Feasibility of amlodipine besylate, chloroquine phosphate, dapsone, phenytoin, pyridoxine hydrochloride, sulfadiazine, sulfasalazine, tetracycline hydrochloride, trimethoprim and zonisamide in SyrSpend(®) SF PH4 oral suspensions.

Objectives: To develop and to study the physicochemical and microbiological stability of omeprazole liquid oral formulations used as therapeutic agent in many acid-related disorders, for pediatric use. Furthermore, to optimize and validate a stability-indicating high-performance liquid chromatography (HPLC) method for the analysis of omeprazole in the studied formulations. Method: Oral liquid suspensions of omeprazole were prepared at 2 mg/mL using crushed omeprazole pellets (formulation A) and pure omeprazole (formulation B) with a complete vehicle including humectant, suspending, sweetening, antioxidant, and flavoring agents. Samples were stored at 4°C and 25°C. Omeprazole content of each formulation was analyzed in triplicate using micro-HPLC at 0, 3, 7, 14, 30, 60, 90, 120, and 150 days. Other parameters were also determined, such as appearance, pH, resuspendibility, and viscosity. Microbiological studies were conducted according to the United Stated Pharmacopeia (USP) guidelines for non-sterile products. Results: Formulation A stayed physicochemical and microbiologically stable at refrigerated (4°C) conditions during at least 150 days and it only stayed stable during 14 days at 25°C. Formulation B was stayed physicochemical and microbiologically stable at refrigerated (4°C) conditions at least 90 days, but it is not recommended to store at 25°C for more than 1 day. Conclusions: Formulation A and formulation B can be stored for at least 150 and 90 days, respectively, at refrigerated conditions. Formulation A can be stored at room temperature for 14 days. Both formulations are perfectly suitable for pediatric patients who are usually notable to swallow solid oral formulations. The proposed analytical method was suitable for the study of stability of different formulations.

Formulation and Stability Study of Omeprazole Oral Liquid Suspension for Pediatric Patients.

Study of quality and stability of ursodeoxycholic acid formulations for oral pediatric administration.

This study reports the stability of extemporaneously prepared gabapentin oral suspensions prepared at 100 mg/mL from bulk drug and capsules in either Oral Mix or Oral Mix SF suspending vehicles. Suspensions were packaged in amber plastic bottles and amber plastic syringes at 25°C / 60%RH for up to 90 days. Throughout the study period, the following tests were performed to evaluate the stability of the preparations: organoleptic inspection to detect homogeneity, color or odor changes; pH measurements; and gabapentin assay using a stability-indicating HPLC-UV method. As crystallization was observed at 5°C, storage at this temperature condition is not recommended. All preparations stored at 25°C / 60%RH remained stable for the whole study duration of 90 days.

/pdf/stability-of-gabapentin-in-extemporaneously-compounded-oral-4b0kqtz5n9.pdf

Stability of gabapentin in extemporaneously compounded oral suspensions.

Objective:Vancomycin is recommended as a first-line therapy for severe Clostridium difficile infection (CDI). Due to the high cost of commercially available vancomycin capsules, hospitals frequently compound oral solution despite a lack of data comparing outcomes. This study was conducted to determine treatment outcome differences based on oral vancomycin formulation.Methods:Medical charts of 76 patients with an initial episode of severe CDI receiving oral vancomycin as a commercially available capsule or a compounded oral solution for at least 72 hours were retrospectively reviewed. The primary objective was to compare the time to clinical cure of CDI.Results:Baseline characteristics between groups were similar except for the median lactate, which was higher in compounded oral solution group (1.5 vs 0.6 mmol/L, P < .001). There was no difference in clinical cure at day 10 (64% solution vs 59% capsules, P = .664). Median time to clinical cure was 8 days for solution and 7 for capsules (P = .597). After ad...

Comparison of oral vancomycin capsule and solution for treatment of initial episode of severe Clostridium difficile Infection.

Ursodiol is used in the treatment and prevention of certain types of gallstones and for patients with primary biliary cirrhosis. Ursodiol is marketed for this purpose by Watson Pharma, Inc. as ACTIGALL, by Axcan Scandipharm Inc. as URSO 250 and URSO Forte, and by a number of generic manufacturers. Ursodiol is available as capsules of varying strengths. The need for other dose-form options for those patients who cannot take capsules has led compounding pharmacies to seek other alternatives, namely oral solutions and suspensions. Additionally, some patients are unable to tolerate suspending agents containing alcohol or sorbitol. The objective of this study was to determine the stability of ursodiol in SyrSpend SF Cherry Flavored which does not contain sorbitol or alcohol. The studied sample was compounded into a 3-mg/mL [corrected] suspension and stored in a low-actinic plastic bottle at temperatures between 2 degrees C and 8 degrees C. Six samples were assayed at each time point out to 66 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced degradation studies. The sample remained within 90% to 110% of the initial concentration throughout the course of the study. The beyond-use-date of this product is at least 66 days, based on data collected when refrigerated and protected from light.

