Soft Capsules Research Articles

Soft Capsule Magnetic Millirobots for Region-Specific Drug Delivery in the Central Nervous System.

Small soft robotic systems are being explored for myriad applications in medicine. Specifically, magnetically actuated microrobots capable of remote manipulation hold significant potential for the targeted delivery of therapeutics and biologicals. Much of previous efforts on microrobotics have been dedicated to locomotion in aqueous environments and hard surfaces. However, our human bodies are made of dense biological tissues, requiring researchers to develop new microrobotics that can locomote atop tissue surfaces. Tumbling microrobots are a sub-category of these devices capable of walking on surfaces guided by rotating magnetic fields. Using microrobots to deliver payloads to specific regions of sensitive tissues is a primary goal of medical microrobots. Central nervous system (CNS) tissues are a prime candidate given their delicate structure and highly region-specific function. Here we demonstrate surface walking of soft alginate capsules capable of moving on top of a rat cortex and mouse spinal cord ex vivo, demonstrating multi-location small molecule delivery to up to six different locations on each type of tissue with high spatial specificity. The softness of alginate gel prevents injuries that may arise from friction with CNS tissues during millirobot locomotion. Development of this technology may be useful in clinical and preclinical applications such as drug delivery, neural stimulation, and diagnostic imaging.

Impact of Maternal Daily Oral Low-Dose Vitamin A Supplementation on the Mother-Infant Pair: A Randomised Placebo-Controlled Trial in China.

Background: The nutritional status of vitamin A in lactating mothers and infants is still not optimistic. Due to the dietary habits and dietary restrictions of postpartum customs in China, vitamin A supplementation has been advocated as a potential strategy to improve vitamin A status of lactating mothers with inadequate dietary vitamin A intake. Existing clinical trials are limited to single or double high-dose maternal administrations. However, in China, vitamin A supplements are readily available in the form of daily oral low-dose supplements, and the effect of these is unknown. This study aimed to evaluate the effects of daily oral low-dose vitamin A supplementation on the retinol levels in the serum and breast milk of lactating mothers and the health status of infants in China. Methods: Lactating mothers who met the inclusion criteria and planned to continue exclusive breastfeeding were randomly assigned to receive either daily oral vitamin A and D drops (one soft capsule of 1800 IU vitamin A and 600 IU vitamin D2), or a matching placebo for 2 months. Before and after the intervention, dietary intake was investigated by instant photography, and the retinol concentration in maternal serum and breast milk was determined by ultra-high performance liquid chromatography-tandem mass spectrometry. During the trial, the health status of infants was diagnosed by a paediatrician or reported by lactating mothers. A total of 245 participants completed the study, with 117 in the supplementation group and 128 in the control group. Results: After the 2-month intervention, maternal serum retinol concentrations increased in the supplementation group with no change in the control group. Although breast milk retinol concentrations decreased significantly in both groups, the decrease in the supplementation group was significantly lower than that in the control group. However, maternal vitamin A supplementation was not associated with a lower risk of infant febrile illness, respiratory tract infection, diarrhoea, and eczema. Conclusions: Daily oral low-dose vitamin A supplementation is helpful in improving maternal vitamin A status, despite having no effect on infant health status through breast milk.

Multi-Class UHPLC-MS/MS Method for Plant Toxins and Cyanotoxins in Food Supplements and Application for Belgian Market Samples.

