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Nitrofurantoin: Bigger Particle Size is Better!
Nitrofurantoin (Furadantin) has been available for the treatment of urinary tract infections (UTIs) since 1953. Its current uses include the treatment of uncomplicated UTIs and prophylaxis against UTIs in people prone to recurrent UTIs. Nausea, vomiting, and diarrhea occurred in an appreciable number of patients, related to the rapid absorption of the drug. A reduction in dosage or administration with food or milk lessened the incidence.
To address the issue, the manufacturer developed a macrocrystalline particle form (Macrodantin) that is more slowly absorbed than the microcrystalline form and is useful for patients who cannot tolerate the microcrystalline form. The absorption is slower and the excretion of Macrodantin is somewhat less, when the two are compared, leading to reduced incidence of GI intolerance with Macrodantin; this does not significantly reduce the clinical effectiveness.
Generally, the trend is to reduce particle size to enhance bioavailability, etc. in product development; however, this is a situation where increased particle size is better for patients. Another twist on this product next week.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
FDA Blunders on Addyi Approval
Millions of women are now hearing about the new "female Viagra," called Addyi, on television, in newspapers, on the radio, and all over the Internet. Without ever having to write a line of advertising copy, little Sprout Pharmaceuticals is being handed the world's biggest misleading advertising campaign for a new drug, it won't cost them a dime and the intense onslaught of shallow mainstream media attention can't be controlled by the FDA.
Calling Addyi a "female" or "pink" Viagra is the same kind of marketing abuse that would land the founders of Sprout right back into the same trouble they experienced when they hyped a testosterone therapy for men as a tonic for HIV. This is a regulatory failure of the worst kind.
http://www.fiercebiotech.com/story/fda-blundered-badly-addyi-approval/2015-08-19
Mylan Cited for Manufacturing Violations, Again!
In a couple of setbacks, Mylan has received an FDA warning over manufacturing concerns at three of its Indian plants. The warnings involve three facilities that Mylan acquired when it bought Indian sterile injectables firm Agila Specialties for $1.75 billion in 2013. The FDA inspected the following three pharmaceutical manufacturing facilities:
- Mylan Laboratories Limited OTL, Bangalore
- Agila Specialties Private Ltd., Bangalore
- Agila Specialties Private Ltd., Bangalore, Karnataka
At all three sites, the FDA identified significant violations of CGMPs causing the drug products to be adulterated. The FDA reviewed the firm's responses of August 29, 2014, October 27, 2014, and March 9, 2015 in detail and noted that they lack sufficient corrective actions.
http://www.pharmatimes.com/Article/15-08-19/Mylan_rapped_over_
manufacturing_violations.aspx
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/
ucm458363.htm
Interesting? Compounders Already Doing Combination Therapy!
If a safe, inexpensive, once-a-day dosage form could substantially reduce the risk of myocardial infarction (MI) or stroke, would people want it? Most would probably say yes. Back in 2003, it was proposed to combine 3 half-dose antihypertensive agents, an intermediate-dose statin, low-dose aspirin, and folic acid into a once per day "polypill" for primary and secondary prevention of cardiovascular disease. Back then, it was estimated that daily use by individuals aged 55 years or older could reduce the incidence of MI and stroke by more than 80%.
In the past 12 years, versions of the polypill have been successfully tested in several phase 2 (safety) studies and a few modest-sized phase 3 (efficacy) trials. The 4 drugs currently included in polypill have long histories of safe use, and all 4 are frequently prescribed individually in the U.S.; however, the FDA has not approved combining them in a single dosage unit.
http://jama.jamanetwork.com/article.aspx?articleid=2429454
Physicians Dissatisfied with Electronic Health Records
Do clinicians, physicians, nurses, and specialists actually using the software like electronic health records (EHRs) any more than they did five years ago? No, they do not, according to the results of a study published by the American Medical Association and the American College of Physicians' American EHR division. Physicians have grown increasingly dissatisfied with their EHRs software during the last five years. "While EHR systems have the promise of improving patient care and practice efficiency, we are not yet seeing those effects," said Shari Erickson, vice president of American College of Physicians.
http://www.healthcareitnews.com/news/doctors-ehrs-even-less-they-did-five-years-ago
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