Question: I keep hearing about “bracketed� stability studies. What are they and can they be used in compounding for stability studies? (Part I)

Answer:
Very definitely! Both “bracketing� and “matrixing� are being used in the pharmaceutical industry for determination of expiration dates and are also appropriate for compounding in determining beyond-use dates.

Bracketing is the design of a stability schedule such that at any time point only the samples on the extremes of certain design factors (e.g., strength, storage temperature, packaging, time) are tested at all time points as in a full design. The design assumes that the stability of the intermediate levels is represented by the extremes tested. If a range of strengths is to be tested, bracketing designs may be particularly applicable if the strengths are identical or very closely related in composition.

The use of a bracketing design would not be appropriate if it cannot be demonstrated that the strengths or container sizes and fills selected for testing are indeed the extremes. A very simple bracketing extreme can be illustrated by the following for 3 different strengths using 3 batches:

B = Batch; S = Strength; T = Tested; NT = Not Tested

Continued next week

REMINDER: For those State Boards of Pharmacy that are not adopting the USP chapters and are preparing their own or using their own modifications of the chapters, easily-modifiable alternative versions of Chapters <795>, <797>, and <800> have been prepared and are available as a free download for use by state boards of pharmacy to modify for their individual states at the following website.

      CompoundingToday.com

Pharmacists may wish to download and send to your state board of pharmacy for consideration.

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

Asthma Specialists Attack Return of Primatene Mist
Both the FDA approval process and clinical need are questioned in the commentary.

The recent FDA decision to put the metered-dose epinephrine inhaler Primatene Mist™ back on drugstore shelves was met with alarm by asthma specialists and respiratory health groups who warned that the move will place asthma patients at risk.

Pulled from the market in 2011, along with other asthma inhalers, due to environmental concerns about their ozone-depleting chlorofluorocarbon (CFC) propellants, a CFC-free version of the drug was approved last November for over-the-counter (OTC) sale -- despite objections from the American Thoracic Society (ATS), American Lung Association, and other health groups that the move could lead to suboptimal treatment and poorer asthma control if patients rely solely on the OTC medication to treat symptoms.
https://www.medpagetoday.com/allergyimmunology/asthma/80863

Did You Know ...

...that I received this cartoon on Common Sense from a good friend? We would like to share it with you in the TIP OF THE WEEK below.

Tip of the Week

IJPC Now on Facebook and Youtube

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

View our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/IJPCompounding.

Looking Back

Buy a jar,
Take it from me,
There’s so much in it,
The last half’s free!
     Burma-Shave