Amber Glass Bottles Research Articles

Stability study of oral pediatric idebenone suspensions

Adapted forms for administration to infants are limited. The proposed study was performed to propose oral liquid formulations of idebenone in Ora-Plus and either Ora-Sweet or Ora-Sweet SF, Ora-Blend, Ora-Blend SF and Inorpha. Each formulation was stored in 30 ml amber glass bottle at 5 or 25 °C for 90 days. Idebenone contents in these suspensions, determined by a stability-indicating high-performance liquid chromatography method, remained stable at least 90 days in Inorpha when stored at the two temperatures. In Ora-Blend, the stability was estimated at 14 days and in other suspensions at 20 days at the two temperatures. After 90 days storage, the pH of Ora-Plus and Ora-Sweet or Ora-Sweet SF changed between −0.10 and −0.25 units. For others suspensions, the pH changes were not significant (< −0.09 unit). No change was observed in color, odor or visual microbiology. To conclude, we recommended the use of idebenone in Inorpha vehicle stable for at least 90 days at 25 °C.

Glass container production planning with warm-ups and furnace extraction variation losses

This article considers the challenging problem of production lot sizing and scheduling that arises in the glass container industry. In such manufacturing environment, a furnace operates continuously feeding its attendant container forming machines with melted glass. Setups in the aforementioned machines interrupt the melted glass flow and, hence, the glass paste undergoes a heat loss. Consequently, a warm-up process is needed after each setup changeover. In addition, setups can affect the furnace output (total amount of glass extracted from the furnace) resulting in extraction variation losses. Both warm-ups and furnace extraction variations prevent the capacity of machines from being fully used and incur in additional costs. This study addresses such specificities for the first time in lot sizing and scheduling literature by introducing a novel integer programming model, which represents the problem appropriately, and a variable neighborhood search (VNS) solution method. A relevant case study conducted in an amber glass bottle plant shows that the model is able to comprise the problem requirements, and the VNS produces good-quality solutions in reasonable computational times. The reproducibility of the results is ensured by additional experiments involving artificial instances.

Color, physicochemical parameters and antioxidant potential of whole grape juices subject to different UV-C radiation doses

ABSTRACT Knowing that moderate stress such as UV radiation can activate defense mechanisms in plants, the use of UV-C radiation appears as hypothesis of a promising technique that would help to stimulate and enhance beneficial compounds for health, through a clean and healthy technology. In this study, the possible induction of secondary metabolism, the increase in the content of phytochemical compounds and physicochemical changes through the use of UV-C radiation were evaluated on whole grape juices produced with Vitis labrusca grapes, cultivar Isabel Precoce. Grapes were harvested, sanitized, exposed to UV-C radiation at doses of 0, 2, 4 and 6 KJ m-2, and then the juices were prepared and packed into amber glass bottles at room temperature. Analyses were performed at 0, 30, 60, 90 and 120 days of storage. Based on results obtained and conditions in which the experiment was performed, UV-C treatment in grapes caused abiotic stress in the fruits, affecting color, titratable acidity, soluble solids/titratable acidity ratio, vitamin C and percentage of protection against oxidation. Application of UV-C did not change levels of phenolic compounds in fruit juices or the percentage of scavenging free radicals, pH and soluble solids.

Production and evaluation of a reference material for moisture, ash, and total fat mass fractions, and titratable acidity in whole milk powder

