Weight Variation Test Research Articles

Non-Aqueous Based HPMC Transdermal Patch of Aceclofenac: In vitro characterization

Background: An effective substitution for conventional administration routes is transdermal medication delivery. The use of transdermal treatments to treat arthritis has increased significantly in recent years. There is a pressing need to develop a new aceclofenac transdermal medication delivery method. Objective: The current study intends to stop aceclofenac from degrading in an aqueous environment in an effort to increase the drug's stability and effectiveness when used therapeutically to treat arthritis. The goal of the current research is to create non-aqueous, hydroxypropyl methyl cellulose-based transdermal patches for aceclofenac that will improve patient compliance, increase therapeutic efficacy, decrease gastrointestinal side effects, and prevent substantial first-pass metabolism. Method: By using a solvent evaporation approach, 18 different aceclofenac transdermal patch formulations, including HPMCK4M, HPMCK100M, and HPMCK15M, were created. The characterization of these prepared transdermal patches was done in vitro. Result: DSC thermograms concluded that there is no interaction between the API and excipients. The mass, weight variation, flatness, moisture content, moisture uptake, folding endurance, thickness, medication content, and swelling tests of these transdermal patches were all assessed. Good in-vitro physicochemical qualities could be seen in all of the improved formulations. The improved transdermal Patch (P13) was chosen for in-vivo investigations based on the findings. Conclusion: In order to increase the stability and effectiveness of aceclofenac during its therapeutic use for arthritis, it can therefore be reasonably inferred that it can be made into nonaqueous transdermal matrix type patches.

Formulation and Evaluation of Domperidone Lozenges

The lozenges are the best dosage forms for formulating large dose medicaments. The anatomy of mouth and cheek helps in easy and effective systemic absorption of drug and also better patient compliance especially for pediatrics and geriatrics due to their taste palatability. The formulation involves mixing of Domperidone with excipients used in the formulation in different ratios by using heat congealing technique in which sucrose and dextrose were heated separately, fused together and reheated, after which polymer HPMC K 100M, and all other excipients were added and moulded. The lozenges were then subjected to evaluation of quality parameters like weight variation test, Physical parameters, drug content and in vitro release studies. Result showed that effect of polymer like HPMC showed better effect in heat & congealing technique. Lozenges were prepared by using HPMC polymer of different ratios which showed a satisfactory result in both in vitro dissolution studies and drug content. Drug content and in vitro drug release of the optimized formulation were 100.59% and 102.61% respectively. Thus, Domperidone lozenges can be used commercially for the better patent compliance which saves time as well as cost.

Quality Evaluation of Locally Manufactured Paracetamol Tablets in East Africa.

Background: Paracetamol, also known as acetaminophen, is categorized as an analgesic and antipyretic medication and is available as over the counter (OTC) medication. It is commonly used in conditions associated with pain and fever. There is a tendency for community to prefer using imported paracetamol tablets from Europe and United States than from Asia and Africa worrying of the quality of the products. Safety, effectiveness, and efficacy of a medicine can be guaranteed when its quality is reliable; however, there is limited data on the quality of locally manufactured paracetamol tablets, thus necessitating this study. Aim: This study is aimed at assessing the quality of paracetamol tablets 500 mg manufactured by local companies by evaluating their physical parameters, assay results, and dissolution profiles. The compliance of these tablets with the specifications outlined in the British Pharmacopoeia (BP) was analyzed. Additionally, a comparative dissolution test was conducted to assess dissolution profile for innovator product and generics. Method: Five different brands from East African countries with 76 tablets from each brand were compared with the innovator product regarding weight variation, hardness, friability, assay, and dissolution test based on the BP specifications. Results and discussion: All samples of paracetamol tablets 500 mg from the local manufacturers in this study met the specifications set by the BP for physical parameters, including weight variation, friability, hardness, and disintegration tests. The weight variation test, directly related to drug content variation, demonstrated compliance within the acceptable deviation of 5%. Similarly, the assay test, which determines the concentration of the active pharmaceutical ingredient (API), confirmed that all samples complied with the acceptable concentration range of 90%-110% for paracetamol. The dissolution test, assessing the percentage release of the API within a specified time, demonstrated that at 15 min, two samples (diodol and enamol) exhibited lower concentration releases than the required 80%, indicating potential delays in their bioavailability and onset of action. Conclusion: To conclude, all samples had good quality and they can be used for their therapeutic purposes.

