Preparation Of Tablets Research Articles

Development and Evaluation of a Polyherbal Tablet for Polycystic Ovarian Syndrome (PCOS)

The main objective of the present study was to develop and evaluate polyherbal tablet for the treatment of Polycystic Ovarian Syndrome (PCOS). For the formulation of tablet, the herbs were selected based on the concepts of pathophysiology and Ayurvedic perspective of the disease. The extracts of <em>T. foenum graceum, C. longa, B. aristata, S. asoka, B. variegata</em> and Guggul purified in cow’s urine was used for the preparation of polyherbal tablet. The physicochemical, phytochemical evaluation and quantification of markers by HPTLC of crude drugs and extracts were performed. The guggul was used as binder in different proportion for the preparation of tablet. Pre-formulation study of the powder blend and post compression evaluation of tablet was done by various parameters like weight variation, friability, hardness, thickness, diameter, disintegration time, in-vitro dissolution and accelerated stability study. The physicochemical evaluations of crude drugs yielded results which were in accordance with the monograph’s standard values. The phytochemical analysis of the extracts revealed the presence of variety of phytoconstituents. From the results of HPTLC quantification the amount of curcumin (7.14%) in <em>C. longa</em>, diosgenin (40.6%) in <em>T. foenum graceum ,T. foenum graceum</em>, berberine hydrochloride (4.83%) in <em>B. aristata</em>, catechin (3.48%) in S. asoka, lupeol (0.11%) in <em>B. variegata</em> and Z-guggulsterone (0.140%) and E-guggulsterone (0.146%) in purified guggul was found. The micrometrics of the powder blend of all the formulations showed good flow properties. Formulation F3 showed better results compared to other formulations in post compression evaluation. Accelerated stability study showed that the formulation F3 was stable during the course of study.

THE USE OF ARABINOGALACTAN IN THE DEVELOPMENT OF TABLETS WITH DIHYDROQUERCETIN

Abstract. The possibility of using arabinogalactan in the preparation of oral tablets based on the natural bioflavonoid dihydroquercetin has been shown. The composition and technology of tablets using the wet granulation method has been developed. The quantitative content of dihydroquercetin in tablets was determined by HPLC. Aim. Development the composition and technology of dihydroquercetin tablets for oral administration using arabinogalactan.

Formulation and evaluation of gastro retentive drug delivery system of candesartan cilexetil

It had became a challenging experience and effort for a formulator to develop and innovate a drug with maximum bioavailability. In the present study the focus of research is in the treatment of Hypertension, which is one of the most prevalent cardiovascular diseases in the world, affecting a big proportion of the adult and old age population. Candesartan Cilexetil angiotensin II to AT1 in many tissues including vascular smooth muscle and the adrenal glands, used for the treatment of high blood pressure. The drug has poor bioavailability due to limited oral absorption and maximum absorption at proximal intestine. This warrants and offers the use of Gastro Retentive Drug Delivery System (GRDDS) for sustained release formulation in order to achieve prolonged action and to improve patients compliance. Wet granulation technique was selected for preparation of tablets and the drug is formulated with HPMC K100M, ethylcellulose, sodium bicarbonate, Micro crystalline cellulose, Gelucire, talc and Aerosil etc. For around twelve formulations were made and evaluated for General appearance, Thickness, Hardness or Crushing strength Test, Friability Test, Estimation of drug content, In-vitro buoyancy studies and In-vitro drug release and the results obtained for the performed tests were found with in the range specified limits.

