Continuing our BCS topic, this week we will look at an extension of the BCS and the Biopharmaceutics Drug Disposition Classification System (BDDCS). The BDDCS was developed in 2005 incorporating the effects of food, absorptive transporters, efflux transporters, and routes of elimination on overall drug absorption and bioavailability for immediate-release oral dosage forms as it considers more than just permeability. The BDDCS classification system is described as:

A diagram of the BDDCS is as follows:

If additional information is added related to pharmacogenomics, the diagram becomes:

The BCS and BDDCS are complimentary and do not compete; they are classification systems that improve, simplify, and speed drug development. Although similar in classifying drugs into four categories using the same solubility criteria, they differ in the criteria for permeability and are used for different purposes; there is a very strong correlation between intestinal permeability rate and the extent of metabolism. In general, the classification of drugs between BCS and BDDCS differs only about 5% to 10%.

More on the BDDCS system next week.

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

Hospira Recalls Hydromorphone HCl Injection and Levophed - Lack of Sterility Assurance
Hospira is voluntarily recalling one lot of Hydromorphone HCI Injection, 2 mg/mL, and four lots of Levophed (Norepinephrine Bitartrate Injection USP) 4 mg/4 mL (1-mg/mL) Vials. This is due to a potential lack of sterility assurance resulting from the use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlerts
forHumanMedicalProducts/ucm574506.htm

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Did You Know ...

� that from the seat of a tractor:

• Timin' has a lot to do with the outcome of a rain dance?
• Always drink upstream from the herd?
• Lettin' the cat outta the bag is a whole lot easier then puttin' it back in?

Tip of the Week

In a committee meeting:

• Listen to others' opinions before expressing your own.
• Organize your opinions to counter those that are disagreeable using facts to support yours.
• Vivid examples can support your opinion and encourage others to remember them.
• Speak, reinforce, and introduce your opinion at critical points in a discussion and especially immediately prior to a vote or decision.
• As in the rain dance example above, timing is important!

Looking Back

The safest rule,
No ifs or buts,
Just drive like everyone
Else is nuts!!
     Burma Shave