Changing Salt-Ester Form for Compliance (Taste)

You have been asked to prepare an oral erythromycin dosage form for a child. You look up the information and find the following:

Erythromycin occurs as a white or slightly yellow, odorless or practically odorless, bitter, crystalline powder. The drug has a solubility of approximately 1 mg/mL in water and is soluble in alcohol.

The bitter taste is going to cause an issue with the child so you look for other options and find the following:

Erythromycin estolate, the sodium lauryl sulfate salt of the propionate ester of erythromycin, occurs as a white, odorless or practically odorless, practically tasteless, crystalline powder. The drug is practically insoluble in water and has a solubility of approximately 50 mg/mL in alcohol.

It becomes apparent that the estolate form of erythromycin would be a good choice because it is practically tasteless and is insoluble in water. You know that keeping a drug in suspension rather than in solution will decrease its taste.

Upon further investigation, you also find the following:

Erythromycin ethylsuccinate occurs as a white or slightly yellow, odorless or practically odorless, practically tasteless, crystalline powder that is very slightly soluble in water and freely soluble in alcohol and soluble in polyethylene glycol.

With this information at hand, one has the decision to select the erythromycin estolate or the erythromycin ethylsuccinate as the form of erythromycin to use. Either one can be used to effectively produce an acceptable-tasting suspension of the drug. The molecular weights of the different forms (erythromycin 733.93; erythromycin estolate 1056.39) will need to be considered to deliver the required dose of erythromycin. Due to the different absorption characteristics of erythromycin ethylsuccinate, the equivalent of erythromycin 250 mg is erythromycin ethylsuccinate 400 mg. The next step is to formulate a good-tasting and stable suspension of the drug for the patient.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Physicians Wined and Dined Excessively
Previously secret details of a lawsuit have been unsealed by a federal judge; the lawsuit was filed by the city of Chicago against five manufacturers of opioid analgesics. This additional information details the amounts the companies paid to doctors to promote their drugs and how they wined and dined potential prescribers. Some of the companies even influenced treatment guidelines that were written by medical organizations; these efforts allegedly included spending hundreds of thousands of dollars to underwrite favorable publications about the use of these potent analgesics.

The new details include spending by the companies on speakers programs. Cephalon, a subsidiary of Teva, spent $6 million on speakers programs to promote its drug Fentora when it launched in 2007. Janssen Pharmaceuticals spent almost $200,000 on speakers programs in Chicago from 2009 to 2013 to promote Nucynta ER, the lawsuit alleges. Endo spent almost $4 million in 2008 to promote 1,000 speaker programs across the country.
http://www.businessweek.com/articles/2014-11-14/drug-companies-didnt-want-you-to-see-allegations-of-lavish-spending

Generic Execs Face Potential Criminal Charges in Pricing Probe
After months of expressing discontent about generic drug price hikes, the U.S. Senate is hauling drugmakers to a hearing. Even though companies face an interrogation spotlight there, speakers won't be arrested there. The real threat lies at the Department of Justice (DOJ), which is likely considering criminal prosecution for price-fixing and other antitrust violations.

Two generic drugmakers—Lannett and Impax Laboratories—recently disclosed that employees had received grand jury subpoenas from the Justice Department, demanding any information on pricing discussions with their competitors. Even though civil antitrust probes in the pharma business are under the Federal Trade Commission (FTC), the DOJ handles civil claims in other industries-and all criminal antitrust violations.

Individuals involved in any price-fixing or anticompetitive activity could actually be prosecuted and might even face prison sentences. According to Law.com, the Sherman Act stipulates fines of up to $1 million and up to 10 years in prison.
http://www.fiercepharma.com/story/generics-makers-execs-face-potential-criminal-charges-us-pricing-probe/2014-11-17

$2.56 Billion to Develop a New Drug
It is reported to now cost $2.56 billion to bring a new drug to market; this is, on average, more than double the price of 11 years ago, according to a recent study. Reportedly, the higher cost comes from clinical trials that are larger and more complex, as well as more drugs that fail in development.
http://www.bloomberg.com/news/2014-11-18/cost-to-develop-a-drug-more-than-doubles-to-2-56-billion.html

FDA Sued by Ranbaxy for Revoking Approvals for Nexium and Valcyte Generics
Ranbaxy has sued the FDA for revoking approvals granted to launch generics of two drugs, including AstraZeneca's Nexium and Roche AG's Valcyte. The FDA told Ranbaxy that it believed its decisions to grant the company tentative approvals for copies of Nexium Valcyte were "in error," after it found that Ranbaxy's plants at the time were not compliant with the FDA's manufacturing quality standards. The FDA also acted to strip Ranbaxy of a six-month market exclusivity on the launch of generic Valcyte.
http://uk.reuters.com/article/2014/11/18/uk-ranbaxy-lab-fda-lawsuit-idUKKCN0J21EJ20141118

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Did You Know ...

�that with lying in the government, lying and partial-truth stories on the news media, lying on the Internet, lying in business, lying in advertising schemes, and lying in society, we are at the point that it is almost impossible to make solid decisions that affect us, our families, our business and our society?

Tip of the Week

Deal honestly with others. Check out everything before making an important decision based on data collected from others. Question everything!

Looking Back

Shaving brushes,
You'll soon see 'em,
Way down east,
In some museum!
     Burma Shave

ACHC is pleased to announce that the following pharmacy has achieved PCAB Accreditation:

Golden Gate Pharmacy, San Rafael, California; Erik Clausen, PharmD, MBA, erik.clausen@ggprx.com. Addition of Sterile Compounding to current Accreditation