Accelerated Storage Conditions Research Articles

Oxidative stability of soybean oil added to coffee husk extract (Coffea arabica L.) under accelerated storage conditions

Abstract Several plants have been studied as potential sources of natural antioxidants for use in the food industry, especially polyphenols. The aim of this study was to evaluate the effects of hydroalcoholic extract from coffee husk on the oxidative stability of soybean oil when stored in an oven. Samples were maintained at a temperature of 60 °C and their oxidative stability was evaluated once every 5 days for a period of 20 days through the Rancimat equipament and analysis of peroxide value, conjugated dienes and tocopherols retention. The oxidation rate in terms of mass gain was evaluated once every 24 hours for a period of 24 days. Although the antioxidant TBHQ showed a better efficiency in the inhibition of oxidation, coffee husk extract showed a synergistic effect when used with the synthetic, delaying the appearance of degradation products. In addition, the freeze-dried extract showed the ability to reduce the mass-gain rate when used alone as well as when used in combination with the synthetic antioxidant butyl hydroxyanisole (BHA), noting a synergistic effect on oxidative stability between the extract and the BHA. Therefore, coffee husk extract could be considered a source of natural antioxidants for synthetic antioxidants substitution.

Drug-Excipient Interactions in the Solid State: The Role of Different Stress Factors.

Understanding properties and mechanisms that govern drug degradation in the solid state is of high importance to ensure drug stability and safety of solid dosage forms. In this study, we attempt to understanddrug-excipient interactions in the solid state using both theoretical and experimental approaches. The model active pharmaceutical ingredients (APIs) under study are carvedilol (CAR) and codeine phosphate (COP), which are known to undergo esterification with citric acid (CA) in the solid state. Starting from the crystal structures of two different polymorphs of each compound, we calculated the exposure and accessibility of reactive hydroxyl groups for a number of relevant crystal surfaces, as well as descriptors that could be associated with surface stabilities using molecular simulations. Accelerated degradation experiments at elevated temperature and controlled humidity were conducted to assess the propensity of different solid forms of the model APIs to undergo chemical reactions with anhydrous CA or CA monohydrate. In addition, for CAR, we studied the solid state degradation at varying humidity levels and also under mechano-activation. Regarding the relative degradation propensities, we found that variations in the exposure and accessibility of molecules on the crystal surface play a minor role compared to the impact of molecular mobility due to different levels of moisture. We further studied drug-excipient interactions under mechano-activation (comilling of API and CA) and found that the reaction proceeded even faster than in physical powder mixtures kept at accelerated storage conditions.

Prooxidant effect of α-tocopherol on soybean oil. Global monitoring of its oxidation process under accelerated storage conditions by 1H nuclear magnetic resonance

The effect of adding α-tocopherol in proportions ranging from 0.002 to 5% in weight on the oxidative stability of soybean oil was studied. For the first time, the oxidation process under accelerated storage conditions including evolution of the molar percentages of the several types of oil acyl groups, and formation and evolution of various kinds of oxidation products comprising hydroperoxides, hydroxy-dienes and other alcohols, epoxides, aldehydes and keto-dienes, was followed by 1H nuclear magnetic resonance. It is proved that, except in the lowest proportion, α-tocopherol not only exerts a prooxidant effect on soybean oil but also modifies its oxidation pathway, affecting the oxidation products generation rate, their nature, relative proportions and concentrations. It is noticeable that the highest α-tocopherol concentrations induce the generation of some toxic compounds at earlier stages of the thermoxidation process and sometimes in higher concentration, such as certain oxygenated α,β-unsaturated aldehydes and monoepoxides derived from linoleic groups.

Thermodynamic and kinetics study of phenolics degradation and color of yacon (Smallanthus sonchifolius) microparticles under accelerated storage conditions.

This study aimed to investigate the kinetics and thermodynamic of the phenolics degradation and the kinetics of degradation of the total color difference of yacon juice microcapsules produced by spray drying using Gum Arabic and polydextrose as wall materials. The degradation of the microcapsule was evaluated by accelerated tests under controlled conditions at 35 and 45°C, and relative humidity of 75 and 90%, for 35days. Degradation of phenolics followed the first order model and the degradation constant was in the range of 0.0124-0.0209days-1. The microparticles with gum Arabic were more stable than those with polydextrose for all conditions studied, with longer half-lives. Both wall materials showed similar thermodynamic characteristics, indicating similar mechanism of degradation of phenolics. With respect to the color parameters, the first order model adjusted to data of the total color difference, and no significant differences were observed for the conditions studied.