Stability of ursodiol in SyrSpend SF Cherry flavored.

Vancomycin is administered orally for the treatment of pseudomembranous colitis induced by Clostridium difficile. Vancomycin is marketed for this purpose by ViroPharma as VANCOCIN in 125-mg and 250-mg capsules. The need for other dose form options for those patients who cannot take capsules has led compounding pharmacies to seek other alternatives, namely oral solutions and suspensions. Additionally, some patients are unable to use suspending agents containing alcohol or sorbitol. The objective of this study was to determine the stability of vancomycin in SyrSpend SF, a suspending agent containing neither sorbitol nor alcohol. The studied sample was compounded into a 50-mg/mL suspension and stored in a low-actinic plastic bottle at temperatures between 2 degrees C and 8 degrees C. Six samples were assayed at each time point out to 90 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced-degradation studies. The sample remained within 90% to 110% of the initial concentration throughout the course of the study. Based on data collected, the shelf life of this product is at least 90 days when refrigerated and protected from light. Based on the final potency data at day 90, the beyond-use date may be longer, but 90 days was the limit of this study.

https://fagron.com/sites/default/files/page/attachment/stability_study_vancomycin_syrspendsf.pdf

Stability of Vancomycin in SyrSpend SF

Omeprazole is used in the treatment of dyspepsia, peptic ulcer disease, gastroesophageal reflux disease, laryngopharyngeal reflux, and Zollinger-Ellison syndrome. Omeprazole is marketed by AstraZeneca under a number of names, most notably Prilosec and Losec, as well as being available from a number of generic manufacturers. Omeprazole is available in both tablet and capsule form, with varying strengths of each. The need for other administration options for those patients who cannot take tablets or capsules has led compounding pharmacies to seek other alternatives. One possible alternative is the use of a suspending agent to create an oral solution or suspension. In the past, this has been accomplished using a sodium bicarbonate solution as the vehicle. However, sodium bicarbonate/omeprazole combination imparts a bitter and unpleasant taste. SyrSpend SF Alka (reconstituted) is a vehicle for making a suspension which has a pleasant taste, thus increasing palpability and compliance. The objective of this study was to determine the stability of omeprazole in SyrSpend SF Alka (for reconstitution). The studied sample was compounded into a 2-mg/mL suspension and stored in a low-actinic plastic prescription bottle at temperatures between 2 degrees C and 8 degrees C. Six samples were assayed at each time point out to 92 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced degradation studies. The shelf life of this product is at least 92 days, based on data collected when refrigerated and protected from light.

Stability of omeprazole in SyrSpend SF Alka (reconstituted).

Gabapentin is used with other medications to control and prevent seizures. It is also used to treat neuropathic pain following surgery due to shingles. Gabapentin comes in many different forms, including capsules, tablets, and oral solutions. Some patients, however, cannot use oral solutions containing alcohol or sorbitol. The objective of this study was to determine the stability of gabapentin in SyrSpend SF, a suspending agent that does not contain either sorbitol or alcohol. The studied samples were compounded into a 50-mg/mL suspension and stored in low actinic bottles at room temperature and refrigerated conditions. Samples were assayed at each time point out to 90 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced-degradation studies. The samples remained within 90% to 110% of the initial concentration throughout the course of the study. Based on data collected, the beyond-use date of this product is at least 90 days when refrigerated or stored at room temperature and protected from light. Based on the final potency data at day 90, the beyond-use date may be longer, but 90 days was the limit of this study.

Stability of Gabapentin in SyrSpend SF

Oseltamivir (Tamiflu) is widely prescribed to treat and prevent influenza virus A, influenza virus B, and H1N1 Flu It is manufactured by Roche in 75-mg capsules The need for other administration options for patients who cannot take capsules and cannot use suspending agents which contain alcohol, sorbitol, or preservatives has led to the compounding of oseltamivir into three suspending vehicles that do not contain these chemicals All three contain neither alcohol nor sorbitol; the third also has no preservatives, a distinct advantage for special patient situations The objective of this study was to determine the stability of oseltamivir in three different suspending agents: SyrSpend SF, Cherry Syrup, and SyrSpend SF (for reconstitution) The studied samples were compounded into 15-mg/mL suspensions and stored in low actinic plastic prescription bottles at temperatures between 2 degrees Celsius and 8 degrees Celsius Triplicate samples were assayed at time intervals out to 30 days by a stability-indicating high-performance liquid chromatography method The method was validated for its specificity through forced degradation studies All of the samples tested remained within 90% to 110% of their initial concentrations throughout the course of the study The shelf life of these products is at least 30 days, based on data collected when the aforementioned products are refrigerated and protected from light Based on the final potency data at day 30, the shelf life may extend past the scope of this study, but 30 days was the limit of this study

Stability of Oseltamivir Phosphate in SyrSpend SF, Cherry Syrup, and SyrSpend SF (For Reconstitution).

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