December 14, 2004 Volume 1, Issue 3
  In This Issue
  Resource Links
 
 
 
 
 
 
Letter from the Editor

  What is the therapeutic blood level for an ophthalmic? What is the therapeutic blood level for a vasoconstrictor nasal spray? What is the therapeutic blood level for a sublingual nitroglycerin tablet?

Throughout history, drugs have been studied by administering increasing doses and following the response of the patient to determine the dosage. In the last third of the 20th century, drug dosage and effect were related to blood levels. This was observed by measuring blood levels by available analytical techniques and the numbers provided a guide for many medications. As dissolution testing became a requirement, it was very convenient to relate blood levels from bioavailability studies to dissolution profiles of drugs.

Actually, the blood is not where most drugs �do their thing� but it has been convenient for the past 30 years. It is now time to go the next step and look at drug levels at the site of action, i.e., receptors, to correlate drug effect with drug concentration at the receptor sites. This will be the most accurate method of determining what dosage is required to produce a desired effect.

There have been many studies demonstrating therapeutic effectiveness with subtherapeutic blood levels but with positive and effective results. Why? Because therapeutic levels are most important at the receptor sites, not necessarily in the blood where the drug is being distributed throughout the entire body. We have now come to the point that we need to approach this topic scientifically and look at receptor or tissue levels as opposed to simply blood levels.

Compounding pharmacists are paving the way by working with physicians and demonstrating effective therapies using new and novel delivery systems that may or may not result in �therapeutic� blood levels but do effectively treat patients tens of thousands of times every day. Keep up the good work.

 
Regulatory Update
The International Academy of Compounding Pharmacists provided this regulatory update.

FDA Responds to IACP�s BET Amicus Brief

Last week, FDA responded to the Amicus Brief that IACP filed in the BET Pharm veterinary compounding case. For more information, visit: http://www.iacprx.org/elinks/12_08_04.html

IACP Unveils New Legislative and Regulatory Resource

SBA Replies to Pharmacists� Concerns about FDA Veterinary Policies IACP recently gave the "legislative updates" link on our website a fresh new face. There, you can find information from the former FDAMA compounding law to the current Vet CPG. Visit: http://www.iacprx.org/legislative/index.html.

 
On the IJPC Compounder's Network Listserv

This week on IJPC�s listserv, pharmacists discussed:

  • Folic Acid Suspension
  • Where can you obtain Cleanroom Design?
  • Listings of Ketoprofen Topical studies
  • Methimazole Suspension for a finicky cat
  • Magnesium Sulfate 20% Oral Solution

Abstracts added to CompoundingToday.com
  • Abdel-Rahman SM, Nahata MC. Stability of fumagillin in an extemporaneously prepared ophthalmic solution. Am J Health Syst Pharm 1999; 56(6): 547-550.
  • Anaizi NH, Swenson CF, Dentinger PJ. Stability of acetylcysteine in an extemporaneously compounded ophthalmic solution. Am J Health Syst Pharm 1997; 54(5): 549-553.
  • Avunduk AM, Avunduk MC, Varnell ED, Kaufman HE. The comparison of efficacies of topical corticosteroids and nonsteroidal anti-inflammatory drops on dry eye patients: A clinical and immunocytochemical study. Am J Ophthalmol 2003; 136(4): 593-602.
  • Barnes AR, Nash S. Stability of ceftazidime in a viscous eye drop formulation. J Clin Pharm Ther 1999; 24(4): 299-302.
  • Bertelmann E, Pleyer U. Immunomodulatory therapy in ophthalmology: Is there a place for topical application? Ophthalmologica 2004; 218(6): 359-367.
  • Bielory L. Ocular allergy and dry eye syndrome. Curr Opin Allergy Clin Immunol 2004; 4(5): 421-424.
  • Chung I, Buhr V. Topical ophthalmic drugs and the pediatric patient. Optometry 2000; 71(8): 511-518.
  • Davies NM. Biopharmaceutical considerations in topical ocular drug delivery. Clin Exp Pharmacol Physiol 2000; 27(7): 558-562.
  • Fechtner RD, Realini T. Fixed combinations of topical glaucoma medications. Curr Opin Ophthalmol 2004; 15(2): 132-135.
  • Fraunfelder FW. Ocular side effects from herbal medicines and nutritional supplements. Am J Ophthalmol 2004; 138(4): 639-647.
  • Fuhrman LC Jr, Stroman RT. Stability of vancomycin in an extemporaneously compounded ophthalmic solution. Am J Health Syst Pharm 1998; 55(13): 1386-1388.
  • Hamacher T, Schinzel M, Scholzel-Klatt A, Neff HM, Maier H, Schlaffer G, Beausencourt E, Jutte M, Scholz R, Lorger C, Stewart WC. Short-term efficacy and safety in glaucoma patients changed to the latanoprost 0.005%/timolol maleate 0.5% fixed combination from monotherapies and adjunctive therapies. Br J Ophthalmol 2004; 88(10): 1295-1298.
  • Hammond RW, Walker TP, McClung HF, Edmondson W. Extemporaneous preparation of antibiotic ophthalmic solutions. J Am Pharm Assoc (Wash) 1996; NS36(3): 206-209.
  • How TH, Loo WY, Yow KL, Lim LY, Chan EW, Ho PC, Chan SY. Stability of cefazolin sodium eye drops. J Clin Pharm Ther 1998; 23(1): 41-47.
  • Lallemand F, Felt-Baeyens O, Besseghir K, Behar-Cohen F, Gurny R. Cyclosporine A delivery to the eye: A pharmaceutical challenge. Eur J Pharm Biopharm 2003; 56(3): 307-318.
  • Levy Y, Zadok D. Systemic side effects of ophthalmic drops. Clin Pediatr (Phila) 2004; 43(1): 99-101.
  • Loftsson T, Stefansson E. Cyclodextrins in eye drop formulations: Enhanced topical delivery of corticosteroids to the eye. Acta Ophthalmol Scand 2002; 80(2): 144-150.
  • McBride HA, Martinez DR, Trang JM, Lander RD, Helms HA. Stability of gentamicin sulfate and tobramycin sulfate in extemporaneously prepared ophthalmic solutions at 8 degrees C. Am J Hosp Pharm 1991; 48(3): 507-509.
  • Nahata MC, Morosco RS, Leguire LE. Development of two stable oral suspensions of levodopa-carbidopa for children with amblyopia. J Pediatr Ophthalmol Strabismus 2000; 37(6): 333-337.
  • Nordmann JP, Auzanneau N, Ricard S, Berdeaux G. Vision related quality of life and topical glaucoma treatment side effects. Health Qual Life Outcomes 2003; 1(1): 75.
  • O'Brien PD, Collum LM. Dry eye: Diagnosis and current treatment strategies. Curr Allergy Asthma Rep 2004; 4(4): 314-319.
  • Perry HD, Donnenfeld ED. Dry eye diagnosis and management in 2004. Curr Opin Ophthalmol 2004; 15(4): 299-304.
  • Robin JS, Ellis PP. Ophthalmic ointments. Surv Ophthalmol 1978; 22(5): 335-340.
  • Schalnus R. Topical nonsteroidal anti-inflammatory therapy in ophthalmology. Ophthalmologica 2003; 217(2): 89-98.
  • Tamilvanan S, Benita S. The potential of lipid emulsion for ocular delivery of lipophilic drugs. Eur J Pharm Biopharm 2004; 58(2): 357-368.
  • Thomas PA. Current perspectives on ophthalmic mycoses. Clin Microbiol Rev 2003; 16(4): 730-797.
  • Tojo K. A pharmacokinetic model for ocular drug delivery. Chem Pharm Bull (Tokyo) 2004; 52(11): 1290-1294.
  • Tripathi RC, Tripathi BJ, Haggerty C. Drug-induced glaucomas: Mechanism and management. Drug Saf 2003; 26(11): 749-767.
  • Wilson CG. Topical drug delivery in the eye. Exp Eye Res 2004; 78(3): 737-743
  • Winfield AJ, Jessiman D, Williams A, Esakowitz L. A study of the causes of non-compliance by patients prescribed eyedrops. Br J Ophthalmol 1990; 74(8): 477-480.
  • Zhang W, Prausnitz MR, Edwards A. Model of transient drug diffusion across cornea. J Control Release 2004; 99(2): 241-258.
 