ESR investigations of gamma irradiated medical devices

Guided tissue regeneration (GTR) and guided bone regeneration (GBR) biomaterials have been employed in recent years for periodontal procedures. In the present study, widely used dental GTR/GBR biomaterials (grafts: G1, G2, G3 and membranes: M1, M2, M3, M4) were exposed to gamma irradiation at an absorbed dose range of 0–50kGy and the radiolytic intermediates that have been created in the samples upon irradiation were characterized in detail by Electron Spin Resonance (ESR) spectroscopy. We aimed to standardize the measurement conditions for practical applications of gamma radiation sterilization of GTR/GBR biomaterials. We investigated the characteristic features of free radicals in gamma irradiated GTR/GBR biomaterials and examined the stability of the induced radicals at room temperature and accelerated stability conditions with ESR spectroscopy including dose-response curves, microwave power studies, dosimetric features of the biomaterials, variations of the peak heights with temperature, and long term stabilities of the radical species. Long-term stability studies have shown that G1 is quite stable even in accelerated storage conditions. The signal intensities of graft-type GTR/GBR biomaterials stored in normal and stability conditions have decreased very rapidly even only a few days after gamma irradiation sterilization. Thus, those samples indicating relatively low stability features can be very good candidates for the radiosterilization process. The beta-tricalcium phosphate and PLGA containing G1 and M1 respectively have found to be the most gamma stable bone substitute biomaterials and be safely sterilized by gamma radiation. ESR spectroscopy is an appropriate technique in giving important detailed spectroscopic findings in the gamma radiation sterilization studies of GTR/GBR biomaterials.

Antioxidant properties of whole-cell Spirulina (Arthrospira platensis) powder expressed in olive oil under accelerated storage conditions

The antioxidant activity of whole-cell Spirulina (Arthrospira platensis) powder was assessed in olive oil at different concentrations of 0.5, 1.0, and 1.5% during accelerated storage. Also, antioxidant activity of Spirulina was compared with that of α-tocopherol and butylated hydroxytoluene (BHT). Spirulina samples exhibited lower primary, secondary, and total oxidation products than the control. In comparison with control (16.94 days), induction periods of various concentrations of Spirulina samples ranged from 19.09 to 20.71 days, indicating that different concentrations of Spirulina can improve the oxidative stability of olive oil. Furthermore, different concentrations of Spirulina improved olive oil stability up to between 12.69 and 22.24%. Spirulina samples can be efficient in their antioxidant activities as a result of the protective effects of bioactive components which are gradually released from Spirulina alga into the olive oil during storage. Among the antioxidants evaluated in this study, BHT showed the highest antioxidant activity, while α-tocopherol exhibited a poorer performance than Spirulina. In conclusion, Spirulina has noticeable antioxidant potential and therefore can be used in olive oil.

Improving oxidative stability of virgin olive oil by addition of microalga Chlorella vulgaris biomass.

Antioxidant activity of Chlorella (Chlorella vulgaris) was evaluated in virgin olive oil (VOO) at different concentrations of 0.5, 1.0, and 1.5% (w/w) under accelerated storage conditions. Antioxidant activity of Chlorella was compared with those of BHT and β-carotene. Chlorella samples significantly retarded the formation of primary, secondary, and total oxidation products in comparison with those of the control. The stability increased as concentrations of Chlorella increased. Samples containing 0.5, 1.0, and 1.5% Chlorella significantly improved VOO stability by 19.99, 28.83, and 33.14%, respectively. Observed effects can be related to the release in the assortment of bioactive compounds from Chlorella algae to the VOO. Among the different antioxidants evaluatedy, BHT exhibited the highest antioxidant activity. On the contrary, β-carotene had no preventive effect against the oxidation of VOO. It also proved incapable of limiting the progress of VOO oxidation and played role as pro-oxidant. In conclusion, Chlorella enhanced VOO oxidative stability. Thus it can be considered as a promising source of natural antioxidants.

