Development and validation of a dissolution method for warfarin sodium and aspirin combination tablets

McCormick, Timothy; Gibson, Alvin B.; Diana, Frank J.

doi:10.1016/s0731-7085(96)01891-2

“…The low solubility in SIF was notable, with no DEF being detected in the supernatant even after 24 h. Thus, these two media appear not suitable for a simple dissolution method, and In the case of studying the dissolution rate of DEF in HCL 0.087 M or 0.1 M [10,11,13], the decomposition of DEF should not to be ignored. Interestingly, McCormick et al [14] developing a dissolution method for tablets containing aspirin and warfarin found that aspirin was unstable in phosphate buffer (the optimum medium for warfarin), and in order to quantitate the amount of aspirin that was originally present in tablets, the amount of salicylic acid formed by hydrolisis was converted to its aspirin equivalent and added to the amount of aspirin remaining in the sample to obtain the total amount of aspirin. A similar procedure should be followed for DEF in aqueous HCL; however, neither the decomposition pathways of DEF in aqueous media nor its degradation products are known at present.…”

Section: Solubility Determination and Dissolution Test Optimizationmentioning

confidence: 99%

Development and Validation of a Dissolution Test for 6 mg Deflazacort Tablets

Sperandeo

¹

,

Kassuha

²

2009

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The aim of this study was to develop and validate a dissolution test for the quality control of deflazacort (DEF) tablets, a drug mainly used for the prevention of organ transplantation rejection, labeled as containing 6 mg of active pharmaceutical ingredient (API), using an RP-HPLC method. After testing sink conditions and stability at 37°C, DEF was found to be unstable, and decomposed as a function of the dissolution media. However, in water the decomposition was not significant enough to interfere with the determination of dissolution for DEF. The best conditions to carry out the dissolution test were paddle at 50 rpm, with 500 mL of deaerated water at 37°C. Under these conditions, the in vitro release profiles of 6 mg DEF tablets produced by two different laboratories, representing all approved products in the national market, shown to be dissimilar. A correlation between disintegration and in vitro dissolution was found for the two investigated formulations. The developed dissolution test was adequate for its purpose and can be applied for the quality control of 6 mg DEF tablets.

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“…This is surprising since DEF is an ester prodrug that can be hydrolyzed in acidic media, as it occurs with aspirin whose hydrolysis to salicylic acid took place before the end of the dissolution test [14].…”

Section: Deflazacortmentioning

confidence: 99%

Development and Validation of a Dissolution Test for 6 mg Deflazacort Tablets

Sperandeo¹

2009

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The aim of this study was to develop and validate a dissolution test for the quality control of deflazacort (DEF) tablets, a drug mainly used for the prevention of organ transplantation rejection, labeled as containing 6 mg of active pharmaceutical ingredient (API), using an RP-HPLC method. After testing sink conditions and stability at 37°C, DEF was found to be unstable, and decomposed as a function of the dissolution media. However, in water the decomposition was not significant enough to interfere with the determination of dissolution for DEF. The best conditions to carry out the dissolution test were paddle at 50 rpm, with 500 mL of deaerated water at 37°C. Under these conditions, the in vitro release profiles of 6 mg DEF tablets produced by two different laboratories, representing all approved products in the national market, shown to be dissimilar. A correlation between disintegration and in vitro dissolution was found for the two investigated formulations. The developed dissolution test was adequate for its purpose and can be applied for the quality control of 6 mg DEF tablets. KeywordsQuality control • In vitro release • RP-HPLC

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“…Meloxicam is official in the British Pharmacopoeia[19]; on the contrary, PRI has not been included yet in the most consulted Pharmacopoeias. A literature search revealed the lack of a validated dissolution test for the combined MEL-PRI formulation, and evidenced that published examples of validated dissolution tests for pharmaceutical associations are scarce[20–22]. Therefore, herein we report the development and validation of a dissolution test for tablets of the MEL-PRI association.…”

mentioning

confidence: 97%

Development and Validation of a Dissolution Test for Meloxicam and Pridinol Mesylate from Combined Tablet Formulation

Vignaduzzo¹,

Castellano²,

Kaufman³

2010

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The association of meloxicam and pridinol is indicated for treating muscular contractures and low back pain. A dissolution test for the meloxicam-pridinol combined tablet formulation was developed and validated, using a suitable HPLC method for simultaneously quantitating both dissolved drugs. The optimized conditions include the use of USP apparatus 2 at a paddle rotation rate of 75 rpm and 900 ml of 50 mM phosphate buffer (pH= 7.5) as dissolution medium, at 37.0±0.5°. The test, which demonstrated to be robust against small changes in bath temperature, paddle rotation speed and pH of the dissolution medium, was applied to two different brands of tablets; the corresponding dissolution profiles were constructed and both brands showed to dissolve at least 75% of the drugs at the 45 min time point.

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Development and validation of a dissolution method for warfarin sodium and aspirin combination tablets

Cited by 9 publications

References 8 publications

Development and Validation of a Dissolution Test for 6 mg Deflazacort Tablets

Development and Validation of a Dissolution Test for 6 mg Deflazacort Tablets

Development and Validation of a Dissolution Test for 6 mg Deflazacort Tablets

Development and Validation of a Dissolution Test for Meloxicam and Pridinol Mesylate from Combined Tablet Formulation

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