Given the importance of reference materials (RM) in the structuring and maintenance of quality management systems for food analysis laboratories, RM were produced for the measurement of moisture, ash, total fat, and titratable acidity in whole milk powder. Two types of packaging and three storage temperatures were evaluated. The RM were considered homogeneous. The materials that were packaged in the pouches and those packaged in the amber glass bottles with screw caps (stored at room temperature) were not stable for moisture. Nevertheless, considering the four measurands, the amber glass bottles under refrigeration and freezing temperatures were the best packaging and storage conditions, respectively. Homogeneity and stability studies were carried out according to the ISO Guide 35, IUPAC harmonized protocol, and ISO 13528, considering the potential applicability of the produced materials as certified reference materials or even as RM for use in proficiency testing schemes. For homogeneity, despite the different criteria, there was agreement between the results. Considering the stability, the agreement depended on the evaluation of the regression assumptions, which is not required by the ISO Guide 35. The contribution of uncertainty associated with homogeneity was greater than that related to stability. The results indicated that the produced materials, i.e., the candidate certified RMs, were suitable for assessing trueness and could be submitted to further inter-laboratory characterization.

Ilex paraguariensis Pellets from a Spray-Dried Extract: Development, Characterization, and Stability.

Several studies have shown the potential use of Ilex paraguariensis in developing products with the aim to protect biological systems against oxidative stress-mediated damages. In the same way, technological studies have demonstrated the feasibility of obtaining dry products, by spray-drying process, from aqueous extracts of I. paraguariensis in laboratory. The present work was designed to develop pellets by extrusion/spheronization process, from an I. paraguariensis spray-dried powder. The pellets were characterized with respect to their chemical, physical, and technological properties, and the thermal and the photostability of the main polyphenol constituents were investigated. The pellets exhibited adequate size, shape, and high process yield (78.7%), as well as a good recovery of the total polyphenols (>95%) and a good dissolution in water (89.44 to 100.05%). The polyphenols were stable against light when conditioned in amber glass bottles; unstable against heat when the samples were conditioned either in open glass bottles or in hermetically sealed glass bottles and demonstrated to be hygroscopic and sensible to the temperature, especially when stored in permeable flasks. These findings pointed to the relevance of reducing the residual moisture content of pellets as well as of conditioning them in opaque humidity tight packages under low temperatures. The feasibility of obtaining pellets from an I. paraguariensis spray-dried powder using extrusion/spheronization technique was, for the first time, demonstrated. This finding represents a novelty for the herbal products in both pharmaceutical and food fields.

Stability of Extemporaneously Compounded Dexamethasone in Glass and Plastic Bottles and Plastic Syringes

Dexamethasone is widely used to treat rheumatic and endocrine disorders and chemotherapy-induced nausea and vomiting. A palatable, alcohol-free liquid formulation, with a suitable concentration to allow reasonable administration volume, is available only via extemporaneous compounding. To evaluate the stability of dexamethasone suspensions in commercially available vehicles (Oral Mix and Oral Mix SF) in various types of containers after storage at 25°C and 4°C for up to 91 days. Dexamethasone suspensions (1 mg/mL) were prepared in Oral Mix and Oral Mix SF and then transferred to amber glass and plastic prescription bottles and plastic oral syringes. Suspensions in all 3 types of containers were stored at 25°C; suspensions in glass and plastic bottles were also stored at 4°C. Samples were collected weekly from each container up to 28 days and then every 2 weeks up to 91 days. The samples were analyzed by a validated, stability-indicating high-performance liquid chromatography - ultraviolet detection method. A suspension was considered stable if it maintained at least 90% of its initial dexamethasone concentration. Changes in colour, taste, odour, precipitation (and ease of resuspension), and pH were used to assess physical compatibility. All suspensions maintained at least 96% of the original concentration for up to 91 days with storage at 25°C or at 4°C. No notable changes in colour, taste, odour, precipitation, or pH were observed over the 91-day period. Dexamethasone suspensions (1 mg/mL) in Oral Mix and Oral Mix SF, stored in amber glass or plastic bottles or plastic syringes at 25°C or in amber glass or plastic bottles at 4°C can be expected to remain stable for up to 91 days.

