Affectors of Laboratory Results: Part VIII

This week, we will conclude our series on laboratory results by presenting a table of different analytical methods that can be used for different compounded dosage forms. This list is not exhaustive and simply provides various analytical methods that can be used in your quality control program. As is evident from this list, there are a number of analytical procedures that can be easily conducted in your pharmacy. In some pharmacies, the workload may be sufficient to actually hire an analytical chemist and/or microbiologist to conduct some of the intermediate level analyses. Keep in mind that if these are done �in-house�, quality control of the analytical department in your pharmacy applies as it does if the analyses are �outsourced�. It is critically important to select an analytical method that accomplishes the desired purpose.

Some of the analytical equipment involved is not really that expensive if amortized out over a period of a few years. Analytical equipment can range from less than a hundred dollars to $50,000 or more. Let�s look at an example. If an instrument is purchased that costs $6,000, then over five years, that is only about $100 per month and the likelihood is that more analyses will be conducted in-house than are outsourced. Most analytical equipment, if well maintained, calibrated, etc., will easily provide at least 5 to 10 years of useful service. If purchased used, it must be cleaned, calibrated and certified prior to use.

Analytical methods that can be reasonably performed in-house with some training include:

• Boiling point, Freezing Point, Melting Point
• Bubble Point Testing (Sterilizing Filters)
• Chromatography (Column, Paper, Thin-layer)
• Color change
• Density/Specific Gravity
• Gravimetric/Weighing
• Immunoassay (EMIT, ELISA, FIA, RIA kits)
• Ion selective electrodes
• Optical rotation (Polarimetry)
• Osmolality
• Particulates (Light-Dark Background)
• pH
• Polarography
• Precipitate formation
• Refractometry/Refractive index
• Viscosity change

Analytical methods that can be reasonably performed in-house with some training include:

• Chromatography, Gas (GC)
• Chromatography, High Performance Liquid Chromatography (HPLC)
• Spectroscopy, Flame emission and Atomic Absorption
• Spectroscopy, Infrared
• Spectroscopy, Ultraviolet/Visible, Fluorescence
• Thermal analysis

Methods other than those listed above should probably be left to the dedicated analytical laboratories. The following table provides suggested analytical methods for various dosage forms. Obviously, not all the tests must be performed on each compounded prescription, but a procedure should be in place for which ones are conducted and their frequency.

Next weeks CT.com Editorial will discuss compounding for office use. Don�t miss it!

Here is sampling of articles related to pain management added to www.compoundingtoday.com this week. Search �pain management� from http://compoundingtoday.com/articles/ and find hundreds more related to this topic.

• Anderson VC, Cooke B, Burchiel KJ. Intrathecal hydromorphone for chronic nonmalignant pain: A retrospective study. Pain Med 2001; 2(4): 287-297.
• Cooper JF, Thoma LA. Screening extemporaneously compounded intraspinal injections with the bacterial endotoxins test. Am J Health Syst Pharm 2002; 59(24): 2426-2433.
• Deer T, Chapple I, Classen A et al. Intrathecal drug delivery for treatment of chronic low back pain: Report from the National Outcomes Registry for Low Back Pain. Pain Med 2004; 5(1): 6-13.
• Hassenbusch SJ, Portenoy RK, Cousins M et al. Polyanalgesic Consensus Conference 2003: An update on the management of pain by intraspinal drug delivery�report of an expert panel. J Pain Symptom Manage 2004; 27(6): 540-563.
• Mercadente S. Cancer pain management in children. Palliat Med 2004; 18(7): 654-662
• Smith DE. Spinal opioids in the home and hospice setting. J Pain Symptom Manage 1990; 5(3): 175-182.

Adding a flavor to a medication to make it more palatable sounds pretty simple. However, the diversity of chemical structures and physicochemical properties of pharmaceuticals presents significant challenges to developing acceptable flavored products for human and veterinary patients. CompoundingToday.com's Flavoring Tool provides resource information on how to effectively prepare better tasting medication.

Sweetening agents are also key ingredients in compounding good tasting medication since many drugs are very bitter and others have a bad taste or odor. Flavoring a medication is not restricted to simply adding a flavoring agent. There are several critical points to be taken into consideration and at CT.com we do that for you.

Use the CT.com Flavor Tool to search by Veterinary Recommendations, which gives a list of animals and the preferred flavor for that animal. Search by General Recommendations Per Drug Class or by General Recommendations Based on Primary Tastes and Odors of Drugs. Searches can be done by Ancillary Agents in Masking Tastes such as fumeric acid and menthol or search by Sweetening Agents.

If you haven�t been to the Compounder�s Network Listserv (CNL), just in the past four days you�ve missed 64 postings from 40 different pharmacists from all over the world. Here are some of the topics up for discussion just this week:
� The negative article published in Drug Topics about compounding pharmacy � Sterility testing
� Where to get HRT dosage measuring spoons
� Compounding training
� PLOs made in chain pharmacies

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