Stability of extemporaneously prepared rosuvastatin oral suspension

2017 ◽  
Vol 74 (19) ◽  
pp. 1579-1583 ◽  
Author(s):  
Abdel Naser Zaid ◽  
Rania Shtayah ◽  
Ayman Qadumi ◽  
Mashour Ghanem ◽  
Rawan Qedan ◽  
...  
Keyword(s):  
Relative Humidity ◽  
High Performance ◽  
Room Temperature ◽  
Microbial Contamination ◽  
Active Pharmaceutical Ingredient ◽  
Storage Conditions ◽  
Dissolution Profile ◽  
Stability Studies ◽  
Organoleptic Properties ◽  
The Stability

Abstract Purpose The stability of an extemporaneously prepared rosuvastatin suspension stored over 30 days under various storage conditions was evaluated. Methods Rosuvastatin suspension was extemporaneously prepared using commercial rosuvastatin tablets as the source of active pharmaceutical ingredient. The organoleptic properties, dissolution profile, and stability of the formulation were investigated. For the stability studies, samples of the suspension were stored under 2 storage conditions, room temperature (25 °C and 60% relative humidity) and accelerated stability chambers (40 °C and 75% relative humidity). Viscosity, pH, organoleptic properties, and microbial contamination were evaluated according to the approved specifications. High-performance liquid chromatography was used for the analysis and quantification of rosuvastatin in selected samples. Microbiological investigations were also conducted. Results The prepared suspension showed acceptable organoleptic properties. It showed complete release of rosuvastatin within 15 minutes. The pH of the suspension was 9.8, which remained unchanged during the stability studies. The microbiological investigations demonstrated that the preparation was free of any microbial contamination. In addition, the suspension showed stability within at least the period of use of a 100-mL rosuvastatin bottle. Conclusion Extemporaneously prepared rosuvastatin 20-mg/mL suspension was stable for 30 days when stored at room temperature.

scholarly journals Stability of the Combination of Ceftazidime and Cephazolin in Icodextrin or PH Neutral Peritoneal Dialysis Solution

2014 ◽  
Vol 34 (2) ◽  
pp. 212-218 ◽  
Author(s):  
Rahul P. Patel ◽  
Madhur D. Shastri ◽  
Mohammad Bakkari ◽  
Troy Wanandy ◽  
Matthew D. Jose
Keyword(s):  
Peritoneal Dialysis ◽  
Body Temperature ◽  
High Performance ◽  
Room Temperature ◽  
Storage Conditions ◽  
Initial Concentration ◽  
Dialysis Solution ◽  
Different Temperatures ◽  
Colour Changes ◽  
The Stability

IntroductionThe objective of this study was to investigate the stability of ceftazidime and cephazolin in a 7.5% icodextrin or pH neutral peritoneal dialysis (PD) solution.MethodsCeftazidime and cephazolin were injected into either a 7.5% icodextrin or pH neutral PD bag to obtain the concentration of 125 mg/L of each antibiotic. A total of nine 7.5% icodextrin or pH neutral PD bags containing ceftazidime and cephazolin were prepared and stored at 1 of 3 different temperatures: 4°C in a domestic refrigerator; 25°C at room temperature; or 37°C (body temperature) in an incubator. An aliquot was withdrawn immediately before (0 hour) or after 12, 24, 48, 96, 120, 144, 168 and 336 hours of storage. Each sample was analyzed in duplicate for the concentration of ceftazidime and cephazolin using a stability-indicating high-performance liquid chromatography technique. Ceftazidime and cephazolin were considered stable if they retained more than 90% of their initial concentration. Samples were also assessed for pH, colour changes and evidence of precipitation immediately after preparation and on each day of analysis.ResultsCeftazidime and cephazolin in both types of PD solution retained more than 90% of their initial concentration for 168 and 336 hours respectively when stored at 4°C. Both of the antibiotics lost more than 10% of the initial concentration after 24 hours of storage at 25 or 37°C. There was no evidence of precipitation at any time under the tested storage conditions. Change in the pH and color was observed at 25 and 37°C, but not at 4°C.ConclusionPremixed ceftazidime and cephazolin in a 7.5% icodextrin or pH neutral PD solution is stable for at least 168 hours when refrigerated. This allows the preparation of PD bags in advance, avoiding the necessity for daily preparation. Both the antibiotics are stable for at least 24 hours at 25 and 37°C, permitting storage at room temperature and pre-warming of PD bags to body temperature prior to its administration.

