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Psychiatric disorders cause long-lasting disabilities across different age groups. While various medications are available for mental disorders, some patients do not fully benefit from them or experience treatment resistance. The pathogenesis of psychiatric disorders involves multiple mechanisms, including an increase in the inflammatory response. Targeting inflammatory mechanisms has shown promise as a therapeutic approach for these disorders. Curcumin, known for its anti-inflammatory properties and potential neuroprotective effects, has been the subject of studies investigating its potential as a treatment option for psychiatric disorders. This review comprehensively examines the potential therapeutic role of curcumin and its nanoformulations in psychiatric conditions, including major depressive disorder (MDD), bipolar disorder, schizophrenia, and anxiety disorders. There is lack of robust clinical trials across all the studied psychiatric disorders, particularly bipolar disorder and schizophrenia. More studies have focused on MDD. Studies on depression indicate that curcumin may be effective as an antidepressant agent, either alone or as an adjunct therapy. However, inconsistencies exist among study findings, highlighting the need for further research with improved blinding, optimized dosages, and treatment durations. Limited evidence supports the use of curcumin for bipolar disorder, making its therapeutic application challenging. Well-designed clinical trials are warranted to explore its potential therapeutic benefits. Exploring various formulations and delivery strategies, such as utilizing liposomes and nanoparticles, presents intriguing avenues for future research. More extensive clinical trials are needed to assess the efficacy of curcumin as a standalone or adjunctive treatment for psychiatric disorders, focusing on optimal dosages, formulations, and treatment durations.

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Stable solid lipid nanoparticles (SLNs) and nanostructured lipid carriers (NLCs) formulations to enhance the dissolution rates of poorly soluble drug spironolactone (SP) were being developed. Probe ultra-sonication method was used to prepare SLNs and NLCs. All NLCs contained stearic acid (solid lipid carrier) and oleic acid (liquid lipid content), whereas, SLNs were prepared and optimised by using the solid lipid only. The particles were characterised in terms of particle size analysis, thermal behaviour, morphology, stability and in vitro release. The zeta sizer data revealed that the increase in the concentration of oleic acid in the formulations reduced the mean particle size and the zeta potential. The increase in concentration of oleic acid from 0 to 30% (w/w) resulted in a higher entrapment efficiency. All nanoparticles were almost spherically shaped with an average particle size of about ∼170 nm. The DSC traces revealed that the presence of oleic acid in the NLC formulations resulted in a shift in the melting endotherms to a higher temperature. This could be attributed to a good long-term stability of the nanoparticles. The stability results showed that the particle size remained smaller in NLC compared to that of SLN formulations after 6 months at various temperatures. The dissolution study showed about a 5.1- to 7.2-fold increase in the release of the drug in 2 h compared to the raw drug. Comparing all nanoparticle formulations indicated that the NLC composition with a ratio of 70:30 (solid:liquid lipid) is the most suitable formulation with desired drug dissolution rates, entrapment efficiency and physical stability.

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The present study was designed to prepare sildenafil carrier free dry powder inhalation (DPI) formulation for the treatment of idiopathic pulmonary arterial hypertension (IPAH). Sildenafil DPI formulations were fabricated by spray drying technique. The ideal formulation was optimized using different solvent type (methanol, dimethyformamide and water), concentration (5 and 50 mg/mL) and pH (2 and 7.4) of feed solution. Particles size distribution, morphology and crystallinity of fabricated microparticles were evaluated by scanning electron microscopy (SEM) and differential scanning calorimetry (DSC) methods, respectively. The aerosolization efficiency of formulations were assessed by next generation impactor equipped with an Aerolizer. Results indicated that evaluated variables had great impacts on powder characteristics which significantly influenced aerosolization performance of formulations. The aerosolized fraction of formulations was improved from 2 to 70% by changing in solvent type and drug concentration in spray dryer feeding solution. Aerosolization performance of powders were well correlated and interpreted by their morphologies as depicted from SEM images. DSC results also indicated that crystallinity of all formulations were reduced by spray drying procedure. Optimization of spray drying technique for production of Sildenafil carrier free DPI formulation in this study may pave a way for locally treatment of IPAH.