DEVELOPMENT AND CHARACTERIZATION OF GASTRO RETENTIVE TABLETS OF CLARITHROMYCIN FOR ANTIULCER EFFECT

Gastroretentive floating drug delivery system (GFDDS) is used to prolong the gastric residence time after oral administration, at a particular site and controlled or modified the release of drug from the formulation.The purpose of the present study is to develop a gastro retentive floating drug delivery system to achieving controlled release so that is improves bioavailability of the formulation, Structure activity relationship based on Biopharmaceutical Properties of Clarithromycin indicates good biopharmaceutical Properties. Floating dosage form of Clarithromycin was designed for the treatment of gastric ulcer caused by Helicobacter pylori. The granules were prepared by wet granulation method and evaluated for flow property, Carrs' index, bulk density, tapped density and Hausner ratio. The dosage form was designed by using polymers of different viscosity as gelling agents, sodium bicarbonate as gas generating agent and other excipients. The granules were further subjected to tablet preparation and the prepared tablets were subjected for evaluated on the basis of different evaluation parameters like hardness, in vitro buoyancy, in vitro drug release. Incorporation of gas generating agent together with polymer improved drug release Optimized formulation (F7) containing Clarithromycin, HPMC, 90 SH , HPMC K4M , sodium bicarbonate, released approximately 86.6% drug in 10 hrs. and the floating lag time was found to be 25 sec. KEYWORDS: GFDDS, Helicobacter pylori, gelling agents, in vitro buoyancy, HPMC, wet granulation.

Formulation and evaluation of gastroretentive drug delivery system of eprosartanmesylate

It had became a challenging experience and effort for a formulator to develop and innovate a drug with maximum bioavailability. Objective: In the present study the focus of research is in the treatment of Hypertension, which is one of the most prevalent cardiovascular diseases in the world, affecting a big proportion of the adult and old age population. Eprosartan mesylate(EPM) is angiotensin-II receptor antagonist used for the treatment of high blood pressure. The drug has poor bioavailability due to limited oral absorption and maximum absorption at proximal intestine. This warrants and offers the use of Gastro Retentive Drug Delivery System (GRDDS) for sustained release formulation in order to achieve prolonged action and to improve patients compliance. Method: Wet granulation technique was selected for preparation of tablets and the drug is formulated with hydroxyl propyl methyl cellulose K100m, hydroxyl propyl methyl cellulose K15m, polyox WSR coagulant, polyox WSR301,polyox WSR N80, Lactose Monohydrate, Micro crystalline cellulose(Avicel), magnesium sterate, ethylcellulose, sodium bicarbonate, tromethamine, etc. Results: For around twenty formulations were made and evaluated for General appearance, Thickness, Hardness or Crushing strength Test, Friability Test, Estimation of drug content.

Preparation and Bio Pharmaceutical Evaluation of Chrono Pharmaceutical Drug Delivery System of Atenolol

A time-adjustable pulsatile release system containing atenolol as an active pharmaceutical agent was developed for bedtime dosage administration and release of medicine in the early morning to manage elevated blood pressure. The system contained an immediate release (IR) core, a sustained-release (SR) plug, and a mucoadhesive cup layer and it was designed by the cup and core technique. The immediate-release layer was composed of atenolol, croscarmellose sodium, microcrystalline cellulose (MCC), sorbitol, talc, and magnesium stearate. The SR plug was composed of hydroxyl propyl methylcellulose (HPMC), polyvinyl pyrrolidine (PVP), MCC, Lactose, talc, and magnesium stearate. The mucoadhesive cup contains polycaprolactone and mucoadhesive polymer chitosan. Bilayer tablets were punched by applying different compressive forces. Based on the Release data of the drug from each layer F5 and S5 were selected for the preparation of the bilayer tablet. Cup composition containing 3% of chitosan provided the highest mucoadhesion time up to 10h. Pulsatile delivery of the drug from the formulation was observed at 300 min after the administration of the drug. The constructed pulsatile delivery systems were compared to that of commercially available atenolol IR tablet. The comparison demonstrated that the formulation is suitable for the intended chronopharmaceutical delivery of antihypertensive drugs. Keywords: Chronopharmaceuticals, Pulsatile Drug Delivery, Hypertension, Mucoadhesive Polymer, Atenolol