The Effect of Temperature on the Stability of In-Use Insulin Pens

2019 ◽  
Author(s):  
Tanawan Kongmalai ◽  
Lukana Preechasuk ◽  
Sarawut Junnu ◽  
Siriphan Manocheewa ◽  
Chatchawan Srisawat ◽  
...  
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Storage Conditions ◽  
Effect Of Temperature ◽  
Nph Insulin ◽  
Acting Insulin ◽  
Cyclic Temperature ◽  
Insulin Pens ◽  
The Stability ◽  
Long Acting

Abstract Background Improper storage of insulin could decrease its potency. Manufacturers recommend that in-use insulin pens should be kept at between 25–30°C, but room temperature in tropical countries often exceeds this range. This study investigates the effect of temperature on the stability of basal insulin in cartridges 28 days after opening. Methods Four different basal insulins were evaluated. Five opened pens of each insulin type were included for each of three storage conditions and 5 unopened insulin pens of each type were stored in the refrigerator as a control. The opened pens were stored for 28 days in either a refrigerator (2–8 °C), at room temperature, or in an incubator (37 °C). Each day insulin pens were mixed 20 times and 2 units were discarded to mimic daily usage. Insulin quantity was evaluated using an ultra-high-performance liquid chromatography assay. Results The average room temperature during the study period was 29.7 °C. After 28 days, the percentage amount of insulin stored at refrigerator, room temperature or incubator, compared with control was 99.0, 99.7, 101.1% for long-acting insulin; 97.4, 97.2, 99.0% for NPH-1; 101.4, 101.5, 100.7% for NPH-2; and 98.7, 97.8, 98.5% for NPH-3. There were no statistically significant differences. However, we observed a trend toward different stability between clear insulin analog and turbid NPH insulin. Conclusions Temperature as high as 37°C and cyclic temperature,had no effect on the stability of in-use insulin pen.

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.

scholarly journals STABILITY STUDIES ON FLUCLOXACILLIN SODIUM IN RECONSTITUTED ORAL SUSPENSIONS

2018 ◽  
Vol 10 (9) ◽  
pp. 21
Author(s):  
Michael Worlako Klu ◽  
John Antwi Apenteng ◽  
Bright Selorm Addy ◽  
David Ntinagyei Mintah ◽  
Elikem Katsekpor
Keyword(s):  
Room Temperature ◽  
Tap Water ◽  
Storage Conditions ◽  
Bottled Water ◽  
Distilled Water ◽  
Stability Studies ◽  
Time Intervals ◽  
The Stability ◽  
Predetermined Time ◽  
Sachet Water

Objective: Stability studies on flucloxacillin sodium in reconstituted oral suspensions were carried out. The experiment sought to investigate the effects that the different types of water for reconstitution and different storage conditions have on the stability of flucloxacillin sodium in the reconstituted suspensions.Methods: Suspensions of flucloxacillin sodium were reconstituted with tap water, commercial bottled water (Voltic brand was used), commercial sachet water (Everpure brand was used) treated tap water and distilled water and stored under refrigeration (RF) (4-6 °C), at room temperature (RT) (31-33 °C) and in a bowl of water (BW) (26-27 °C). Assay of flucloxacillin sodium was by iodimetry at predetermined time intervals for 8 d.Results: The amount of flucloxacillin sodium in all the suspensions stored under the various storage conditions reduced with time and at different rates. The percentage breakdown, a parameter of stability, was calculated for each reconstituted suspension stored at the different conditions investigated and they were as follows: commercial bottled water (RT-22.40 %, RF-9.90 % and BW-15.90 %), distilled water (RT-29.14 %, RF-18.0 %, BW-28.80 %), tap water (RT-25.0%, RF-14.60 % and BW-25.10 %) and commercial sachet water (RT-25.0 %, RF-10.17 % and BW-22.50 %).Conclusion: At the end of the study, it was found that those suspensions reconstituted with the commercial bottled water were the most stable and had the smallest breakdown of flucloxacillin sodium whereas those reconstituted with distilled water were the least stable and had the largest breakdown of flucloxacillin sodium. Commercial sachet water reconstituted more stable suspensions than tap water. Also, the suspensions stored under refrigeration were the most stable followed by those stored in a bowl of water. The formulations kept at room temperature were the least stable and thus, had the largest breakdown of flucloxacillin sodium.