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Clarithromycin (CLR) formulation was prepared as PLGA nanoparticles in order to enhance the therapeutic effects using the distinctive features of a nanoparticulate delivery system. CLR loaded PLGA nanoparticles were prepared by Quasi Emulsion Solvent Diffusion (QESD) method using Poly lactic-co-Glycolic Acid (PLGA) as a biodegradable polymer. Antibacterial activity of the prepared formulations was evaluated against clinical strains of Helicobacter pylori, isolated from gastric biopsies of patients with gastritis, duodenal ulcer, peptic ulcer, and gastroesophageal reflux disease undergoing endoscopy, by using agar dilution method.Spherical nanoparticles with relatively narrow size distribution (between 200 and 800 nm) in the size range of 305 ± 138, 344 ± 148 and 362 ± 110 nm were achieved for F22, F23 and F23 respectively. CLR encapsulation percentages were measured to be 57.4 ± 4.3 to 80.2 ± 4.0%. CLR loaded PLGA nanoparticles showed equal or enhanced eradication effect against H. pylori strains according to the declined MIC values in comparison with the untreated CLR.In conclusion, the prepared CLR nanoformulation showed appropriate physicochemical properties and improved activity against H. pylori that could be a suitable candidate for oral preparations.

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The aim of the current investigation was to prepare and evaluate the potential use of solid lipid nanoparticles for the dermal delivery of spironolactone (SP). The spironolactone loaded SLN (SP-SLN) was prepared by emulsion-solvent evaporation method followed by ultrasonication. The properties of obtained SLNs were characterized by photon correlation spectroscopy (PCS), scanning tunneling microscopy (STM) and differential scanning calorimetry. FT-IR was also used to investigate any interaction between SP and excipients in the molecular level during the preparation of SLNs. The performance of the formulations was investigated in terms of drug release, skin permeation and also the retention of drug by the skin. The SP-SLNs presented spherical shape with the mean diameter, zeta potential and entrapment efficiency of 88.9 nm, -23.9 mV and 59.86%, respectively. DSC study showed that SP alone encapsulated in SLNs was in the amorphous form. FT-IR analysis revealed that there were hydrogen bond interactions between the SP alone and SLN components. The dissolution results revealed that the drug release from SP-SLNs was at least 4.9 times faster than original SP within the first 30 min. The cumulative amount of SP penetrated through rat skin from SP-SLNs was almost twofold that of the SP alone in 24h after the administration. In vitro permeation studies indicated that SP-SLN may be a promising vector for use in the topical treatment. It can be concluded that SLNs provide good skin permeation for SP and may be a promising carrier for topical delivery of spironolactone offering the biphasic release pattern that might be interesting for topical application resulting in an effective treatment for skin disorders such as acne.

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The objective of this study was to investigate the effect of sundried pistachio by-products (PBP) as a replacement of alfalfa hay (AH) on blood metabolites, rumen fermentation and populations of rumen bacteria involved in biohydrogenation (BH) in Baluchi sheep. Four adult male Baluchi sheep (41 ± 1.3 kg, BW) fitted with ruminal cannulae were randomly assigned to four experimental diets in a 4 × 4 Latin square design. The dietary treatments were as follows: (i) control, (ii) 12% PBP (0.33 of AH in basal diet replaced by PBP), (iii) 24% PBP (0.66 of AH in basal diet replaced by PBP) and (iv) 36% PBP (all of AH in basal diet replaced by PBP). The basal diet was 360 g/kg dry matter (DM) alfalfa hay, 160 g/kg DM wheat straw and 480 g/kg DM concentrate. The trial consisted of four periods, each composed of 16 days adaptation and 4 days data collection including measurement of blood metabolites, rumen fermentation and population of bacteria. No differences were observed in rumen pH among the treatments, while rumen ammonia-N concentrations were decreased (p< 0.05) with increasing PBP by up to 36% DM of the diets. Using of 36% PBP in the diet reduced (p < 0.05) total volatile fatty acids (VFA) concentrations and the molar proportion of acetate, while the concentration of propionate, butyrate and acetate to propionate ratio were similar to all other treatments. The concentration of blood urea nitrogen (BUN) decreased (p < 0.01) with increasing PBP by up to 36% DM in the diets of sheep. However, other blood metabolites were not affected by the experimental diets. It was concluded that PBP in replacement of AH had no effects on the relative abundance of Butyrivibrio fibrisolvens and Butyrivibrio proteoclasticus in relation to the control diet.

