Pharmacopeia Limits Research Articles

Mineral Composition of Blackcurrant (Ribes Nigrum L.) Fruits and Leaves

Background Plants as living systems are characterized by the appropriate degree of accumulation of macro- and microelements, which, acting as factors of the external environment, are basic modulators for synthesizing biologically active substances. Blackcurrant (Ribes nigrum L., Grossulariaceae) is widespread worldwide. Berries, leaves, and buds are medicinal raw materials in folk medicine. The regularity of inorganic elements accumulation in this plant and their impact on the quality of raw materials are topical and need to be studied. Aims This work aimed to study the mineral composition of R. nigrum raw materials collected in Western Ukraine (Ivano-Frankivsk and Ternopil regions) and find the regularity of their accumulation in the plant parts and from the soils. Methods The elemental compositions of R. nigrum fruits and leaves, as well as the soils of the growth places, were studied using the method of atomic emission spectrometry with inductively coupled plasma iCAP 7000 Duo. Results The content of 19 inorganic elements in R. nigrum raw materials was established. Their quantities don’t differ significantly depending on the growth places. All the fruits had high K, Na, Mg, P, and Ca contents, which were slightly lower in leaves. Thus, the fruits contain 590-675 mg/kg of Mg, while in leaves, there are just 98-106 mg/kg. Most of Fe was accumulated in the fruits (73-85 mg/kg). The content of Mn was observed in the leaves (57-64 mg/kg), slightly higher than in the fruits (47-51 mg/kg). The content of heavy metals in the objects was within the permitted limits of European Pharmacopeia. The results testify to the inverse relationship between the content of most elements in the soils and the coefficient of their accumulation in the plant. Conclusion The content of macro- and microelements in R. nigrum fruits and leaves had similar profiles but differed in their quantitates. The regularity of element accumulation in R. nigrum raw materials corresponds to the following profile in accordance with their quantitative content in the raw materials: K> Na> P> Mg> Ca> Si> Fe> Mn> Al> Se> Zn> Cu> Co> I> Pb> Ni> Mo> Sr> Cd. The regularity of their accumulation in the plant parts from the soils was established.

Formulation and Characterization of Niacinamide and Collagen Emulsion and Its Investigation as a Potential Cosmeceutical Product

Cosmeceuticals are one of the fast-growing areas of the natural personal care industry. Cosmeceuticals are cosmetic products with medicinal or drug-like benefits that can affect the biological functioning of the skin depending on the ingredients in the composition. The development of one formulation acting on the dermis and stimulating the collagen production is very important for the hydration of the skin. The association of collagen with other ingredients can have a positive effect on increasing the natural production of collagen in the skin. An example of such an ingredient is niacinamide, which, having a recognized nutritional value, has been quite recently studied. Considering these aspects, this study focused on developing oil-in-water (O/W) emulsions, based on natural ingredients (vegetable oils, floral waters, and essential oils) and hydrolyzed collagen and niacinamide as active ingredients, and on evaluating the stability, pH, optical, superficial, rheological and textural properties, as well as microbiological tests of the emulsions, in order to investigate their potential as a cosmeceutical product. All the obtained emulsions proved to be stable at variable temperatures and had a pH value compatible with natural pH of the skin, allowing their safe application. Over goniometric analysis, a partial wetting and a hydrophilic character of the emulsions were emphasized. Following the rheological analyses, all dermatocosmetic emulsions exhibited non-Newtonian pseudoplastic behavior and a thixotropic character, these properties being very important for their production process and their application on the skin surface to generate an optimal therapeutic effect. The textural characteristics recorded for all emulsions indicated adequate spreadability at the application site. All tested samples respected the Pharmacopoeia limits of microbiological contamination. All prepared emulsions have good stability, are safe for the skin and have appropriate physicochemical and microbiological characteristics; therefore, they can be used as a cosmeceutical product.

