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

2019 ◽  
Vol 55 (5) ◽  
pp. 314-322
Author(s):  
Oriana Boscolo ◽  
Francesco Perra ◽  
Leandro Salvo ◽  
Fabián Buontempo ◽  
Silvia Lucangioli
Keyword(s):  
High Performance ◽  
Pediatric Patients ◽  
Hplc Method ◽  
Stability Study ◽  
Oral Formulations ◽  
Liquid Suspension ◽  
Oral Liquid ◽  
Microbiological Stability ◽  
Pediatric Use ◽  
Liquid 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.

scholarly journals Stability of 5 mg/mL Nitrendipine Oral Suspension in Syrspend® SF PH4

2018 ◽  
Vol 3 (1) ◽  
pp. 31-37
Author(s):  
Romain Bellay ◽  
Anne-Claire Bonnaure ◽  
Pauline Rault ◽  
Sophie Pertuisel ◽  
Marie-Antoinette Lester ◽  
...  
Keyword(s):  
High Performance ◽  
Generic Drugs ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Oral Suspension ◽  
Tablet Form ◽  
Microbiological Stability ◽  
Glass Bottles ◽  
Pediatric Use ◽  
Liquid Chromatographic

Abstract Background Nitrendipine is prescribed to children for the treatment of primary hypertension (off-label use). Available specialties (Nidrel®, Baypress® and others generic drugs) are only marketed in tablet form, which is unsuitable for pediatric use. A hospital preparation of nitrendipine oral suspension at 5 mg/mL was developed. The aim of the study was to determine physicochemical and microbiological stability of the nitrendipine oral suspension in order to set a shelf life for the preparation. Methods A validated high-performance liquid chromatographic (HPLC) method was developed for the assay of nitrendipine. Nitrendipine oral suspensions were prepared using 20 mg Nidrel® tablets and suspending vehicle Syrspend® SF PH4. These preparations were packaged in amber glass bottles and stored at room temperature. The physicochemical (pH, osmolality, nitrendipine concentration, macroscopic changes) and microbiological stability of the preparation was tested over 90 days. Nitrendipine concentration at day 0 was considered as 100 % and nitrendipine concentration in subsequent samples greater than 95 % were considered stable. Results The developed HPLC method was validated in terms of linearity, accuracy, precision and specificity. After 90 days, no significant pH and osmolality variation was observed. No microbial growth was noted. Concentrations of nitrendipine were found to be always higher 95 % of the initial concentration. Conclusions Nitrendipine oral suspensions 5 mg/mL are stable for at least 90 days when stored at temperature room and in amber glass bottles. This suspension is more suitable for children than tablets and allows obtaining accurate doses based on patient’s body weight.

Design and stability of pediatric oral formulation of imatinib

2021 ◽  
pp. 107815522199120
Author(s):  
Mélanie Hinterlang ◽  
Amandine Gendron ◽  
Thomas Fleury ◽  
André Rieutord ◽  
Anastasia Vrana ◽  
...  
Keyword(s):  
High Performance ◽  
Protein Tyrosine Kinase ◽  
Pediatric Patients ◽  
Kinase Inhibitor ◽  
Philadelphia Chromosome ◽  
Oral Solution ◽  
Stability Study ◽  
Uv Detector ◽  
Stability Parameters ◽  
Tablet Dosage

Background Imatinib is a protein-tyrosine kinase inhibitor which is currently only commercially available as a tablet dosage form in the strength of 100mg and 400mg. The elaboration of new oral liquid formulations is suitable in pediatrics and for patients who have difficulties to swallow, notably in the absence of commercial forms. This enables the adaptation of dosage and secure the administration. Objectives The formulation of an oral pediatric solution of imatinib at a concentration of 30 mg/mL and the evaluation of its stability for the treatment of pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia. Methods The physicochemical stability parameters: appearance, pH, osmolality, and drug content of formulation were evaluated for 30 days when stored at 2–8°C. Concentration of solution was measured with a validated method using high performance liquid chromatography (HPLC) coupled with an absorbance UV detector. Equally, microbiological stability was performed. Results The remaining imatinib concentration was at least 95% of the initial concentration after 30 days stored in fridge temperature. No changes were observed regarding the physical properties of the formulation during the study period. Conclusions The stability study showed that the imatinib oral solution at a concentration of 30 mg/mL provides an alternative option at the commercial tablet dosage forms for pediatric patients and patients who have difficulties to swallow.

scholarly journals Investigation of the Physical, Chemical and Microbiological Stability of Losartan Potassium 5 mg/mL Extemporaneous Oral Liquid Suspension