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INTRODUCTION: Recent advances have proven that the combinational therapy of extended release dipyridamole (DYP) and fast release aspirin (ASP) can improve clinical indices of heart failure in several vascular disorders. Although pharmaceutical industries always supported fast, simple and cost saving techniques in their productions, there is no simple reported method available for this purpose. The aim of this study was to check the possibility of preparing a FDC product, containing individual dosage units of extended release DYP microparticles and fast release ASP, using the spray-drying technique as a practice compatible with pharmaceutical industries. MATERIALS AND METHOD: Solid dispersions of DYP in different polymeric substances (ethyl cellulose, carnauba wax, and Eudragit PO 100), were prepared using the spray-drying method. The physicochemical properties and structure of the prepared microparticles were analyzed using different techniques, such as the particle size analyzer (PSA), differential scanning calorimetry (DSC), scanning electron microscopy (SEM), X ray diffraction (XRD), and USP dissolution tester. ASP tablets were prepared individually and tested according to pharmacopeia. RESULTS AND DISCUSSION: Results showed that prepared microparticles measured about 2.3 µm in size. Statistical analysis of the release data revealed that there is no significant difference in the mean release amount of the selected formulation compared to the innovative brand (Aggrenox®). CONCLUSION: Findings proposed a new formulation (F7) as an alternative to innovative brand and proved spray drying as a practice compatible with pharmaceutical industries and as a successful method for sustaining the DYP release rate from prepared microparticles in a FDC dosage form.

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Researchers have demonstrated that antimicrobial agents in nanoparticle (NP) forms have better activities. Vancomycin (VCM), as a glycopeptide antibiotic with antimicrobial activity against gram positive bacteria, is poorly absorbed from the intestinal tract. Enterococcus is a genus of bacteria that became resistant to a wide range of antibiotics in last decades, and cause severe infections in hospitalized patients. This paper describes preparation of VCM--loaded poly (lactic-co-glycolic acid) (PLGA) NPs and compares the antimicrobial effects with drug solution against clinical Enterococcus isolates. VCM-loaded PLGA NPs were fabricated by W1/O/W2 solvent evaporation method. The comparison of obtained Minimum Inhibitory Concentration (MIC) values showed a significant decrease in the antimicrobial effect of VCM -loaded NPs. Results also indicated that the potency of the NPs against VCM resistant isolates of Enterococcus was less than VCM susceptible isolates. The reduced antimicrobial effect of formulated NPs in invitro condition is perhaps related to the strong electrostatic linkage between hydrophilic drug (VCM) and hydrophobic polymer (PLGA) that lead to the slow release of the antibiotic from polymeric NPs.

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BACKGROUND: The aim of this study was to determine the bioequivalence of generic (test) and branded (reference) formulations of betamethasone injectable suspension in healthy Iranian subjects for the purpose of meeting regulatory requirements for bioequivalence of the generic formulation in Iran. METHODS: 24 healthy Iranian male volunteers were participated for this single-dose, randomized, open label, 2 period crossover study separated by a 2-week washout period. For the assessment of betamethasone, blood samples were obtained before and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 h after drug administration. Plasma concentration of betamethasone was analyzed with a simple, rapid and validated high performance liquid chromatography method with ultraviolet detection. Pharmacokinetic parameters, representing the rate (Cmax, Tmax), and the extent (AUC0-t and AUC0-∞) of betamethasone absorption were calculated and analyzed for 2 formulations. The 2 formulations were to be considered bioequivalent if the 90% confidence intervals (CI)s for the logarithm-transformed values of Cmax, AUC0-t and AUC0-∞ fell within the predetermined range of 80-125%. RESULTS: The 90% CIs of Cmax, AUC0-t and AUC0-∞ were 85.4-104.4%, 96.2-112.1% and 98.3-115.8%, respectively. CONCLUSION: Based on the 90% CIs of Cmax, AUC0-t and AUC0-∞ in these healthy Iranian male subjects, the test and reference formulations of betamethasone injectable suspension met the regulatory requirements for bioequivalence.

