Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

Musko, Monika; Sznitowska, Małgorzata

doi:10.2478/acph-2014-0037

Cited by 12 publications

(12 citation statements)

References 11 publications

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“…sorbitoli (70%), mucillago methylcellulosae (1%), mucillago gummi arabici (1%), mucillago gummi xanthani (1%), mucillago NaCMC (1%). [11][12][13][14][15][16][17] The full list of excipients and the combinations of them are summarized in Table 1.…”

Section: Composition and Preparation Of Nitrofurantoin Model Vehiclesmentioning

confidence: 99%

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Stability study of extemporaneously compounded nitrofurantoin oral suspensions for pediatric patients

Pehlivanov¹,

Stoeva²,

Simitchiev³

et al. 2022

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Aim: To evaluate the stability of nitrofurantoin suspended in different extemporaneously compounded vehicles after storage at 4°C and at 25°C. To formulate an effective, readily available vehicle that can guarantee extended stability and precise dosing. Materials and methods: Nitrofurantoin was suspended at a concentration of 10 mg/mL in seven different vehicles compounded of different blends of Syrupus simplex, sorbitol 70%, methylcellulose 1%, gummi arabici 1%, gummi xanthani 1%, and sodium carboxymethylcellulose (NaCMC) 1%. Samples of 100 mL of every compounded suspension were stored in dark in graded glass bottles at 4°C and at 25°C. Samples were analyzed at the beginning and every 10 days up to day 30 and every 30 days after. Variations of physical properties such as sedimentation, ease of resuspension, color and odor were evaluated visually and organoleptically. Rheological analysis was also performed in order to determine suspensions’ behavior during storage and dosing. Variations in nitrofurantoin concentration and pH were evaluated with suitable analytical procedure (UV-Vis; HPLC; pH/ORP). Microbiological stability was evaluated via incubation on suitable culture media. Results: To the 30th day, only three of the compounded suspensions exhibited significant physical stability and slight change in taste and odor stored at both temperatures. Two samples stored at 25°C exhibited nitrofurantoin concentration greater than 95% and 4 samples stored at 4°C – concentration greater than 95%. All models showed no microbial growth up to day 30. At 120 days, only three of the compounded suspensions, stored at 4°C, exhibited relatively high nitrofurantoin concentrations: 88.2%, 92%, and 81.1%, respectively. Only one model suspension showed chemical and physical stability (≥95% of the initial concentration) for 102 days. No model suspension remained sterile after 30 days. Conclusions: The suspensions compounded with vehicles of blends of syrups, xanthan, croscarmellose (NaCMC), and sorbitol exhibited low to none sedimentation, good uniformity of content and are suitable organoleptically for pediatric administration. The model suspension stored at 4°C (NTF VII 4°C – with major excipients: sucrose 16%, sorbitol 17%, xanthan gum 0.25%, NaCMC 0.25%) stands out with nitrofurantoin concentration higher than 95% along with no or little signs of sedimentation. After adding a suitable preservative agent or system, a formulation with these characteristics might have an expiration date of at least 90 days.

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Section: Composition and Preparation Of Nitrofurantoin Model Vehiclesmentioning

confidence: 99%

“…The found value is corresponding to those published in different official sources. [9][10][11][12][13][14][15][16][17][18] At this wavelength, the standard equation is:…”

Section: Preliminary Uv-vis Spectrophotometrical Determination Of Con...mentioning

confidence: 99%

Stability study of extemporaneously compounded nitrofurantoin oral suspensions for pediatric patients

Pehlivanov¹,

Stoeva²,

Simitchiev³

et al. 2022

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“…[12,13] Due to the legal regulations in some countries, the final cost of prepared extemporaneous syrups is high due to unregistered components for pharmaceutical use. [13,14] In this study, we focused on the cost analysis of antihypertensive pediatric formulations in Saudi Arabia. The rationale behind the New Vision of Saudi Arabia 2030 is to aim at privatization, determine the cost and the profits of these extemporaneous formulations and to compare the prices of different formulations and chose the cheapest one in preparing these formulations in the future.…”

Section: S3mentioning

confidence: 99%

Cost Analysis of Clinical Compounding in Saudi Arabia: Antihypertensive of Pediatric Formulations