COMPARATIVE IN VITRO BIOAVAILABILITY TESTING FOR DIFFERENT BRANDS OF FLUCONAZOLE UNCOATED TABLETS

Our current study aimed to evaluate and compare the five different brands of Fluconazole tablets that are commercially available in Chennai. The physicochemical equivalence of five brands of Fluconazole tablets was determined through the evaluation of various standard parameters such as weight variation, friability, hardness, disintegration, dissolution rate, and amount of drug present. All the brands were found to be bioequivalent and comply with the official tests for weight variation, friability, disintegration, and dissolution tests. The tested brands showed identical drug release profiles. All the five brands evaluated can be considered as biopharmaceutical and physiochemically equivalent. Therefore, it is safe for the patients to switch over from one brand to another

Statistical Optimization of Fast Dissolving Tablet Contains Isosorbide Dinitrate for the Treatment of Angina Pectoris

ABSTRACT: The ultimate objective about this experiment was to create a fast-dissolving tablet Isosorbide dinitrate that released its medication quickly. The physical properties of tablets, such as hardness, angle of repose, weight variation, and friability were assessed. In-vitro release was investigated, and a 22-factorial design was created. The results show that the in-vitro release shows that the F2 formulation has the highest release at 20 min. Tablet disintegration time ranges from 31 to 48 s. The hardness ranges from 6-7 kg/cm3. The friability test shows the range from 0.49-0.68%. The weight variation test shows that all the formulation passes the tests. ANOVA statistical analysis revealed that the generated formulations are statistically significant. It is concluded that FDT formulations have optimum and reproducible disintegration time and increased dissolve characteristics, resulting in higher patient compliance.

Measurement uncertainty for < 905 > Uniformity of Dosage Units tests using Monte Carlo and bootstrapping methods – Uncertainties arising from sampling and analytical steps

Uniformity of dosage unit (UDU) test is widely used to assess the quality, safety, and effectiveness of dosage forms in unit doses. An increased variability of the amount of drug (API – Active Pharmaceutical Ingredient) in each dose unit may lead to low quality, unsafety, and ineffective medicines. The aim of this work was to evaluate the measurement uncertainty associated with the acceptance value (AV) using the Monte Carlo and Bootstrapping methods, as well as to estimate the risk of false decisions regarding compliance/non-compliance due to uncertainty. Haloperidon 5 mg tablets and ofloxacin 200 mg tablets were subject to content uniformity (CU) and weight variation (WV) tests, respectively. Measurement uncertainty evaluation of UDU tests considered both uncertainties arising from sampling analytical steps. Uncertainty values were quantified using Monte Carlo (sampling) or bootstrapping (resampling) methods. Confidence intervals at 95% confidence level (CI95%) for AV value obtained for haloperidol 5 mg tablets were found to between 8.1 and15.8 and between 8.1 and 16.9 for Boostrapping and Monte Carlo methods, respectively. There is an increased risk of false conformity assessment for haloperidol UDU test (6.5% and 12.1% risk values for Bootstrapping and Monte Carlo methods). Considering the ofloxacin 200 mg tablets, the CI95% for AV value were found to be between 4.0 and 11.3 and between 4.9 and 11.4 for Bootstrapping and Monte Carlo methods, respectively. Uncertainty arising from sampling and analytical steps were both relevant to the overall uncertainty of AV values. Measurement uncertainty evaluation provided relevant information to support conformity assessments with a reduced risk of false decision making.

Facile fabrication of an extended-release tablet of Ticagrelor using three dimensional printing technology.