IDENTIFIKASI DAN UJI ANTI KANKER TABLET EKSTRAK DAUN PALIASA (KLEINHOVIA HOSPITA LINN) SECARA MTT ASSAY

Indonesia has several plants that can be developed into cancer drugs. This study aims to make tablet preparations containing Paliasa leaf extract to produce pharmaceutical preparations for anticancer use. Paliasa leaves were extracted by maceration using 70% alcohol; then, the tablets were made using the wet granulation method. The extract obtained from 2,207 kg of dried simplicia paliasa leaves was 542 grams, with a yield of 24.56%. The flavonoid content in the extract was 1.79%, and the tablet was 0.75%. There are active compounds, namely 4H-Pyran-4-one, 2,3-dihydro-3,5-dihydroxy-6-methyl, a powerful antioxidant blend, hexadecanoic acid, or palmitic acid functions as an antibacterial and antioxidant, and kaempferol is one of the compounds, which has potential as an anticancer. The identification of extracts and tablets of paliasa leaf (Kleinhovia hospital Linn) resulted in IC50 above > 30 ppm in the inactive category, so the bioactivity of paliasa leaf extract was studied further fractionation.

Profil Penggunaan Obat Imunomodulator Masa Pandemi pada Konsumen dengan Imun yang Lemah di Apotek Kimia Farma Jatibarang Kota Indramayu

Based on data on the use of Immunomodulator drugs from 1,170 transactions, 64 transactions were obtained. Drugs given through prescriptions. Based on the data I obtained, the most prescriptions for immunomodulators occurred in April 2021 by doctors at Kimia Farma Pharmacy, Indramayu city with a total of 26 prescriptions. The purpose of the study is to determine the pattern of use (prescription or non-prescription) of consumers of immunomodulatory drugs at Kimia Farma Pharmacy, Indramayu City. This type of research uses a qualitative design with descriptive research methods. Data collection was carried out, namely all data that met the inclusion and exclusion criteria. The results showed that the sales of Immunomodulator drugs for the period April – June 2021 were 1,170. Based on the pattern of prescription use, there are 64 transactions, while the pattern for non-prescription use is 1,106 transactions. From the research I did, it can be concluded that the trade names of Immunomodulator drugs containing echinacea, meniran, and morindae in the Imunos Tablet and Fituno Tablet preparations are the most widely used, with the rule of taking 1 tablet a day and 2 tablets a day, and the dosage form is tablets.

Preparation of skim milk powder tablet and finite element analysis of its pressing die

AbstractThe skim milk powder (SMP) has problems of quantification and handling during milk reconstitution for tea and coffee making. To address these issues, a novel product, “SMP tablet,” was made by varying moisture content (3, 5, 10, and 15% wet basis) of SMP and compression force (625, 750, 875, 1,000, and 1,125 N) during tableting. A die containing upper, lower, and grooved punches was designed, fabricated, and analyzed with finite element method. The tetrahedral type of mesh with 1.9078–2.356 mm element size, 0.095–0.118 mm tolerance, 80,420–85,107 nodes, and 53,041–57,252 elements resulted in 40.53–68.60 MPa maximum stress and 1.9–4 minimum factor of safety advocating acceptability of design. The SMP was pressed inside die through universal testing machine in controlled manner and disintegration time (DT), tensile strength (TS), and insolubility index (ISi) of SMP tablets were evaluated. Response surface methodology showed cubic model as best fit (p < .0001 and R2 > .97) for all the responses. The numerical optimization showed 4.6% wb moisture and 1,125 N compression force favorable for good quality attributes (103.8 kPa TS; 318 s DT; 40.5 mg ISi). Further, sugar addition (10%), as a disintegrating agent, improved DT (178 s) and TS (159 kPa). The SMP tablet with sugar had 14.90 ± 0.05 mm average diameter, 5.04 ± 0.18 mm thickness, 625 ± 6 mg weight, and 3.45% weight variation with similar total soluble solids (5%) at 60°C compared with SMP. The direct consumable, no artificial additives/binders and ease in quantification are tablets' novelty comparing SMP.Practical applicationsPoor quantification and handling are the two major issues with SMP. This can be easily combated by pressing the powder and converted into tablet form. The quantity of required number of SMP tablets for milk reconstitution can be easily remembered like sugar cubes. The SMP tablets can be marketed as novel dairy products and taken directly or used in coffee and tea making. Moreover, this study will provide an insightful information to dairy industry for commercial application of SMP tablets.

