/UCM438176.pdf

http://www.fiercepharmamanufacturing.com/story/us-sterile-manufacturer-racks-13-observations-fda-visit/2015-03-17

New Apple Watch Gets a Drug-Adherence App
Mango Health, a San Francisco, California-based company, is launching a new app on the Apple Watch. The app sends reminders to users to take their meds and gives them graphic feedback on how well they're complying with their drug regimens. Many companies, including the pharmaceutical industry, are trying to utilize mobile technology to keep patients on their medications.
http://www.fiercepharmamarketing.com/story/it-had-happen-apple-watch-gets-drug-adherence-app/2015-03-17

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Did You Know ...

...that the FDA continues to intrude on state's rights and physicians' treatment decisions by dictating what can and cannot be individualized for patient therapy?

Tip of the Week

With the low success rate of many governmental intrusions into private professional practices and individual state's issues, it is incumbent on professionals to join in the efforts to protect state's rights and patient treatment options!

Looking Back

These signs
We dedicate,
To men who've had
No date of late!
     Burma Shave