Stability of Capecitabine by Simple Suspension Method

Kimura, Kumi; Mitsuhashi, Mayumi; Narawa, Tomoya; Otori, Katsuya; Yago, Kazuo; Itoh, Tomoo

doi:10.5649/jjphcs.38.751

Cited by 3 publications

(3 citation statements)

References 4 publications

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“…11) Although there have been other reports on the stability of individual anticancer drugs with respect to pH, none have yet covered as many drugs as in this study. [12][13][14][15][16] The pH information obtained in this study will be useful for testing the stability of suspensions and for selecting dissolution solutions. Little changes in pH were observed before or after passage through the tube, suggesting that the drugs tested in this study were unaffected by the tube.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Simple Suspension Method for Oral Anticancer Drugs

Abe,

Kusakabe,

Naoi

et al. 2024

YAKUGAKU ZASSHI

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The simple suspension method (SSM) involves administering tablets or capsules using a tube after disintegration and suspension in hot water without crushing or opening the capsule. Particularly, for anticancer drugs, it is an excellent method of administration that reduces the risk of exposure during dispensing. In contrast, information on SSM for individual drugs is insufficient. Anticancer drugs present a therapeutic challenge because their information is limited. We investigated whether SSM is possible with 36 anticancer drugs. Furthermore, we examined the pH of the suspension of these drugs, for which no information on SSM is available. We found that suspension was possible for 24 of the 36 drugs. Furthermore, the pH of the suspension was measured, which provided important information when considering dissolution solutions other than hot water. Little changes in the pH were observed before or after passing through the tube. The results of this study may improve medication adherence in patients with cancer experiencing dysphagia.

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Section: Discussionmentioning

confidence: 99%

Evaluation of the Simple Suspension Method for Oral Anticancer Drugs

Abe,

Kusakabe,

Naoi

et al. 2024

YAKUGAKU ZASSHI

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“…It has been reported that cosuspending drugs such as aspirin [ 5 ], amlodipine besilate [ 6 ], and capecitabine [ 7 ] with MgO or other agents that increase the suspension pH reduces the amount of the principal agent in the suspension by degradation or other changes. With clopidogrel bisulfate, the amount of clopidogrel (molecular form) isolated from test solutions A and B was similar to the amount of clopidogrel bisulfate used to prepare the test solutions, and this indicates that formulating these test solutions caused no degradation.…”

Section: Discussionmentioning

confidence: 99%

Mixture of clopidogrel bisulfate and magnesium oxide tablets reduces clopidogrel dose administered through a feeding tube

Aoki

Naya

Arima

et al. 2021

J Pharm Health Care Sci

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Background In clinical practice, a mixed suspension of clopidogrel bisulfate and magnesium oxide (MgO) tablets is administered frequently via a feeding tube. However, there is no report on the changes occurring when suspensions of these two drugs are combined, including the effects or potential decrease in dose following tube administration. Thus, the purpose of our study was to investigate the (i) changes caused by mixing clopidogrel bisulfate (ion form) and MgO tablets and (ii) effects on the administered clopidogrel dose after passing through a feeding tube. Methods The molecular structure of clopidogrel generated in a mixture of clopidogrel bisulfate and a basic compound, such as sodium bicarbonate or MgO tablet, was determined by 1H-NMR after extraction and purification. The suspension of clopidogrel bisulfate tablet alone and the mixed suspension of clopidogrel bisulfate tablet and MgO tablet were passed through a feeding tube. We compared the yield of the molecular form of clopidogrel from each passed fraction. Results The substance obtained from the mixture of clopidogrel bisulfate tablet and sodium bicarbonate or MgO tablet was identified as the molecular form of clopidogrel, and chemical degradation did not occur under these conditions. In the tube passage test, the yield of clopidogrel (molecular form) from the mixture of clopidogrel bisulfate and MgO tablets was lower than that from the suspension of clopidogrel bisulfate tablet alone. Conclusions The mixture of clopidogrel bisulfate and MgO tablets caused a considerable reduction in the administered dose passed through the feeding tube. Therefore, it is recommended to administer the suspensions of clopidogrel bisulfate and MgO tablets separately for safe and effective pharmacotherapy.

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“…[2][3][4][5][6][7][8] In these studies, all medicines tested were shown to be stable in each suspension when applied alone to the simple suspension method. With regard to concomitant suspensions with other medicine, chemical decomposition was observed for L-dopa, 2) aspirin 5) and capecitabine, 8) when suspended with an alkaline drug or under pH-altered conditions. The use of this method has been increasing in Japan, but its application to drugs that are susceptible to chemical hydrolysis, such as prodrugs, remains controversial.…”

Section: Introductionmentioning

confidence: 99%

Stability of Ester Prodrugs with Magnesium Oxide Using the Simple Suspension Method

Suryani

Sugiyama

Kurata

et al. 2013

Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care a

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The simple suspension method is a method of administering drugs via a feeding or gastrostomy tube, and it involves allowing tablets or capsules to be disintegrated and suspended in warm water at 55℃ without crushing. The present study evaluated the stability of two prodrugs suspended alone or in combination with an alkaline agent according to the simple suspension method. The study used two ester-prodrugs, acemetacin (AMT) and cefpodoxime proxetil (CPP), which are hydrolyzed at higher pH. Drug concentrations in the suspension were measured by high-performance liquid chromatography. AMT and CPP were not hydrolyzed when suspended alone, but decomposed under alkaline conditions with the addition of magnesium oxide (MgO). The AMT concentration decreased to 55.5％ and 38.9％ at 30 min and 60 min, respectively, whereas its active metabolite, indomethacin (IMT), increased from 0 to 90.7 µg/mL and 122.7 µg/mL at 30 and 60 min, respectively. The CPP concentrations with MgO were decreased to 47.9, 28.5, 20.8 and 12.7％ at 30, 60, 90, and 120 min, respectively. Therefore, AMT and CPP should not be administered in the simple suspension method in combination with an alkaline drug that increases the suspension pH.

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Stability of Capecitabine by Simple Suspension Method

Cited by 3 publications

References 4 publications

Evaluation of the Simple Suspension Method for Oral Anticancer Drugs

Evaluation of the Simple Suspension Method for Oral Anticancer Drugs

Mixture of clopidogrel bisulfate and magnesium oxide tablets reduces clopidogrel dose administered through a feeding tube

Stability of Ester Prodrugs with Magnesium Oxide Using the Simple Suspension Method

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