Preparation and evaluation of bilayer-core osmotic pump tablets contained topiramate.

Topiramate (TPM) was an antiepileptic agent commonly used in clinical. Studies showed that an oral preparation of TPM with extended-release manner could bring some benefits for epileptics. In this paper, controlled release push-pull osmotic pump (PPOP) tablets of sparingly water-soluble TPM were successfully prepared. This bi-layer tablet core mainly consisted of sodium chloride as osmotic promoting agent and polyethylene oxide as suspending and pushing agents. The influences of osmotic agents, pushing agents and the compositions of coating membrane on TPM release profiles were evaluated. An optimal formulation of TPM-PPOP was obtained through single-factor experiments. In vitro release tests showed that the optimum formulation could release TPM at an approximate zero-order rate up to 8 h. Pharmacokinetic behaviors of TPM-PPOP tablets were evaluated and compared with the immediate release capsules after an oral single dose in beagle dogs. Pharmacokinetics results demonstrated that the TPM-PPOP tablet was able to provide a prolonged release of TPM with longer tmax and mean residence time. Lower fluctuations of drug plasma levels could also be achieved with TPM-PPOP tablets. These results suggested that sparely water-soluble drugs as TPM can be designed to PPOP for efficacy and safety use.

Blind-Watermarking-Proof-of-Concept of a Novel Approach to Ensure Batch Traceability for 3D Printed Tablets.

Falsified medicines are a major issue and a threat around the world. Various approaches are currently being investigated to mitigate the threat. In this study, a concept is tested that encodes binary digits (bits) on the surface of Fused Deposition Modelling (FDM) 3D printed geometries. All that is needed is a computer, a FDM 3D printer and a paper scanner for detection. For the experiments, eleven different formulations were tested, covering the most used polymers for 3D printing in pharma: Ethylene-vinyl acetate (EVA), polyvinyl alcohol (PVA), polylactic acid (PLA), Hypromellose (HPMC), ethyl cellulose (EC), basic butylated-methacrylate-copolymer (EPO), and ammonio-methacrylate-copolymer type A (ERL). In addition, the scanning process and printing process were evaluated. It was possible to print up to 32 bits per side on oblong shaped tablets corresponding to the dimensions of market preparations of oblong tablets and capsules. Not all polymers or polymer blends were suitable for this method. Only PVA, PLA, EC, EC+HPMC, and EPO allowed the detection of bits with the scanner. EVA and ERL had too much surface roughness, too low viscosity, and cooled down too slowly preventing the detection of bits. It was observed that the addition of a colorant or active pharmaceutical ingredient (API) could facilitate the detection process. Thus, the process could be transferred for 3D printed pharmaceuticals, but further improvement is necessary to increase robustness and allow use for more materials.

Development of novel persulfate tablets for passive trichloroethylene (TCE)-contaminated groundwater remediation