FORMULASI KRIM ANTI JERAWAT DARI NANOPARTIKEL KITOSAN CANGKANG UDANG WINDU (PENAEUSMONODON)

Chitosan has the potential to be used as an antimicrobial agent, as it contains the enzyme lysozyme and aminopolisakarida groups which can inhibit the growth of microbes. Physical modification of chitosan in the form of nanoparticles add value to chitosan as an antimicrobial material. In this research, anti-acne cream was formulated by using nanoparticles chitosan with variations emulsifier that are Novemer®, Span-Tween, and Viscolam®. The cream then evaluated for physical stability include kriming volume, the thickness (viscosity), drops dispersed, and phase inversion before and after accelerated storage conditions. Then, test of antibacterial activity against Propionibacterium acne was performed. The results showed that the three creams were physically stable during storage. Formula cream with tween span emulsifier (FII) showed the greatest inhibition against Propionibacterium acne with a diameter of 13.46 mm zone of inhibition.

Humidity induced phase transformation of poloxamer 188 and its effect on physical stability of amorphous solid dispersion of AMG 579, a PDE10A inhibitor

Poloxamer 188, a commonly used emulsifying and solubilizing agent, was found to be the cause of crystallization of an investigational drug, AMG 579, from its amorphous solid dispersion at accelerated storage conditions. Investigation of this physical stability issue included thorough characterization of poloxamer 188 at non-ambient conditions. At 40°C, poloxamer 188 becomes deliquescent above relative humidity of 75%. Upon returning to ambient conditions, the deliquescent poloxamer 188 loses water and re-solidifies. The reversible phase transformation of poloxamer 188 may cause physical and chemical stability issues and this risk should be assessed when selecting it as an excipient for formulation development.

Multicomponent solid forms of felodipine: preparation, characterisation, physicochemical and in-vivo studies.

This study aimed to improve biopharmaceutical parameters of the poorly soluble antihypertensive drug, felodipine, by preparing multicomponent solid forms using three coformers, viz. imidazole, nicotinamide and malonic acid. The multicomponent solid forms were prepared by mechanochemical synthesis and characterised by various analytical techniques. These solid forms were further assessed for their physicochemical parameters. Pharmacokinetic and in-vivo antihypertensive activity was performed in rats. Felodipine (FEL) was found to be cocrystallised with imidazole (FEL-IM) while it formed eutectic with nicotinamide (FEL-NCT) and malonic acid (FEL-MA). Cocrystal was sustained by NH…N and NH….O hydrogen-bonded network. Solubility and intrinsic dissolution studies in 0.1 N HCl (pH 1.2) revealed that eutectics exhibited higher solubility and release rate than cocrystal vis-a-vis pure drug and were found to be stable under accelerated storage condition. Significant enhancement of bioavailability was observed in eutectics (3.5- to twofold) and cocrystal (1.3-fold) compared with the pure drug. Antihypertensive activity of new solid forms in an animal model showed a marked decrease in systolic blood pressure. Mechanochemical approach was successful to prepare multicomponent solid forms that have the potential to improve biopharmaceutical parameters of the poorly soluble drug, FEL.

Role of Water Sorption in Tablet Crushing Strength, Disintegration, and Dissolution.

Drugs formulated as tablets are subjected to accelerated stability conditions with the goal of identifying a stable formulation that will exhibit a sufficiently long shelf life. Water sorption at a condition such as 40°C/75% RH can result in significant changes in tablet properties such as a decrease in dissolution rate, the cause of which may be difficult to interpret, given the complex nature of ingredients and their interactions in a tablet. In this research, three drugs, displaying a wide range of physicochemical properties, were formulated with commonly used diluents, disintegrants, and binders, using a design of experiments approach. The tablets were stored at accelerated conditions and assessed for content, dissolution, disintegration, and crushing strength, as well as other properties. The research demonstrated many water-induced effects in tablet properties. Due to the experimental design approach that revealed many interactions, it was possible to interpret all of the changes observed in tablet crushing strength, disintegration, and dissolution for the drugs using a common set of physical principles. Specifically, the relevant factors considered were (1) mechanical properties of materials, (2) water sorption surface effects in surface diffusion and capillary condensation, (3) water sorption bulk effects for amorphous materials such as viscous flow/spreading, and (4) water-induced stress on interparticle bonding arising from volume expansion. These physical principles enable a comprehensive interpretation of the complex changes observed in tablet properties, which should be valuable in the design of tablet formulations that will be stable to accelerated storage conditions.