The presence of plant toxins and/or cyanotoxins in food supplements implies consumer health risks. Therefore, a targeted ultra-high performance liquid chromatographic-tandem mass spectrometric method to detect/quantify 25 toxins simultaneously in food supplement formulations was developed and validated. Full validation for tablets/powders and secondary validation for a liquid and soft gel capsule indicated that most compounds were efficiently extracted (≥ 75%), while others were only partly extracted (18 - 61%). Trueness was fulfilled (70 - 120%), with some exceptions (mostly at the lowest validation level). Intralaboratory repeatability, intra- and interlaboratory reproducibility values of ≤ 20%, ≤ 25%, and ≤ 25% were obtained for most, respectively. Matrix effects were found to be significant for most compounds. Good sensitivity (µg/kg level) was observed for galegin(e), lycopsamine, lycorine, rubiadin, skimmiamine, and vascin(e), in contrast to helveticoside, lucidin, lucidin-3-primveroside, plumbagin(e), and thujone, which were detected at the mg/kg level. The other compounds were characterized by a sensitivity between 10to 1000 µg/kg. The validated methodology was applied for 52 food supplements (tablets, capsules, liquids/syrup, etc.) purchased from the Belgian market. In more than 25% of the samples, one or more toxins were detected (concentrations determined using standard addition). Lycopsamine, microcystin LR, solamargine, thujone, and vasicin(e) were the most frequently detected toxins. A clear link between the toxins detected and the plant species on the food supplement ingredient list could not always be established. This generic "dilute-and-shoot" procedure can be used for further research on toxins in food supplements and by extension other plant/algae-based food/feed commodities (herbs, edible flowers, etc.).

Development and validation of a gas chromatography method for the determination of \u03b2-caryophyllene in clove extract and its application

The purpose of this study is to check the effectiveness of the analysis method that separates and quantifies β-caryophyllene among clove extracts and validate according to current ICH guidelines. The β-caryophyllene was active constituent of clove buds. The developed method gave a good detection response. In the specificity test, the standard solution was detected at about 17.32 min, and the test solution was detected at 17.32 min. The linearity of β-caryophyllen was confirmed, and at this time, the correlation coefficient (R2) of the calibration curve showed a high linearity of 0.999 or more in the concentration range. The levels of LOD and LOQ were 1.28 ug/mL and 3.89 ug/mL, respectively. The accuracy was confirmed to be 101.6–102.2% and RSD 0.95 ~ 1.31%. As a result of checking the repeatability and inter-tester reproducibility to confirm the precision, the RSD was found to be 1.34 ~ 2.69%. This validated GC method was successfully applied to a soft capsule containing clove extract and other materials for clinical trials. Therefore, this method can be used as an analytical tool for quality control of various samples, including clove extracts and their products of food and pharmaceutical uses.

Biostatistics Health Assessment of Matrix Metalloproteinases in Vaginal Secretions in Late Pregnant Women

Objective: The health management of pregnant women in late pregnancy is difficult. Once vaginal infection occurs, adverse pregnancy outcomes will occur. The aim of this study was to explore the application value of biostatistics health assessment of matrix metalloproteinases (MMP) in vaginal secretions in late pregnant women with vaginal infection. Methods: A total of 120 late pregnant women with vaginal infection, including vulvovaginal candidiasis (WC) in 70 cases and bacterial vaginosis (BV) in 50 cases, were selected as the experimental group. Another 80 pregnant women with normal vaginal secretion in the same gestational week were randomly selected as the control group. Vaginal soft capsule of mycomycin was used in the treatment. The expression levels of MMP-8 and MMP-9 in vaginal secretions before and after treatment were detected by enzyme-linked immunosorbent assay (ELISA) and smear immunohistochemistry, Results: Both the ELISA and immunohistochemistry analysis showed that the levels of MMP-8 and MMP-9 in the vaginal secretion of experimental group were significantly increased than the data of control group (P < 0.05). After effective intervention, the levels of MMP-8 and MMP-9 were significantly lower than those before treatment (P < 0.05). Conclusion: The late pregnant women with vaginal infection was accompanied by the high level of MMP-8 and MMP-9 in vaginal secretions. Effective intervention will lead the reduction of MMP. Thus, the biostatistics health assessment of MMP is important for the late pregnant women with vaginal infection.

Economical irregular silica as an effective dispersive solid-phase extraction sorbent for the quantification of calcitriol in soft capsules

