The Blurred Line Between "Topical" and "Transdermal", Part O
This week, we will continue with "Formulating for Successful Transdermal Delivery."
In continuing our discussion on formulating for a successful transdermal/topical preparation, we will look at two more general rules in addition to the two provided last week.
- Select an appropriate drug (see last week's newsletter)
- Drug flux considerations (see last week's newsletter)
- Maintain saturation for maximum delivery
The driving force for permeation is the thermodynamic activity of the API in the vehicle. Maximum flux is generally obtained with the drug saturated in the vehicle. So, the drug should be at its solubility limit at about 32�C. Drug depletion over time resulting in non-saturation can be addressed by adding a slight excess of drug in a suspended state.
- Possibly improve drug flux using formulation manipulation
Vehicles that aid in skin hydration and solvents that also contain penetration-enhancing properties can improve drug flux. Also, specific penetration-enhancing excipients can be added to formulation to enhance flux and the amount of drug delivered through the skin. There are many excipients that can be used but should be selected after considering compatibility and stability issues.
We will continue next week with the last two additional "general guidelines" for formulating a successful transdermal preparation.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
HAPPY MOTHER'S DAY
(Being a mother is the most important job in the world!)
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News
[What? Another one?]
NABP and United Compounding Management Announce a New Accreditation Program for Compounding Pharmacies
United Compounding Management ("UCM") announced a strategic partnership with the National Association of Boards of Pharmacy ("NABP") to enhance the process and standards of accreditation for compounding pharmacies. "NABP views its partnership with UCM as a leading effort to ensure the safety of patients receiving compounded products," said NABP Executive Director/Secretary Carmen A. Catizone, MS, RPh, DPh. "Since UCM's inception, we remain committed to our mission of delivering solutions to the marketplace that make quality compounding affordable and accessible," stated UCM CEO, David Ott.
http://www.businesswire.com/news/home/20150505005446/en/National-Association-Boards-Pharmacy-United-Compounding-Management#.VUzBbGfws5u
Drugmakers to Pledge More Transparency on Price
PHARMA companies, worried about a backlash over soaring drug prices, are increasingly talking with insurers in advance about paying for new therapies that could cost six figures a year. Biogen Inc., Amgen Inc., and Sanofi are aware and concerned over the negative attention Gilead Sciences Inc. received over hepatitis C cure Sovaldi, which surprised the industry in late 2013 with its cost -- $84,000 for 12 weeks of treatment. This price had the U.S. House calling for an explanation. Biogen and Amgen are talking with insurers and Sanofi is considering how to work with insurers to determine how pricey gene therapies get paid for. Last week, Gilead reported that 210,000 U.S. patients have started its treatments for the liver disease since December 2013, and that at least 250,000 will begin this year. U.S. drug spending rose 13% last year, the fastest rate in more than a decade.
http://www.bloomberg.com/news/articles/2015-05-04/gilead-s-gaffe-leads-drugmakers-to-pledge-more-openness-on-price
5 New Diet Drugs with Serious Side Effects Approved by FDA
After spending $60 million on lobbying, the FDA, which had a 13-year history of rejecting new diet drugs, has approved five new diet products with potentially serious side effects, including suicidal thoughts and increased cancer risk. The drugs include Belviq (lorcaserin), Qsymia (phentermine and topiramate), Contrave (bupropion and naltrexone), Saxenda (liraglutide), and Vyvanse (lisdexamfetamine dimesylate).
http://www.huffingtonpost.com/2015/05/06/fda-diet-drugs_n_7214948.html
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