Development and Validation of the MEKC Method for a Stabilityindicating Assay of Midazolam in Pediatric Syrup

The preparation of a parenteral solution for oral use leads the clinician to question the stability of drugs when used in conjunction with flavored oral suspending vehicles. Therefore, the purpose of this study was the evaluation of the stability of midazolam, frequently used as an oral premedication in children, in extemporaneously prepared pediatric syrup, using micellar electrokinetic capillary chromatography (MEKC). The optimization of parameters affecting electrophoretic separation provided adequate separation of the analyte of interest, the internal standard (nitrazepam) and the syrup ingredients in a short time of 8 min. As a separation buffer 10 mM sodium tetraborate, 30 mM SDS and 15% methanol were used. During the separation process analytes were detected at 254 nm. Suitable linearity ranged from 1 to 50 µg/ml (r= 0.998), sensitivity (limit of detection 0.12 µg/ml) and recovery (in the range of 100.1% for 50 μg/mL to 119.0% for 1 μg/mL) were achieved. In this experiment syrup samples were stored at different temperatures (4°C, 25°C and 40°C) in amber glass bottles to protect them from access to light. The analysis of properly prepared samples was carried out for 30 days, indicating the concentration of active substances and the pH of the syrup. Studies have confirmed that the most stable formulation was one stored in a refrigerator. The elaborated method can find reasonable application in the determination of midazolam in pharmaceutical formulations, as a stability-indicating assay. Keywords: Micellar electrokinetic chromatography (MEKC), midazolam, pediatric syrup, stability.

TCH-049 Topical Morphine Gels For Painful Wounds

BackgroundThe use of morphine applied topically to painful wounds has potential advantages such as a lower dose than with systemic administration and fewer side effects. Gels are known to be...

Physicochemical Characteristics and the Effect of Packaging Materials on the Storage Stability of Selected Cucurbits Oils

Physicochemical properties and the effect of packaging materials on the quality of oil extracted from Cucumeropsis manni, Lagenaria sicceraria and Citrullus lanatus were studied in this work. Oil was extracted from Lagenaria sicceraria (bottle gourd), Cucumeropsis manni (white melon) and Citrullus lanatus (watermelon) seeds, some physicochemical attributes of the oil extracted were determined. The three samples of oil were stored in amber glass bottle, transparent glass bottle and transparent plastic bottle at ambient temperature for 12 weeks during which stability of the oil to oxidative and hydrolytic deterioration was assessed by determining peroxide value and free fatty acid value at 2weeks interval. The results show that the physicochemical characteristics of oil samples extracted from Lagenaria sicceraria, Cucumeropsis manni and Citrullus lanatus seeds were: specific gravity 0.89, 0.90, 0.87; refractive index 1.517, 1.520, 1.518; iodine number 97.16 mgI2/g, 101.52 mgI2/g, 98.26 mgI2/g; saponification value 215.99 mgKOH/g, 221.60 mgKOH/g, 183.73 mgKOH/g; thiobabituric acid number 4.45 mgMA/Kg, 2.03 mgMA/Kg, 2.19 mgMA/Kg; free fatty acid value 18.80%, 0.57%, 5.31% and peroxide value 0.02 Meq/kg, 0.14 Meq/kg, 0.09 Meq/kg respectively. The result of storage stability shows that the oil samples may be relatively stable to oxidation and hydrolysis when properly stored in a good packaging material. Oil samples stored in plastic transparent bottle recorded highest lipid peroxidation values while amber glass bottle gave the maximum protection against lipid peroxidation.

