Abstract
The present study describes the development and validation of a dissolution method for carvedilol compression-coated tablets. Dissolution test was performed using a TDT-06T dissolution apparatus. Based on the physiological conditions of the body, 0.1N hydrochloric acid was used as dissolution medium and release was monitored for 2 hours to verify the immediate release pattern of the drug in acidic pH, followed by pH 6.8 in citric-phosphate buffer for 22 hours, to simulate a sustained release pattern in the intestine. Influences of rotation speed and surfactant concentration in medium were evaluated. Samples were analysed by validated UV visible spectrophotometric method at 286 nm. 1% sodium lauryl sulphate (SLS) was found to be optimum for improving carvedilol solubility in pH 6.8 citric-phosphate buffer. Analysis of variance showed no significant difference between the results obtained at 50 and 100 rpm. The discriminating dissolution method was successfully developed for carvedilol compression-coated tablets. The conditions that allowed dissolution determination were USP type I apparatus at 100 rpm, containing 1000 ml of 0.1N HCl for 2 hours, followed by pH 6.8 citric-phosphate buffer with 1% SLS for 22 hours at 37.0 ± 0.5 ºC. Samples were analysed by UV spectrophotometric method and validated as per ICH guidelines.
Highlights
Dissolution testing has been proven to be important tool for evaluating the performance of solid dosage forms (Dressman et al, 1998)
Lipophilic drugs are classified into classes II or IV by the Biopharmaceutical Classification System (BCS), depending on their apparent permeability (Papp values)
The present study describes the process of selection, development and validation of a dissolution method for 25 mg carvedilol compression-coated tablets
Summary
Dissolution testing has been proven to be important tool for evaluating the performance of solid dosage forms (Dressman et al, 1998). The present study describes the development and validation of a dissolution method for compressioncoated tablets with quick and slow release characteristics. Carvedilol has a greater antioxidant activity than other commonly-used β blockers (Nakamura et al, 2002; Kukin et al, 1999) It is widely prescribed for the treatment of essential hypertension, angina pectoris (Packer et al, 2002; Ruffolo et al, 1992) and congestive heart failure (Poole-wilson et al, 2002). Conventional controlled dosage forms delay the release of the drug but do not provide a rapid onset of action. This can be overcome by quick/slow release pattern of compression-coated tablets. The present study describes the process of selection, development and validation of a dissolution method for 25 mg carvedilol compression-coated tablets. A dissolution method for carvedilol compression coated tablets had not been reported in the literature
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