In this study, a biodegradable binder, hydroxypropyl methyl cellulose (HPMC), was used for the first time to mix with persulfate powder for developing novel persulfate-releasing tablets to remediate trichloroethylene (TCE)-contaminated groundwater. To obtain feasible parameters for the preparation of persulfate tablets, different pressures, HPMC/tablet mass ratios, and persulfate dosages were evaluated. The results showed that the persulfate tablet released 2868 mg-persulfate/day for 12 days under the optimal manufacturing parameters of HPMC/tablet mass ratio of 0.5 and pressure of 4.90 × 108 N/m2. Persulfate diffusion and gel layer erosion were dominant mechanisms for controlling the persulfate released in water. The persulfate release time and rate can be controlled by adjusting the persulfate dosage at the optimal HPMC/tablet ratio. In the column experiment, TCE with an initial concentration of 70 mg/L reached 55% removal efficiency by the tablet, which showed that the developed tablet was capable of degrading highly concentrated TCE. The results of electron spin resonance (ESR) spectroscopy showed that both SO4−· and ·OH were responsible for the oxidation of TCE. During 150 days of incubation, the biodegrading efficiency of HPMC by microbes in soil and activated sludge was 67% and 80%, respectively, under aerobic conditions, while 58% of HPMC was removed by soil bacteria under anaerobic conditions. The results showed that persulfate tablets could be used as a passive groundwater remediation system. There is no waste generated after persulfate is completely released during groundwater remediation. The developed persulfate tablets are environmentally friendly and meet the green remediation aspect.

Design of an innovative technique for application of the immobilized Rhizomucor miehei (CBS: 370.65) rennin-like enzyme on paraffin wax in cheese-making process and the kinetic properties of the immobilized enzyme

This research aimed to invent a new method for cheese making using Rennin-like enzyme from fungus with high efficiency and reusability. Accordingly, Rhizomucor miehei (CBS: 370.65) showed a promising milk clotting (MCF) activity and the mycotoxin test was negative. The partially purified enzyme was immobilized by entrapment in paraffin wax using different techniques. Wax-enzyme tablets preparation exhibited complete immobilization yield (100%). Ca2+ had a marked stimulating effect on the activities of both the free and immobilized enzyme forms. The immobilized enzyme (MCI) exhibited more than sixteen effective reuses to produce cheese in a batch reactor. The free and the immobilized forms recorded their optimum activities at pH 5.6 and 55 °C, respectively. The immobilization process reduced the consumed activation energy (Ea) to 39%. The immobilized enzyme was more stable than the free form. Among all the used substrates, buffalo milk and full cream milk showed the highest immobilized enzyme activity (7142.9 U). km value was unaffected by the immobilization process and was 600 mg reaction−1, for both. Schematic setup was used as semi-pilot example for a repeated batch of MCI wax tablets. This design solved the clotting problem completely by the refine bundle nominated its agreeability in the cheese-making process.

Study on the ue of mannitol as inert homeopathic vehicle.

Homeopathic medicaments are prepared associating the active substance to an inert excipient which becomes an integral part of the remedy. The aim of this research was to analyze the use of mannitol as a homeopathic inert excipient, as a possible substitute to lactose in the preparation of tablets and powder. Research was conducted in homeopathic and manipulation pharmacies in the regions Centro and Icaraí of Niterói, Rio de Janeiro, July to September, 2006. The use of mannitol as inert excipient was detected in all manipulation/homeopathic pharmacies of Niterói researched. The main declared reason for the use of mannitol as an option in the preparation of tablets and powders was the solicitation in medical prescriptions for patients with intolerance to lactose or diabetes. There was no report of undesirable effects related to the use of mannitol according to the people interviewed.

Improvement on compactibility of the alcoholic extract of Zingiberis Rhizoma by co-spray drying with HPMC

Aiming to solve the poor compactibility of the alcoholic extract of Zingiberis Rhizoma(ZR), this study explored the feasibility of its physical modification using co-spray drying with a small amount of hydroxypropyl methyl cellulose(HPMC). Based on the univariate analysis, the influence of two independent variables(the HPMC content in the product and the solid content of spray material) on the powder properties and tablet properties of the dried product was investigated by the central composite design. With the tensile strength and disintegration time of the tablets as the evaluation indexes, the optimal prescription was determined as follows: the HPMC content was 15% and the solid content of spray material was 25.6%. The accuracy of the regression model established for predicting tensile strength and disintegration time of tablets was verified, and the results revealed that the measured values were close to the predicted ones with deviations of 0.47% and-8.2%, indicating good prediction and reproducibility of the model. The tensile strength(4.24 MPa) of tablets prepared with the optimal prescription was 3.59 times that(1.18 MPa, far lower than the baseline of 2 MPa for qualified tablets) with the spray-dried powder of the ZR. On the other hand, due to the addition of HPMC, the disintegration time of tablets increased from 7.3 min to 24.6 min. On the whole, this study provided a new strategy to solve the common problem of poor compactibility of raw Chinese medicinal materials, which facilitated the successful preparation of Chinese medicinal tablets with high drug loads.