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This single dose, randomized, open label, 2-period and crossover study in healthy Iranian adult volunteers was conducted to compare the bioavailability of 2 branded formulations of olanzapine 10 mg tablets. 24 volunteers received one tablet of each olanzapine 10 mg formulation. Drugs were administered after a 12 h overnight fast in each of 2 treatment days which separated by a 2-week washout period. Serial blood samples were collected over a period of 72 h. Plasma was analyzed using a validated high performance liquid chromatography method with ultraviolet detection in the range of 2-24 ng/mL with a lower limit of quantitation of 1.25 ng/mL. A non-compartmental method was employed to determine the pharmacokinetic properties (Cmax, Tmax, AUC0-t, AUC0-∞ and T1/2) to test to bioequivalence. Cmax, AUC0-t and AUC0-∞ were used to test the bioequivalence after log-transformation of plasma data. The mean (SD) Cmax, AUC0-t and AUC0-∞ for the test formulation were 15.82 (3.15) ng/mL, 447.19 (100.64) ng.h/L and 570.75 (130.55) ng.h/L respectively. Corresponding values for the test formulation were 15.72 (4.25) ng/mL, 440.37 (98.75) ng.h/mL and 558.66 (129.57) ng.h/mL. For test formulation vs. the reference formulation, the 90% CIs of the least squares mean test/reference ratios of Cmax, AUC0-t and AUC0-∞ were 97.6-110.0%, 96.4-109.4% and 97.3-109.2%. In these volunteers, based on the FDA regulatory definition, results from the pharmacokinetic analysis suggested that the test and reference formulations of olanzapine 10 mg tablets were bioequivalent.

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Interleukin-12 (IL-12) as a cytokine has been proved to possess antitumor effects via stimulating the immune system. Non-viral gene delivery systems offer several advantages, including easiness in production, low cost, safety; low immunogenicity and can carry higher amounts of genetic material without limitation on their sizes.pUMVC3-hIL12 loaded Low Molecular Weight chitosan/ß-cyclodextrin (LMW CS/CD) nanoparticles were prepared using ionotropic gelation method and characterized in terms of size, zeta potential, polydispersity index, morphology, loading efficiency and cytotoxicity against the CT-26 colon carcinoma cell line.All prepared particles were spherical in shape and nano-sized (171.3±2.165 nm, PdI: 0.231±0.014) and exhibited a positive zeta potential (34.3±1.55). The nanoparticles demonstrated good DNA encapsulation efficiencies (83.315%±2.067). Prepared pUMVC3-hIL12 loaded LMW CS/CD nanoparticles showed no cell toxicity in murine CT-26 colon carcinoma cells. At the concentration of 0.1 µg/ml of nanoparticles, the transfection ability was obviously higher than that of the naked DNA.LMW CS/CD-plasmid DNA nanoparticles encoding IL-12 prepared using ionotropic gelation method with no toxic effect on the tested cells can be considered as a basis for further gene delivery studies both in vitro and in vivo to enhance the expression of IL-12.

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In the present study pharmacokinetics and bioequivalence of 2 brands of ciprofloxacin 500 mg were evaluated in 24 healthy male volunteers after a single dose oral administration in an open, randomized, 2-way crossover study.Blood samples were taken before and within 12 h after the administration of the drug. Plasma concentrations of ciprofloxacin were determined by a simple HPLC method with ultraviolet detection. The used method was validated for specificity, accuracy, precision and sensitivity. The mobile phase consisted of 0.025 M phosphoric acid, acetonitrile, and triethylamine. Analytical column was 5 µm Eurosphere C8 with a Eurosphere C8 guard column. The detector wavelength was set at 278 nm and the retention time was 10 min. The pharmacokinetic parameters, including peak plasma concentrations and time needed to reach the peak were obtained directly from plasma concentration-time profiles. The area under the curve was calculated using non-compartmental methods.The Cmax of 1476.8±319.9 ng/mL and 1 423.0±278.4 ng/mL were attained in about 1.67 and 1.58 h for test and reference formulations, respectively. The mean±SD values for AUC0-∞ were 9 665.3±2 880.2 and 9 716.1±2 572.1 ng.hr/mL for test and reference formulations, respectively. The pharmacokinetics parameters AUC0-t, AUC0-∞ and Cmax were calculated for bioequivalence after log-transformation of data. The 90% confidence intervals of test/reference for AUC0-t, AUC0-∞ and Cmax were (95.6-109.9%), (91.8-106.3%) and (95.2-112.8%), respectively and all were within the bioequivalence acceptance range of 80-125%.These results indicate that 2 tested formulations are bioequivalent and thus could be prescribed interchangeably.