Decontamination protocol in the production of herbal medicines: a short communication

Background: The effectiveness and safety of natural products depend not only on the inherent properties of the plant, but also on careful preparation, which includes critical steps such as cleaning to remove impurities and washing to eliminate surface contaminants. Thus, the scientific literature emphasizes the significance of thorough cleaning in ensuring botanical purity, directly impacting the ultimate quality of the product. Methods: The study utilized the plant species Cordia verbenacea, Alternanthera brasiliana, and Lippia alba, cultivated in Tatuí - SP, subjected to a rigorous selection process, and processed through a washing and drying protocol. The washing involved a two-stage process, including immersion in clean water and a sodium hypochlorite solution. Microbiological analyses were conducted on washed and unwashed samples, including enumeration of viable colony-forming units (CFUs) and detection of pathogens. Moisture content was determined using the oven drying method, and ash content was assessed following the Brazilian Pharmacopeia guidelines. Results: Microbiological results indicate the absence of Salmonella sp. and Staphylococcus aureus in all analyzed plant drugs, regardless of washing and stabilization conditions. Pseudomonas aeruginosa was observed only in unwashed/stabilized Cordia verbenacea and Alternanthera brasiliana samples. Escherichia coli was identified in an unwashed/stabilized Lippia alba sample. The washing/stabilization process significantly reduced total bacterial and fungal counts, especially when exceeding the limit set by the Brazilian Pharmacopeia (103 CFU/g). Total ash content remained unchanged after the washing/stabilization process in the three plant species, staying within the Brazilian Pharmacopeia limits (14%). Moisture content did not differ statistically between washed/stabilized and unwashed/unstabilized plant species and met Brazilian Pharmacopeia specifications (8-14%). Conclusion: The washing/stabilization process effectively reduced microbial load in Lippia alba, Alternanthera brasilians, and Cordia verbenacea, with no significant changes in ash and moisture content. Preliminary analysis suggests that processing control ensures minimum quality conditions, enhancing overall safety for consumers.

An evaluation of the quality of Annona muricata leaf products.

Annona muricata, also known as graviola, is traditionally used for the treatment of a range of disorders including cancer. Interest in A. muricata use has increased in recent years. This study investigated the quality and safety of a selection of commercially available A. muricata leaf products. Seven commercially available products were purchased via online shopping sites. Each product was assessed for quality indicators including weight variation, quantification of the bioactive constituent annonacin, presence of annonaceous acetogenins and contaminants. The samples were evaluated by thin-layer chromatography, high-performance liquid chromatography, liquid chromatography-mass spectroscopy, low-resolution mass spectrometry and nuclear magnetic resonance spectroscopy. Microbial analysis was carried out in accordance with the British Pharmacopoeia. Heavy metals were analysed by inductive coupled plasma mass spectrometry. Of the seven products analysed, one product contained less than half of the content stated on the label. The labelled dosage recommendation varied between products. There was a high variation in annonacin concentration (1.05-3.09 mg/g) and the presence of annonaceous acetogenins. One of the products was found to have a total aerobic microbial count above the United States Pharmacopoeia limit. The variation in the indicators of quality and safety of commercially available A. muricata leaf products tested have implications for clinicians and people living with cancer who use these herbal products.

Analysis of injectable drugs (Pentazocine and Diazepam) sampled from shops and companies in Anambra State, Nigeria

The incidences of drug adulteration and drug resistance have been a major problem facing mankind in recent years. Low and medium-income countries like Nigeria are most affected. An investigation was carried out to determine the quality of Pentazocine and Diazepam injections in circulation in Anambra State. The injections were sampled from different markets, shops, and pharmaceutical companies within the State. Imported and locally manufactured brands of the injections were analysed. Identification, pH, Assays, Bacteria Endotoxin, sterility, and sub-visible particulate matter contamination were analysed. The results of the Identification, Bacteria Endotoxin (BET), Particulate matter count, and pH are all within the British Pharmacopeia. The Pentazocine Assays obtained were (98.31%- 102.5%) which are within the British Pharmacopeia limit of (95% – 105%). This is good for health management. The Assays of two of the Diazepam injections tested were between (111.33% - 111.53%), which is above the approved British Pharmacopeia limit of (90%-110%). This is an indication of high level of impurities and not good for health care management.