The objective of the study was to fabricate tailored extended-release tablets of blood thinner Ticagrelor as once-daily dosing using additive manufacturing for better compliance in heart failure therapy. The solid work design of the tablet was printed using hot melt extrusion (HME) based 3D printing by optimized mixture of Eudragit RS-100, plasticizer and drug for producing extrudable and printable filaments. FTIR and TGA results showed no covalent interaction among ingredients and no decomposition during HME process, respectively. Friability, weight variation, assay and content uniformity tests met USP requirements, while the mean hardness of the tablets was calculated in a value between 40 and 50 kg. According to DSC and XRD results, the crystallinity state of the Ticagrelor was converted to an amorphous one in the tablet matrix. Smooth surfaces with multiple deposited layers were observed using SEM. In comparison, the maximum Ticagrelor release of 100% after 120 min from Brilinta® tablets was decreased to 97% in 400 min from the 3D tablet at infill of 90%. Korsmeyer-Peppas kinetic model showed the drug release mechanism is affected by diffusion and swelling. In general, fabrication of the extended-release 3D printed tablet of Ticagrelor using HME-based-additive manufacturing has the potential to provide specific doses with tailored kinetic release for personalized medicine, improving adherence at point-of-care.

Screening of Marketed Formulations of Shatavari Tablets to Establish Pharmaceutical Equivalence

Using an in vitro dissolving research, compare the pharmacological equivalent of three brands of Shatavari tablets sold in India. According to IP rules, the dissolution was performed using apparatus I (the paddle device). According to the Indian Pharmacopoeia, evaluation of physicochemical characteristics including weight variation test, content uniformity test, hardness test, friability test, disintegration test, and dissolution test was conducted. For weight fluctuation, content homogeneity, hardness, friability, disintegration time, and dissolving study, all brands complied with official specifications. Two out of the three brands of Shatavari tablets achieved more than 75% dissolve in just 60 minutes, according to the dissolution profile. Out of three brands of Shatavari tablets, the results indicated that two of them had satisfactory quality and had passed all of the pharmacopoeia's tests.&#x0D; Keywords: Asparagus racemosus, pharmaceutical equivalence, in vitro dissolution.

Formulation and Estimation of Rapidly Dissolving Sublingual Thin Film of Vildagliptin

The purpose of the present research was to develop a fast and rapidly dissolving polymeric sublingual thin film of vildagliptin due to its simplicity of use as an alternative to oral disintegrating tablets and better compliance for diabetic patients. Nine different formulations (F1-F9) of vildagliptin sublingual films were produced using diverse concentrations of polymer A and plasticizer B by solvent casting method. Several physicochemical properties, including morphological properties, weight variation test, film thickness, folding endurance, surface pH, percentage of moisture loss, in-vitro disintegration test, in-vitro dissolution test, trinocular microscopic imaging of film, differential scanning calorimetry (DSC), FTIR study and content uniformity were evaluated. The ratios of polymer A-plasticizer B were as follows (5:1), (7:1), (7.67:1), (8:1), (8.5:1), (8.67:1, (9.67:1), (10:1), (11:1) which made the film smooth, mechanically strong and easy to peel out. Among all the different formulations, the F1 formulation showed the most significant result concerning in-vitro dissolution (98.95%) in 5 minutes, minimum disintegration time (38 sec.), less film thickness (116.67 ± .58 μm) and better folding endurance (403 times). Bangladesh Pharmaceutical Journal 26(2): 212-218, 2023 (July)

A COMPARATIVE QUALITY STUDY OF SELECTED AUTHORIZED AND SMUGGLED MEDICINES IN ADEN, YEMEN

In Yemen, most of the medicines are imported. Drugs that enter the country by legal means undergo some tests by Supreme Board for Drugs and Medical Appliances (SBDMA) to evaluate the quality of the product. However, some medicines enter the country illegally (smuggling) and this makes them bypass the evaluation of their quality by the SBDMA. This work was carried out to determine the physical quality control parameters of authorized and smuggled drug products marketed in Aden pharmacies. The authorized and smuggled brands of cefuroxime (CEF), atorvastatin (ATR), and carvedilol (CAR) tablets available in Aden pharmacies were selected. The tablets were evaluated for their physical properties and quality control parameters including weight variation, hardness, friability, and disintegration test. The level of drug content also was evaluated using UV spectroscopy. The physical assessment showed that the authorized and smuggled brands of the same products were uniform in shape, color, packing, and labeling information except for the registration number and manufacture date which were present only on the authorized brands. The three authorized and smuggled brands of CEF, ATR, and CAR complied with the official specifications for weight version, diameter, thickness and hardness, friability, and disintegration tests except for the hardness value of ATR. All authorized brands agreed with the label claims whereas some smuggled brands contained the appropriate active ingredients but did not contain the right amounts.