Chiral Stability Study of Oral Liquid Clopidogrel Formulations for Infants

ABSTRACTBackgroundClopidogrel is used in at‐risk infants to prevent thrombotic complications. There is no commercially available liquid preparation and existing formulations have not been evaluated for the chiral stability of clopidogrel.AimTo determine the stability of clopidogrel 1 mg/mL liquid formulations using chiral chromatography.MethodClopidogrel 1 mg/mL suspension was formulated using Plavix (clopidogrel) tablets and Ora‐Plus:Ora‐Sweet 1:1, and stored at room temperature and under refrigeration. Samples were also prepared using a variety of co‐solvents and stored at room temperature. Samples were taken for up to 49 days and assayed for S‐clopidogrel, R‐clopidogrel and S‐acid using high‐performance chiral liquid chromatography. Percentage of S‐clopidogrel remaining (at least 90% of nominal content) and percentage of degradation product formation were used to estimate shelf‐life.ResultsOnly the refrigerated Ora‐Plus:Ora‐Sweet mixture did not have degradation products that exceeded USP limits for clopidogrel impurities for at least 30 days. The estimated shelf‐lives of the Ora‐Plus:Ora‐Sweet mixtures at room temperature (25 °C) and under refrigeration (4 °C) were 19 and 37.5 days, respectively. There was no improvement in stability when mixtures were prepared using a variety of co‐solvents.ConclusionClopidogrel 1 mg/mL suspension made with Ora‐Plus:Ora‐Sweet and stored in amber glass bottles was stable for 1 month under refrigeration and 2 weeks at room temperature.

Assessment of sample preservation techniques for pharmaceuticals, personal care products, and steroids in surface and drinking water

Proper collection and preservation techniques are necessary to ensure sample integrity and maintain the stability of analytes until analysis. Data from improperly collected and preserved samples could lead to faulty conclusions and misinterpretation of the occurrence and fate of the compounds being studied. Because contaminants of emerging concern, such as pharmaceuticals and personal care products (PPCPs) and steroids, generally occur in surface and drinking water at ng/L levels, these compounds in particular require such protocols to accurately assess their concentrations. In this study, sample bottle types, residual oxidant quenching agents, preservation agents, and hold times were assessed for 21 PPCPs and steroids in surface water and finished drinking water. Amber glass bottles were found to have the least effect on target analyte concentrations, while high-density polyethylene bottles had the most impact. Ascorbic acid, sodium thiosulfate, and sodium sulfite were determined to be acceptable quenching agents and preservation with sodium azide at 4 °C led to the stability of the most target compounds. A combination of amber glass bottles, ascorbic acid, and sodium azide preserved analyte concentrations for 28 days in the tested matrices when held at 4 °C. Samples without a preservation agent were determined to be stable for all but two of the analytes when stored in amber glass bottles at 4 °C for 72 h. Results suggest that if improper protocols are utilized, reported concentrations of target PPCPs and steroids may be inaccurate.

Proximal Input of Polynuclear Aromatic Hydrocarbons (PAHs) in Groundwater Sources of Okrika Mainland, Nigeria

The Port Harcourt Refinery Company situated at Okrika Mainland discharges its effluent into the Creeks surrounding this coastal land. The current study examined the presence of polynuclear aromatic hydrocarbons in groundwater sources of the coastal settlement. Ten replicate samples were collected from 10 boreholes in the settlement using sterilized amber glass bottles and fixed with concentrated H2SO4. They were later analyzed using Gas chromatography (GC). The Pearson product moment correlation coefficient (r) was used to determine the interactions of the PAHs detected while the One-way ANOVA was used to determine spatial variance equality in means of the PAHs components at P Fcrit(3.85563)]. A further structure detection revealed that the inequalities were contributed by all the PAH components, especially between BH 3 and BH 1, BH 4 and BH 2 and 5, as well as between BH 6 and BH 10. Very strong associations were observed between the PAH components at P < 0.01. BH 8 recorded the highest contamination level of the various PAHs due basically to its proximity to the refinery’s effluent discharge point (Ekerekana Creek) and channel. Hence the source of these pollutants could best be fingerprinted to the nearby Port Harcourt Refinery Company’s effluent discharges. These PAHs are not only ingested by drinking contaminated waters, but are further consumed when this water is used to prepare foods. This creates a great cause for public health concerns especially as several PAHs are known carcinogens. It is therefore, recommended that technologically advanced techniques of water treatment be developed in order to take care of the presence of PAHs in drinking water sources of the coastal dwellers.