Evaluation of a compact composite sensor array for concentration monitoring of solutions and suspensions via multivariate analysis

Compact composite probes were identified as a priority to alleviate space constraints in miniaturized unit operations and pharmaceutical manufacturing platforms. Therefore, in this proof of principle study, a compact composite sensor array (CCSA) combining ultraviolet and near infrared features at four different wavelengths (280, 340, 600, 860 nm) in a 380 × 30 mm housing (length x diameter, 7 mm diameter at the probe head), was evaluated for its capabilities to monitor in situ concentration of solutions and suspensions via multivariate analysis using partial least squares (PLS) regression models. Four model active pharmaceutical ingredients (APIs): warfarin sodium isopropanol solvate (WS), lidocaine hydrochloride monohydrate (LID), 6-mercaptopurine monohydrate (6-MP), and acetaminophen (ACM) in their aqueous solution and suspension formulation were used for the assessment. The results demonstrate that PLS models can be applied for the CCSA prototype to measure the API concentrations with similar accuracy (validation samples within the United States Pharmacopeia (USP) limits), compared to univariate CCSA models and multivariate models for an established Raman spectrometer. Specifically, the multivariate CCSA models applied to the suspensions of 6-MP and ACM demonstrate improved accuracy of 63% and 31%, respectively, compared to the univariate CCSA models [1]. On the other hand, the PLS models for the solutions WS and LID showed a reduced accuracy compared to the univariate models [1].

Formulation and Evaluation of Molexicam Orally Disintegrating Tablet (ODT)

The aim of the present study was to develop and evaluate an oral disintegrant tablet of meloxicam. Drug delivery systems became sophisticated and pharmaceutical scientists acquire a better understanding of the physicochemical and biochemical parameters pertinent to their performance. Over the past three decades, mouth dissolving or orally disintegrating tablets have gained considerable attention as a preferred alternative to conventional tablets due to better patient compliance. 
 Orally is the most preferable route of drug administration which has some limited to drug candidate that show poor permeability across the gastric mucosa and those, which are sparingly soluble. A large majority of the new chemical entities and many new existing drug molecules are poorly soluble, thereby limiting their potential uses and increasing the difficulty of formulating bioavailable drug products, so lastly the purpose of this study was to grow mouth dissolve tablets of Meloxicam. 
 Meloxicam is a non steroidal anti-inflammatory drug (NSAID) which a newer selective COX-1 inhibitor. Different five formulations were prepared in his study and evaluated. These tablets were prepared by direct compress procedure. 
 Results: The results indicate that formulation number five is the best formula were friability is 0.65% < 1%, wetting time is 5.5 sec. and disintegration time is 18 sec.
 Dissolution test indicate that more than 75% of drug dissolve in the first 5min. and assay test is 99.1% which is within the pharmacopeia limit (90-110%). The systematic formulation approach helped in understanding the effect of formulation processing variables. 

Evaluation of Microbiological Contamination of Some Selected Syrups and Suspentions Solid in Katsina Metropolis

Presented study attempted to evaluate the Microbiological contamination of some selected syrups and suspensions sold in Katsina metropolis. This study was conducted in Biological sciences laboratory Al-qalam University Katsina between the months of November 2021 to January 2022. Eighteen different types of oral liquid drugs (9 syrups and 9 suspensions) manufactured in different pharmaceutical industries of Nigeria were microbiologically examined using standard cultural and biochemical methods. All the samples were found to be contaminated with total viable bacteria and fungi with a maximum load of 103 cfu/ml among all samples were exceeded the United States Pharmacopeia (USP) limit (<102 cfu/ml). While the presences bacteria including; E.coli, Salmonella spp., Shigella spp., were found to be presences in almost all samples, (the former of E.coli in 11 syrups and suspension samples, the Salmonella spp. in 3 suspension samples and the Shigella spp. In 8 suspensions). Existence of microorganisms in the oral liquid samples might explain the treatment complicacy of the diseased children. A routine microbiological study of such drugs is thus suggested.

