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Wrong Suppository Vehicle Results in Seizures
The same dosage of a drug can be administered but can vary significantly in its rate of absorption, distribution, etc. when formulated into different preparations. For example, a teenager with epilepsy was prescribed diazepam 10-mg suppositories. It was compounded using the diazepam powder and cocoa butter as the vehicle. However, the teen has been to the emergency room twice with uncontrolled seizures, even after using the suppositories in an effort to try to bring the seizures under control.
Note: Cocoa butter is a fatty acid base and diazepam is a lipophilic or fat-soluble drug. When diazepam is placed in a cocoa butter base and administered rectally, the cocoa butter base melts and the diazepam has a much greater tendency to reside in the melted cocoa butter than to partition into the aqueous mucosal fluids and diffuse to the membrane wall for absorption. In this situation, the suppository should be reformulated using a water soluble base, such as polyethylene glycol. When the polyethylene glycol base dissolves in the aqueous mucosal fluids, the diazepam will disperse and come into greater contact with the membrane wall and be available for absorption.
In fact, there is a product called Diastat, which is a rectal gel composed of 5 mg/mL diazepam, propylene glycol, ethyl alcohol (10%), hydroxypropyl methylcellulose, sodium benzoate, benzyl alcohol (1.5%), benzoic acid, and water. This product should function in a similar manner by spreading out over the mucosal fluids and mixing with them providing good contact with the membrane for absorption.
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
Pharmaceutical Industry Spends More on Marketing than on Research
Think about the following industry: (1) It generates higher profit margins than any other and is no stranger to multi-billion dollar fines for malpractice, and (2) it has widespread accusations of collusion and over charging. It is interesting that this industry is responsible for the development of medicines to save lives and alleviate suffering, not the generation of profit for its own sake. It is also interesting that pharmaceutical companies have developed the vast majority of medicines known to humankind and have profited handsomely from doing so, even though it is not always by legitimate means.
Pfizer, the world's largest drug company by pharmaceutical revenue, made a 42% profit margin. Last year, five pharmaceutical companies made a profit margin of 20% or more. Is profiteering involved? With some drugs costing upwards of $100,000 for a full course, and with the cost of manufacturing just a tiny fraction of this, it's not hard to see why they are so profitable. Drug companies justify the high prices they charge by arguing that their research and development costs are huge. However, the data shows that drug companies spend far more on marketing drugs—in some cases twice as much—than on developing them.
No wonder, then, that the World Health Organization (WHO) has talked of the "inherent conflict" between the legitimate business goals of the drug companies and the medical and social needs of the wider public.
http://www.bbc.com/news/business-28212223
Why Are Generic Drug Prices Increasing?
Originally, generic drugs were supposed to save Americans millions of dollars, but today some cost as much or more than brand-name drugs. The increase in prices has some congressmen shocked, and they're joining doctors, pharmacists, and patients in asking why. Examples include two generic drugs, including Simvastatin for high cholesterol and amlodipine for high blood pressure, with an increase in total cost that has tripled from $45 to $140 per month; an ointment for eczema and psoriasis is another example which used to cost $10 for an entire tube and now costs $300.
http://chicago.cbslocal.com/2014/10/31/prices-soar-for-some-generic-drugs-why/
Ebola Treatment Clinical Trials and Placebos
FDA Assistant Commissioner Dr. Luciana Borio is troubled by European Ebola-trial plans that lack a placebo group. A European consortium, made up of European universities and medical groups, plans to give experimental drugs to West African Ebola patients without assigning some to a placebo group; this has touched off an intense trans-Atlantic quarrel over what is ethical and effective in treating the virus.
The academic and medical groups in the U.K. and France, the Wellcome Trust, Doctors Without Borders, and Institut Pasteur of France, have decided to give the drugs to sick African patients without randomly assigning other patients to a control group not getting the medicines. The rationale is that in a ghastly epidemic, it is unethical to hold back treatment from anyone. This has put them at odds with senior US officials at the FDA and NIH in the US.
http://online.wsj.com/articles/plan-to-offer-ebola-drugs-without-clinical-trials-draws-fire-1414713563
FDA Regulatory Requirements Increasing
Working as a US regulatory professional is difficult, as there are thousands of regulations to understand, scientific knowledge to know, colleagues to convince, and regulators to placate. And now new data supports a commonly held belief that the job really is getting more difficult every year. According to recent data, the number of regulatory requirements imposed by the US FDA increased by 15% between the years 2000 and 2012. Formerly, regulatory professionals working with the FDA needed to know just 16,329 requirements in 2000; in 2012 they needed to know 18,777, according to the data.
http://www.raps.org/Regulatory-Focus/News/2014/10/30/20656/Its-Not-Just-You-FDA-Regulatory-Requirements-Really-Are-Increasing/
India's Drug Company Profit Plunges from US Export Bans
Wockhardt Ltd., an Indian generic drugmaker, reported a 97% drop in quarterly net profit, as regulatory bans on the company's manufacturing plants in India due to poor production processes hit sales in the US, its largest market. Last year, the US FDA banned two of Wockhardt's major manufacturing plants from exporting to the US after finding manufacturing quality violations there. Also, in May of this year, Wockhardt said the FDA had also expressed concerns over production processes at its Chicago-based Morton Grove Pharmaceuticals unit, which accounts for more than 50% of Wockhardt's sales in the US.
http://www.reuters.com/article/2014/11/03/wockhardt-results-idUSL4N0ST36220141103
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