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Question

Posted on: March 6 2013

A 70-year-old lady should take Plavix, but can't swallow those tablets.

Can I crush Plavix tablets 75 mg finely to make syrup? Does an extended operation nullify? How long will the beverage remain sustainable? < br/>

Answer

If I read the package leaflet, added to Plavix 75mg, I do not have the impression that there is talk of prolonged action, given the rapid absorption of clopidogrel. So the tablets can be traced to powder. With regard to the shelf life I have found two references in the literature.

In IJPC Vol 15, N ° 5, 2011: [Considering I have to do here with a secured PDF file I can not perform copy-paste operation but I send you the scan from the main page.] In AJHP Vol 67, N ° 7, 2010: Stability of an extemporaneously prepared clopidogrel oral suspension, Katherine L. Skillman, Regine L. Caruthers and Cary E. Johnson

Purpose The stability of an extemporaneously prepared Clopidogrel oral suspension was studied.

Methods Clopidogrel Oral Suspension (5mg/mL) was prepared using Clopidogrel bisulfate tablets, Ora-Plus, and Ora-Sweet. Six 2-oz samples were prepared; Three were stored at room temperature and three under refrigeration. One Milliliter was withdrawn from each sample, diluted to 10 mL with methanol, and exposed to high-frequency sound waves in a water bath to ensure complete dissolution of clopidogrel. A 300-Μl sample was then withdrawn, diluted with mobile phase to an expected concentration of 15 μg/mL, and assayed in duplicate using high-performance liquid chromatography immediately after preparation and at 7, 14, 28, and 60 days. The stability of the clopidogrel suspension was determined by calculating the percentage of the initial concentration remaining on each test day. Stability was defined as retention of at least 90% of the initial concentration.

Results AT Least 97% of the initial clopidogrel concentration remained throughout the 60-day study period, regardless of storage conditions. There were no detectable changes in color, odor, taste, or pH and no visible microbial growth in any sample. The preparation was palatable, with a slightly gritty consistency and a slightly bitter aftertaste; The bitterness intensified slightly between 28 and 60 days but remained fairly mild.

Conclusion Extemporaneously compounded suspensions of clopidogrel, 5mg/mL, in a 1:1 mixture of Ora-Plus and Ora-Sweet were stable for at least 60 days when stored in amber plastic bottles at room temperature and under refrigeration.

Decision:

May use a coffee mole to grind the tablets Use perhaps best 50% sorbitol syrup not crystallizable due to the somewhat bitter taste; Apply with a flavor if requested by the client; Use a shelf life of 28 days due to an increase in bitter taste after a retention period of 28 days. Store in refrigerator not necessary but can reduce bitterness.