Brought to you by the International Journal of Pharmaceutical Compounding
November 18, 2005 Volume 2, Issue 44
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  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.

Editorial: Acacia is Not Just Used in Drugs

I think that it is interesting that many of the ingredients used as excipients in pharmaceutical compounding or pharmaceutical products are "borrowed" from the food industry. The most common example would probably be sucrose, used in syrups, as a diluent, etc. You might be surprised, however, how much acacia is used.

There are many, many other examples besides acacia, including alginic acid, tannic acid, agar, brown algae, red algae, ammonium alginate, calcium alginate, corn silk, cuprous iodide, guar gum, carob bean gum, karaya gum, gum tragacanth, hydrogen peroxide, licorice, potassium alginate, and sodium alginate. It is interesting, and very informative, to read the labels of the foods you eat. You will probably be in "familiar territory."

Acacia, or Gum Arabic, is an official excipient used in pharmaceutical dosage forms. Acacia is a dried, gummy exudate from the stems and branches of Acacia Senegal (Linne) Willdenow or of other related African species of Acacia (Fam Leguminosae). Well, there goes those that don't like "natural products." For those who complain they don't get enough "chemistry", acacia consists primarily of calcium, magnesium, and potassium salts of the polysaccharide Arabic acid, which on acid hydrolysis yields L-arabinose, L-rhamnose, D-galactose, and D-glucuronic acid. It is insoluble in alcohol but almost completely soluble in twice its weight of water at room temperature; the resulting solution is acid to litmus.

Acacia is used as an emulsifying agent (10-20%), pastille base (10-30%), suspending agent (5-10%) and tablet binder (1-5%) as well as for other purposes. Did you also know that it is in many of the foods you eat?

Acacia has maximum usage levels in various food products as follows:

Beverages2.0%
Chewing gum 5.6%
Confections and frostings12.4%
Dairy product analogs1.3%
Fats and oils1.5%
Gelatins, puddings, and fillings2.5%
Hard candy and cough drops46.5%
Nuts and nut products8.3%
Quiescently frozen confection products 6.0%
Snack foods4.0%
Soft candy85.0%
All other food categories1.0%

The use of acacia in these products is generally as an emulsifier, flavoring agent, adjuvant, thickener, stabilizer, surface-finishing agent, and texturizer. The World Health Organization has not set an acceptable daily intake for acacia when used as a food additive because the levels necessary to achieve a desired effect were not considered to represent a hazard to health. You might remember that Acacia Mucilage is 35% acacia in water. It is recognized as a GRAS (Generally Recognized As Safe) ingredient in commercial products.

Incidentally, acacia is also used in cosmetics.


Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

 
Are You Missing Out?

There is a whole group of compounding pharmacists (1000+) the world over talking on the Compounders Network List. Here are some of the topics they discussed this week:

  • Information on Nitrogen Mustard topical preparation
  • Formulation for Transderm-Scop Patches due to backorder
  • Capsule counting machines
  • Canine itching treatments
Don't miss out next week. Join IJPC's CNL. It's free. It's easy. Click here: http://compoundingtoday.com/CNL/
 
Book Feature

Salt Your Way To Health, David Brownstein, M.D.
This is a no-nonsense easy to read book that befriends sea salt and elucidates the dramatic difference between refined table salt and unrefined sea salt. This powerful book is filled with common sense physiology and dispels the myths about salt. For a more complete review of this book, see CompoundingToday.com's Book Review Section.

 
Articles Added to CT.com focus on Endocrinologic Disorders

32 citations and abstracts were added to CompoundingToday.com's literature search database related to urogenital and sexual dysfunction in women. Below is a sampling of the articles added:

  • Chu MC, Lobo RA. Formulations and use of androgens in women. Mayo Clin Proc 2004; 79(4 Suppl): S3-S7.
  • Johnson CE, Berman JR. The role of androgens in hormone replacement therapy. Expert Opin Pharmacother 2005; 6(11): 1815-1831.
  • NAMS Board of Trustees. The role of testosterone therapy in postmenopausal women: Position statement of The North American Menopause Society. Menopause 2005; 12(5): 497-511.
  • Rivera-Woll LM, Papalia M, Davis SR et al. Androgen insufficiency in women: Diagnostic and therapeutic implications. Hum Reprod Update 2004; 10(5): 421-432.
  • Shifren JL, Braunstein GD, Simon JA et al. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med 2000; 343(10): 682-688.

 
CompoundingToday.com: The Resource for Compounding Information

CompoundingToday.com is the information center for compounding resources and references. Every day hundreds of pharmacists sign on and download information they need to fill prescriptions for their patients, answer questions from doctors and market their practices. They save time and money with CompoundingToday.com's quick click tools and data. Here are the top ten categories accessed and the number of downloads or hits in the past 30 days:

  • 3925 Formula Downloads
  • 1649 Standard Operating Procedures
  • 422 Abstracts and Citations
  • 199 Veterinary Transdermal Tool
  • 156 Compliance Articles (DEA, FDA, NIOSH, and USP)
  • 131 Preservative and Antioxidant Tool
  • 113 Flavoring Tool - Ancillary Agents in Masking Tastes
  • 102 Oral Vehicle Tool
  • 101 Patient Advisory Leaflets
  • 92 Flavoring Tool - Sweetening Agents

What do you need today?...
...whatever it is, you'll likely find it on CompoundingToday.com, like Standard Operating Procedures. There are now more than 300 SOPs that can be downloaded and customized for your pharmacy. Here are the top 10 SOPs downloaded from CompoundingToday.com in the last month:

  • 56 Cleaning and Disinfection
  • 29 Room Cleaning Procedures - Compounding Room
  • 23 Employment Information
  • 22 Documentation of Employee Training
  • 22 Geometric Dilution Pulverization by Intervention with Manual Mortar and Pestle
  • 22 Prescription Order Intake
  • 21 Room Cleaning Procedures - Clean Room
  • 20 Annual Controlled Substances Inventory
  • 20 Tacky Mat Maintenance
  • 17 Refrigerator Temperature Monitoring

 
Regulatory Update

This Regulatory Update has been provided by the International Academy of Compounding Pharmacists. For more information, www.iacprx.org.

Docket Update
There have been many recent postings on the dockets for the CHASM and Wyeth Citizens Petitions that call for increased FDA regulatory action around compounded respiratory and BHRT therapies. For notable filings and trends, as well as a listing of current content, click here.

 
Compounding Tip of the Week

Need an inexpensive black and white background for visual checking for particulate matter?
They are commercially available which would be the recommended source. However, if that is not an option, then take a 1' x 2' or 2' x 2' piece of Masonite and on the smooth surface, paint one-half of it flat white and the other half flat black. Mount it to a vertical flat surface (wall) with a fluorescent light immediately above it. Slowly and gently swirl the compounded preparation and observe it against both the black and white backgrounds; invert it, swirl it, and observe it again against both the black and white backgrounds. The size and arrangement can be varied to optimize the viewing process.

 
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