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Pentoxifylline is a xanthine derivative that is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. In the present study, prior to the in vivo study, an in vitro comparative dissolution test was performed by the paddle method for 2 oral sustained release pentoxifylline tablets (400 mg) following the bioequivalence guidance of FDA. Metrics of peak exposure (Cmax) and total exposure to 24 h (AUC24) were compared using a randomized, single oral, open-label, 2-period, 2-sequence, 2 treatments crossover study in 24 healthy male volunteers under fasted conditions. After an overnight fast, the volunteers received 400 mg pentoxifylline and the blood samples were collected over a 24-h period following drug administration. Plasma drug concentrations were measured by a reverse-phase HPLC method with ultraviolet detection. In vitro dissolution tests requirements were met by both formulations. Observed exposure metrics for test and reference products were 140.6±51.5 and 132.6±48.5 ng/ml for Cmax and 986.4±350.7 and 1 035.8±350.3 ng.h/ml for AUC0-24 respectively. The confidence intervals (90%) around ratios (test/reference) of least squares means derived from logarithmic transformed exposure metrics were 0.9912-1.1564% for Cmax and 0.8886-1.0535% for AUC0-24. Therefore it can be concluded that both products are bioequivalent in terms of peak and total exposure and therefore interchangeable.

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Novel drug delivery systems such as nanoparticles (NPs) have been proved to enhance the effectiveness of many drugs. Clarithromycin is a broad spectrum macrolide antibiotic, used in many infectious conditions like upper and lower respiratory tract infections, and skin and other soft tissue infections. This paper describes the preparation and enhanced in vitro antibacterial activities of clarithromycin loaded poly (lactic-co-glycolic acid) (PLGA) nanoparticles. A modified quasi-emulsion solvent diffusion (MQESD) method was used to prepare clarithromycin (CLR) NPs. The antibacterial activity of the NPs was evaluated using the agar well diffusion method against Escherichia coli (PTCC 1330), Haemophilus influenzae (PTCC 1623), Salmonella typhi (PTCC 1609), Staphylococcus aureus (PTCC 1112) and Streptococcus pneumoniae (PTCC 1240). The inhibition zone diameters related to each nano formulation were compared with those for untreated CLR at the same concentrations. The results indicated that the mean inhibition zone diameters of NPs against all the bacteria tested were significantly higher than those of untreated CLR, particularly in the case of S. aureus. The increased potency of CLR NPs may be related to some physicochemical properties of NPs like modified surface characteristics, lower drug degradation, and increased drug adsorption and uptake.

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The aim of this study was to evaluate microencapsulated controlled release preparations of tolmetin sodium using ethylcellulose as a retardant material. Microspheres were prepared by using water-in-oil-in-oil (W/O(1)/O(2)) double-emulsion solvent diffusion method, using different ratios of ethylcellulose to tolmetin sodium. Span 80 was used as the droplet stabilizer and n-hexane was added to harden the microspheres. The prepared microspheres were characterized for their micromeritic properties, drug content, loading efficiency, production yield, and particle size. Fourier transform infrared spectroscopy, differential scanning calorimetry, X-ray powder diffractometry and scanning electron microscopy were used to characterize microparticles. The in vitro release studies were performed in pH 1.2 and 7.4. The prepared microspheres were spherical in shape. The drug-loaded microspheres showed near to the theoretical of entrapment and release was extended up to 24. The X-ray diffractogram and differential scanning thermographs showed amorphous state of the drug in the microspheres. It was shown that the drug: polymer ratio, stirring rate, volume of dispersing medium and surfactant influenced the drug loading, particle size and drug release behavior of the formed microparticles. The results showed that, generally, an increase in the ratio of drug: polymer (0.5:1) resulted in a reduction in the release rate of the drug which may be attributed to the hydrophobic nature of the polymer. The in vitro release profile could be modified by changing various processing and formulation parameters to give a controlled release of drug from the microparticules. The release of tolmetin was influenced by the drug to polymer ratio and particle size and was found to be diffusion and erosion controlled. The best-fit release kinetic was achieved with Peppas model.

