Production:
 
Pilocarpin hydrochloride 250mg (two hundred and fifty milligrams)
Dissolve in Glandomed®   500ml
Ad hydrochloric acid 10%    2,0ml  for pH adjustment
 
 
 
Analysis:
 
The pH for the ready to use solution is about pH 6.5 to 7.0
The examination of the pH value with the pH indicator paper MERCK (pH 1-10) is sufficiently exact.
 
 
Stability

was examined by Klaus Schmelzer by means of HPLC. The stability after 4 weeks storage at room temperature is approxamitly 88%. It ist recommended to use the solution four weeks ater preparation. The degradation product of pilocarpine is ineffective.

 
Application:
 
This solution serves to stimulate the salivary glands of patients with dry mouth due to radiation for head neck cancer or a combined radio/chemotherapy. the rinse is effective if parts of the salivary glands are intact. If there is no noticeable salivary flow after one or two weeks of application the rinsing with pilocarpine could be stopped.
 
The rinsing can take place 3 times a day with 10 to 15 milliliters (= 5.0 to 7.5 mg Pilocarpine hydrochloride). Keep the solution 2 minutes in your mouth and then spit it out. Do not drink it. For reasons of the toxcity the bottles are to be provided with a child-safe catch.
 
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Customers information:
 
Pilocarpine - Glandomed 0,05%
 
HPLC - protocol
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