Molecules ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 301
Author(s):  
Lisa Foley ◽  
Jennifer Toney ◽  
James W. Barlow ◽  
Maura O’Connor ◽  
Deirdre Fitzgerald-Hughes ◽  
...  
Keyword(s):  
Shelf Life ◽  
Storage Conditions ◽  
Losartan Potassium ◽  
Microbial Count ◽  
E Coli ◽  
Physical Chemical ◽  
Liquid Suspension ◽  
Oral Liquid ◽  
Microbiological Stability ◽  
Stability Data

Extemporaneous oral liquid preparations are commonly used when there is no commercially available dosage form for adjustable dosing. In most cases, there is a lack of stability data to allow for an accurately assigned shelf life and storage conditions to give greater confidence of product safety and efficacy over its shelf life. The aim of this study was to evaluate the physical, chemical and microbiological stability of an extemporaneous oral liquid suspension of losartan potassium, 5 mg/mL, used to treat paediatric hypertension in Our Lady’s Children’s Hospital Crumlin, Ireland. The losartan content of extemporaneous oral suspensions, prepared with and without addition of water, was measured by UV and confirmed by HPLC analysis. Suspensions were stored at 4 °C and room temperature (RT) and were monitored for changes in; pH, colour, odour, re-dispersibility, Total Aerobic Microbial Count, Total Yeast and Mould Count and absence of E. coli. Results showed that suspensions prepared by both methods, stored at 4 °C and RT, were physically and microbiologically stable over 28 days. Initial losartan content of all suspensions was lower than expected at 80–81% and did not change significantly over the 28 days. HPLC and NMR did not detect degradation of losartan in the samples. Suspensions prepared in water showed 100% losartan content. The reduced initial losartan content was confirmed by HPLC and was related to the acidic pH of the suspension vehicle. Physiochemical properties of the drug are important factors for consideration in the selection of suspension vehicle for extemporaneous compounding of oral suspensions as they can influence the quality, homogeneity and efficacy of these preparations.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF β-ACETYLDIGOXIN

2016 ◽  
Vol 9 (1) ◽  
pp. 54
Author(s):  
Megha Sharma ◽  
Neeraj Mahindroo
Keyword(s):  
High Performance ◽  
Degradation Products ◽  
Hplc Method ◽  
Stability Study ◽  
Array Detector ◽  
Forced Degradation ◽  
Simple Method ◽  
Stability Indicating ◽  
Rp Hplc

Objective: The objective of the present study was to develop and validate a novel stability indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for determination of β-acetyldigoxin, an active pharmaceutical ingredient (API).Methods: The chromatographic separation was carried out on Agilent Technologies 1200 series HPLC system equipped with photo diode array detector and C-18 (4.6x250 mm, 5 µ) column. The mobile phase consisted of water: acetonitrile (65:35 v/v), delivered at a flow rate of 1.5 ml/min and eluents were monitored at 225 nm.Results: The retention time of β-acetyldigoxin was 9.2 min. The method was found to be linear (R2= 0.9995) in the range of 31.25-500 µg/ml. The accuracy studies showed the mean percent recovery of 101.02%. LOD and LOQ were observed to be 0.289 µg/ml and 0.965 µg/ml, respectively. The method was found to be robust and system suitability testing was also performed. Forced degradation analysis was carried out under acidic, alkaline, oxidative and photolytic stress conditions. Significant degradation was observed under tested conditions, except for oxidative condition. The method was able to separate all the degradation products within runtime of 20 min and was able to determine β-acetyldigoxin unequivocally in presence of degradation products.Conclusion: The novel, economic, rapid and simple method for analysis of β-acetyldigoxin is reported. The developed method is suitable for routine quality control and its determination as API, and in pharmaceutical formulations and stability study samples.

scholarly journals Stability and Compatibility of Diphenhydramine Hydrochloride in Intravenous Admixtures: A New Look at an Old Drug

2018 ◽  
Vol 54 (5) ◽  
pp. 330-334
Author(s):  
Daniel Sabins ◽  
Tuong Diep ◽  
Pamela McCartan ◽  
Shashi Patel ◽  
Fang Zhao
Keyword(s):  
Sodium Chloride ◽  
High Performance ◽  
Hplc Method ◽  
Stability Study ◽  
Limited Data ◽  
Diphenhydramine Hydrochloride ◽  
Drug Concentrations ◽  
The Stability ◽  
Initial Drug ◽  
Predetermined Time