Opiniões e atitudes dos consumidores em relação a embalagens e rótulos de cachaça

A técnica de grupo de foco foi utilizada para obter informações detalhadas a respeito das opiniões e atitudes dos consumidores em relação a embalagens e rótulos de cachaça. Objetivou-se gerar informações para os produtores do setor de cachaça e aumentar a competitividade desse produto no mercado. Foram realizadas três sessões de 90 minutos com oito participantes em cada. Quatro embalagens de cachaça foram apresentadas, separadamente e, para cada apresentação, foi seguido um roteiro de perguntas, previamente elaborado. Verificou-se que os participantes não aprovam a garrafa de vidro de cor âmbar com tampa metálica tipo coroa (igual à da garrafa de cerveja) para acondicionar cachaça, porém preferem a garrafa de vidro incolor com capacidade igual a 700 mL e com tampa metálica rosqueável e ilustrações do rótulo que estejam relacionadas com o processo produtivo de cachaça. A marca, selos de qualidade, premiações recebidas e as informações a respeito do local onde a cachaça foi produzida, do tempo de envelhecimento e do tipo de madeira do tonel no qual a cachaça foi envelhecida também influenciam na compra de cachaça. Observou-se ainda que os participantes apresentaram um padrão de preferência, sendo a maioria influenciada pelos mesmos fatores, no momento da compra de cachaça.

Characterization of NIES CRM No. 23 Tea Leaves II for the determination of multielements

A candidate environmental certified reference material (CRM) for the determination of multielements in tea leaves and materials of similar matrix, NIES CRM No. 23 Tea Leaves II, has been developed and characterized by the National Institute for Environmental Studies (NIES), Japan. The origin of the material was tea leaves, which were ground, sieved through a 106-microm mesh, homogenized, and then subdivided into amber glass bottles. The results of homogeneity and stability tests indicated that the material was sufficiently homogeneous and stable for use as a reference material. The property values of the material were statistically determined based on chemical analyses by a network of laboratories using a wide range of methods. Sixteen laboratories participated in the characterization, and nine certified values and five reference values were obtained. These property values of the candidate CRM, which are expressed as mass fractions, were close to the median and/or mean values of the mass fractions of elements in various tea products. The candidate CRM is appropriate for use in analytical quality control and in the evaluation of methods used in the analysis of tea and materials of similar matrix.

Long-term stability of extemporaneously prepared captopril oral liquids in glass bottles

The long-term stability of captopril in extemporaneously prepared oral liquids was studied. Captopril solutions of 1 and 5 mg/mL were prepared in sterile water for irrigation with sorbitol, disodium edetate, and sodium benzoate. The samples were stored in 100-mL amber glass bottles with a headspace of air at 22 degrees C for 12 months. The captopril concentration was determined by high-performance liquid chromatography at 0, 3, 6, 9, and 12 months. The pH of the solutions was also measured, and the physical appearance was recorded. The stability of the 1-mg/mL captopril preparation during 1 month of simulated use when stored at 2-8 degrees C was tested at the start and the end of the 12-month study period. Chemical stability was defined as retention of at least 90% of the initial captopril concentration. The microbiological quality of the preparations was tested at 0, 6, and 12 months (1 mg/mL) and 0 and 12 months (5 mg/mL). Throughout the 12-month study period, the captopril concentration in the oral liquids exceeded 90% of the initial concentration. The lowest concentration (98.5%) was detected in the 5-mg/mL preparation after 3 months of storage. The 1-mg/mL preparation was stable during 1 month of simulated use, both at the start and the end of the 12-month study period. No microbiological growth was observed in any of the samples tested. Extemporaneously prepared oral liquid formulations of captopril 1 and 5 mg/mL were chemically stable when stored in glass bottles at room temperature for 12 months when stabilized with 0.1 mg/ mL disodium edetate at a low pH.

