The aim of this study is to develop Darunavir (DRV) proliposome powder for oral delivery. Darunavir-loaded oral proliposome powder (OPP) was prepared by a solvent evaporation technique with varying ...independent variables at three different levels. Based on different levels, proliposome powder formulation was optimized by using Box-Behnken design. The formulations were analyzed for its size distribution, entrapment efficiency, and surface morphology. Optimized proliposome batch A was evaluated for physical parameter, morphological parameters, entrapment efficiency, followed by in vitro, ex vivo, and in vivo studies. Oral proliposome powder showed good micromeritic properties with angle of repose was less than 30°, Carr's index and Hausner's ratio were also less than 21 and 1.25, respectively. The mean size of the vesicles was in the range of 180-290 nm. The assay and entrapment efficiency of pro-liposome powder formulations were 79.00 ± 0.2 and 93.46 ± 0.2%, respectively. In vitro release of DRV proliposome powder was 78.17 ± 0.1% after 24 h which shows good release from the vesicle of proliposome. Ex vivo permeation study shows 58.11% enhancement which shows good permeation. The optimize batch A of proliposome powder indicated 50% enhancement in the relative bioavailability as compared to the DRV suspension. The results showed that proliposome powder containing DRV can efficiently deliver in to the blood stream. This drug delivery system has been designed as a novel platform for potential oral delivery of drugs having poor water solubility and high first-pass metabolism.
Tartrazine is approved as a food color additive internationally with INS number 102, in the United States as food color subject to batch certification “Food, Drug, and Cosmetic” (FD&C) Yellow No. 5, ...and in Europe as food color additive with E number 102. In their evaluation of the color (2013), the European Food Safety Authority (EFSA) expressed concerns of potential genotoxicity, based primarily on one genotoxicity study that was not conducted according to Guidelines. The present in vivo genotoxicity study was conducted according to OECD Guidelines in response to EFSA's request for additional data. The animal species and strain, and the tissues examined were selected specifically to address the previously reported findings. The results of this study show clear absence of genotoxic activity for Tartrazine, in the bone marrow micronucleus assay and the Comet assay in the liver, stomach, and colon. These data addressed EFSA's concerns for genotoxicity. The Joint WHO/FAO Committee on Food Additives (JECFA) (2016) also reviewed these data and concluded that there is no genotoxicity concern for Tartrazine. Negative findings in parallel genotoxicity studies on Allura Red AC and Ponceau 4R (published separately) are consistent with lack of genotoxicity for azo dyes used as food colors.
•The genotoxicity of Tartrazine was determined in a GLP- and OECD Guideline-compliant study in mice.•Tartrazine was negative for genotoxicity in the bone marrow micronucleus assay.•Tartrazine was negative for genotoxicity in the Comet assay in the liver, stomach, and colon.•The study was conducted in response to request for additional information by the European Food Safety Authority (EFSA).
Allura Red AC is an approved food color additive internationally with INS number 129, in the United States as food color subject to batch certification “Food, Drug, and Cosmetic” (FD&C) Red No. 40, ...and in Europe as food color additive with E number 129. In their evaluation of the color (2013), the European Food Safety Authority (EFSA) expressed concerns of potential genotoxicity, based primarily on one genotoxicity study that was not conducted according to Guidelines. The present in vivo genotoxicity study was conducted according to OECD Guidelines in response to EFSA's request for additional data. The animal species and strain, and the tissues examined were selected specifically to address the previously reported findings. The results show clear absence of genotoxic activity for Allura Red AC, in the bone marrow micronucleus assay and the Comet assay in the liver, stomach, and colon. These data addressed EFSA's concerns for genotoxicity. The Joint WHO/FAO Committee on Food Additives (JECFA) (2016) also reviewed the study and concluded that there is no genotoxicity concern for Allura Red AC. Negative findings in parallel genotoxicity studies on Tartrazine and Ponceau 4R (published separately) are consistent with lack of genotoxicity for azo dyes used as food colors.
•The genotoxicity of Allura Red AC was determined in a GLP- and OECD Guideline-compliant study in mice.•Allura Red AC was negative for genotoxicity in the bone marrow micronucleus assay.•Allura Red AC was negative for genotoxicity in the Comet assay in the liver, stomach, and colon.•The study was conducted in response to request for additional information by the European Food Safety Authority (EFSA).
