Stability of midazolam in syrspend SF and syrspend SF cherry.

Midazolam is a short-acting benzodiazepine central nervous system depressant available as an injection, tablet, or oral syrup. The need for alternative dosage form options for patients unable to take tablets and shortages of other forms of the drug have led compounding pharmacies to seek alternatives, mainly 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 midazolam in sorbitol-free, alcohol-free SyrSpend SF and SyrSpend SF Cherry suspending agents. The studied samples were compounded into a 1-mg/mL suspension and stored in low-actinic plastic bottles at temperatures between 2 degrees C to 8 degrees C and at room temperature conditions. Six samples were assayed at each time point out to 58 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 the data collected, the beyond-use date of these preparations is at least 58 days when protected from light at both refrigerated and room temperature storage conditions.

Stability of captopril in SyrSpend SF.

Captopril is an angiotensin-converting enzyme inhibitor available as a tablet. Patients who are unable to take tablets have led compounding pharmacies to seek alternative dosage forms including solutions and suspensions. The objective of this study was to determine the stability of captopril in sorbitol-free, alcohol-free SyrSpend SF suspending agent. The studied samples were compounded into a 0.8-mg/mL suspension and stored in low-actinic plastic bottles at temperatures between 2 degrees C to 8 degrees C. Six samples were assayed at each time point out to 32 days by a stability-indicating high-performance liquid chromatography method. The samples remained within 90% to 110% of the initial concentration throughout day 14 of the study. Based on the data collected, the beyond- use date of these preparations is 14 days when protected from light and refrigerated.

Stability of minoxidil in Espumil foam base.

Minoxidil is a drug used to stimulate hair growth and to slow balding. It is marketed under a number of trade names, including Rogaine, and is available in varying strength dose forms from a number of generic manufacturers. Minoxidil is available in oral and topical forms. In topical form, it can be applied by a metered-spray or rub-on applicator. A hydroalcoholic compounding vehicle can minimize greasiness, itching, burning, and contact dermatitis where low concentrations of ethanol and propylene glycol are present. Espumil Foam Base contains low concentrations of these ingredients and also can form a foam on topical application. Espumil's unique delivery by foam-activating packaging assures simple application to difficult-to-treat areas, and it vanishes quickly after application, keeping it in place and avoiding health skin areas. The objective of this study was to determine the stability of minoxidil in Espumil Foam Base. The studied sample was compounded into a 50-mg/mL solution and stored in a plastic foam-activating bottle at room temperature conditions. Three 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 beyond-use-date is at least 90 days, based on data collected when this formulation was stored at room temperature, protected from light.

Stability of omeprazole in SyrSpend SF Alka (reconstituted).

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 vancomycin in SyrSpend SF.

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.