Calcitriol is an active product of vitamin D produced by the liver and kidney hydroxylase metabolism with strong physiological activity. It is the preferred form of medicine for patients with insufficient bone mineralization due to chronic kidney disease. Calcitriol soft capsule is one of the common preparation forms, the main drug content of which is very low (1.55 μg g−1), and the pharmaceutical excipients interfere greatly, especially the oily matrix medium-chain triglycerides. Therefore, removing the interference of oily matrix is ​​the main challenge in the content determination. At present, the commonly used sample purification method for the determination of calcitriol in soft capsules is liquid-liquid extraction, but it usually consumes a lot of toxic organic solvents and it is costly. The adoption of SPE purification method, on the one hand, requires specific experimental equipment, and on the other hand, the organic solvent used in the experiment may cause the dissolution of SPE column tube materials, which will interfere with the subsequent detection. Herein, in order to achieve a cost-effective and reliable determination of calcitriol soft capsule content, we developed a dispersive solid-phase (DSPE) extraction method that directly uses irregular silica as sorbent, which is followed by high-performance liquid chromatography equipped with a UV detector(HPLC-UV)analysis. Selective retention of calcitriol is achieved by the polar interaction between calcitriol and silica, what’s more, sufficient contact between washing solvent and sorbent can be guaranteed. Therefore, after pretreatment with DSPE, the interference of oily matrix on detection can be mostly removed and then improve the accuracy of the method compared to the SPE method. Under the optimal conditions of DSPE, calcitriol showed a good linear relationship in the range of 0.15−2.99 μg g−1, the R2 was 0.997. Satisfactory recoveries ranging from 101.1%–102.0% for calcitriol were achieved in the oily matrix at the levels of 0.75, 1.50 and 2.24 μg g−1. And the intra-day and inter-day RSD were less than 2.5 % and 3.2 %. Meanwhile, the LOD and LOQ of calcitriol was 0.01 μg g−1 and 0.02 μg g−1, which is in full compliance with the regulatory level fixed by the EU, China or other countries. This method was further verified to determine the content of calcitriol in commercial calcitriol soft capsules and the recoveries of three batches of products was 86.2 %–94.4 %. Based on these characteristics, the proposed method makes it possible to determine the low content of weakly polar drugs in the oily matrix in a simple, low-cost and reliable way.

Effect of Nigella sativa oil extract on cardiometabolic risk factors in type 2 diabetes: A randomized, double-blind, placebo-controlled clinical trial.

The objective of this study was to determine the effects of Nigella sativa oil extract on cardiometabolic risk factors in people with type 2 diabetes (T2D). A randomized, controlled, clinical trial was conducted on 43 patients with T2D (23 women and 20 men; aged 53.5 ± 7.4 years). The intervention group (N= 23) received two 500-mg per day soft gel capsules containing Nigella sativa oil extract and the control group (N= 20) received two identical placebo soft gel capsules containing sunflower oil per day for the same period, 8 weeks. Pre- and post-intervention cardiometabolic risk factors were measured. Compared with the placebo, the N. sativa oil significantly decreased FBS (p= .03(, HbA1c (p= .001), total cholesterol (p= .04), TG (p= .003), LDL-c (p= .001), BMI (p< .001), waist circumference (p< .001), SBP (p= .001), and DBP (p= .002). HOMA-IR (p= .51) and HDL-c (p= .91) did not change significantly following Nigella sativa supplementation. Nigella sativa oil exerted beneficial effects on glycemic control, serum lipid profile, blood pressure, and body weight among people with T2D. Further long-term trials in the future may help confirm the current therapeutic benefits of Nigella sativa in T2D.

Peak shape enhancement using diethylamine in hydrophilic liquid interaction chromatography: Application in simultaneous determination of methionine and paracetamol

Methionine (MET) is combined with paracetamol (PAR) in a pain relief soft capsule in order to prevent the haematologic damage of paracetamol. A hydrophillic liquid chromatographic (HILIC) method was developed for simultaneous determination of PAR and MET in the combined formulation. Various analytical conditions were investigated, and the final method was chosen using silica column (150 × 4,6 mm; 5 μm), mobile phase of acetonitrile – aqueous solution of 10 mM formic acid 5 mM diethylamine (60:40, v/v), UV detection at 254 nm for PAR and 210 nm for MET. The method was validated according to ICH guidelines in terms of selectivity, linearity, accuracy, precision and robustness. The method was successfully applied for quantitation of both compounds in soft capsule preparations bought from the market. Notably, in this study, a novel approach was proposed to improve peak shape of amino acid – a problem often observed in HILIC. The addition of diethylamine to mobile phase shortened the retention time of MET and significantly improved peak shape on both silica and cyano columns, due to electrostatic interaction competition and silanol end-capping effect. The result of this research demonstrated the advantages of HILIC in simultaneous analysis of a polar compound amino acid, especially in combination with a less polar substance. The use of diethylamine as a mobile phase modifier to enhance peak shape is a new suggestion that can be used in further studies on amino acid analysis by HILIC.