Efficacy and Stability of Scorpion Antivenom: At Different Storage Conditions

The aim of this study was to investigate the efficacy and stability of scorpion antivenom brand. Several tests were applied on scorpion antivenom samples obtained from the same batch. The samples were subdivided into two groups. The first group was stored at real storage conditions i.e. at (3 ± 2°C) dry storage areas while the second group was subjected to accelerated storage conditions i.e. (25 ± 3°C, RH75%). Many samples taken from both conditions were tested chemically through determining the pH values, m-cresol preservative levels, albumin content by polyacryl amide gel electrophoresis (PAGE) and measuring the protein content. These samples were also tested pharmacologically for determining the potency, measuring the LD50 (lethal dose which kills 50% of the test animals), pyrogen testing, sterility testing and abnormal toxicity. The results obtained from both chemical and pharmacological tests using antivenom samples stored at real time storage condition (3 ± 2°C) and accelerated storage condition (25 ± 3°C, RH75%) showed no significant changes in terms of potency, pH values, sterility, preservative content, the pharmacological effect and efficacy.

Ethylcellulose oleogels for lipophilic bioactive delivery - effect of oleogelation on in vitro bioaccessibility and stability of beta-carotene.

The in vitro lipolysis and β-carotene (BC) transfer from oil to aqueous phase of canola oil ethylcellulose (EC) oleogels were measured using a static monocompartmental model simulating oral, gastric, and duodenal digestive stages. The effects of EC oleogelation on gel in vitro digestibility were examined, using un-structured canola oil as a control. The physicochemical properties of oleogels containing BC were also measured. It was found that oleogels made with 10% 10 cP and 10% 20 cP did not differ significantly in their extent of lipolysis or BC transfer compared to canola oil; however 10% 45 cP and 15.5% 20 cP had a significantly lower extent of lipolysis and BC transfer compared to other formulations. The structure and mechanical strength of the oleogels were both determined to be factors affecting lipolysis and transfer. The presence of BC did not significantly affect the mechanical strength of the gels and EC oleogelation delayed BC degradation under accelerated storage conditions compared to a heated canola oil control. These findings could contribute to the development of new applications for EC oleogels, specifically for the effective delivery of lipophilic molecules.

Evaluation of inhibitory effect of Benjakul on lipopolysaccharid- stimulated prostaglandin E2 production during accelerated storage condition

Inflammation of muscles is a common symptom of all ages caused by various reasons, which could occur in specific areas or spread extensively. Muscle relaxants and non-steroid anti-inflammatory drugs (NSAID) are commonly used to relieve pain and symptom. However, both have several side effects. Therefore, drugs for external use are often used together with oral drugs to relieve symptoms. Benjakul, a Thai herbal remedy, is commonly used in Thai traditional medicine. It consist of five hot herbs, namely Piper chaba Hunt., Piper sarmentosum Roxb., Piper interuptum Opiz., Plumbago indica Linn., (Plumbago rosea Linn), and Zingiber officinale Roscoe. The anti-inflammatory effects of Benjakul have been recorded since ancient times. A recent study has found that Benjakul has effect to inhibit PGE2 production but the stability of the activity has not been reported. However, in view of developing an anti-inflammatory product, the stability of this activity has to be evaluated. The objective of this study was to evaluate the inhibitory effect of Benjakul on lipopolysaccharid (LPS)-stimulated prostaglandin E2 (PGE2) [1] production during accelerated storage conditions. The 95% ethanol extract of Benjakul was used. It was kept at 40 degree Celsius with 75% humidity condition, which was called accelerated condition [2], then collected every 30 day for 6 months and tested for inhibition of PGE2 production. The study found that there was no statistically significant difference in inhibition of PGE2 production activity among samples collected from different periods of time. From the result, it can refer to the abilities that the inhibitory effect of Benjakul extract is stable to inhibit PGE2 production activity for 2 years. These results suggest that Benjakul extract may potentially be developed as phytopharmaceutical product to treat muscle inflammation.