Purpose: Intravenous (IV) admixtures of diphenhydramine are widely used in hospitalized patients to prevent or treat hypersensitivity reactions. However, there is limited data to support the admixture preparation in this manner. This study was designed to investigate the stability and compatibility of diphenhydramine in IV admixtures with a goal to establish a 14-day beyond-use dating with storage under refrigeration. Methods: The commercially available 50 mg/mL diphenhydramine hydrochloride injection vials were used to prepare the 0.2 and 1.0 mg/mL IV admixtures in 0.9% sodium chloride injection and 5% dextrose injection in 50 mL polyvinyl chloride (PVC) bags. The IV bags were sealed and stored under refrigeration (2°C-8°C) for the stability study. At each predetermined time point, samples were taken for visual inspection, pH measurement, and analysis by a stability-indicating high-performance liquid chromatography (HPLC) method. Results: The freshly prepared IV admixtures appeared clear, colorless, and particulate-free with pH readings of 4.44 to 4.60. The initial drug concentrations of all samples were confirmed by HPLC to be within 101.8% to 103.6% of the label claims. Over the 14 days of the study period, there was no significant change in the appearance or pH values for all stability samples. The HPLC results also confirmed that there was no more than ±2% change of the initial drug concentration in any stability samples. Conclusion: Diphenhydramine hydrochloride IV admixtures of 0.2 and 1.0 mg/mL are compatible with 0.9% sodium chloride injection and 5% dextrose injection in PVC bags. These IV admixtures are stable chemically and physically for up to 14 days when stored under refrigeration (2°C-8°C).

scholarly journals Evaluation of Physical-Chemical and Microbiological Stability of Fluconazole Oral Suspensions for Hospital Use

2020 ◽  
Vol 4 (1) ◽  
pp. 39-43
Author(s):  
Camilo Marques D'Amore ◽  
Elisa De Saldanha Simon ◽  
Martin Steppe
Keyword(s):  
Analytical Method ◽  
High Performance ◽  
Active Pharmaceutical Ingredient ◽  
Oral Formulation ◽  
Porto Alegre ◽  
Pet Bottles ◽  
Physical Chemical ◽  
Oral Liquid ◽  
Microbiological Stability ◽  
New Formulation

Fluconazole is an important drug in the treatment of cutaneous and systemic mycoses. The Hospital de Clínicas de Porto Alegre performs a derivation of fluconazole capsules to obtain an oral liquid formulation that is easily administered and whose dose can be adjusted. In order to replace the derivation for a formulation produced from an active pharmaceutical ingredient, this study sought to develop a liquid oral formulation, evaluate its physical chemical and microbiological stability and demonstrate suitability of the analytical method for the formulation assay. Seven different formulations of pharmaceutical suspension form were produced and evaluated for pH, viscosity, sedimentation volume and assay. The analytical method by High Performance Liquid Chromatography was demonstrated. Two most promising formulations were manipulated in the Farmácia Semi-Industrial do Hospital de Clínicas de Porto Alegre and stored in amber PET bottles under three different conditions: room temperature, under refrigeration (2 to 8 ºC) and in an oven (40 ° C). Samples were collected after 0, 7 and 14 days to evaluate physical-chemical stability, assay, pH and macroscopic aspects. Samples were collected after 0 and 21 days to evaluate microbiological stability. It was possible to demonstrate stability for one of the formulations for a 14-day period. Throughout the study, the chosen formulation presented adequate quantification of fluconazole, constant pH, no organoleptic changes and no microbial growth. The results suggest the incorporation of a new formulation for fluconazole to the Farmacia Semi-Industrial portfolio).

Stability-indicating HPLC method to determine the stability of extemporaneously prepared vancomycin oral solution cups

2021 ◽  
Author(s):  
Ankit Rochani ◽  
Vinh Nguyen ◽  
Robin Becker ◽  
Gagan Kaushal
Keyword(s):  
Relative Humidity ◽  
High Performance ◽  
Room Temperature ◽  
Hplc Method ◽  
Oral Solution ◽  
Hplc Assay ◽  
Stability Indicating ◽  
Oral Formulations ◽  
Unit Dose ◽  
The Stability

Abstract Purpose To determine the stability of compounded sweetened vancomycin oral formulations in plastic unit dose cups stored up to 180 days under 2 temperature conditions: refrigeration (2°C-6°C) and room temperature (25°C with 60% relative humidity). Methodology A stability-indicating high-performance liquid chromatography (HPLC) method was developed to analyze vancomycin in the presence of degradation peaks. The stability of extemporaneously compounded vancomycin solution stored in oral unit dose cups was investigated using this method. The tested vancomycin oral solutions were compounded formulations of 125 mg/2.5 mL and 500 mg/10 mL. Three oral unit dose cups from each storage condition were withdrawn and assessed for stability on days 0, 3, 7, 15, 22, 30, 90, 120, 150, and 180 as per United States Pharmacopeia guidelines. The assay of vancomycin was carried out by using a calibrated stability-indicating HPLC method. Results The stability-indicating HPLC assay showed that vancomycin completely degraded within 2 hours when exposed to highly acidic or basic pH conditions. No precipitation, cloudiness, or color changes were observed during the study under either temperature condition. The HPLC assay revealed that vancomycin oral solution cups retained greater than 90% of the initial concentrations of vancomycin for 30 days when stored at room temperature (25°C and 60% relative humidity) and for 180 days with refrigeration (2°C-6°C). Conclusion Vancomycin oral formulations were stable for long-term storage periods beyond those specified in manufacture guidelines. Our data suggests the extended stability of vancomycin oral solutions compounded for hospital use can be extended.