Comparative Study of Different Brands of Ranitidine Available in India

It can be challenging to choose the safest, most cost-effective, and effective brand of ranitidine because it is used to treat peptic ulcers and is marketed under numerous names. The purpose of this study is to determine whether the various brands of ranitidine HC pills sold in Karachi, Pakistan, are comparable to one another. For the study, four different brands of (150 mg) were used. Six quality control measures were carried out according to USP specifications, including weight variation test, hardness test, thickness test, friability disintegration test, and dissolving test. In terms of hardness, weight fluctuation, thickness friability, disintegration, and dissolution, the results showed that all brands are within tolerances. All brands' disintegration times were under 15 minutes, which was commendable according to the USP. Within 45, all brands displayed Q values more than 80%.

In vitro comparative quality evaluation of different brands of carbamazepine tablets commercially available in Dessie town, Northeast Ethiopia

BackgroundGood-quality drugs that fulfill the regulatory parameters and are produced per the current good manufacturing practice (cGMP) standards are very critical for the best therapeutic outcomes. However, the variety of branded drugs circulation in the market often put clinicians and pharmacists in a difficult situation of choice due to the possibility of interchangeability among brands, so we should ascertain the quality of the various brands of drugs, available in the drug market. The purpose of the study was to evaluate the quality and physicochemical equivalence of six brands of carbamazepine tablets that are commercially available in Dessie town, Northeast Ethiopia.MethodsAn experimental study design was used. Six different brands of carbamazepine tablets were purchased from community pharmacies in Dessie town, Northeast Ethiopia, which were selected using simple random sampling methods. Identification, weight variation, friability, hardness, disintegration, dissolution test, and assay for the content of active ingredients were evaluated according to the procedures described in the United States Pharmacopeia (USP) and British Pharmacopeia (BP), and the results were compared with USP and BP standards. The difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements.ResultsThe identification test results revealed that all samples contained the stated active pharmaceutical ingredients and all brands of carbamazepine tablets complied with the official specification for weight variation, friability, and hardness tests. The percentage concentration of carbamazepine was found in the range of 97.85 to 102.09, which met the USP specification of 92% to 108% of the stated amount. Similarly, all samples fulfilled disintegration time (i.e., ≤ 30 min) except brand CA1 (34.183 min) and dissolution tolerance limits (i.e., Q ≥ 75% at 60 min), which was found in the range of 91.673% -97.124%. The difference factor (f1) values were < 15 and the similarity factor (f2) values were > 50 for all the tested brands of carbamazepine tablets.ConclusionThe present study revealed that all brands of carbamazepine 200 mg tablets met the quality control parameters as per pharmacopoeial specifications except the disintegration test of brand CA1, and could be used each brand interchangeably to achieve the desired therapeutic effect.

Formulation and Evaluation of Anti-Diabetic Tablet from Insulin Plant (Costus Igneus)

In this research article we prepare tablet formulation of Costus igneus plant i.e., Insulin plant by its ethanolic leaves extract and mixing with suitable excipients. Extract was prepared by collecting Costus igneus plant leaves and go for shade drying for 4-7 days, after drying its crushed by mill to form powder and taken for extraction. After extraction we prepare powder for taking different chemical qualitative test and laboratory flow properties such as; (Angle of repose, Loose bulk density, Tapped bulk density , Compressibility index) and after checking flow properties and then punch tablet by direct compression method we take two forms of tablet formula changes in main API one is extract and other is only powder and go for evaluation study such as; ( Color ,Weight variation Test ,Hardness, Friability, Disintegration Time, Thickness)

Development of optimal in vitro release and permeation testing method for rectal suppositories

