Dissolution instability of encapsulated marketed tablets

Desai, Divyakant; Ranadive, Sunanda A.; Lozano, Ruben; Varia, Sailesh A.

doi:10.1016/s0378-5173(96)04740-0

Cited by 8 publications

(4 citation statements)

References 5 publications

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“…30,31) The experimental temperatures and oxygen pressures were 15°C, 25°C, 35°C, 45°C (or 288. 15 Ascorbic acid is unstable in aqueous solutions. It is reported that the degradation of ascorbic acid obeys apparent zero-order kinetics in high concentration, such as 10% or …”

Section: Experimental and Resultsmentioning

confidence: 99%

“…[12][13][14][15][16][17] The theoretics found in the literature was the comparison of the standard oxidation (or reduction) potentials of antioxidants and that of drugs. 18) According to the theoretics of physical chemistry, these standard potentials are related to DG 0 and K, the increment of standard Gibbs function and the equilibrium constant of the chemical reactions.…”

mentioning

confidence: 99%

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Compressed Oxygen in Drug Stability Experiments

Yan

Lin

et al. 2007

CHEMICAL & PHARMACEUTICAL BULLETIN

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A drug stability experiment accelerated by compressed oxygen was established. The stability of 10% ascorbic acid solution as a model was studied and the kinetic parameters were obtained with the newly established experimental method. Because ascorbic acid degrades under both anaerobic and aerobic conditions, the total rate constant k total can be expressed as: k total ‫؍‬k anaerobic ؉k aerobic , where k anaerobic and k aerobic are the rate constants of anaerobic and aerobic degradations, respectively. The k anaerobic can be expressed as k anaerobic ‫؍‬ A anaerobic · exp(؊E a,anaerobic /RT ) according to Arrhenius equation, and the k aerobic was found to be k aerobic ‫؍‬ A aerobic · exp(؊E a,aerobic /RT ) · p O 2 in our study.

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Section: Experimental and Resultsmentioning

confidence: 99%

mentioning

confidence: 99%

Compressed Oxygen in Drug Stability Experiments

Yan

Lin

et al. 2007

CHEMICAL & PHARMACEUTICAL BULLETIN

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“…According to Desai et al. (1996), slower dissolution is presumed to be a result of changes in capsule shell integrity.…”

Section: Discussionmentioning

confidence: 99%

High failure rate of the dissolution tests for 500-mg amoxicillin capsules sold in Cambodia: is it because of the product or the test method?

Okumura¹,

Taga²,

Tey³

et al. 2010

Tropical Medicine &Amp; International Health

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Summaryobjectives During the survey of substandard medicines in Cambodia in 2007, it was found that more than 90% of 500-mg amoxicillin (AMPC) capsules failed the United States Pharmacopeia (USP) 30 TEST 1 dissolution test. In the USP, several monographs provide multiple methods for performing the dissolution test. By using the 500-mg AMPC capsule as an example, we aimed to identify the problems and implications of the USP methods adopted for the dissolution test as a global standard. results All 500-mg AMPC capsules used for the comparison passed the quantitative test. Samples that passed the USP 28 and USP 30 TEST 2 dissolution tests were identical, and the pass rate was 97.1% (34 ⁄ 35), whereas the pass rate with the USP 30 TEST 1 was 8.6% (3 ⁄ 35). The difference in the dissolution results between the three methods was significant (P < 0.0001).conclusion This study revealed that many users would select the most stringent method when multiple methods exist in the USP. This may lead to a high failure rate of the tests. Because USP is a global standard, we recommend that it take into consideration the developing countries and create a more detailed user-friendly manual for selection for appropriate methods.

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“…To enable the precise dissolution of API, the remaining inert excipients each play important roles in aiding its precise release. Some APIs are poorly soluble and therefore the formulation would require carefully selected excipients which promote disintegration and dissolution so that the function of the API is able to be carried out (Buggins et al, 2007, Desai et al, 1996, Loftsson, 2015. These materials aid in the disintegration of the tablet into smaller fragment which provides a larger surface area for the dissolution of the API (Desai et al, 2016).…”

Section: Pharmaceutical Tablet Formulationmentioning

confidence: 99%

The effect of roller compaction and tableting stresses on pharmaceutical tablet performance

et al. 2019

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For tablets made by roller compaction the relationships between formulation composition, manufacturing conditions and in-vitro performance were examined. Two filler materials with different characteristics were studied. During tablet production, two main stresses are experienced by a material. The first stress occurs during granulation and the second stress during tableting. These stresses were investigated in terms of the tablet properties and disintegration behaviour. Roller compaction granulation, a continuous dry granulation process, was used to produce granules. The granules were then compacted using varying tableting stresses. The tablets were characterised by their porosity and tensile strength (i.e. compactibility), and were also examined using X-ray to determine the internal tablet structure. The tablet internal structure indicated that the final tablet compactibility was dependent on the RC stress used, which governs the consequent granular properties. The granular material is then affected by the tableting stress used Publications Journal papers:  The effect of roller compaction and tableting stresses on pharmaceutical tablet performance, A

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Dissolution instability of encapsulated marketed tablets

Cited by 8 publications

References 5 publications

Compressed Oxygen in Drug Stability Experiments

Compressed Oxygen in Drug Stability Experiments

High failure rate of the dissolution tests for 500-mg amoxicillin capsules sold in Cambodia: is it because of the product or the test method?

The effect of roller compaction and tableting stresses on pharmaceutical tablet performance

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