Stability and viscosity of a flavored omeprazole oral suspension for pediatric use

Burnett, Jane E.; Balkin, Ethan R.

doi:10.2146/ajhp060026

Cited by 23 publications

(17 citation statements)

References 14 publications

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“…At neutral pH, PPIs exist as lipophilic prodrugs without intrinsic activity, which can cross cell membranes. When the pH is less than 4, the pyridyl nitrogen is protonated, resulting in a chemical rearrangement to form a reactive cyclic sulfonamide, the pharmacologically active form of the drug (4).…”

Section: Introductionmentioning

confidence: 99%

Influences of Sodium Carbonate on Physicochemical Properties of Lansoprazole in Designed Multiple Coating Pellets

Yang²,

Fan³

et al. 2010

AAPS PharmSciTech

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Lansoprazole (LSP), a proton-pump inhibitor, belongs to class II drug. It is especially instable to heat, light, and acidic media, indicating that fabrication of a formulation stabilizing the drug is difficult. The addition of alkaline stabilizer is the most powerful method to protect the drug in solid formulations under detrimental environment. The purpose of the study was to characterize the designed multiple coating pellets of LSP containing an alkaline stabilizer (sodium carbonate) and assess the effect of the stabilizer on the physicochemical properties of the drug. The coated pellets were prepared by layer-layer film coating with a fluid-bed coater. In vitro release and acid-resistance studies were carried out in simulated gastric fluid and simulated intestinal fluid, respectively. Furthermore, the moisture-uptake test was performed to evaluate the influence of sodium carbonate on the drug stability. The results indicate that the drug exists in the amorphous state or small (nanometer size) particles without crystallization even after storage at 40°C/75% for 5 months. The addition of sodium carbonate to the pellet protects the drug from degradation in simulated gastric fluid in a dose-dependent manner. The moisture absorbed into the pellets has a detrimental effect on the drug stability. The extent of drug degradation is directly correlated with the content of moisture absorption. In conclusion, these results suggest that the presence of sodium carbonate influence the physicochemical properties of LSP, and the designed multiple coating pellets enhance the drug stability.

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Section: Introductionmentioning

confidence: 99%

Influences of Sodium Carbonate on Physicochemical Properties of Lansoprazole in Designed Multiple Coating Pellets

Yang²,

Fan³

et al. 2010

AAPS PharmSciTech

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“…For this study, we used omeprazole syrup which was prepared in Faculty of Pharmacy, Shiraz University of Medical Sciences by omeprazole capsules (20 mg) as the control group which was purchased from Exir Pharmaceutical Co, (Brojerd, Iran) (37,38). Each mL of the liquid concentrate, for oral administration, contains 2 mg of omeprazole.…”

Section: 3drug Preparationmentioning

confidence: 99%

Effects of Quince syrup on clinical symptoms of children with symptomatic gastroesophageal reflux disease: A double-blind randomized controlled clinical trial

Zohalinezhad

Imanieh

Mohammadi-Samani

et al. 2015

Complementary Therapies in Clinical Practice

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“…7 Specific findings of previous studies are found in Table 1. [8][9][10][11][12][13] Nasogastric tube administration adds another layer of complexity. Suspensions containing PPIs are often formulated as intact granules or granulates for suspension to overcome acid degradation in the stomach.…”

Section: Introductionmentioning

confidence: 99%

Comparative Stability of Compounded Omeprazole Suspension Versus Commercial Omeprazole Kit When Stored in Oral Syringes Under Refrigerated Conditions

Jackson

Lewis

Brown

2020

Journal of Pharmacy Technology

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Background: Omeprazole is a proton pump inhibitor used to manage gastrointestinal disorders. Special populations may require omeprazole to be given as an oral suspension. Objective: The purpose of this project was to compare the stability of omeprazole in the FIRST kit product to a traditionally compounded omeprazole suspension, when stored in refrigerated unit-dosed syringes. NG tube delivery of the 2 products was also investigated. Methods: Five batches of compounded omeprazole oral suspension and 5 kits of FIRST-Omeprazole were prepared to an initial concentration of 2 mg/mL. Suspensions were aliquoted into 5-mL doses in clear plastic oral syringes, and stored at 2-8 °C. Syringes from each batch were analyzed at baseline and after 7, 14, 21, and 30 days for omeprazole potency using HPLC. To assess suitability for NG tube administration, 20 mL of each suspension were administered through NG tubes (8Fr, 10Fr, and 18Fr), and percent omeprazole recovery assessed. Results: The chemical potency remained within 90-110% for 14 days and 30 days for compounded samples and FIRST-Omeprazole samples, respectively. There was a statistically significant difference in initial concentration; 1.89 mg/mL versus 1.98 mg/mL for compounded and FIRST-Omeprazole, respectively. After 30 days, FIRST-Omeprazole demonstrated 97.20% API recovery. Neither suspension experienced statistically significant loss of potency following NG tube passage. Conclusion: FIRST-Omeprazole suspension may be stored in refrigerated clear luer-lock oral syringes for 30 days. Traditionally compounded omeprazole suspension should be used within 14 days. Both suspensions are suitable for NG tube administration.

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Stability and viscosity of a flavored omeprazole oral suspension for pediatric use

Cited by 23 publications

References 14 publications

Influences of Sodium Carbonate on Physicochemical Properties of Lansoprazole in Designed Multiple Coating Pellets

Influences of Sodium Carbonate on Physicochemical Properties of Lansoprazole in Designed Multiple Coating Pellets

Effects of Quince syrup on clinical symptoms of children with symptomatic gastroesophageal reflux disease: A double-blind randomized controlled clinical trial

Comparative Stability of Compounded Omeprazole Suspension Versus Commercial Omeprazole Kit When Stored in Oral Syringes Under Refrigerated Conditions

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