Stability of Cyclophosphamide in Extemporaneous Oral Suspensions

Kennedy, R. Moffatt; Groepper, Daniel; Tagen, Michael; Christensen, Robbin; Navid, Fariba; Gajjar, Amar; Stewart, Clinton F.

doi:10.1345/aph.1m578

Cited by 17 publications

(4 citation statements)

References 21 publications

(29 reference statements)

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“…For nononcologic indications, oral cyclophosphamide dosing usually in the range of 2.5 to 3 mg/kg daily for a period of 60 to 90 days is recommended for both initial and maintenance dosing, and can be used in place of a low-dose intravenous formulation. It is soluble in water at between 10 and 50 mg/mL, and liquid formulations using the lyophilized intravenous formulation may be prepared in a 10 mg/mL concentration [ 97 ].…”

Section: The Next Wave Of Oral Liquid Formulation Development—formula...mentioning

confidence: 99%

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

Parrish

Ashworth²,

Löbenberg

et al. 2022

Pharmaceutics

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The purpose of this work was to evaluate the suitability of recent US Food and Drug Administration (US-FDA)-approved and marketed oral liquid, powder, or granule products for children in North America, to identify the next group of Active Pharmaceutical Ingredients (APIs) that have high potential for development as commercially available FDA-approved finished liquid dosage forms, and to propose lists of compounded nonsterile preparations (CNSPs) that should be developed as commercially available FDA-approved finished liquid dosage forms, as well as those that pharmacists should continue to compound extemporaneously. Through this identification and categorization process, the pharmaceutical industry, government, and professionals are encouraged to continue to work together to improve the likelihood that patients will receive high-quality standardized extemporaneously compounded CNSPs and US-FDA-approved products.

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Section: The Next Wave Of Oral Liquid Formulation Development—formula...mentioning

confidence: 99%

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

Parrish

Ashworth²,

Löbenberg

et al. 2022

Pharmaceutics

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“…The use of Ora-Plus® extemporaneous oral suspension has provided satisfactory stability for aminophylline, cyclophosphamide, domperidone, granisetron, itraconazole, ursodiol and tramadol hydrochloride associated with acetaminophen [14,78]. However, for captopril, hydralazine hydrochloride and tetracycline hydrochloride, the suspensions were reported as not having enough stability.…”

Section: Cellulose Derivatives In Oral Liquid (Suspensions) Extemporamentioning

confidence: 99%

Cellulose and Its Derivatives Use in the Pharmaceutical Compounding Practice

Marques-Marinho¹,

Vianna-Soares²

2013

Cellulose - Medical, Pharmaceutical and Electronic Applications

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“…There are notable methods available, such as gas chromatography with mass detector (GC-MS) [6], high performance liquid chromatography (HPLC) [7][8][9][10][11][12], and UVspectrophotometric methods [1, 13 and 14]. Recently, Liquid chromatography with mass detector (LC-MS) methods [15][16][17][18][19][20] and UPLC-MS/MS methods [21,22], have been also been used to measure the CP in formulations and biological samples.…”

Section: Introductionmentioning

confidence: 99%

Application of Charge Transfer Reactions for the Quantitative Spectrophotometric Determination of Cyclophosphamide in Pure and Pharmaceutical Formulation

Siddappa

Hanamshetty²

2015

CPA

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The present investigation describes two simple, sensitive and validated spectrophotometric methods for the determination of Cyclophosphamide (CP) in pure and formulated forms. The methods are mainly based on the formation of charge transfer (CT) complex, with the reagents 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) (Method A) and p-Chloranilic acid (PCA) (Method B), hence a stable, 1:1 stoichiometric complex was obtained, which shows orangeyellow and pink colors, respectively. The produced chromogens optical densities were measured at 352 and 522 nm, respectively. The Beer's law was tested in the range of 2-16 and 5-50 µg mL -1 . The optical characteristics such as molar absorptivity (ɛ), and Sandell's sensitivity values were calculated. Other analytical parameters like, Limit of Detection (LOD), Limit of Quantification (LOQ), accuracy and precisions were evaluated. The proposed methods were successfully applied for the determination of the CP in tablet formulation with higher accuracy, better recoveries and less than 2% relative standard deviation.

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Stability of Cyclophosphamide in Extemporaneous Oral Suspensions

Abstract: Background-Cyclophosphamide, an alkylating agent, is widely used for the treatment of many adult and pediatric malignancies. The stability of cyclophosphamide in aqueous-and methylcellulose-based oral suspending vehicles is currently unknown.

Cited by 17 publications

References 21 publications

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

Cellulose and Its Derivatives Use in the Pharmaceutical Compounding Practice

Application of Charge Transfer Reactions for the Quantitative Spectrophotometric Determination of Cyclophosphamide in Pure and Pharmaceutical Formulation

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