Currently there are no compendial assays for testing drug release from rectal suppositories. It is therefore essential to study different in vitro release testing (IVRT) and in vitro permeation testing (IVPT) methods for identifying a suitable technique to compare in vitro drug release and to predict in vivo performance of rectal suppositories. In the present study, three different rectal suppository formulations of mesalamine (CANASA, Generic, and In-house) were studied for in vitro bioequivalence. All the different suppository products were characterized by performing weight variation, content uniformity, hardness, melting time, and pH tests. Viscoelastic behavior of the suppositories was also tested both in presence and absence of mucin. Four different IVRT techniques such as Dialysis, Horizontal Ussing Chamber, Vertical Franz cell, and USP apparatus 4. IVPT studies were performed using Horizontal Ussing chamber and Vertical Franz cell methods. Q1/Q2 equivalent products (CANASA, Generic) and a half-strength product were studied to understand the reproducibility, bio relevance, and discriminatory ability of the IVRT and IVPT methods. This study is the first of its kind where molecular docking studies were performed to determine the potential interactions of drug (mesalamine) with mucin, IVRT studies were conducted with and without the presence of mucin, and porcine rectal mucosa was used to perform IVPT tests. The USP 4 method and Horizontal Ussing chamber methods were found to be suitable IVRT and IVPT techniques, respectfully, for rectal suppositories. RLD (Reference Listed Drug) and Generic rectal suppositories were found to exhibit similar release rate and permeation profiles obtained from USP 4, and the IVPT studies, respectfully. Wilcoxon Rank Sum/Mann-Whitney rank test, conducted for the IVRT profiles obtained using USP 4 method, proved the sameness of RLD and Generic suppository products.

Application of ISO 17025 Standards in the Validation of a Spectrophotometric Method for Quality Assessment of Generic Brands of Cetirizine Tablets marketed in Nigeria.

Background: The concern for the quality of medicines is to ensure effiffifficacious clinical outcomes and quality health care. The World Health Organization (WHO) estimates that 10–20 % of medicines in&nbsp;developing country markets are sub-standard. Continuous&nbsp; monitoring of the quality of medicines&nbsp;requires both competent analysts and well-equipped drug quality control laboratories with&nbsp;&nbsp;international accreditation. The objective of the study was to evaluate the quality control parameters of&nbsp;the generic cetirizine&nbsp; dihydrochloride 10 mg tablets marketed in Abuja metropolis of Nigeria and to&nbsp;validate and apply a UV spectrophotometric method to&nbsp; the assay of the commercial tablet&nbsp;formulations.&nbsp; Method: Nine brands of cetirizine dihydrochloride tablets were randomly selected from retail&nbsp;pharmacy stores and quality control&nbsp; tests of weight variation, friability, hardness, disintegration, and&nbsp;dissolution parameters were conducted per United States&nbsp; Pharmacopoeia (USP) standards. Thickness&nbsp;and diameter were also evaluated by standard methods. AUVspectrophotometric method&nbsp; was adopted&nbsp;and validated according to ICH guidelines and applied for the drug assay of the tablet dosage units.&nbsp; Results: The&nbsp; thickness, diameter, hardness and disintegration tests for the drug samples ranged from&nbsp;2.81–3.76 mm, 3.88–8.11 mm&nbsp; 1.65–7.50 KgF and 0.44–4.90 min, respectively. All the samples met the&nbsp;compendial specififications for the weight variation test and also&nbsp; for the friability and dissolution tests&nbsp;which ranged 0.18–0.56 % and 90.15–109.18 % at 30 min, respectively. The studies for&nbsp; validation of&nbsp;the UV method demonstrated good linearity with a correlation coeffiffifficient of r2 = 0.9989 in the&nbsp;concentration range of&nbsp; 2.5–25 µg/mL of cetirizine dihydrochloride (CTZ) reference standard and the&nbsp;limit of detection (LOD) and limit of quantitation (LOQ)&nbsp; were 0.42 µg/mL and 1.29 µg/mL,&nbsp;respectively. The % RSD of the precision studies was less than the 2 % standard limit and the&nbsp; accuracy&nbsp;(recovery) ranged from 100.9‒103.4 %. The percentage contents of the generic brands were&nbsp;determined and ranged from&nbsp; 99.12–103.21 % and were within the offiffifficial specififications.&nbsp; Conclusion: The UV method was simple, sensitive and rapid and&nbsp; successfully applied to the assay of&nbsp;nine commercial brands of CTZ&nbsp; tablets. All the drugs met the compendial specififications on the quality&nbsp;parameters.&nbsp;&nbsp

Quality evaluation of the Azithromycin tablets commonly marketed in Adama, and Modjo towns, Oromia Regional State, Ethiopia.