Compounding Pharmacy in the News
Burke's pharmacy denies lawsuit's claims of medication mix-up Published Sunday, December 5th, 2004

BEAUFORT -- Burke's Main Street Pharmacy has denied the major allegations in a lawsuit brought by a Hilton Head Island man who says he suffered permanent brain damage from a medication mix-up. The pharmacy agrees that it compounded and dispensed the prescription pain medication in February to the 43-year-old plaintiff, Christopher M. O'Leary, according to an answer filed Nov. 23. It also concedes that a doctor who was treating O'Leary contacted pharmacist David Burke with concerns about the medication, but it denied that Burke gave any assurances about it.

For full story,http://www.islandpacket.com/news/briefs/story/4273067p-4068099c.html

 
New Products

Gallipot Introduces New One-Step Suspension System
Gallipot is pleased to introduce a new one-step suspension system for converting active bulk powders and oral solid dosage forms to liquids. SyrSpend� SF�s Active Suspending Technology allows pharmacists to prepare suspensions for their patients in an easy and economical manner. The unique formulation of SyrSpend� SF allows a suspension to be made with a one-step process, saving time during compounding. Additionally, the formulation is pH buffered to maximize compatibility and has very low osmolality (<50 mOsmol), making it suitable for both young and elderly patients. SyrSpend� SF contains only one-fourth the calories found in other systems. Its design prevents caking of added ingredients, allowing better dispersion when shaken.

We are very pleased to bring SyrSpend� SF to compounding pharmacists because it provides several advantages in terms of flexibility, patient acceptance, compounding time, inventory and shelf space,� said Gallipot�s Gary Schneider. The product is available in both cherry and unflavored formulas, allowing pharmacists to flavor according to patient preference. The unflavored SyrSpend� SF Formula comes in both pint and gallon sizes, selling at $9.90 and $48.00. The SyrSpend� SF Cherry Formula is also available in pints and gallons, selling at $10.50 and $52.00 respectively. To order, call Gallipot at 1-800-423-6967 or via fax at 1-800-339-1596.

Visit www.gallipot.comfor more information.

 

EPS® Storage and Transport Products
Responding to its customers� needs, EPS®, Inc. has expanded its line of storage and transport items. In addition to its line of tote, emergency drug and refrigeration boxes, EPS has added� �Medication Exchange Bins for the efficient handling of IV bags. �Bulk Supply Tubs for large, unwieldy items. �Durable Stock Bins for transporting small products. �Autoclavable Instrument Trays for delicate instruments and supplies requiring special handling. �and Mobile Utility Workstation Carts to move work areas and supplies at the same time! or see the website:

For additional information, please contact info@medidose.com or see the website : www.medidose.com.