Pharmacognostic and Phytochemical Features of Cleome gynandra Whole Plant and its Powder

Cleome gynandra is one among the plants used as a remedy for various human and animal diseases. It is commonly called nalvelai in Tamil and belongs to the family cleomaceae. Aim of the present study is used to assess quality of the powdered plant materials. The prime objective of this study is to assess characteristic features of powder preparation, pharmacognostic value like ash value, extractive value, chromophore by fluorescent assay and also to study phytochemical markers. Powder microscopy, organoleptic character assessment, physiochemical, fluorescent features, microbial load and preliminary phytochemical features like pharmacognosy of this plant were studied by making use of standard textual procedures. Plant powder is yellowish green in colour with a bitter taste. Plant powder showed 0% foreign matter, 4.9%w/w total ash with higher water extractive (23.7%w/w). Variable chromophores were detected with different acid and alkali treatment. Treatment of nitric acid showed violet brown coloration under long UV radiation. Microbial load was within the limits of pharmacopeial standards of raw drugs and no pathogenic organisms were detected. All the pharmacognostic results were within the limits of ayurvedic pharmacopeia of India. Whole plant powder showed the presence of terpenoids, flavonoids, polyphenols and saponins, which could be a phytochemical marker. GC-MS report revealed the presence of 20 Compounds in crude powder preparation. Histochemical study also confirmed the presence of tannin, saponin, flavonoids, steroids, Terpenoids and polyphenols, which could also confirm the water-soluble compounds in the C. gynandra whole plant powder. These observations would be of immense value in the botanical identification and standardization of drugs in a crude form.

Pharmacognostic and Phytochemical Features of Andrographis echioides Whole Plant Powder

Andrographis echioides is one of the stress tolerant plant that belongs to the family Acanthaceae commonly called as Kopuramthangi in Tamil, commonly found in central region of Tamilnadu, India. Local peoples used this plant for fever, to relieve griping, irregular stools and loss of appetite. Indian siddha and ayurvedic pharmacopeia provide standardization criteria for herbal drugs. The aim of the study is to provide quality standards for the powder drug from the whole plant of Andrographis echioides. In order to provide herbal standards for this plant, the present study was undertaken with the objectives to assess pharmacognostic, physiochemical and phytochemical markers of the drug powder of Andrographis echioides whole plant. Andrographis echioides whole plant was collected, authenticated and processed for all pharmacognostic activity using standard textual methods. Powder analysis showed the presence of calcium oxalate crystals, trichomes, fibres, vessel elements and parenchyma cells. The powder is yellowish green in colour with 3.6% ash value with higher water extractive (19.4%). Powder contains a smaller number of microbial flora and no pathogens detected. Multiple fluorochromes were detected in fluorescence test. The pharmacognostic results were within the limits of ayurvedic pharmacopeia of India. Whole plant powder showed the presence of terpenoids, flavonoids, Saponins, phenolic compounds and carbohydrates which could be responsible for all biological activities of the plant. Histochemical analysis also confirmed the availability of phytoconstituents like flavonoids and tannins. The observations made through this study would be of immense value in the pharmacological evaluation and standardization of crude powder of the plant materials.

QUALITY CONTROL TESTING OF CONVENTIONAL CLOPIDOGREL BISULFATE TABLETS MARKETED IN IRAQ

Objective: This study was employed to evaluate the quality of marketed oral tablets containing clopidogrel bisulfate. Tablets produced by various companies and commercialized in the Iraq market were used in the study. Methods: Batches of clopidogrel bisulfate conventional tablets (containing 75 mg of drug) were exposed to the quality control tests. These tests involved friability, weight variation, hardness, drug content, disintegration time, and in vitro release study; these tests were conducted depending on USP pharmacopeia. Results: The data indicate that all batches of clopidogrel bisulfate complied with the limitations of USP pharmacopeia for variation of weight, results of the hardness of tablets were 7.2-9.6 Kg/cm2. Friability value (% loss) was less than one, which was within the required limits. The time of disintegration was less than 25 min in both artificial gastric fluid (AGF) and artificial intestinal fluid (AIF). Drug content was observed between 97.1 % and 99.8 %, indicating compliance with the limits of pharmacopeia (85-115 %). An in vitro release study of batches was greater than 80 % within 25 min. Conclusion: All batches of clopidogrel bisulfate were manufactured within the criteria of tablet manufacturing. The quality control tests of tablets showed acceptable pharmaceutical properties (effectiveness and safety) that lie within the limits of USP pharmacopeia.