Azithromycin is a therapeutically" relevant macrolide antibiotic registered on the Essential Medicines List of the World Health Organization. The fact that medicine is selected as an essential drug doesn't mean that it is of good quality. Hence, a continuous quality evaluation of the drug should be mandated to verify that the right medication is available on the market. To evaluate the quality of Azithromycin Tablets commonly marketed in Adama, and Modjo town, Oromia Regional State, Ethiopia. All six brands were subjected to in-vitro quality control tests, which were carried out according to procedures described in the manufacturer's method, the United States Pharmacopeia, and the WHO inspection tool. All quality control parameters were compared by one-way ANOVA. Statistically, significant difference was considered when P<0.05. The in-vitro dissolution profiles of the brands were also compared statistically using the post-hoc Dunnett test, model-independent and model-dependent approaches. All of the evaluated brands agreed with WHO visual inspection criteria. All of the tablets achieved the thickness, and diameter test requirements of the manufacturer's specification (±5%). All brands passed the hardness, friability, weight variation, disintegration, identity, and assay tests as stipulated by USP. The dissolution rate was more than 80% in 30 minutes, which was within the USP specification. The model-independent parameters have confirmed that only two brands (2/6) were deemed better brands for interchangeability. Weibull and Korsemeyer's Peppas model were the best release models. All of the evaluated brands passed the quality specification. The model dependent approaches revealed that drug release data fit well to the Weibull, and Korsemeyer's Peppas release models. However, the model-independent parameters have confirmed that only two brands were deemed better brands (2/6) for interchangeability. Due to the dynamic nature of low-quality medications, the Ethiopian Food, and Drug Authority should keep an eye on marketed products to guarantee their quality, especially for drugs like azithromycin for which non-bioequivalence data from the study has revealed a clinical concern.

Evaluation And Standardization Of Marketed Poly Herbal Formulations Of Different Brands

Objective: To set a preliminary quality control parameters this may be helpful to the scientific community as well as manufacturing industries.&#x0D; Material and Methods: Five different sealed packs of Mahasudarshan Tablet were procured from the Pharmacy Shop, which were evaluated on Organoleptic tests, Physico-chemical parameters such as pH, water soluble extractive, Alcoholic soluble extractive, Loss on drying, Ash value, Acid insoluble ash, Water soluble ash, and Specific tests for tablets such as weight variation test, friability, disintegration, dissolution time as per standard guidelines were carried out.&#x0D; Results and Discussion: Phytochemical test indicates the presence of alkaloid, glycosides, terpenoids, tannins, and steroids in both formulations. Parameters for loss of drying, ash values, and extractive values documented. Pharmaceutical parameters, such as hardness, friability, weight variation, and disintegration, were found to be within acceptable values.&#x0D; Conclusion: Quality control parameters are the fundamental factors for evaluating the purity, standards and effectiveness of any formulation. Therefore, the findings of the present study may be considered as first step towards generating scientific evidence of quality assurance for marketed formulations.

Practices of tablet splitting and dose uniformity of fragments at public hospitals in Ethiopia: A cross-sectional study supported by experimental findings.