scholarly journals EVALUATION OF THE STABILITY OF VIGABATRIN IN HOSPITALAR EXTEMPORANEOUS FORMULATIONS

2019 ◽  
Vol 3 (1) ◽  
pp. 51-60
Author(s):  
Marcio Vinicius Ayres ◽  
Sarah Chagas Campanharo ◽  
Elfrides Schapoval ◽  
Nathalie Ribeiro Wingert ◽  
Martin Steppe
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Storage Time ◽  
Storage Conditions ◽  
Time Interval ◽  
Ph Change ◽  
British Pharmacopoeia ◽  
Pet Bottles ◽  
Different Temperatures ◽  
The Stability

The aim of this study was to analyze the chemical stability of the anticonvulsant vigabatrin extemporaneous formulation from tablets in storage conditions of different temperatures and types of packaging used. The analysis of vigabatrin extemporaneous formulations were performed by high-performance liquid chromatography (HPLC). The method described in British Pharmacopoeia was co-validated for specificity, linearity, precision and accuracy. Vigabatrin extemporaneous solutions were prepared in triplicate and placed in amber glass and PET bottles, which were stored under three different conditions: at room temperature (15 to 30 °C), under refrigeration (2 to 8 °C), and oven (40 °C). Samples of solutions stored at room temperature and refrigeration were collected every 7 days along 35 days. The same was done for solutions kept at 40 °C, but for a period of 28 days. It was also analyzed the solutions pH in each sampling time. Vigabatrin extemporaneous solutions showed variations within the limits of British Pharmacopoeia 2016 up to 21 days in amber PET and glass bottles at room and refrigerated temperatures. Vigabatrin content for formulations kept in oven decreased above 10% after 7 days of study. The lowest pH change occurred in amber glass bottle stored under refrigeration. Results of this study will be applied as a reference for vigabatrin extemporaneous formulation in hospital, once it was demonstrated the reliability of storage time interval and proper conditions for the use. Thus, pediatric patients with fractionated doses or use of nasogastric probe will have adequately prepared extemporaneous formulations, reducing the risk of dilution errors and microbiological contamination, improving the efficacy and safety, and enabling more time for nursing assistance.  

scholarly journals Stability Evaluation of Extemporaneously Compounded Vancomycin Ophthalmic Drops: Effect of Solvents and Storage Conditions

Pharmaceutics ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 289
Author(s):  
Christopher Ross ◽  
Basir Syed ◽  
Joanna Pak ◽  
Vishal Jhanji ◽  
Jason Yamaki ◽  
...  
Keyword(s):  
Normal Saline ◽  
High Performance ◽  
Hplc Analysis ◽  
Room Temperature ◽  
Storage Temperature ◽  
Storage Conditions ◽  
Drug Of Choice ◽  
Initial Ph ◽  
The Stability ◽  
Saline Solutions