The effect of soft oral capsule of rose oil on sexual dysfunction in women of reproductive age: A randomised clinical trial

IntroductionSexual dysfunction is defined as a disorder occurring at any stage of the sexual cycle which results in distress or interpersonal disturbances. The aim of this trial was to determine the effect of oral rose oil on sexual dysfunction in women of reproductive age. MethodsThis triple-blind randomized placebo controlled clinical trial (RCT) was conducted on 80 women referred to Tehran University of Medical Sciences clinics. Women with sexual dysfunction were randomly assigned to either the rose oil or the placebo group. In the rose oil group, women consumed two soft capsules containing 15 mg of rose oil daily for eight weeks. Women in the placebo group took a placebo containing sunflower oil, daily for eight weeks. Data collected included demographic information, and completion of the Female Sexual Function Index (FSFI) and the Beck Depression Inventory (BDI). The FSFI questionnaire was completed before the beginning of the study, at the end of week four, and at the end of the study. Data were analysed using SPSS-16 software. ResultsThe average female sexual function score in the rose oil group was significantly improved within eight weeks after intervention (26.7 ± 5.13) compared to the beginning of the study (20.90 ± 3.34) (P < 0.001). The difference was not significant for the control group at any time (P = 0.320). The difference in the mean score of the female sexual function index between the intervention and the control group at the end of the study was statistically significant (P < 0.001). ConclusionThis study suggests that the daily consumption of soft capsules containing rose essential oil for eight weeks can improve female sexual function in women of reproductive age.This clinical trial was registered in the Iranian Registry of Clinical Trials (No.: IRCT2017051333951N1).

Naturally occurring kaolinite as a sorbent for solid-phase extraction of calcitriol in soft capsules

An environmentally friendly, simple and reliable method to quantify calcitriol in soft capsules was developed. Calcitriol with strong physiological activity has a low content (1.55 μg·g−1) in calcitriol soft capsules. Due to the poor stability of calcitriol, a large amount of medium chain triglycerides (>99.99%) need to be used as excipients to protect it. Herein, to achieve accurate quantification of the active ingredients in the calcitriol soft capsules, removing the interference of fat-soluble matrix is the main challenge. This experiment developed a cost-effective solid-phase extraction (SPE) clean-up method based on natural kaolinite (Kaol), which is followed by liquid chromatography coupled with Photodiode array detector (HPLC-DAD) analysis. In the self-made Kaol-SPE, calcitriol could remain on the Kaol sorbent (Al2O3: 39.5%, SiO2: 46.5% and H2O: 14.0%) by polar interactions, n-π interaction and lewis acid base interaction, whereas the hydrophobic medium chain triglycerides could be sufficiently washed off by n-hexane. Thus, the selective extraction of calcitriol and clean-up of fat-soluble matrix were achieved. Kaol was characterized by Fourier transform infrared spectrometry, scanning electron microscopy, transmission electron microscopy, X-ray diffraction and nitrogen adsorption-desorption. Adsorption isotherms were determined to infer the adsorption mechanism and adsorption capacity of calcitriol on Kaol. The fitting results showed that it was followed Langmuir model and the maximum adsorption capacity was 5.495 mg·g−1 (fast adsorption rate, 1 min). Various parameters such as SPE cartridges, Sorbent dosage (20–120 mg), washing solvent, eluting solvent and its volume (0.2–4.0 mL) were investigated. Under optimized conditions, good linear range was 0.15–2.99 μg∙g−1. Recoveries is satisfactory (98.15–101.64%), and the relative standard deviations (RSDs) are only 1.22%. Minor matrix effect was 96.72%, which was excellent. Moreover, low quantitation limit (LOQ) of calcitriol is 0.015 μg·g−1. This method was further validated to determine the content of calcitriol in different batches of commercial calcitriol capsules. The method can directly process diluted samples without liquid-liquid extraction, and has the feature of automation. Thus, this work provides a simple, convenient and economical platform for the determination of calcitriol in complex matrices on a large scale and promotes natural-based materials in pharmaceutical analysis field.