Proximate composition, phenolic content and in vitro antioxidant activity of aqueous extracts of the seaweeds Ascophyllum nodosum, Bifurcaria bifurcata and Fucus vesiculosus. Effect of addition of the extracts on the oxidative stability of canola oil under accelerated storage conditions

Extracts from three macroalgae species (Ascophyllum nodosum (ANE), Bifurcaria bifurcata (BBE) and Fucus vesiculosus (FVE)) were tested for proximate composition (total solid, protein and total carbohydrate contents), total phenols content (TPC), and for their antioxidant activities in vitro in comparison to that of BHT compound by using four different assays (ABTS radical cation decolouration, DPPH free radical scavenging activity, ferric reducing antioxidant power (FRAP) and oxygen radical absorbance capacity (ORAC)). The inclusion of the extracts as oil stabilizers in canola oil in substitution of the synthetic antioxidant (BHT) was also evaluated by assessing lipid oxidation parameters (peroxide value (PV), p-anisidine value (AV), TBARS value, conjugated dienes (CD) and TOTOX index) under accelerated storage conditions (16days, 60°C). There was an inverse relationship between total solid content and total polyphenols content in the seaweed extracts. FVE showed an intermediate TPC (1.15g PGE/100g extract), but it presented the highest in vitro antioxidant activity when measured using the ABTS, DPPH and FRAP tests. BBE, that displayed the highest TPC (1.99g PGE/100g extract), only showed the highest in vitro antioxidant activity when measured using the ORAC test. ANE showed the lowest TPC and the lowest antioxidant activity in all the tests performed. The seaweed extracts added in a 500ppm concentration significantly reduced the oxidation during canola oil storage at 60°C, being this antioxidant effect significantly higher than that of BHT added at 50ppm. Results indicate that seaweed extracts can effectively inhibit the oxidation of canola oil and they can be a healthier alternative to the synthetic antioxidants in the oil industry.

Fabrication of Laboratory Scale Ohmic Heater and Its Application in Wheat Bran Stabilization

A laboratory scale ohmic heater was developed and assessed its performance on stabilization of raw wheat bran. Electrical conductivity (EC) of wheat bran samples was measured at three moisture content (w.b.) 40, 50 and 60%, respectively, by applying voltage gradients from 35 to 50 V/cm. The EC increased significantly with increase in temperature and moisture content. From the temperature range of 25–90C, the range of EC values (siemens per meter) for wheat bran were observed from 0.04 to 0.12, 0.05 to 0.20 and 0.15 to 0.50 S/m at 40, 50 and 60% moisture content (w.b.), respectively. The treated (ohmically heated) and control (raw) wheat bran sample was stored under accelerated storage conditions. The free fatty acid (FFA) concentration of the treated samples showed a very slow growth in comparison to the control for storage period of 90 days. It was observed that ohmic heating is a significant method for effective stabilization of wheat bran. Practical Applications Wheat bran is easily available and a by-product in wheat milling industry. Wheat bran contains good amount of fibers, protein, minerals and fat but its applications are limited due to formation of free fatty acid. Due to their high levels of polyunsaturated fatty acids and enzymes, wheat germs are susceptible to deterioration. Therefore, they are stabilized and dried in a gentle heat treatment process. The following are the benefits of stabilization: (a) no partial deoiling, (b) increase in vitamin E content, (c) high nutritional value and density, (d) delicious taste: nutty and crisp and (e) pure wheat product. In this study, ohmic heating was performed rather than conventional methods to stabilize the wheat bran. The application of ohmic heating on wheat bran will provide solutions to the food industries as it has various applications in food, fermentation, feed and medicine industries.