Vancomycin is the drug of choice for methicillin-resistant Staphylococcus aureus keratitis and other ocular infections. Vancomycin ophthalmic drops are not commercially available and require compounding. The present study was designed to investigate the stability of vancomycin ophthalmic drops in normal saline, phosphate-buffered saline (PBS), and balanced salt solution (BSS) while stored at room temperature or under refrigeration. Vancomycin ophthalmic drops (50 mg/mL) were aseptically prepared from commercially available intravenous powder using PBS, BSS, and saline. Solutions were stored at room temperature and in a refrigerator for 28 days. The vancomycin stability was tested by a microbiology assay and high-performance liquid chromatography HPLC analysis immediately after formulation and at days 7, 14, and 28 after storage at room temperature or under refrigeration. The pH, turbidity was also tested. Vancomycin formulations in PBS, BSS and normal saline had initial pH of 5; 5.5; 3 respectively. The formulation in PBS developed turbidity and a slight decrease in pH upon storage. Microbiological assay did not show any change in zone of inhibition with any of the formulation upon storage either at room temperature or under refrigeration. HPLC analysis did not detect any decrease in vancomycin concentration or the accumulation of degraded products in any of the formulations upon storage either at room temperature or under refrigeration. Vancomycin ophthalmic drops prepared using PBS, BSS, and normal saline were stable up to the tested time point of 28 days, irrespective of their storage temperature.

Stability of dronabinol capsules when stored frozen, refrigerated, or at room temperature

2016 ◽  
Vol 73 (14) ◽  
pp. 1088-1092 ◽  
Author(s):  
Michael F. Wempe ◽  
Alan Oldland ◽  
Nancy Stolpman ◽  
Tyree H. Kiser
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Oxidative Degradation ◽  
Storage Condition ◽  
Sesame Oil ◽  
Forced Degradation ◽  
Product Packaging ◽  
Time Points ◽  
The Stability ◽  
Minimal Reduction

Abstract Purpose Results of a study to determine the 90-day stability of dronabinol capsules stored under various temperature conditions are reported. Methods High-performance liquid chromatography (HPLC) with ultraviolet (UV) detection was used to assess the stability of dronabinol capsules (synthetic delta-9-tetrahydrocannabinol [Δ9-THC] mixed with high-grade sesame oil and other inactive ingredients and encapsulated as soft gelatin capsules) that were frozen, refrigerated, or kept at room temperature for three months. The dronabinol capsules remained in the original foil-sealed blister packs until preparation for HPLC–UV assessment. The primary endpoint was the percentage of the initial Δ9-THC concentration remaining at multiple designated time points. The secondary aim was to perform forced-degradation studies under acidic conditions to demonstrate that the HPLC–UV method used was stability indicating. Results The appearance of the dronabinol capsules remained unaltered during frozen, cold, or room-temperature storage. Regardless of storage condition, the percentage of the initial Δ9-THC content remaining was greater than 97% for all evaluated samples at all time points over the three-month study. These experimental data indicate that the product packaging and the sesame oil used to formulate dronabinol capsules efficiently protect Δ9-THC from oxidative degradation to cannabinol; this suggests that pharmacies can store dronabinol capsules in nonrefrigerated automated dispensing systems, with a capsule expiration date of 90 days after removal from the refrigerator. Conclusion Dronabinol capsules may be stored at room temperature in their original packaging for up to three months without compromising capsule appearance and with minimal reduction in Δ9-THC concentration.

scholarly journals THE INFLUENCE OF THE STORAGE CONDITIONS OF RAW MATERIALS ON THE PRESERVATION OF THE PROPERTIES OF THE FUR SEMI-FINISHED PRODUCT

2021 ◽  
Vol 53 (3) ◽  
pp. 52-58
Author(s):  
Natalya P. Bodryakova
Keyword(s):  
Elevated Temperature ◽  
Relative Humidity ◽  
Raw Materials ◽  
Storage Conditions ◽  
Strength Properties ◽  
Biological Factor ◽  
Point Scale ◽  
Complex Characteristic ◽  
Characteristic Features ◽  
The Stability

This article deals with the problem of preserving the properties of a semi-finished fur product under the influence of a biological factor during the storage of raw materials. The characteristic features of the biodegradation of untreated rabbit skins during storage at elevated temperature and relative humidity are identified and described. A complex characteristic of a semi-finished fur product developed from raw materials of various degrees of microbiological spoilage is given. The author offers a point scale of assessment dynamics of the processes of destruction of fur raw materials and a point assessment of the organoleptic indicators of the semi-finished product was developed. As a result of comprehensive studies, it was found that the degree of damage to the fur raw materials being processed affects the decrease in the stability of the structure and strength properties of the finished semi-finished product.