Efficacy and safety of long-term treatment with monthly calcifediol soft capsules in vitamin D deficient patients

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Evaluation of the Effectiveness of Cinnamon Oil Soft Capsule in Patients with Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

Background Different effects of cinnamon and its oil in traditional medicine in the treatment of diseases, including gastrointestinal diseases, were reported. The aim of this study is to evaluate the efficacy and safety of cinnamon oil (Cinnamomum zeylanicum) in patients with functional dyspepsia in a double-blind, randomized placebo-controlled trial. Methods Soft gelatin capsule was made using the rotary die process, and the final capsule was standardized based on its cinnamaldehyde amount and analyzed by high-performance liquid chromatography (HPLC) method. Sixty-four patients with symptomatic functional dyspepsia were randomized to receive cinnamon oil soft capsule (n = 29) or sesame oil soft capsule as placebo (n = 35) for 6 weeks. The primary efficacy variable was the sum score of the patient's gastrointestinal symptom (five‐point scale). Secondary variables were the scores of each dyspeptic symptom including severity of vomiting, sickness, nausea, bloating, abdominal cramps, early satiety, acidic eructation/heartburn, loss of appetite, retrosternal discomfort, and epigastric pain/upper abdominal pain, as well as any reported adverse events. Results The results showed that, after 6 weeks of treatment, the cinnamon oil and placebo groups significantly decreased the total dyspepsia score compared to the baseline at the endpoint (P < 0.001). However, there was no significant difference between the cinnamon oil and placebo groups in terms of the baseline and endpoint values of the outcome variables (P=0.317 and P=0.174, respectively). Two patients in the cinnamon oil group complained of rashes, and three patients in the placebo group complained of nausea. Conclusion This study showed significant improvements in gastrointestinal symptom score in both treatment and placebo groups. However, there was no significant difference between the cinnamon oil and sesame oil groups in terms of the baseline and endpoint values of the outcome variables. This study was registered as https://clinicaltrials.gov/ct2/show/IRCT20170802035460N2, 29 December 2017, in the Iranian Registry of Clinical Trials with https://www.IRCT.ir.

Nigella sativa as a promising intervention for metabolic and inflammatory disorders in obese prediabetic subjects: A comparative study of Nigella sativa versus both lifestyle modification and metformin.

This study aimed at evaluating the effect of Nigella sativa (NS) on anthropometric, metabolic and inflammatory parameters and examining its related molecular mechanisms in obese prediabetic individuals as compared to both lifestyle modification (LM) and Metformin (Met). This study included 117 obese prediabetic subjects who were randomized into LM group which followed controlled diet and exercise regimen, metformin group received metformin 500 mg tablets twice daily and NS group received NS oil soft gelatin capsules 450 mg twice daily. Anthropometric (weight, BMI), glycemic, lipid, inflammatory parameters and genetic expressions of Sirtuin-1 (SIRT1) and p53 genes were assessed before and six months after interventions. Post-intervention pairwise comparison revealed that, NS was statistically similar to metformin in improving anthropometric, glycemic parameters and SIRT1 gene expression. There was non-significant difference between LM and NS regarding their effects on anthropometric and most of glycemic parameters. Lifestyle modification group showed significantly higher HOMA-B and SIRT1 expression than NS and metformin. Nigella sativa improved lipid panel and significantly reduced TNF-α level and Castelli risk index-I as compared to other interventions. Nigella sativa uniquely improved lipid panel and significantly suppressed inflammation. Therefore, Nigella sativa may represent a promising intervention for obese prediabetic subjects. Clinicaltrial.gov ID: NCT03925714.

