Capsule Formulation Research Articles

Content-related quality of food supplements with vitamin D on the market of Republic of Srpska

<p><strong>Introduction.</strong> Vitamin D is a liposoluble vitamin that has many important roles in the human body. Daily requirements for vitamin D are met through intake of food and exposure to sunlight. The high frequency of vitamin D deficiency is a public health problem that can be corrected using food supplements (FS), which is why its consumption is increasing. The quality of FS, including the content of active components, depends on the good manufacturing practice which is not strictly regulated for the production of FS, as well as the formulation, packaging and storage. Because of that, the quality of FS can be variable. The aim of our pilot study was to examine the conformity of the actual determined content of vitamin D and the declared content in 49 FS, in the form of tablets and capsules, present on the market in Republic of Srpska. <strong>Method.</strong> Determination of vitamin D content was performed by high-performance liquid chromatography (HPLC). <strong>Results.</strong> The range of the determined content of vitamin D in relation to the declared content, expressed as a percentage, was from 64,4% to 188,8%, whereby the deviation is not statistically significant (mean: 100.50%; Cl 95% -0.54 to 0.17; p=0.313 tablets; mean: 98.02%; Cl 95% -3.00 to 0.42; p=0.127 capsules). When measurement uncertainty is taken into account, only one sample (2.0%) was outside the legally allowed range (88.8% more than labeled). <strong>Conclusion.</strong> Therefore, it has been shown that most of the examined products are of satisfactory quality in terms of vitamin D content, but it is necessary to continuously monitor the food supplements that are on the market.</p>

DIPG-54. UPDATED FINDINGS FROM THE PHASE IB STUDY OF UNESBULIN (PTC596) IN CHILDREN WITH NEWLY-DIAGNOSED DIFFUSE INTRINSIC PONTINE GLIOMA (DIPG) AND HIGH-GRADE GLIOMA (HGG): A REPORT FROM THE COLLABORATIVE NETWORK FOR NEURO-ONCOLOGY CLINICAL TRIALS (CONNECT)

Abstract BMI-1 represents a potential therapeutic target in pediatric HGG given its role in self-renewal and DNA-damage signaling, high expression levels in these tumors, and resultant proliferation blockade, mitotic abnormalities, and radiosensitization when modulated by unesebulin, a microtubule polymerization inhibitor. This phase Ib study sought to determine the recommended phase 2 dose (RP2D) and pharmacokinetic (PK) profiles of unesbulin administered concurrently with radiotherapy and as maintenance therapy in children with newly-diagnosed DIPG or HGG, as well as assess intratumoral PKs and target inhibition within a surgical cohort. As previously reported, the established RP2D from the dose-finding cohort (parts A [capsule] and C [tablet]), consisting of 27 patients (median age: 9 years; 18 with DIPG, 9 with HGG) is 200mg/m2 twice weekly. Eleven additional patients (5 with DIPG, 6 with HGG) have been enrolled in an expansion cohort (part D [tablet]), with no dose-modifying toxicities to date. Among 38 total patients, most common drug-related grade 3/4 adverse effects observed are neutropenia (49%), leukopenia (31%), and elevated ALT (18%). Pharmacokinetic profiles are comparable between capsule and tablet formulations, and corroborate adult data. Genomics correlatives are underway on 13 biopsy and 5 autopsy specimens (2 paired samples). Five patients (median age: 5 years; 4 with DIPG, 1 with HGG) have enrolled in the surgical cohort (part B [tablet]) at the RP2D. PK analyses performed on the first three samples confirm intratumoral unesbulin exposure. In summary, the RP2D of unesbulin at 200mg/m2 twice weekly concurrent with and post-radiotherapy is feasible and well-tolerated, with evidence of blood-brain barrier and tumor penetrance. Survival outcomes as well as ongoing analyses of intratumoral BMI-1 pathway inhibition in surgical cohort samples, plus comprehensive molecular profiling (focusing on BMI-1 and cell cycle signaling) of biopsy and autopsy specimens from the entire cohort, will be shared at time of presentation.

Preclinical studies of toxicity and anti-cholangiocarcinoma activity of the standardized capsule formulation of Atractylodes lancea (Thunb.) DC

BackgroundCholangiocarcinoma (CCA), the adenocarcinoma of the biliary duct, is commonly reported in Asia, with the highest incidence in northeastern Thailand. Chemotherapy of CCA has been limited by the lack of effective chemotherapeutic drugs. A series of previous in vitro and in vivo studies support further research and development of Atractylodes lancea (Thunb.) DC. (AL) as a potential candidate for treating CCA as a crude ethanolic extract. In the present study, we evaluated the toxicity and anti-CCA activity of the CMC (Chemistry, Manufacturing, and Control) capsule formulation of the ethanolic rhizome extract of AL (CMC-AL) in animals.MethodsMajor steps included acute, subchronic and chronic toxicity testing in Wistar rats and anti-CCA activity in a CCA-xenografted nude mouse model. The safety of CMC-AL was determined based on the maximum tolerated dose (MTD) and no-observed-adverse-effect level (NOAEL) according to the OECD guideline. The anti-CCA activity of CMC-AL in nude mice was evaluated after transplantation of CL-6 cells to evaluate inhibitory effects on tumor size progression and metastasis and survival time prolongation. Safety assessments included hematology, biochemistry parameters and histopathological examination. Lung metastasis was investigated using VEGF ELISA kit.ResultsAll evaluations confirmed satisfactory pharmaceutical properties of oral formulation and safety profile of the CMC-AL with no overt toxicity up to the MTD and NOAEL of 5,000 and 3,000 mg/kg body weight, respectively. CMC-AL exhibited potent anti-CCA efficacy with regard to inhibitory activity on tumor progression and lung metastasis.ConclusionsCMC-AL is safe and should be further investigated in a clinical trial as a potential therapy for CCA patients.