Formulasi dan Evaluasi Tablet Effervescent dari Ekstrak Buah Tampoi (Baccaurea macrocarpa)

Tampoi is one of the many plants found in East Kalimantan, has secondary metabolic content in the form of saponins, flavonoids, and alkaloids, and has antioxidant activity. The antioxidants produced by the human body are not sufficient to fight free radicals, therefore the body requires the intake of antioxidants from the outside, so to help increase public interest in consumption, researchers are interested in making preparations in the form of extracts and formulated as effervescent tablets from tampoi fruit extract which are useful as antioxidants and increase immunity. The purpose of this study was to determine a good formula for making effervescent tablets from tampoi fruit extract with variations of PVP K30 as a binder. Making tablets using direct compression method with an evaluation of effervescent powder including the angle of repose test, flow rate, setting, compressibility, and moisture of the powder. Evaluation of effervescent tablets included organoleptic test, weight uniformity test, tablet friability test, tablet hardness test, and tablet dissolving time test. The results obtained in the evaluation of the effervescent powder, the angle of repose test has met the requirements, while the test for flow velocity, sizing, compressibility, and moisture of the powder has not met the requirements. The results of the physical evaluation of the tablet weight uniformity test on F1 and F2 were in accordance with the requirements, the tablet friability test on F3 and F4 had met the requirements, the F3 tablet hardness test had met the requirements, and the tablet dissolving time test resulted that all formulas met the requirements with the best formula namely F1 which has the fastest tablet dissolution time. The conclusion of the study from the evaluation of the dissolving time which is the main parameter of the effervescent tablet preparation of tampoi fruit extract, the best formula was obtained, namely F1 with a PVP K30 concentration of 0.5 mg resulting in a tablet dissolving time of 01.99 minutes.

Formulation of Orally Disintegrating Tablets of Captopril as Superdisintegrant using Corncob (Zea mays L.)

AIM: This study aimed to make corncobs the basic material for the manufacture of microcrystalline cellulose. METHODS: Manufacture of corncob cellulose microcrystals (CCMs) by isolating alpha-cellulose from corncobs, then hydrolyzed with HCl 2.5 N. The yield of CCMs of 14.51% can be used as orally disintegrating tablet (ODT) and has similarities with Avicel as standard comparison. RESULTS: Both organoleptic results were pH 5.6 and 6.54; drying shrinkage 3.33% and 4.39%; total ash content 0.17% and 0.02%; and water solubility 0.9% and 0.12%. Furthermore, the real specific gravity is 0.317 and 0.306 g/cm3, incompressible density is 0.379 and 0.375 g/cm3, the true density is 1.291 and 1.206 g/cm3, Hausner index is 1.195 and 1.225, compressibility index is 19.55 and 22.55%, and porosity is 75.5 and 74.6%. CONCLUSION: Captopril ODT tablet preparations with CCM as filler have almost the exact tablet evaluation results compared to Avicel and to meet the requirements.

Prediction of entire tablet formulations from pure powder components’ spectra via a two-step non-linear optimization methodology