scholarly journals FORMULATION, CHARACTERIZATION AND STABILITY STUDY OF FAST DISSOLVING THIN FILM CONTAINING ASTAXANTHIN NANOEMULSION USING HYDROXYPROPYLMETHYL CELLULOSE POLYMER

2021 ◽  
pp. 17-22
Author(s):  
LUSI NURDIANTI ◽  
IYAN SOPYAN ◽  
TAOFIK RUSDIANA
Keyword(s):  
Thin Film ◽  
Mechanical Characteristics ◽  
Storage Conditions ◽  
Stability Study ◽  
Matrix System ◽  
Stability Studies ◽  
Casting Method ◽  
Hydroxypropylmethyl Cellulose ◽  
The Stability ◽  
Physical And Mechanical Characteristics

Objective: The present study was conducted to formulate and characterize the thin film containing astaxanthin nanoemulsion (TF-ASN) using Hydroxypropylmethyl Cellulose (HPMC) polymer as a film matrix system. The stability studies in different storage conditions were also performed. Methods: Astaxanthin nanoemulsion (As-NE) was prepared by using self-nanoemulsifying method, followed by incorporation into the HPMC matrix system by solvent casting method to forming TF-ASN. Evaluation of TF-ASN was performed by physical and mechanical characterizations. Stability study was carried out in both of accelerated (temperature of 40±2 °C/75±5% RH) and non-accelerated (at ambient temperature) conditions. Assay of astaxanthin in individual TF-ASN was determined compared to pure astaxanthin. Results: TF-ASN had good physical and mechanical characteristics that suitable for intraoral administration. Conclusion: For the study of stability under different storage conditions, it was proven that nanoemulsion form was packed in a HPMC matrix could enhance the stability of the astaxanthin.

scholarly journals The Effect of Ultrasound, Oxygen and Sunlight on the Stability of (−)-Epigallocatechin Gallate

Molecules ◽  
2018 ◽  
Vol 23 (9) ◽  
pp. 2394 ◽  
Author(s):  
Jiajun Zeng ◽  
Huanhua Xu ◽  
Yu Cai ◽  
Yan Xuan ◽  
Jia Liu ◽  
...  
Keyword(s):  
Aqueous Solution ◽  
High Performance ◽  
Room Temperature ◽  
Degradation Rate ◽  
Epigallocatechin Gallate ◽  
Important Conclusion ◽  
Beneficial Effects ◽  
Periodontal Infection ◽  
The Stability ◽  
Ultrasonic Conditions

(−)-Epigallocatechin gallate (EGCG), is the main catechin found in green tea, and has several beneficial effects. This study investigated the stability of EGCG aqueous solution under different stored and ultrasonic conditions to determine whether it can be used with an ultrasonic dental scaler to treat periodontal infection. Four concentrations (0.05, 0.1, 0.15, 2 mg/mL) of EGCG aqueous solution were prepared and stored under four different conditions (A: Exposed to neither sunlight nor air, B: Exposed to sunlight, but not air, C: Not exposed to sunlight, but air, D: Exposed to sunlight and air) for two days. The degradation rate of EGCG was measured by high performance liquid chromatography (HPLC). On the other hand, an ultrasonic dental scaler was used to atomize the EGCG solution under four different conditions (a: Exposed to neither air nor sunlight, b: Not exposed to air, but sunlight, c: Not exposed to sunlight, but air, d: Exposed to air and sunlight), the degradation of EGCG was measured by HPLC. We found that the stability of EGCG was concentration-dependent in water at room temperature. Both sunlight and oxygen influenced the stability of EGCG, and oxygen had a more pronounced effect on stability of EGCG than sunlight. The most important conclusion was that the ultrasound may accelerate the degradation of EGCG due to the presence of oxygen and sunlight, but not because of the ultrasonic vibration. Thus, EGCG aqueous solution has the potential to be used through an ultrasonic dental scaler to treat periodontal infection in the future.

Sign in / Sign up

Export Citation Format

Share Document