Sustained release matrix tablet of 100 mg losartan potassium: Formulation development and in vitro characterization

Sustained release matrix tablets of 100 mg losartan potassium HCl were fabricated with two release retarding polymers namely HPMC K100 M and affinisol by direct compression method. Nine trial formulations were prepared by varying content of these polymers, each from 50 mg to 100 mg; keeping the total weight of the tablet 310 mg. The best formulation was selected based on in vitro drug release profile for 12 hours conducted in Type II dissolution apparatus at 50 rpm and water as dissolution medium. Pre-compression parameters such as bulk density, tap density, Carr’s index and Hausner ratio were evaluated for the selected tablet. The tablets were subjected to thickness, weight variation test, drug content, hardness and friability. Drug release kinetics, surface morphology and accelerated stability study were investigated for that selected formulation. Formulation F4 with the composition of 75 mg HPMC K100M and 100 mg affinisol was selected as the best formulation that extended the drug release up to 12 hours. Pre-compression parameters and other tableting properties were within the Pharmacopoeia limit. Release kinetics analysis proved non-fickian zero-order drug release and that was further confirmed by surface morphology of the tablets before and after dissolution study visualized by SEM. The developed formulation was found to be stable for one month stored at 60 ○C.

Formulation and Evaluation of Cefaclor Extended-Release Tablet

Over past 30 years as the expanse and complication involved in marketing new drug entities have increased, with concomitant recognition of the therapeutic advantages of controlled drug delivery, greater attention has been focused on development of extended or controlled release drug delivery systems.
 In the present research work an attempt has been made to optimize, formulate and characterize extended-release tablet of Cefaclor. The preformulation studies were performed for the drug (e.g., physico-chemical properties, melting point, solubility etc.). The drug had shown the results under standard specifications. UV spectroscopic analytical method was also performed for quantitative determinations by plotting standard curve. Before this the pure drug was also scanned for the ƛ max value at different concentrations.
 The pre-compressions parameters and the post compression parameters for the nine formulated tablets were performed. The drug release study of the selected formulations EF3, EF6 and EF9 was performed as those formulations has shown the results within pharmacopoeia limits. The Formulation EF9 was then taken for release kinetic study as it has shown best results among the other three formulations. So, it confirms the drug release by Higuchi diffusion mechanism. From the results, conclusion can be drawn that the formulation consisting 10-12% concentration of hydroxypropyl methyl cellulose K4-M with 1% microcrystalline cellulose and 25% of lactose are considered as ideal for the optimized extended-release tablet formulation for Cefaclor.
 Keywords: Extended release, Cefaclor, Higuchi diffusion mechanism, PBP, bacterial cell wall synthesis.

Fabrication and Characterization of Polymeric Pharmaceutical Emulgel Co-Loaded with Eugenol and Linalool for the Treatment of Trichophyton rubrum Infections.

Trichophyton rubrum (T. rubrum) is the main cause of chronic dermatophytosis which is highly prevalent worldwide. This study was aimed to fabricate and characterize polymeric emulgel of eugenol and linalool for the treatment of T. rubrum infections. Using the slow emulsification method, the emulgel was prepared and characterized for thermodynamic stability, pH analysis, viscosity, spreadability, swelling behavior, %drug content, surface morphology, globules size, polydispersity index, surface charge (mV), thermal behavior, in vitro drug release and XRD studies. Biological activities of emulgel were conducted against T. rubrum in vitro and in vivo. Results indicated that emulgel formulations were thermodynamically stable. The pH of the formulations was within an acceptable range for skin. The viscosity and spreadability were optimum for the better patient compliance. The swelling behavior was 111.10 ± 1.25% after 90 min. The drug content was within the official pharmacopeia limit i.e., 100 ± 10%. The surface morphology revealed by scanning electron microscopy showed a spherical-shaped structure with characteristic larger cracks and wrinkles. The droplet size, PDI, and surface charge of the optimized emulgel were 888.45 ± 8.78 nm, 0.44 and −20.30 mV, respectively. The emulgel released 84.32% of eugenol and 76.93% of linalool after 12 h. There was complete disappearance of the diffraction peaks corresponding to the drugs after XRD analysis. In rabbits, the infection was safely and completely recovered after 12 days and the emulgel produced significant effects (p < 0.05) similar to the standard product Clotrim®. It is concluded that the eugenol–linalool emulgel best described all its physical properties and can be applied topically for the treatment of T. rubrum infections.