RAPID AND SIMPLE DETERMINATION OF IBUPROFEN AND CAFFEINE IN FIXED-DOSE COMBINATION FORMULATIONS: APPLICATION TO DISSOLUTION STUDIES

Objective: To develop a UV-derivative spectrophotometric method with zero-crossing determinations for the simultaneous quantification of ibuprofen (IBU) and caffeine (CAF) in fixed-dose combination formulations (soft gelatin capsules). The proposed method was validated, and it was applied to determine the in vitro dissolution performance of IBU and CAF from a commercial formulation.&#x0D; Methods: The method is based on the use of the second-derivatives of the zero-order spectra and measurement at zero-crossing wavelengths. Linearity, accuracy, precision, stability, and influence of the filter were evaluated. Dissolution profiles of IBU and CAF were obtained with the USP Apparatus 2 at 100 rpm and 900 ml of 0.1 M phosphate buffer pH 7.4 as dissolution medium. Dissolution samples were treated with the proposed UV-derivative method and results were compared with data previously published.&#x0D; Results: The zero-crossing points for the determination of IBU and CAF were found at 235.6 nm and 218.8 nm, respectively. The method was linear in the range of 7.5-15 µg/ml for IBU and 5-25 µg/ml for CAF (R2&gt;0.999, *P&lt;0.05). The precision and accuracy of the method were within acceptable criteria (CV&lt;0.99% and recovery 97.97% for IBU and CV&lt;1.76% and recovery 99.05% for CAF). Fiberglass filters were the best option to filter samples and stability of all drugs was adequate when solutions were stored at 25 °C during 24 h. Dissolution of IBU and CAF at 60 min was 99-100% with dissolution profiles of sigmoidal S-shape. Weibull function and Logistic were the best-fit models that describe the in vitro dissolution performance of both drugs.&#x0D; Conclusion: The proposed UV-derivative method allows the simultaneous determination of IBU and CAF in fixed-dose combination formulations. The method generates reliable information that can be compared with published data. The proposed UV-derivative method is rapid and simple and can be easily adopted for routine analysis of IBU and CAF.

Development and Evaluation of Fluoxetine Fast Dissolving Films: An Alternative for Noncompliance in Pediatric Patients

The most used pharmaceutical formulations for children are syrups, suppositories, soft chewable capsules, and mini-tablets. Administrating them might create an administration discomfort. This study aimed to develop and evaluate orodispersible films (ODFs) for pediatric patients in which the fluoxetine (FX) is formulated in the polymeric matrix. Six FX fast dissolving films (10 mg FX/ODF), FX1, FX2, FX3, FX4, FX5, and FX6, were prepared by solvent casting technique. In the composition of the ODFs, the concentration of the hydroxypropyl methylcellulose and the concentration of the propylene glycol were varied. Each formulation of fluoxetine ODF was evaluated by determining the tensile strength, folding endurance, disintegration, behavior in the controlled humidity and temperature conditions, and adhesiveness. All the obtained results were compared with the results obtained for six ODFs prepared without FX. The disintegration time of the FX ODFs was of maximum 88 s for FX2. Via the in vitro releasing study of the FX from the ODFs it was noticed that FX1 and FX2 allow a better release of the drug 99.98 ± 3.81% and 97.67 ± 3.85% being released within 15 min. From the obtained results it was also confirmed that FX ODFs were found to follow first-order release kinetic.

Effects of delta-tocotrienol supplementation on Glycemic Control, oxidative stress, inflammatory biomarkers and miRNA expression in type 2 diabetes mellitus: A randomized control trial.

The study aimed to ascertain the effects of delta-tocotrienol (δT3) supplementation on glycemic control, oxidative stress, inflammation and related micro-ribonucleic acid (miRNA) expression in patients with type 2 diabetes mellitus (T2DM). Total 110 patients of T2DM on oral hypoglycemic agents, were randomly divided into tocotrienol and placebo groups and given 250 mg δT3 or cellulose soft gel capsule once daily respectively for 24 weeks. Glycemic control, oxidative stress, inflammatory biomarkers, and miRNAs expression were measured in serum at baseline and end of the intervention by using standard laboratory methods. Compared to the placebo, δT3 supplementation resulted in a significant (p≤ .05) reduction [mean difference (95% confidence interval)] in plasma glucose [-0.48 (-0.65, -0.30)], insulin [-1.19 (-1.51, -0.87)], homeostatic model assessment of insulin resistance [-0.67 (-0.86, -0.49)], glycosylated hemoglobin [-0.53 (-0.79, -0.28)], malondialdehyde [-0.34 (-0.45, -0.22)], high sensitive-C-reactive protein[-0.35 (-0.54, -0.16)], tumor necrosis factor-alpha [-1.22 (-1.62, -0.83)], and interleukin-6[-2.30 (-2.91, -1.68)]. More than twofold downregulation in miRNA-375, miRNA-34a, miRNA-21, and upregulation in miRNA-126, miRNA-132 expression was observed in the δT3 group compared to the placebo. The study demonstrated that δT3 supplementation in addition to oral hypoglycemic agents, improved glycemic control, inflammation, oxidative stress, and miRNA expression in T2DM without any adverse effect. Thus, δT3 might be considered as an effective dietary supplement to prevent long-term diabetic complications.

