Editorial: Quality Assurance of Special Hard Gelatin Capsules

Editor's Note: This is the sixth in a series of brief quality-assurance notes and reminders on different compounded dosage forms. Many of the testing methods can be done in-house and some may need to be outsourced; this is up to the individual pharmacist. However, a program of quality assurance is the responsibility of compounding pharmacists in all aspects of their practice.

Special hard gelatin capsules can include those that contain liquids, semisolids, and even some uniquely made or special composite semisolids. Example tests that can be used for quality-control assessment include the following:

• Weight-overall average weight
• Weight-individual weight variation
• Dissolution of capsule shell
• Disintegration/dissolution of capsule contents
• Active drug assay
• Physical appearance
• Color
• Uniformity
• Uniformity of extent of fill
• Closure integrity
• Leakage
• Physical stability (discoloration or other changes)

Depending upon the contents of the capsules and their physical form, some modifications to routine tests may be necessary. It is important to include appropriate standard operating procedures that describe in detail how to conduct these assessments as well as any modifications that have been made to them.

Source: Allen LV Jr. Standard operating procedure for quality assessment of special hard-gelatin capsules. IJPC 1999; 3(4): 312-313.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Healthcare News
The media has reported that America's healthcare bill is $2.5 trillion a year. That's $8,200 for every American. Healthcare industry officials have unveiled a plan to offer the government $2 trillion in cost reductions over 10 years ($200 billion per year). The industry executives are trying to make a deal now to help get coverage for all Americans in the hopes they can prevent legislation that would restrict their profitability in future years. For example, insurers want to avoid the creation of a government health plan that will directly compete with them to enroll middle-class workers and their families. Industry executives are worried that future requirements may include passing a cost-benefit test before they can win approval. Also, hospitals and doctors are concerned the government could dictate what they get paid to care for any patient, not only the elderly and the poor.

Editor's Notes: (1) At a $2.5 trillion annual costs and a savings of $200 billion posed by the pharmaceutical industry, that still leaves a cost of $2.3 trillion per year in annual costs); (2) Why is it that in all the media coverage about the new healthcare plan, "pharmacy" is not mentioned?
www.therapeuticsdaily.com/news/article.cfm?contentValue=1915200&contentType=Sentryarticle&channelID=33

Potential Problems with Proposed Solutions
The potential problems with the solutions submitted by the pharmaceutical industry are that the proposals are vague and none are enforceable. Also, none of the savings are guaranteed. Medical providers have a long record of avoiding fiscal constraints; the Medicare cost containment activities are an example. None of the groups at the White House can actually dictate prices to their members. Doctors and hospitals are basically free to charge what the market will bear. Also, there is no guarantee that any of the savings will be used to help cover uninsured Americans.
The ASHP Daily Briefing - Ashp_daily_briefing@ashp.custombriefings.com

Glaxo Purchases Generic Drug Manufacturer
GlaxoSmithKline is purchasing a 16% stake in South Africa's Aspen Pharmacare Holdings, giving Aspen the right to distribute Glaxo drugs in that country. In addition, Glaxo is transferring eight products and a factory in Germany to Aspen, and the company will have global distribution rights to these eight products.
www.therapeuticsdaily.com/news/article.cfm?contentValue=1915632&contentType=Sentryarticle&channelID=33

This week I (Editor-in-Chief) am participating in a program in Barcelona on Friday (May 15) sponsored by Fagron Iberica SAU. The program emphasizes pediatric and dermatological compounding with many different health professional speakers and attendees. Then, on to Amsterdam, where a presentation will be made on the current status of pharmaceutical compounding in the U.S.

�it was announced this week that the Social Security system is broke. In fact, even the reserves have previously been spent for other purposes. It has been stated that they will print more money that has no basis for its value!

Spend Your Hours Wisely
One hour of watching mindless television programs is either not productive or is counterproductive; whereas, one hour of learning something new or sharing your life with others brings dividends and is a great investment.