Patent Continuation: Room Temperature [Technosphere] Powder

[mnholdem]

Application Number: 14750840 Application Date: 18.07.2014 
Publication Number: 3021834 Publication Date: 25.05.2016 
Publication Kind : A1  
PCT Reference: Application Number:US2014047304 ; Publication Number: Click to see the data 

IPC:
A61K 9/00
A61K 31/395

Applicants: MANNKIND CORP

Inventors:

 FABIO KARINE
GUARNERI JOSEPH J
CURLEY KIERAN
GRANT MARSHALL L
LEONE-BAY ANDREA

Priority Data:

201361847981 18.07.2013 US
2014047304 18.07.2014 US

Title:

(FR) COMPOSITIONS PHARMACEUTIQUES EN POUDRE SÈCHE STABLES À LA CHALEUR ET PROCÉDÉS
(EN) HEAT-STABLE DRY POWDER PHARMACEUTICAL COMPOSITIONS AND METHODS
(DE) HITZESTABILE PHARMAZEUTISCHE TROCKENPULVERZUSAMMENSETZUNGEN UND VERFAHREN

Abstract:

(FR) L'invention concerne des poudres sèches stables à la chaleur qui comprennent des peptides ou une protéine comme l'oxytocine, destinées à être utilisées comme composition pharmaceutique. La composition est très stable aux températures élevées et dans des environnements à humidité relativement élevée et sont destinées à être stockées à température ambiante avec une durée de vie en stockage améliorée. En particulier, les poudres sèches sont destinées à l'inhalation, mais cependant d'autres voies d'administration peuvent être utilisées après reconstitution en solution.
(EN) Disclosed herein are heat-stable dry powders which include peptides or protein such as oxytocin for use as a pharmaceutical composition. The composition is highly stable at increased temperatures and relatively high humid environments, and are intended for storage at room temperature with an improved shelf-life. In particular, the dry powders are intended for inhalation, however, other routes of administration can be used when reconstituted in solution.

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Source: patentscope.wipo.int/search/en/detail.jsf?docId=EP173660217&recNum=1&maxRec=762&office=&prevFilter=&sortOption=Pub+Date+Desc&queryString=FP%3A%28mannkind%29&tab=NationalBiblio

NOTE: Additional information is available via links located on the documents page.

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Is it true that Afrezza can be safely stored at room temperature, but that the FDA would not allow that to be put on the label?  I recall that there was a discussion on this a few years ago...

[peppy]

Afrezza Extreme Storage challenge

afrezzadownunder.com/

During the early stages of Afrezza’s development, it was claimed that it could go without refrigeration for more than two months. However, the packaging instead says to only store at room temperature for 10 days. This extreme test goes 16x longer than the labelling to see how it still performs.

Since starting on Afrezza I have been wondering if Afrezza really does require refrigeration. As you will see in the video, where I stored the insulin was certainly much warmer than average room temperature.

[suebeeee1]

Yep...have only rarely refrigerated. No loss in effect!

[matt]

All drug regulators require extensive testing on molecular stability under a range of conditions (light, temperature, humidity, etc.) and times (3 mo, 6 mo, 1 yr, 2 yrs, 3 yrs are typical). Those test results make their way into the label copy and expiration dating. I suspect that if all MNKD could prove was two months stability, FDA would have required two month expiration dating which would be a nightmare for the distribution channel to manage. Most drugs can withstand considerably more abuse than implied on the label and expiration dating, but you never know what the real limits are unless you are the person doing the testing.

The FDA defines "room temperature" to be 20-25 degrees Celsius (about 68-77F) with brief excursions within a range of 15-30C (59-86F) and very brief exposure to 40C(104F). "Refrigerated" means 2-8C (36-46F). Most long-term stability testing for room temperature profiling is done at 25C +/- 2C and 60% humidity so I suspect Afrezza had stability issues under those conditions. It may be that the drug can handle that temperature but the powder formulation cannot withstand the humidity; refrigeration removes humidity so that may be the reason for specifying storage in the refrigerator after 10 days.