EVALUATION OF 68Ge/68Ga GENERATOR PRE-ELUTION EFFICIENCY ON METALLIC IMPURITIES IN THE COMPOSITION OF 68GaPSMA-11 RADIOPHARMACEUTICAL IN NUCLEAR MEDICINE PET CHEMISTRY

Objective: The presence of metallic impurities can pose a serious concern due to their interaction with receptor-specific biomolecules that require the highest possible specific activity, especially in radioactive labeling. There are studies in which Zn and other toxic metal pollution increases if the generator is not used for a long time. In this study the effect of pre-elution on chemical and radiochemical impurities in the synthesis product was investigated. Material and Methods: In the study, 68GaPSMA-11 labeling was performed with the generator eluate that was not used for one month (sample 1). A blank elution was taken 24 hours after using the generator (sample 2). In the next 24 hours, the second 68GaPS-MA-11 labeling was performed (sample 3). Six hours after this labeling, another 68GaPSMA-11 synthesis was performed (sample 4). Eluates were analyzed by Inductively Coupled Plasma Mass Spectrometry (ICP-MS). Results: Results was reported as a table in μg/ml. 68Ge levels determined at 0.018 ppm, 0.012 ppm and 0.009 ppm levels in the labeled products were determined below the pharmacopoeia limits. Zn(II) impurities were found as 0.625 ppm in the labeling performed without generator pre-elution. In generator pre-eluted labelings; Zn(II) impurities were determined as 0.133 ppm and 0.108 ppm.&nbsp;Conclusion: Pre-elution of the generator prior to synthesis does not seem to be a chemical requirement other than zinc pollution. 68GaPSMA-11 can be pre-eluted for high labeling efficiency, but it is thought that pre-elution is not significant in terms of chemical and radiochemical contamination.

Tablet Splitting in Elderly Patients with Dementia: The Case of Quetiapine.

Quetiapine is an atypical antipsychotic approved for treating schizophrenia, bipolar depression, and mania but is frequently used in an off-label manner to control the behavioral and psychological symptoms of dementia in elderly patients with dementia. Due to the need to personalize doses for elderly patients with dementia, quetiapine tablet manipulation is widespread in hospital settings, long-term care facilities, and patient homes. The aim of this study was to assess the impact of the different splitting techniques on quetiapine fumarate tablets by analysing the obtained sub-divided tablets and to discuss compliance with the European Pharmacopoeia limits on whole and split tablets. Quetiapine fumarate tablets of two dose strengths were taken at random (in a number able to assure a power of 0.8 during statistical comparison) and were split with a kitchen knife or tablet cutter. The weight and the drug content were determined for each half tablet. The obtained data were compared to the European Pharmacopoeia limits. The differences between the different splitting techniques were statistically tested. Data showed that split tablets, independently of the dose strength and the technique employed, were not compliant with the European Pharmacopoeia specifications for both entire and subdivided tablets in terms of weight and content uniformity. Thus, such a common practice could have potential effects on treatment efficacy and toxicity, especially when also considering the fragility of the elderly target population in which polypharmacotherapy is very common. These results indicate a compelling need for flexible quetiapine formulations that can assure more accurate dose personalization.