Process analytical technology in the pharmaceutical industry requires the monitoring of critical quality attributes (CQA) through calibrated models. However, the development, implementation, and maintenance of these quantitative models are both resource and time-intensive. This study proposes the implementation of a non-linear iterative optimization technology (IOT) to study the magnitude of analytical errors when the calibration tablet used to extract the λ vector deviates physically and chemically from the test samples. IOT is based on mathematical optimization of excess spectral absorbance. It requires minimum calibration effort and allows simultaneous prediction of the entire formulation instead of only the active pharmaceutical ingredient (API), with just one standard and pure component spectral data. Unlike Partial Least Squares (PLS), which requires the development of standards to incorporate variations in the process, this non-destructive methodology minimizes significant calibration effort by developing a mathematical model that uses only one standard and spectral information of pure powders present in the tablet. The method described in this study allows a fast re-calculation to include factors such as change of spectroscopic instruments, variations in raw materials, environmental conditions, and methods of tablet preparation. The robustness of the proposed approach for variation in compaction (physical changes) and variation in composition (chemical changes) was evaluated for correlated and uncorrelated formulations. For uncorrelated formulation a PLS model was also constructed to compare the robustness of the proposed methodology. The RMSEP of API in target formulation predicted using non-linear IOT method was varied from 0.17 to 1.50 depends on compaction of tablet chosen to compute λ vector. On the other hand, the RMSEP of API in target formulation predicted using PLS-based model was varied from 0.13 to 0.57 depending on compaction of tablet. The additional accuracy achieved in PLS based model required significant calibration effort of preparing 84 tablets compared to just one in proposed non-linear IOT method.

Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay.

Objectives Recently, an estradiol immunoassay manufacturer (Beckman Coulter, USA) issued an ‘important product notice’ alerting clinical laboratories that their assay (Access Sensitive Estradiol) was not indicated for patients undergoing exogenous estradiol treatment. The objective of this analysis was to evaluate immunoassay bias relative to liquid chromatography tandem mass spectrometry (LC-MS/MS) in transgender women and to examine the influence of unconjugated estrone on measurements.Design Cross-sectional secondary analysis.MethodsEstradiol concentrations from 89 transgender women were determined by 3 immunoassays (Access Sensitive Estradiol (‘New BC’) and Access Estradiol assays (‘Old BC’), Beckman Coulter; Estradiol III assay (‘Roche’), Roche Diagnostics) and LC-MS/MS. Bias was evaluated with and without adjustment for estrone concentrations. The number of participants who shifted between three estradiol concentration ranges for each immunoassay vs LC-MS/MS (>300 pg/mL, 70–300 pg/mL, and <70 pg/mL) was calculated.ResultsThe New BC assay had the largest magnitude overall bias (median: −34%) and was −40%, −22%, and −10%, among participants receiving tablet, patch, or injection preparations, respectively. Overall bias was −12% and +17% for the Roche and Old BC assays, respectively. When measured with the New BC assay, 18 participants shifted to a lower estradiol concentration range (vs 9 and 10 participants based on Roche or Old BC assays, respectively). Adjustment for estrone did not minimize bias.ConclusionsImmunoassay measurement of estradiol in transgender women may lead to falsely decreased concentrations that have the potential to affect management. A multidisciplinary health care approach is needed to ensure if appropriate analytical methods are available.

AN EXPERIMENTAL DESIGN IN THE OPTIMIZATION OF VARIOUS TABLET EXCIPIENT FORMULATIONS = A CONCISE REVIEW

The use of an experimental design technique in the development of various pharmaceutical preparations, including tablet preparations, has become the latest trend. Because of their ease of use, tablet formulations are popular among both producers and patients. To increase the usage of tablets in diverse circles and settings, researchers are working to develop a variety of tablet excipients for various functions. Fast dissolving tablets (FDT), effervescent tablets, modified-release tablets, oral mucoadhesive tablets, gastroretentive tablets, and colon targeted tablets are some of the tablet formats that have been developed in addition to traditional tablets. This review will look at how formulation optimization in tablet preparations has been done during the previous ten years using specific literacies. The articles for this review were found using the keywords tablet, excipient, matrices, formulation, and QBD in specialized databases such as Elsevier, Pubmed, and Cambridge. Other options include Springer publications, material from the Internet, and articles published online by The Lancet Respiratory Medicine, Medscape, and Statpearls. The formulation design strategy is based on the experimental design approach carried out on the kind of tablet preparation, which has distinct important quality parameters.