HPLC Study on HPLC Characteristic Spectrum of Huoxiang (Herba Agastachis) Eliminating Summer-heat Soft Capsule

To establish HPLC characteristic spectrum of Huoxiang (Herba Agastachis) Eliminating Summer-heat Soft Capsule. Chromatographic separation was performed on Tech Mate C18-ST (5 um, 4.6×250 nm) column by Agilent 1260 high performance liquid chromatograph, eluted with acetonitrile and 0.05% phosphoric acid in a gradient elution at a flow rate of 1.0 mL∙min-1. The detection wavelength was set at 270 nm. Hesperidin was selected as the reference peak to calculate the RSD of the relative retention time. Precision, stability and reproducibility were investigated as well. 80 different samples from 5 manufacturers were included in this study. The HPLC characteristic spectrum of Huoxiang Eliminating Summer-heat Soft Capsule was constructed with 11 specific chromatographic peaks in 80 samples. The method is accurate, reliable and with good reproducibility, and could overall control the quality of Huoxiang Eliminating Summerheat Soft Capsule.

The Clinical Effects of Supplementation with Oral Strip and Soft Gelatin Capsule of Vitamin D in Deficient Patients: a Single-Blinded Clinical Trial

The Clinical Effects of Supplementation with Oral Strip and Soft Gelatin Capsule of Vitamin D in Deficient Patients: a Single-Blinded Clinical Trial

Nanofiller-Enhanced Soft Non-Gelatin Alginate Capsules for Modified Drug Delivery.

Capsules are one of the major solid dosage forms available in a variety of compositions and shapes. Developments in this dosage form are not new, but the production of non-gelatin capsules is a recent trend. In pharmaceutical as well as other biomedical research, alginate has great versatility. On the other hand, the use of inorganic material to enhance material strength is a common research topic in tissue engineering. The research presented here is a combination of qualities of alginate and montmorillonite (MMT). These two materials were used in this research to produce a soft non-gelatin modified-release capsule. Moreover, the research describes a facile benchtop production of these capsules. The produced capsules were critically analyzed for their appearance confirming resemblance with marketed capsules, functionality in terms of drug encapsulation, as well as release and durability.

Forced degradation study and characterization of main impurities of ibuprofen soft gelatin capsules by LC-MS-QTOF.

Ibuprofen soft gelatin capsules were subjected to degradation under acidic, basic, oxidation, photolytic, thermal, humidity, and metal ions conditions. To analyse the degradation products, a reversed-phase liquid chromatography (RP-LC) indicative stability method was successfully developed. Chromatographic separation was achieved using a Poroshell HPH-C18 150 x 4.6 mm, 4 μm, column at 25 °C, with a mobile phase constituted by 0.1% phosphoric acid and acetonitrile in gradient at a flow rate of 1.0 mL• min -1 , using ultraviolet detection at 220 nm and injection volume of 20 μL. In total, eight unknown impurities were found. The peaks RRt 0.49, RRt 0.75, and RRt 0.95 were above 0.17%, corresponding to the identification threshold. Those were identified and characterized by LC-MS-QTOF, with the same chromatographic conditions, except for the exchange of 0.1% phosphoric acid for 0.1% formic acid. The impurities originated from the interaction of ibuprofen with excipients: esterification with PEG, with sorbitol/sorbitan, and with glycerol by-products, which has not yet been reported in the literature. The developed method can be used in several pharmaceutical areas as quality control of impurities, studies of forced degradation, and for the development of future formulations.