| DOI: https://doi.org/10.14456/mujps.2015.16 | Pharm Sci Asia 2015; 42(3), 126-134 |
Chemical and physical stability investigations of captopril extemporaneous suspension for oral administrationN. Sathapanapitagkit1, M. Prokati1, J. Leanpolchareanchai1,2, D. Chantasart1,2, M. Laohajeeraphan3, J. Suksiriworapong1,2*
1 Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand
2 Center of Excellence in Innovative Drug Delivery and Nanomedicine, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand
3 Pharmacy Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Captopril is frequently used for hypertension and heart failure in pediatrics. In Thailand, no captopril liquid formulation is available because of its instability. The aim of our study was to develop the physically and chemically stable captopril extemporaneous suspension. The captopril suspension was prepared by grinding captopril tablets and triturating with syrup 80% w/v to the desired volume resulting in 1 mg/mL captopril suspension. For the formulations containing stabilizers, citric acid 2% w/v, vitamin C tablets 4 and 5 mg/mL were triturated with the ground captopril tablet before mixing with the vehicle. All formulations were kept in amber bottles at 2-8oC for 90 days and 30oC for 60 days. At each time point, the appearance, pH and number of redispersibility were evaluated for the physical stability. For the chemical stability, the amounts of captopril and dimer were quantified. The addition of vitamin C increased the number of redispersibility and minimally lowered the pH of formulations. Citric acid decreased the pH of formulation from 4.53-4.67 to 2.50-2.80. As the storage time increased, the number of redispersibility and the dimer content increased while the captopril amount reduced. The increased concentration of vitamin C had no effect on the stability. Obviously, the increasing storage temperature decreased the chemical stability. At 2-8?C, the addition of all stabilizers could preserve the amount of captopril over 90% for 90 days whereas the drug in the formulation without stabilizer remained over 90% for 74 days. At 30?C, the drug content was less than 90% after 28 days.
Keyword:
Captopril, Extemporaneous preparation, Stabilizer, Suspension, Syrup
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