Stability of Omeprazole Mixtures: Implications for Paediatric Prescribing

ABSTRACTBackgroundCommercial omeprazole paediatric mixtures are not available. The stability of omeprazole mixtures prepared from Probitor capsules or omeprazole powder has not been established.AimTo determine the physicochemical stability of two omeprazole mixtures, prepared from Probitor capsules or omeprazole powder BP, over a 45–day period under refrigeration or at room temperature, shaken or unshaken.MethodOmeprazole 2 mg/mL mixtures were prepared using standard procedures by either emptying the contents of Probitor capsules or by adding omeprazole powder to preserved sodium bicarbonate 8.4% solution. Each formulation was stored in 100 mL amber glass bottles under refrigeration (2–8°C) or at room temperature (21 ± 2°C). One bottle of each formulation was shaken and the other not shaken, pH was measured and colour change determined using a visual scale. Omeprazole concentrations were measured using liquid chromatograph tandem mass spectrometry on Days 1, 7, 14, 28 and 46.ResultsOmeprazole 2 mg/mL mixture prepared from Probitor capsules was stable over 45 days when refrigerated and regularly shaken. When unshaken, the omeprazole concentration decreased rapidly over 7 days. Mixtures prepared from omeprazole powder had lower concentrations compared to the mixtures prepared from Probitor capsules, but tended to be more stable when stored at room temperature. Observed colour changes did not correlate with measured omeprazole concentrations and pH remained constant.ConclusionOmeprazole mixture prepared from Probitor capsules was stable over 45 days, when refrigerated and regularly shaken. Omeprazole concentration markedly decreased in the mixture prepared from omeprazole powder when refrigerated.

Stability of an extemporaneous oral liquid aprepitant formulation

Aprepitant is currently recommended for the prevention of acute antineoplastic-induced nausea and vomiting in adults receiving highly emetogenic therapy. The lack of an oral liquid dosage form is one barrier to its use in children. The purpose of this study was to develop a stable oral liquid formulation of aprepitant using the marketed aprepitant capsules. Aprepitant 20-mg/mL oral liquid was prepared from 125-mg capsule contents in Orablend(R). Twelve test samples were prepared: six packaged in amber glass and six in polyethylene terephthalate (PET) containers, three of each stored at either 23 degrees C or 4 degrees C. The physical characteristics of the oral aprepitant liquid stored in amber glass bottles were evaluated at the time of compounding and on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, and 91. The aprepitant content of three test solutions of each container type and storage temperature was determined using a stability-indicating assay at 5, 9, 14, 29, 48, 62, 73, and 111 days after compounding. All samples stored in glass demonstrated suitable physical characteristics and those stored in either glass or PET retained more than 94.0% of the initial concentration. Based on the higher limit of the 95% confidence interval of the degradation rate, suspensions stored at 23 degrees C achieved 10% loss within 66 to 85 days, compared to greater than 100 days when stored at 4 degrees C. The extemporaneous aprepitant oral suspension formulation described is physically and chemically stable for at least 90 days when refrigerated. The bioavailability of this formulation is unknown.

Preparation and stability of extemporaneous oral liquid formulations of oseltamivir using commercially available capsules