A novel, rapid, selective, precise and accurate stability-indicating reversed phase high-performance liquid chromatography (RP-HPLC) method was developed for Pterostilbene. The method was validated ...accord¬ing the Q2(R1) guidelines of International Conference on Harmonization (ICH) with respect to system suitability, linearity, range, LOD, LOQ, accuracy, precision. The forced degradation was validated according to International Conference on Harmonization (ICH). The chromatographic analysis was performed on Agilent 1260 Infinity HPLC instrument using an ACE C-18 Column (150 x 4.6mm, 3um) and mobile phase comprising water: ACN (35:65 v/v) at the flow rate of 1 ml/min. The column eluent was monitored at 306nm. The total run time was 6 min and the average retention time of Pterostilbene was found to be 3.19 min. The method showed excellent linear response with correlation coefficient values (R2) of 0.999 which were within the limit of correlation coefficient (R2 >0.995). Average percentage recovery of Pterostilbene was 98.65 found within acceptable limits (97.0-103%). The LOD and LOQ were 0.006875ng and 0.020626 ng respectively. Percent RSD values of intra-day precision study were below 2%. Pterostilbene showed significant degradation when exposed to water, acid (0.1N HCL), base (0.1N NaOH), oxidizing agent (10% H2O2), and UV light. Pterostilbene content of the aqueous extract (extractive yield: 5.25%) of Pterocarpus marsupium powder by using proposed HPLC method was found to be 1.732µg. Similarly, for aqueous-ethanolic extract (extractive yield: 10%) was found to be 30.540µg. Ninety five % ethanolic extract (extractive yield: 3.33%) was found to contain 34.663µg Pterostilbene.
Due to the unrivalled abundance of chemical components, natural products derived from medicinal plants, whether in their pure form or as standardised extracts, provide limitless potential for new ...medications. Natural remedies have been used all over the world as alternatives to hormone replacement therapy and as treatments for chronic illnesses like asthma, cancer, diabetes, inflammatory, and analgesic conditions since ancient times. Bioactive substances are used in a variety of commercial fields, including the pharmaceutical, food, and chemical industries, demonstrating the need for the best and most standardised technique to remove these active components from plant materials. As truth, a lot of conventional extraction techniques have a number of drawbacks, including poor effectiveness, high energy costs, and low yields. Hence, the development of new and advanced extraction techniques is essential. Higher productivity, less work, and reduced costs are a few benefits of the new technology. A variety of innovative extraction technology combinations that are also appropriate for heat-labile chemicals have been found. The objective of this review work is to offer a thorough overview of the various approaches for extracting natural compounds from medicinal plants.
The developmental neurotoxicity of calcium cyclamate was evaluated in Sprague Dawley Crl:CD(SD) rats, administered in drinking water, in comparison to a concurrent control group (water) and a ...positive control group given propylthiouracil (PTU). Calcium cyclamate was administered to F0 females for 4 weeks prior to pairing, throughout mating, gestation and lactation and to F1 offspring from weaning to 12 weeks of age, PTU was administered by gavage to F0 females from Day 6 of gestation up to Day 20 of lactation. Target calcium cyclamate doses were 0, 250, 500 and 1,000 mg/kg bw/day, while the PTU dose was 0.5 mg/kg bw/day. No treatment-related effects of cyclamate were observed in either the F0 or F1 generations on reproductive performance or neurobehavioral development. In comparison, PTU exposure resulted in developmental delays, memory impairment and a number of neuropathological and morphometric outcomes. The results from the unique developmental neurotoxicity study design, corroborate the absence of hyperactivity and any other neurotoxic effects following cyclamate administration at levels up to 878 mg/kg bw/day in F0 females and 784 mg/kg bw/day in F1 animals. This demonstrates the suitability of PTU as a positive control and confirms the safe use of cyclamate as a no-calorie sweetener.
•Cyclamate is a low/no calorie sweetener.•Neurotoxicity assessment for food ingredients.•Use of a positive neuro-behavioral control Propylthiouracil.•Food additive human hazard assessment.
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