Clinical pharmaceutics is the application of the unique knowledge base in pharmaceutics to patients and to clinical situations. A drug is simply a chemical substance until it is incorporated into a form that can be administered to a patient; the dosage form. A compounder/formulator should be well aware of the fact that almost anything placed into the "dosage form" can alter the clinical result when administered to a patient. Inherent in formulating/compounding a drug dosage form are the following considerations of both APIs and Excipients in dosage forms that should be addressed, as they can affect both the clinical response and cause adverse events.

• Adsorption/Adhesion
• Buffer Capacity
• Colligative Properties
• Complex Organic Molecules
• Crystallinity
• Dosage Form Selection and Properties
• Endotoxin Calculations/Levels
• Hydrates and Solvates
• Melting Point
• Organic Salts and Esters
• Particle Size and Surface Area
• Partition Coefficient
• pH
• pKa/Dissociation Constant
• Potency Designations
• Precipitation
• Preservation
• Rate Reactions
• Rheology/Viscosity
• Sedimentation
• Solubility
• Surface Tension/Wetting

We will look at examples, both positive and negative, of how the above considerations have resulted in change(s) in patient responses from the formulation. Next week, we will look at the effect of a change in diluent in phenytoin capsules and the resulting phenytoin intoxication in patients.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Regulatory Creep at the FDA
The FDA is broken and many have advocated for significant changes, if not its complete elimination or makeover. There is a need for rules, policies, and a level playing field for all drug, biologics, and device innovators; norms and standards are required, as are audits and inspections, particularly of foreign manufacturers. There have been historical instances where the FDA has worked well, so it is possible.

However, an insidious disease has settled-in over the years, and it has caused regulatory creep; the FDA has become increasingly more powerful and with that power, it has come to believe that it can impose medical utopia on the citizens. The FDA thinks that it can change the laws of human learning and behavior with respect to new medical products. There is a belief that the "all-powerful" U.S. government can create an idealized medical world that solves all problems has taken root. This, we know, is not true.
http://thehill.com/blogs/congress-blog/healthcare/218237-regulatory-creep-can-be-defeated-by-leadership

Drug Shortages Continue Despite FDA's Best Efforts
A sharp reduction in new shortages doesn't keep the total number of drug shortages from increasing. The number of new drug shortages in the U.S. has fallen dramatically during the last few years. However, the total number of shortages continues to grow, leaving doctors to figure out how to change treatment plans when medications are unavailable.

As a Government Accountability Office (GAO) recent report pointed out, while the growth has slowed, the total number of drug shortages has gotten larger every year since 2007. It reached 288 through June of last year. There were 456 active shortages during 2012, made up of 195 new shortages, and 261 shortages that began before 2012 but remained ongoing at least some period of time in 2012.

One of the problems is that many of the generic sterile injectable drugs are low-margin products made at old plants that are more prone to quality issues. Sometimes drug companies decide there is not enough profit in them to invest money into plant upgrades needed to keep producing. Recently, the FDA has been battling a shortage of saline solution; two of the producers had to recall saline last year because of particulate found in some of the products.
http://www.fiercepharma.com/story/drug-shortages-vex-us-despite-fdas-best-efforts/2014-02-11?utm_medium=nl&utm_source=internal

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Did You Know ...

...that we live today based upon the decisions we made yesterday?

Tip of the Week

Teach those in your "sphere of influence" to make good decisions today for a better life tomorrow.

Looking Back

If hugging on highways,
Is our sport,
Trade in your car,
For a davenport!
     Burma Shave

ACHC is pleased to announce that the following pharmacies have achieved PCAB Accreditation:

Auxilium Specialty Apothecary Pharmacy, Hattiesburg, Mississippi; April Malone, PharmD, aprilmccoy@hotmail.com. Initial Accreditation for Nonsterile Compounding

Coastal Compounding Pharmacy, West Palm Beach, Florida; Ephrem Degefu, RPh, mrefi@comcast.net. Initial Accreditation for Sterile and Nonsterile Compounding

Carolina Compounding and Nutritional Pharmacy, Charlotte, North Carolina; Kelvin Sloan, RPh, asloan@ccnprx.com. Initial Accreditation for Sterile and Nonsterile Compounding

Reliant Rx, LLC; Spokane, WA; Tammy Kroetch tammyk@reliantrxwa.com; Initial Accreditation for Sterile & Non-Sterile Compounding

Professional Compounding Pharmacists of Western Pennsylvania, Leechburg, Pennsylvania; Donald Williams, don@compoundingpros.com. Initial Accreditation for Nonsterile Compounding

Stonegate Pharmacy, Austin, Texas; Andres Ruiz, PharmD, andyruiz@stonegaterx.com. Initial Accreditation for Sterile and Nonsterile Compounding

All Care Pharmacy, Allen Park, Michigan; Indu Joshi, PhD, indu.joshi@gmail.com. Re-accreditation for Nonsterile Compounding

Rx3 Compounding Pharmacy, Chester, Virginia; Chris Currin, RPh, ckcurrin@yahoo.com. Initial Accreditation for Sterile and Nonsterile Compounding