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The influence of glycyrrhizin extracted from Glycyrrhiza glabra var. glandulifera (licorice roots) on the percutaneous absorption of diclofenac sodium from sodium carboxymethylcellulose (NaCMC) gels or oil-in-water (o/w) emulsion was investigated. Skin permeation experiments were carried out using excised abdominal rat skin. The results showed that the efficiency of glycyrrhizin as an enhancer agent is greater in gel formulations than it is in the emulsions. The enhancer with the concentration of 0.1% w/w in gel increased diclofenac sodium flux value to tenfold compared with the control gel.

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Eudragit RS and RL are biocompatible non-swelling polymers that widely used in the preparation of sustained release drug delivery systems. In this study, the effect of thermal treating on the tensile strength of tablets and release of indomethacin from Eudragit RS and RL matrices were investigated. The results showed that thermal treating at 40 degrees C has no effect on the release of the drug, whereas heat-treating at temperatures higher than 50 or 60 degrees C decreases the release rate of indomethacin from Eudragit RS or RL, respectively. It was shown that the duration of the heat treatment was also an important factor in controlling the release rate of indomethacin from Eudragit matrices. The results showed that an increase in the duration of the heat treatment from 2 to 24 h resulted in a reduction in the release rate of the drug. The heating of the matrices over 24 h had no significant effect on the release rate of indomethacin. It was shown that heat treatment of the matrices over the glass transition temperature of the polymer can prolong the drug release but had no significant effect on the tensile strength of tablets.

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El ácido acetilsalicílico (AAS) se encapsuló con eftalato de acetilcelulosa (EAC), etilcelulosa (EC) o sus mezclas mediante un método de adición de emulsión no disolvente. Se evaluaron los perfiles de liberación de AAS en microcápsulas preparadas en diversas proporciones de fármaco y polímero (10:1 y 4:1) y microcápsulas en comprimidos en un pH 1,2 ó 6. Los resultados mostraron que al reducir la proporción de fármaco respecto al polímero se reducía la velocidad de liberación. Las microcápsulas preparadas con EC presentaron el índice de liberación más bajo. Los estudios de liberación in vitro indicaron que la velocidad de liberación del fármaco disminuía tras la preparación del comprimido, debido a la formación de una matriz no desintegrable. La liberación de AAS en un pH 6 es significativamente mayor en todas las microcápsulas, incluso si se utiliza EC, que no es hidrosoluble. Esto se debe probablemente a la mayor solubilidad del AAS en un pH 6, lo que indica la formación incompleta de la película alrededor de las partículas de AAS. Los datos de liberación se examinaron cinéticamente y se calcularon los modelos ideales para la liberación del fármaco. Los resultados mostraron que en las microcápsulas en comprimidos el coeficiente de correlación más elevado se obtuvo con la liberación de orden cero. En las microcápsulas en comprimidos que contenían EAC o una mezcla de EAC y EC, la contribución de la erosión fue mayor que en las microcápsulas que no estaban en comprimidos (AU)

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Different species of Crataegus, commonly called Hawthorn, were reported to possess wide pharmacological effects on the cardiovascular system. In the present study, chloroform, ethylacetate and methanol (70%) extracts of the flowering tops of Crataegus meyeri A. Pojark. were studied. The extracts were tested on the incidence and severity of arrhythmias induced by a period of myocardial ischaemia in open-chest anaesthetized male Wistar rats. Infusion of a hydroalcohol extract (1 mg/kg/min) resulted in a significant decrease in the total number of ventricular ectopic beats (from 1494 +/- 362 in the control to 634 +/- 102), mainly by reduction of beats occurring as ventricular tachycardia. A chloroform extract (1 mg/kg/min) also reduced the total number of ventricular ectopic beats but this reduction was due to the decrease of single extrasystoles. A significant reduction in the time spent for ventricular fibrillation was seen by the hydroalcohol and ethylacetate extracts. There were no significant changes in the heart rate and blood pressure during the extract infusion. However, bolus injection of all the extracts caused a significant reduction in the blood pressure. Thus, the extracts of Crataegus meyeri have a hypotensive and a potential antiarrhythmic action on ischaemic myocardium and may possess active principles.

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