ObjectivesTo develop a simple, standardized method for the extemporaneous compounding of an oral liquid form of oseltamivir from commercially available Tamiflu 75 mg capsules (Roche Pharmaceuticals) and to determine the stability of oseltamivir in this preparation. DesignChemical and microbial stability study. SettingLaboratory. ParticipantsNone. InterventionExtemporaneous oral liquid formulations of oseltamivir (15 mg/mL) were prepared in Cherry Syrup (Humco) and Ora-Sweet SF (Paddock Laboratories) using methods consistent with current compounding practice in a pharmacy setting. Preparations were stored in amber glass and amber polyethyleneterephthalate bottles at 5°C ± 2°C (41°F ± 4°F) and 25°C ± 2°C (77°F ± 4°F) at 60% ± 5% relative humidity (RH) for 35 days and 30°C ± 2°C (86°F ± 4°F) at 65% ± 5% RH for 13 days. Outcome measuresSamples were monitored for appearance, pH, assay, degradation products, and microbiologic stability. ResultsThe Cherry Syrup preparation, in either bottle type, was stable for up to 35 days under refrigeration (5°C) and up to 5 days at room temperature (25°C). It was not stable when stored at 30°C for 5 days. The Ora-Sweet SF preparation was stable for up to 35 days at 5°C or 25°C and for up to 13 days at 30°C in either bottle type. Both preparations maintained microbiologic stability for 35 days. ConclusionBoth preparations are stable under the described conditions and may provide an option in situations where the marketed suspension is unavailable.

Formulation and efficacy of triamcinolone acetonide mouthwash for treating oral lichen planus

The stability of a triamcinolone acetonide mouthwash and its efficacy in treating oral lichen planus are described. The solubility of triamcinolone acetonide in ethanol, propylene glycol, and glycerin was determined by shaking and equilibrating an excess of triamcinolone acetonide with the solvents for 72 hours. All three solvents were used in formulating a mouthwash. A stock solution of triamcinolone acetonide standard was prepared in ethanol and diluted to yield concentrations of 2, 4, 8, 12, and 16 microg/mL. Analytical sample solutions were prepared by pipetting 0.1 mL of triamcinolone acetonide mouthwash into 10-mL volumetric flasks and diluting to volume with the mobile phase. Accelerated stability studies were conducted by storing the samples in 60-mL amber glass bottles at 45, 60, 70, and 80 degrees C and 75% relative humidity until the triamcinolone concentration decreased markedly. Efficacy was tested by 20 subjects with a clinical diagnosis of and histologically confirmed symptomatic oral lichen planus who were randomized to use the mouthwash (n = 11) or the commercially available triamcinolone acetonide paste (n = 9). The mouthwash had a satisfactory shelf life and was well accepted by patients. Ten of 11 patients treated with the mouthwash for four weeks reported a positive response, and a complete response in signs and symptoms occurred in 4 and 5 of 11 patients, respectively. No significant difference in clinical improvement was observed between groups. A triamcinolone acetonide mouthwash had a satisfactory shelf life and was well accepted by patients. It did not have a significantly different therapeutic efficacy from the commercial paste dosage form in the treatment of oral lichen planus.

Chemical Stability of Extemporaneously Prepared Lorazepam Suspension at Two Temperatures

The objective of this study was to determine the chemical stability of extemporaneously prepared lorazepam suspension (1 mg/mL) stored at two temperatures (4°C and 22°C) for 3 months. Lorazepam tablets marketed by two manufacturers (Mylan Pharmaceuticals and Watson Laboratories) were used to extemporaneously formulate two independently prepared suspensions. Each suspension was prepared using sterile water, Ora-Plus(®) and Ora-Sweet(®) to achieve a final concentration of 1 mg/mL. The two brands of tablets required different volumes of vehicles to prepare a pharmaceutically optimal suspension. The suspensions were stored in amber glass bottles at 4°C and 22°C for 91 days. Samples were analyzed by high performance liquid chromatography at baseline and on days 2, 3, 7, 14, 21, 28, 42, 63, and 91. The suspensions were considered stable if the mean lorazepam concentration remained greater than 90% of the initial concentration.The chemical stabilities of these two extemporaneously prepared lorazepam suspensions were comparable throughout the study. Both lorazepam suspensions were stable for 63 days when stored at 4°C or 22°C, and both were stable for 91 days when refrigerated at 4°C. When stored at room temperature, the suspension prepared from the Watson tablet retained 88.9 ± 1.4% of the initial concentration on day 91 and was therefore considered unstable, while the suspension prepared from the Mylan tablet was stable for the entire 91-day study.