An Exploratory Study of a New Vancomycin Eye Drops Formulation for Extemporaneous Compounding

2020 ◽  
pp. 001857872097388
Author(s):  
Pang Chen ◽  
Zin Mar ◽  
Anthony Giannetti ◽  
Susan Hughes ◽  
Justine Gilbert ◽  
...  
Keyword(s):  
High Performance ◽  
Antimicrobial Prophylaxis ◽  
Hplc Method ◽  
Stability Study ◽  
Initial Time ◽  
Eye Drops ◽  
Sterility Testing ◽  
Vancomycin Hydrochloride ◽  
Drug Concentrations ◽  
New Formulation

Purpose: Compounded eye drop solutions of vancomycin hydrochloride have important clinical applications, such as postoperative antimicrobial prophylaxis and bacterial keratitis. There exists a plethora of data to support the use of various liquid vehicles to compound vancomycin hydrochloride eye drops. However, there are a number of limitations for implementation, especially the frequent shortage or discontinuation of the vehicle products. This study was designed to investigate the use of an OTC eye wash product as the evergreen vehicle and to evaluate the physical and chemical stability of the new formulation. Methods: The Advance Eye Relief® eye wash and vancomycin hydrochloride for injection vials were used to prepare 10 and 50 mg/mL vancomycin eye drop solutions. The solutions were packaged in Steri-Droppers® bottles and stored in a freezer for 14 days followed by 28 days in refrigeration. The 14-day period of freezing was included to allow time for sterility testing. At pre-determined stability time points, samples were taken for visual inspection, pH and osmolality measurement, and analysis by a stability-indicating high performance liquid chromatography (HPLC) method. Results: Freshly prepared vancomycin eye drops were clear, colorless, and free of particulates. The pH readings were 7.03 and 6.28 for the 10 and 50 mg/mL solutions, respectively. The osmolality of both solutions were within the range of 300-330 mOsmol/kg and considered isotonic. Initial drug concentrations of all samples were confirmed by HPLC to be within 100%-103% of the label claims. Throughout the stability study period, there were no significant changes in the appearance, pH, or osmolality of any samples. The HPLC results also confirmed that the drug concentrations in all stability samples were within 98%-101% of the initial time zero values and no significant degradation product peaks were observed. Conclusion: A new compounded vancomycin eye drop formulation was developed to mitigate vehicle sourcing issues. This eye drop formulation was easy to prepare, exhibited satisfactory properties for ophthalmic applications, and remained stable chemically and physically when stored for 14 days in freezer followed by 28 days in refrigerator.

Physicochemical and microbiological stability of two new oral liquid formulations of clonidine hydrochloride for pediatric patients

2018 ◽  
Vol 24 (4) ◽  
pp. 465-478
Author(s):  
V. Merino-Bohórquez ◽  
M. Delgado-Valverde ◽  
M. García-Palomo ◽  
M.C. Dávila-Pousa ◽  
C. Cañete ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Oral Liquid ◽  
Clonidine Hydrochloride ◽  
Microbiological Stability

scholarly journals Pharmacokinetic comparisons of S-oxiracetam and R-oxiracetam in beagle dogs

2016 ◽  
Vol 66 (2) ◽  
pp. 279-287 ◽  
Author(s):  
Wusan Wang ◽  
Hui Ji ◽  
Tingting Li ◽  
Yuanwei Jia ◽  
Haitang Xie
Keyword(s):  
High Performance ◽  
Conformational Stability ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Stability Study ◽  
Normal Phase ◽  
Pharmacokinetic Analysis ◽  
Beagle Dogs ◽  
Random Crossover ◽  
Liquid Chromatographic

Abstract A pharmacokinetic comparison and conformational stability study of S-oxiracetam (S-ORT) and R-oxiracetam (R-ORT) in beagle dogs was used to investigate the possible mechanism of different effects of two oxiracetam enantiomers through a random crossover design. After drug administration to beagle dogs, blood samples were collected at different time points for pharmacokinetic analysis using the UPLC-ESI-MS/MS method. Parts of plasma samples were used for conformation transformation studies using a normal phase high performance liquid chromatographic (NP HPLC) method. The study showed that oxiracetam enantiomers maintained their original conformation when administered orally to beagle dogs. Concentrations of S-ORT were significantly higher than R-ORT 1.5 and 2 h after administration; the AUC0-∞ of S-ORT after oral administration tended to be higher than that of R-ORT, which showed that the different effects between S-ORT and R-ORT may be partly associated with their distinctive absorption at least.

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