Formulation of avanafil in a solid self-nanoemulsifying drug delivery system for enhanced oral delivery

Avanafil was incorporated into solid self-nanoemulsifying systems with the aim of improving its oral bioavailability. Labrafil, Labrafac, and Miglyol 812 N were investigated as oils, Tween 80 and Cremophor EL as surfactants, and Transcutol HP as a co-surfactant. Nine formulations produced clear solutions of 13.89–38.09nm globules after aqueous dilution. Adsorption of preconcentrate onto Aeroperl 300 Pharma at a 2:1 ratio had no effect on nanoemulsion particle size. Differential scanning calorimetry, X-ray diffraction, and scanning electron microscopy indicated that avanafil was molecularly dispersed within the solid nanosystems. A formulation containing 10% Labrafil, 60% Tween 80, and 30% Transcutol HP had the highest drug loading (44.48mg/g) and an acceptable in vitro dissolution profile (96.42% within 30min). This formulation was chemically and physically stable for 6months under accelerated storage conditions and it produced a 3.2-fold increase in bioavailability in rabbits, as compared to conventional commercially available avanafil tablets (Spedra®).

Effect of different polymers on avanafil–β-cyclodextrin inclusion complex: in vitro and in vivo evaluation

In this study, we examined the effect of different polymers on the chemical, physical and pharmacokinetic properties of avanafil–β-cyclodextrin (β-CD) inclusion complex. Equimolar mixtures of drug and β-CD were used to prepare 25 ternary drug–β-CD-polymer inclusion complexes using five different polymers, polyethylene glycol (PEG 4000), polyvinyl pyrrolidone (PVP K-30), chitosan, hydroxypropylmethyl cellulose, and hydroxyethyl cellulose, each in five different concentrations, 1, 3, 5, 7, and 10% (w/w). The addition of 10% (w/w) PEG 4000 resulted in a significant decrease of drug solubility, where the infrared spectra and differential scanning thermograms revealed an interaction between PEG 4000 and avanafil which hindered drug inclusion. In contrast, addition of 7% (w/w) PVP K-30 facilitated drug inclusion as concluded from differential scanning thermograms, X-ray diffraction patterns and scanning electron micrographs. This resulted in a subsequent improvement in drug solubility and in vitro dissolution. This ‎formula was chemically and physically stable for 6 ‎months under accelerated storage conditions. The formula had a relative bioavailability of 125.56% in rabbits as compared to conventional commercially available avanafil‎ tablets (Spedra®).

Antioxidant efficacy of rosemary ethanol extract in palm oil during frying and accelerated storage

The rosemary extract is a new natural antioxidant. In this study, the stability of palm oil with rosemary extract during frying and accelerated storage was studied. The antioxidant of palm oil with different concentrations of rosemary ethanol extract were evaluated at 180°C and 65°C. The effect of rosemary ethanol extract was also compared with the one of synthetic antioxidants. Results showed that the optimum addition of rosemary ethanol extract in palm oil during frying and accelerated storage were 0.12g/kg and 0.7g/kg. Under such conditions, a significant antioxidant effect was observed. Rosemary ethanol extract can effectively reduce the peroxide value, P-anisidine value, free fatty acid value and absorbances at 232 and 268nm, especially in the long-time frying process. It can also reduce the production of saturated fatty acids after 25h of frying and 24d of accelerated storage. Under frying condition, the oil with rosemary ethanol extract showed an enhanced stability compared to the oil with synthetic antioxidants. Under accelerated storage condition, rosemary ethanol extract could prevent the palm oil from oxidation the same as the synthetic antioxidants, but it is safer than synthetic antioxidants.

Quality assessment and shelf life prediction of spray dried tamarind pulp powder in accelerated environment using two different packaging materials

Tamarind pulp powder (TPP) was produced using optimum spray drying conditions, packed in two different packaging materials viz., aluminium laminated polyethylene (ALP) and 4-ply laminate pouches (polythene-aluminium-polythene-paper) and stored under accelerated conditions (40 ± 1 °C temperature, 90 % relative humidity). The powder was analyzed for various quality parameters (moisture content, color, acidity, and powder flowability) at an interval of 7 days upto 70 days of storage period. Both packaging material and storage period showed significant effect on the powder properties. Kinetic study of color change of tamarind pulp powder during storage revealed that color change followed zero order reaction kinetics with a rate constant of 0.495 and 0.369 for the powder packed in ALP and 4-ply laminate, respectively. The magnitude of quality changes of TPP measured during accelerated storage suggested that 4-ply laminate was better than ALP for long term storage of spray dried TPP. The shelf life of TPP under accelerated storage condition was predicted on the basis of flowability of the powder and was calculated to be 53 and 66 days in ALP and 4-ply laminate, respectively.