Over the next several weeks, we will look at each BCS class in more detail and discuss associated compounding technologies. This week, we will look at Class 1, High Permeability, High Solubility drugs, which includes the following examples:

List of Class 1 Drugs

A list of Class 1 drugs gathered from several sources includes the following:

Compounding Considerations for Class 1 Drugs

• Class 1 drugs generally provide the least problems in compounding of all the classes. They are sufficiently soluble based on their dose, and they are highly permeable once in solution.
  
  
• The rate-limiting step is drug dissolution and, if dissolution is very rapid, then the gastric-emptying rate becomes the rate-determining step.
  
  
• For immediate-release dosage forms that dissolve very rapidly, the absorption rate will be controlled by the gastric-emptying rate and no correlation with dissolution rate is expected.
  
  
• Generally, these drugs will be good candidates for modified drug delivery if suitable pharmacokinetically and pharmacodynamically.
  
  
• If the situation requires a slower release rate, then hydrophilic gelling agents (cellulose derivatives) can be incorporated into the formulation.

Next week, we will look in more detail at Class 2.

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

Even though the report language asserts that FDA's current policy effectively banning office-use compounding goes against congressional intent, Upton and Bishop argue that compounders are using the report language to rewrite the legislative intent behind the Drug Quality and Security Act (DQSA).

Upton and Bishop state that "Four years after the enactment of the DQSA, and five years after the outbreak which led to nineteen fatalities in our districts, compounders are seeking to undo the 2013 Act. Congress must not allow this to happen."

IACP, which lobbied for the report language, argues that the provisions are "absolutely essential for protecting patient access" to compounded medicines. "We are grateful for all the Members of Congress that have shared constituent stories and statements during the FY 2018 Appropriations Full Committee markup in support of preserving patient access to these vital compounded medications. We are encouraged that Congress will continue to direct the FDA to act within Congressional intent to protect patient access to vital and often life-saving compounded medications," IACP told IHP in a statement.
https://insidehealthpolicy.com/

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Did You Know ...

"�that it looks like less than 15 state Boards of Pharmacy have adopted USP <800>? Most of the remaining states appear to be rewriting it to meet the needs of patients and pharmacies in their own states and some are holding further discussions.

Looking Back

Unless your face,
Is stinger free,
You'd better let,
Your honey be!
     Burma Shave