To assess the practices and dose uniformity of tablet splitting at selected public hospitals in Northwest Ethiopia. A hybrid study method was employed to see the overall practices of tablet splitting. A prospective cross-sectional study was conducted to explore the practices of tablet splitting by administering structured questionnaires to patients and pharmacy professionals. Experimental data on dose and content uniformity of split tablets were obtained from the results of drugs split by study subjects. The content uniformity assay was performed using UV/Vis spectrophotometry. A total of 241 patients and 82 pharmacy professionals participated in the cross-sectional study. The majority of patient participants (51.3%) faced problems while splitting their tablet medications and this had a significant association with the education level of the patients (χ2 = 60.5; p = 0.001). Enteric-coated formulations were dispensed to be split, despite the precaution given by the manufacturers against splitting or crushing these products. Splitting of enteric-coated products accounts for 11% of the total drugs that were dispensed to be taken after a split. The mean of weight variation test for the half tablets does not meet the specifications set in pharmacopoeias when splitting was done by patients. The unscored haloperidol tablets were hard to split and resulted in a significant weight variation of half-tablets than the scored furosemide tablets. Moreover, the weight of 4 out of 20 fragments that were split by patients deviated at least by 15%. This finding showed that the tablet-splitting practices are poor and do not meet the specifications set by pharmacopoeias. Splitting by patients resulted in significantly higher dose variation and weight loss of fragments than splitting by pharmacists.

Assessment of the Mineral Composition and the Selected Physicochemical Parameters of Dietary Supplements Containing Green Tea Extracts.

Our aim was to assess the mineral composition as well as the physicochemical quality of green tea-based dietary supplements (capsules and tablets) with respect to average weight, size and shape, friability, breaking force and disintegration time. Products were analysed by flame atomic absorption spectrometry for Ca, K, Mg, Na, Cr, Cu, Fe, Zn, Mn, Pb and Cd. Approximately 60% of the analysed supplements met the requirements of European and Polish regulations. The dietary supplements passed weight variation tests, but not all products had compliant capsule sizes. One product in tablet form failed the friability test, and eleven dietary supplements in tablet form failed the disintegration test. The supplements were characterised by a varied elemental composition, with the highest values found for Ca, Fe, Zn and Mn. The recommended daily allowance realisation for Fe and Zn in two dietary supplements (capsule form) exceeded 100%. As a result of the estimation of the monthly intake of toxic metals, it was concluded that the tested products do not pose a risk to consumer health. Significant relationships (p &lt; 0.001) were found for K, Mg, Na, Cu, Fe, Mn and Zn. The application of factor and cluster analyses allowed the verification of the similarity of green tea extracts contained in dietary supplements to the natural raw material, green tea leaves, used as a reference material.

Decellularized fennel and dill leaves as possible 3D channel network in GelMA for the development of an in vitro adipose tissue model

The development of 3D scaffold-based models would represent a great step forward in cancer research, offering the possibility of predicting the potential in vivo response to targeted anticancer or anti-angiogenic therapies. As regards, 3D in vitro models require proper materials, which faithfully recapitulated extracellular matrix (ECM) properties, adequate cell lines, and an efficient vascular network. The aim of this work is to investigate the possible realization of an in vitro 3D scaffold-based model of adipose tissue, by incorporating decellularized 3D plant structures within the scaffold. In particular, in order to obtain an adipose matrix capable of mimicking the composition of the adipose tissue, methacrylated gelatin (GelMA), UV photo-crosslinkable, was selected. Decellularized fennel, wild fennel and, dill leaves have been incorporated into the GelMA hydrogel before crosslinking, to mimic a 3D channel network. All leaves showed a loss of pigmentation after the decellularization with channel dimensions ranging from 100 to 500µm up to 3μm, comparable with those of human microcirculation (5-10µm). The photo-crosslinking process was not affected by the embedded plant structures in GelMA hydrogels. In fact, the weight variation test, performed on hydrogels with or without decellularized leaves showed a weight loss in the first 96h, followed by a stability plateau up to 5weeks. No cytotoxic effects were detected comparing the three prepared GelMA/D-leaf structures; moreover, the ability of the samples to stimulate differentiation of 3T3-L1 preadipocytes in mature adipocytes was investigated, and cells were able to grow and proliferate in the structure, colonizing the entire microenvironment and starting to differentiate. The developed GelMA hydrogels mimicked adipose tissue together with the incorporated plant structures seem to be an adequate solution to ensure an efficient vascular system for a 3D in vitro model. The obtained results showed the potentiality of the innovative proposed approach to mimic the tumoral microenvironment in 3D scaffold-based models.