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February 8, 2019  |  Volume 16  |  Issue 6
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
Pharmaceutical Compounding Questions and Answers

Question: What is mean kinetic temperature (MKT) and how is it calculated? Are there software programs that can be used to calculate it?

Answer:

What it is:
Mean kinetic temperature is defined as "the single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures. It may be considered as an isothermal storage temperature that simulates the non-isothermal effects of storage temperature variations."

What it is not:
It is not a simple arithmetic mean; it differs in that higher temperatures are given greater weight in computing the average. Disproportionate weighting of higher temperature in a temperature series, according to MKT, gives proper recognition to the accelerated rate of thermal degradation of products at higher temperatures. It is not a perfect process, but it is the standard.

How is it calculated?:
The following can be used if the temperature readings are taken at the same time interval (i.e., every 24 hours).

Mean Kinetic Temperature Calculation

Where

  • TK is the mean kinetic temperature in degrees kelvin
  • ∆ H is the activation energy (in kJ)
  • R is the gas constant (in J mol-1 K-1)
  • T1 to Tn are the temperatures at each of the sample points in degrees kelvin
  • n is the number of sample time points.

Does it have to be done manually?
No, in fact, there are three basic ways to obtain the MKT from your temperature data, as follows:

  1. Manually for those of you that enjoy working with a calculator. (Difficult)
  2. Using an Excel Spreadsheet Calculator. (Medium)
  3. Using a commercial software package or device. (Easy)

Using the manual method, here are the steps to follow (from the Vacker resource below):

  1. Convert �C to kelvin by adding 273.15 to each reading.
  2. Calculate ∆H/(R � Temperature Reading). Delta H = 83.14472 kJ/mole & Gas Constant = 0.008314472 kJ/mole/degree.
  3. Calculate the sum of all results of Step 2.
  4. Divide the result of Step 3 by the number of readings.
  5. Calculate natural logarithm of the result in Step 4.
  6. Calculate the numerator Delta H divided by Gas Constant.
  7. Calculate result of Step 5 by result of Step 6.
  8. Convert kelvin to degree centigrade. This gives the MKT value.

Templates using the Excel spreadsheet can be downloaded from the Internet at no cost.

Also, the USP has a new proposed chapter titled "Using Mean Kinetic Temperature to Evaluate Temperature Excursions During Storage and Transportation" that is proposed to be in Pharmacopeial Forum 45(3): [May-Jun 2019].

Resources:
Dickson
https://www.dicksondata.com/blog/measure-mean-kinetic-temperature-excel-calculator-mkt-formula-download-free/

Vacker
https://www.temperaturemonitoringuae.com/how-to-calculate-mean-kinetic-temperature-mkt-in-excel/


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

Another Hospital Group to Aid in Alleviating Drug Shortages in the U.S.
Premier, a publicly traded company and purchasing organization primarily owned by healthcare providers, has announced the formation of ProvideGx to help its members obtain drugs that are constantly in short supply. ProvideGx has struck a deal with Baxter International to manufacture and supply injectables and will be available competitively to any health system or healthcare provider. A spokesperson said Premier has had "91 shortage drugs available through legacy programs," but metoprolol injection will be the first for the ProvideGx program.
https://www.fiercepharma.com/manufacturing/another-hospital-group-attacks-drug-shortages-and-says-blood-pressure-med-metoprolol

Amazon Has National Online Pharmacy Plans with New Licenses
Amazon's purchase of San Francisco-based online pharmacy startup PillPack last year represented a big step into the retail pharmacy space. Pillpack's Phoenix, Arizona facility has been granted nine additional state pharmacy licenses in the past two months, allowing that site to sell into other states. Now the combined company's effort to win approval for more pharmaceutical licenses hint at its larger ambitions.

The Arizona site now has active pharmacy licenses across 19 states with three applications pending. This is in addition to the company's mail-order facilities in Manchester, New Hampshire (which has licenses in 49 states), Miami, Florida (which has licenses in 45 states), and Austin, Texas (which has licenses in 43 states). Pillpack's New York location has licenses in only two states.
https://medcitynews.com/2019/02/amazon-hints-at-national-online-pharmacy-plans-with-new-licenses/

Johnson & Johnson Becomes First to Add Prices to Television Ads
Johnson & Johnson announced it will start adding the price of its medicines to television commercials by next month, becoming the first to respond to a call by President Donald Trump for price transparency of drugs advertised directly to consumers on TV. They said it will include both the list price of a product as well as the potential out-of-pocket costs that patients will pay. The move won swift praise from U.S. Health and Human Services Secretary Alex Azar.
https://www.reuters.com/article/us-johnson-johnson-advertising/jj-becomes-first-drugmaker-to-add-prices-to-television-ads-idUSKCN1PW2WL

The Centers for Disease Control and Prevention Say Children are Using too Much Toothpaste
Nearly 40 percent of kids age 3 to 6 use more toothpaste than recommended by dentists, a CDC study found. The CDC and the American Dental Association recommend that children in that age group should use no more than a pea-size amount of paste. Children younger than 3 should use only a smear, only the size of a rice grain.

Brushing with too much toothpaste can damage enamel because children could swallow too much fluoride while their teeth are developing, the CDC says. That can cause dental fluorosis, white marks, and discoloration of teeth.
https://www.usatoday.com/story/news/health/2019/02/04/children-using-too-much-toothpaste-unhealthy-cdc/2766121002/

 

Did You Know ...

�that the following has been said?:

"Why worry? If you've done the very best you can, worrying won't make it any better."

 

Tip of the Week

Why is it we expect the best from some, less than the best from others, and very little from a few? There are many factors involved in whether or not an individual becomes what might be called "successful." However, if one has properly prepared, performed correctly and completely, and accomplished what was expected, then they should consider that they have been successful. Success takes preparation, hard work, and responsibility. Unless of course, one desires to be successful at doing nothing!

 

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Looking Back

Jonah took no brush
To mop his face,
Where Jonah went,
He needed space!
     Burma Shave

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