Alomi¹,

Bahadig²,

Alhadab³

et al. 2019

IJPCS

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Objectives: The primary objective of this study was to explore cost analysis of pediatric formulations in Riyadh city, Saudi Arabia. Methods: This is a retrospective study of cost analysis of pediatric formulations at 300-bed pediatric and maternity hospital in Riyadh city, Saudi Arabia. The pharmacy section of this hospital receives the specific formulation from the physician. Then, the expert pharmacist applied the international standard for clinical compounding and provides services to the healthcare staff and patients over 8 hr per day for 5 days per week. The pediatric formulations consisted of but not limited to antibiotics, anti-tuberculosis (TB) medications and anti-hypertensive medications. The cost analysis included the variable expenses such as personal cost, material cost and supply cost and fixed expenses such as direct cost, non-salary cost and overhead cost. The cost was derived from the Ministry of Health information database. All costs used have been analyzed in US dollar currency. In this study, we analyzed the cost of antihypertensive medications for pediatric use through the Microsoft Excel software (version 10). Results: The estimated average total standard cost of pediatric formulations per hour was 53.82 USD and consisted of 58.58% (31.53 USD) for personal cost, 25.14% (13.53 USD) for overhead cost, 3.34% (1.8 USD) for material and supply cost and 12.93% (6.96 USD) for the non-salary cost. The average estimated cost of Propranolol, Captopril, Methyldopa, Amlodipine and Hydralazine per each preparation was 8.27 USD, 2.37 USD, 6.88 USD, 17.385 USD and 49.44 USD, respectively. Conclusion: To the best of our knowledge, this is the first study which demonstrated the cost analysis of antihypertensive pediatric formulation in the Kingdom of Saudi Arabia. The pediatric formulations with cost analysis can involve health insurance coverage. Targeting the cost analysis of all pediatric formulation is highly recommended to fit with Saudi vision 2030 in the Kingdom of Saudi Arabia.

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“…Ferreira et al prepared a SDZ formulation using SyrSpend ® SF PH4 and demonstrated stability for 120 days. However, these vehicles are not available in many countries and the final cost of the prepared extemporaneous suspensions is high; moreover, commercial suspending media are not registered for pharmaceutical use . Thus, it is indispensable to assess the stability of SDZ in suspensions, which could be prepared extemporaneously, easily and cheaply.…”

Section: Introductionmentioning

confidence: 99%

Stability of extemporaneous sulfadiazine oral suspensions from commercially available tablets for treatment of congenital toxoplasmosis

Costa

Nascimento

Amorim

et al. 2020

Tropical Med Int Health

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Objectives To determine the physicochemical and microbiological stability of sulfadiazine suspensions (100 mg/mL) in simple syrup (A) and sorbitol (B) formulations prepared from commercially available tablets. Methods An ultra‐performance liquid chromatographic assay was developed and validated to determine the chemical stability of sulfadiazine. Three samples were prepared and stored at 5 and 25 °C and assayed at 0, 7, 14 and 30 days. Physical parameters (appearance, pH, particle size and viscosity) were also monitored. Microbiological examination was performed through the suitable counting method. Results The formulations presented a sulfadiazine concentration of around 95% at the beginning at both temperatures. There was some variation in pH, viscosity and particle size distribution over time. The samples met the pharmacopoeia criteria of microbiological quality over 30 days, but only sulfadiazine formulated in syrup stored at 25 °C was suitable for use after one week. Conclusion The sulfadiazine suspension in simple syrup was chosen as the most suitable formulation because it demonstrated stability for 14 days at room temperature, providing an alternative liquid dosage form of sulfadiazine for congenital toxoplasmosis treatment.

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Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

Cited by 12 publications

References 11 publications

Stability study of extemporaneously compounded nitrofurantoin oral suspensions for pediatric patients

Stability study of extemporaneously compounded nitrofurantoin oral suspensions for pediatric patients

Cost Analysis of Clinical Compounding in Saudi Arabia: Antihypertensive of Pediatric Formulations

Stability of extemporaneous sulfadiazine oral suspensions from commercially available tablets for treatment of congenital toxoplasmosis

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