Parmaceutical Drug Analysis (Stability Study, Drug Verification)

The efficacy of a pharmaceutically prepared drug(s) maybe called into question if it doesn't react once administered to the individual.  It may contain the correct type of drug, however, with a lower than the target concentration. It can be surmise that the drug was tampered, or simply degradation of the compound has occurred.  If the former is the case, usually the drug is replaced with an un-reactive substance say saline, etc. or perhaps the correct amount of drug was not added so that the solution is diluted.  If the latter is considered, then a stability study of the drug is important.

1. Verification

    Analysis of a commercially or pharmaceutically prepared drug is an important task to determine if the drug prepared drug solution contains the correct concentration and type of drug.  The drug solution could be questionable if after administration, the individual is unresponsive to the medication. 
   
Toxicological testing of drugs is also available on other fluids other than the more common blood, serum, or urine, and solids. These include CSF, Stool, Saline, IV Solution, etc. Typical specimen requirements are minimum of 2 mls (liquid) and/or 2 gr (solid). If this is not available, we will work with what you provide us.  Most test can be done on a Stat basis. If available, please provide us with as much information as possible about the case (i.e. suspected drugs, amount, etc.).  Base fees for Corporate, Institution/Organization ONLY.


2. Stability Study

    This is an important task to determine the length of drug stability so that drug disposable and inventory can be manage more efficiently.  This can be a great savings, especially in this times of economic hardships where wasting a good product can be reduced if not altogether avoided.
   
A drug study can be done in many ways.   As an example, University Hospital Pharmacy needs to determine the concentration of Morphine with an initial drug of concentration  of 50 mg/ml over a period of time say 6 months.  They decided to conduct this study, because of raised concerns of the disposal of Morphine, in which it is disposed after 48 hrs. at room temperature after it is prepared by the pharmacy technician.  The Pharmacy prepared over 5000, 100 ml solution of Morphine everyday, and out 5000 approximately 12 % or 600 solutions worth over $75,000.00 are disposed because of reduced concentration after 48 hrs., that may not be effective when administered.
    The following is an example scenario for determining the length of time Morphine diminishes in concentration at 50 mg/ml every 5 days for 90 days.  The protocol calls for disposal of the drug solution when the concentration reduces to 10 %.
   
From the data below, the day at which the concentration is reduced by 10 % or 45 mg/ml is at 45 days.  So from this study, Morphine solution is good for 45 days.  A great savings for the Pharmacy in avoiding wasting a perfectly good solution.
   
Of course, the study can be done in any way that you
feel is best for your facility.  We will try to accommodate your needs and work with you in your study

Table 1 Drug concentration versus time
Time (day) Concentration (mg/ml Time (day) Concentration (mg/ml
0 50.0 45 45.1
5 49.8 50 44.7
10 49.5 55 44.2
15 49.2 60 43.5
20 49.0 65 41.4
25 48.7 70 38.5
30 48.5 75 35.2
35 48.3. 80 33.0
40 47.8 85 28.0

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