Stability of Drugs when Prepared for Tube Administration by Simple Suspension Method

Yano, Katsuko; Takezawa, T; Mochizuki, Toshihide; Ikarashi, Nobutomo; K, Ito; Orii, Takao; Kurata, Nori; Sugiyama, Kiyoshi

doi:10.5649/jjphcs.32.1094

Cited by 21 publications

(7 citation statements)

References 11 publications

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“…Yano et al 8) confirmed that 8 types of suspended drugs, including phenytoin and digoxin, were found to be stable. Suryani et al 9) demonstrated that suspended ester prodrugs (acemetacin, cefpodoxime proxetil)…”

Section: Introductionmentioning

confidence: 66%

Solubility Estimation for Drugs Treated with the Simple Suspension Method Using Available Dissolution Test Profiles

Sakurada

Shimoyama

Itoh

et al. 2015

Jpn. J. Pharm. Health Care Sci.

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The simple suspension method (SSM) is a method of administering drugs via feeding or gastrostomy tubes to those who have difficulty swallowing. In the SSM, solid formulations (eg, tablets, capsules) are immersed in hot (55℃) water. This promotes the disintegration and dissolution of the drugs and changes their solubility. However, pharmaceutical companies have not issued test results on the solubility and dissolution behaviors of suspended drugs prepared according to the SSM. For this study, we chose 10 drugs, 8 listed and 2 not listed in the Japanese Orange Book, to compare the dissolution behaviors of each drug, treated vs untreated with the SSM. Dissolution was classified into three patterns: rapid (gliclazide and famotidine), moderate (propranolol, pindolol, metoprolol), and slow (furosemide, ibuprofen, glimepiride). The initial dissolution rates of the moderate-dissolution drugs increased markedly by employing the SSM. In this study, hydroxyzine capsules and phenytoin tablets, neither of which is listed in the Japanese Orange Book, were compared with different dosage/administration forms of those drugs listed in the book (ie hydroxyzine tablets and phenytoinphenobarbital combination tablets).

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Section: Introductionmentioning

confidence: 66%

Solubility Estimation for Drugs Treated with the Simple Suspension Method Using Available Dissolution Test Profiles

Sakurada

Shimoyama

Itoh

et al. 2015

Jpn. J. Pharm. Health Care Sci.

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“…5) In some previous studies, the suspension was preliminarily separated into the dissolved and undissolved drugs by centrifugation for the determination of drugs. [3][4][5][6] In this study, however, we did not differentiate the dissolved and undissolved drugs, since the extraction procedure using methanol was performed after sampling from the dispersed suspension at designated times and determined the concentrations of the suspensions. Although the water solubility of AMT and CPP are known to be low, 18,19) the hydrolysis reaction could be proceeding on the surface of small particles in suspensions.…”

Section: Discussionmentioning

confidence: 99%

“…[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.…”

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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“…A simple suspension method has been developed for the nasogastric tube administration of tablets and capsules. [1][2][3] In this method, tablets (and capsules) are disintegrated in warm water (55 C) without grinding (or opening) them. After a 10-min period to decrease the water temperature to body temperature level, disintegrated tablets (and capsules) are administered via a nasogastric tube.…”

Section: Introductionmentioning

confidence: 99%

Effect of water temperature on a simple suspension method for lansoprazole orally disintegrating tablets

Chono

Matsui

Nakamura

2019

Journal of Generic Medicines

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In this study, we examined the physical properties, including disintegration, passage through a nasogastric administration tube, and acidoresistance, of one branded and five generic formulations of lansoprazole orally disintegrating (OD) tablets containing enteric-coated granules to examine the feasibility of a simple suspension method. The generic tablets immediately disintegrated in warm (55 C) and lukewarm water (35 C) and released the enteric-coated granules, which passed through an administration tube. Moreover, the released enteric-coated granules were stable under a simulated gastric acid environment. However, although the branded tablet disintegrated in warm water, the released enteric-coated granules formed aggregates that did not pass through the administration tube. Meanwhile, the granules released from the branded tablet in lukewarm water did not form aggregates. The present study demonstrated the applicability of a simple suspension method using warm or lukewarm water for generic lansoprazole OD tablets. Additionally, the method is applicable to branded lansoprazole OD tablets using lukewarm water.

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Stability of Drugs when Prepared for Tube Administration by Simple Suspension Method

Cited by 21 publications

References 11 publications

Solubility Estimation for Drugs Treated with the Simple Suspension Method Using Available Dissolution Test Profiles

Solubility Estimation for Drugs Treated with the Simple Suspension Method Using Available Dissolution Test Profiles

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

Effect of water temperature on a simple suspension method for lansoprazole orally disintegrating tablets

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