EVALUATION OF THE QUALITY OF DIFFERENT BRANDS OF ASCORBIC ACID IN FREETOWN, SIERRA LEONE

Objective: This study evaluates the registration status and the quality of nine brands of Vitamin C sold in Freetown, Sierra Leone, using official and non-official methods of analysis. Methods: The parameters taken into consideration during the study include non-official methods (friability and disintegration) and the official methods (identification test, uniformity of dosage unit, and assay by titrimetric and colorimetric tests). The different brands of vitamin C were selected and classified as registered and unregistered based on the data derived from the National Medicines Regulatory Authority. Results: One vitamin C product collected was unregistered at the National medicines regulatory authority (Pharmacy Board of Sierra Leone). All nine vitamin C products met the requirements for uniformity of dosage unit. The vitamin C products also conformed to the BP specification for friability and identification test (retention factor). The identification test showed that each brand contained vitamin C (ascorbic acid). The disintegration test was not applicable for chewable tablets. Three of the four non-chewable vitamin C products complied with the BP specification for disintegration, while one failed and did not meet the requirement. The assay results for ascorbic acid using titration and colourimetric method were comparable and appropriate for determining vitamin C. Out of a total of nine samples; seven met the requirement for BP specification (Passed) for assay. In contrast, one product did not meet the BP requirement (failed), and one sample had more vitamin C than the Pharmacopoeia limit. Conclusion: Periodic quality evaluation and routine checks for pharmaceutical products can ascertain the quality of products, their storage conditions and identify potential counterfeit medications.

Stability of pemetrexed disodium in sodium chloride 0.9% w/v intravenous Viaflo infusion bags

ObjectivesThe aim of this study was to assess the stability of pemetrexed disodium (Alimta), reconstituted in 100 mL sodium chloride 0.9% w/v intravenous infusion bags (Baxter Viaflo) at two target...

Preparation and Evaluation of Zafirlukast Compression Coated Tablets for Chronotherapeutic Drug Delivery

The objective of the present study was to formulate and evaluate an oral, time-controlled drug delivery system of Zafirlukast. Zafirlukast belongs to BCS class II drugs as it has poor aqueous solubility and good permeability. Hence an attempt has been made to improve its aqueous solubility by solid dispersion technique so that its dissolution, bioavailability, and therapeutic effect can be optimized. The optimized solid dispersion was then formulated into a chronotherapeutic drug delivery system by compression coating technology. FT-IR study revealed that there was no chemical interaction between the drug and polymers used. Tablets were prepared by direct compression method using different super disintegrants and then followed by compression coating using natural polymers. Pre-compression and post-compression parameters complied with the Pharmacopoeia limit for the tablets. In vitro release studies were performed and the results indicated the formulation Z9F9 to be the optimized formulation.

Health Hazard Assessment Due to Slimming Medicinal Plant Intake

According to the World Health Organization (WHO), about 80% of people rely on medicinal plants for their primary health needs. Traditional medicine's principal benefits are their vast population knowledge, low severe adverse effects rate, low cost, and the lack of a medical prescription to use them. While obesity has become a global health issue, an increase in finding cheap and fast ways to lose weight escalates medicinal herbs' use for this purpose, both in dietary supplements or in teas. At the same time that Brazil aims to expand traditional medicine, reports regarding toxicology and poisoning put natural products' safety in check. Plants can accumulate heavy metals and metalloids leading to health risks; however, there is a lack of information on that matter, possibly due to a lack of international standardization regarding elemental contamination - this study aimed to determine metal and metalloid concentrations in slimming medicinal plants and their respective teas and evaluate their safety consumption. Metal and metalloid content were determined by inductively coupled plasma optical emission spectrometry (ICP OES). All plants and teas were within the set limits for tolerable upper intake level (UL), provisional tolerable daily maximum intake (PTDMI), and provisional tolerable weekly intake (PTWI). The hazard quotient index (HQ) was above 1 for almost all plants, and the Hibiscus sabdariffa tea regarding aluminum content. The arsenic level was above the Brazilian Pharmacopeia limit in natura plants demonstrating risk in their consumption. Some herbs also presented detection for elements with no safety limits set, such as lead, cadmium, and arsenic, which could mark as a red flag for consumption once their security intake is not precise yet.