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<p>In this work, the dissolution profiles of sixteen tablets containing 12.5 mg of carvedilol marketed in Argentina were evaluated. The <i>in vitro</i> dissolution characteristics were determined using the USP Apparatus 2 and three dissolution media: hydrochloric acid pH 1.2, acetate buffer pH 4.5, and phosphate buffer pH 6.8. As per the present study, all the brands complied with the single-point USP Pharmacopoeia specification (Test 2) for the release of drug substances. The sixteen products studied dissolved in simulated intestinal fluid without pancreatin, but only six brands seemed to produce a dissolution curve that was similar to the reference product. The dissolution profiles in phosphate buffer pH 6.8 were evaluated by fitting experimental data to the zero and first-order, Hixson-Crowell, Higuchi, and Weibull models. The Akaike Information Criteria (AIC) was used to test the pertinence of the release models. The similarity factors obtained indicated that not all the brands evaluated can be used interchangeably. Our results indicated that both the solubility and the dissolution profile of carvedilol are strongly dependent on the medium pH.</p>

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Comparison of In Vitro Dissolution Profiles in Different Media of Sixteen Immediate-Release Commercially Available Carvedilol Tablets

  • 期刊论文

  • 发表日期：

    2025年6月1日

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  • Lina Leguizamón Salcedo,
  • Adriana I. Segall

摘要

In this work, the dissolution profiles of sixteen tablets containing 12.5 mg of carvedilol marketed in Argentina were evaluated. The in vitro dissolution characteristics were determined using the USP Apparatus 2 and three dissolution media: hydrochloric acid pH 1.2, acetate buffer pH 4.5, and phosphate buffer pH 6.8. As per the present study, all the brands complied with the single-point USP Pharmacopoeia specification (Test 2) for the release of drug substances. The sixteen products studied dissolved in simulated intestinal fluid without pancreatin, but only six brands seemed to produce a dissolution curve that was similar to the reference product. The dissolution profiles in phosphate buffer pH 6.8 were evaluated by fitting experimental data to the zero and first-order, Hixson-Crowell, Higuchi, and Weibull models. The Akaike Information Criteria (AIC) was used to test the pertinence of the release models. The similarity factors obtained indicated that not all the brands evaluated can be used interchangeably. Our results indicated that both the solubility and the dissolution profile of carvedilol are strongly dependent on the medium pH.