Examining the Effects of Caffeine Supplementation on the Arousal of University Football Players

It is generally known that caffeine has ergogenic characteristics and research has shown that it can improve both the physical and technical aspects of a player's performance. The objective of this study was to discover the impact of caffeine on arousal of male university football players in the South Punjab zone of Pakistan. A randomized placebo controlled, single blind parallel group design was used to perform the study. A total of (n=120) players were selected for the study (age: 22.39 ± 1.69 Years; Height: 172.9 ± 5.85 cm; Body mass 70.12 ± 5.03 kg; Body mass index: 23.45 ± 1.43 kg/m2 Mean ± SD) were distributed into n=4 groups (n=30 in each group) to identify the effect of caffeine on the arousal of the players. In this study (n=3) various doses of caffeine in capsule form were given to three experimental groups. Group A was administered caffeine at 3 mg/kg-1 (LD-CAF: 3 mg/kg-1). Group B was administered caffeine at 6mg/kg-1 (MD-CAF: 6mg/kg-1). Group C was administered caffeine at 9 mg/kg-1 (HD-CAF: 9 mg/kg-1). Whereas, group D was considered a placebo control (PC) group, administered zero mg of caffeine (CAF: 0 mg/kg-1). Felt Arousal Scale (FAS) survey was completed in pre and post-test. Overall, all experimental groups had prominent effects (P < 0.01) on the arousal of male university football players. Results also indicated that a high dose (HD) of caffeine 9mg/kg-1 was more effective (131%) than others.

Difference in persistence between tablets and capsules.

e18894 Background: More recently, pharmaceutical companies have developed capsule and tablet forms of their drugs to allow a choice on dosage form. As both capsules and tablets should be bioequivalent, adherence rates between members prescribed capsules and tablets should be the same. This study compares persistency between capsule and tablet forms of enzalutamide and palbociclib. Methods: This retrospective cohort study included adult Caremark members who received enzalutamide and palbociclib between 03/01/2021 and 03/01/2022 with continuous eligibility for six months prior and 12 months post-index into the study. Members were excluded if they had a > 60-day gap in fill or switched from a capsule to a tablet or vice versa during the study period. Adherence was measured using the prescription-based proportion of days covered (PDC) and defined as the sum of days with medication on hand divided by the number of days between index fill and exhaust of last fill. Continuous variables were compared with the student’s t-test and Mann-U tests; categorical variables were compared with a chi-square test. Logistic regression was utilized to assess adherence differences in capsules vs. tablets; p-values < 0.05 were significant. Results: 5,997 members were included in the enzalutamide cohort; there were no insurance type or region differences (all p > 0.05) between members receiving capsules and tablets. There were no significant differences in mean PDC (mean (SD) 0.963 (0.080) vs. 0.964 (0.073); p = 0.521) or adherence rates (94.2% vs. 95.2%); p = 0.215) between members receiving capsules and tablets. After adjusting for the variables in the model, there was no difference in adherence rates between tablets and capsules. Members less than 65 years of age had significantly lower adherence rates (odds ratio (OR)) 0.5 (95% confidence interval (CI), 0.35-0.71) compared to those aged 65-74. 5,361 members were included in the palbociclib cohort; there were significant differences in age, gender, type of insurance and region (all p < 0.05) between members receiving capsules and tablets. There were no significant differences in PDC (0.962 (0.072) vs. 0.960 (0.072); p = 0.534) or adherence rates (94.9% vs. 94.9%); p = 1.0) between members receiving capsules and tablets. Conclusions: In this study, capsule and tablet forms of enzalutamide and palbociclib had similar adherence rates when adjusting for confounders.

Formulation and Evaluation of Garlic Capsules for Hypertensive

Although garlic is believed to have health-promoting benefits, many of the claimed benefits are not supported by good scientific studies. This research critically examined current scientific literature concerning claims of cardiovascular benefits from regular consumption of garlic or garlic preparations. The vast majority of recent randomized, placebo-controlled studies do not support a role for garlic in lowering blood lipids. There also is insufficient evidence to support a role in reducing blood pressure. While there have been indications of antiatherosclerotic effects associated with garlic consumption, there are insufficient data in humans. Investigation of antithrombotic effects of garlic consumption appears to hold promise, but too few data exist to draw firm conclusions.

Analysis of Pork DNA in Non-Halal Certified Jamu Capsule Shells Using Polymerase Chain Reaction (PCR) Method

Jamu is an original Indonesian medicine, one of which is formulated in the form of capsules. The rise of products that are not certified halal is a problem that needs to be studied more deeply, especially regarding the halalness of a product. Capsules are produced from animal gelatin, the alleged use of pork gelatin is the core of the problem in this study. The purpose of this study was to determine the presence or absence of pork DNA in the shells of jamu capsules. The sample was taken through one of the e-commerce with certain criteria. From several products, 5 jamu capsules were selected, which were marked with samples A, B, C, D, and E. The five samples were isolated to obtain pure DNA which was then amplified using the right primer to form millions of DNA using the PCR method, and electrophoresis to see the DNA bands produced on agarose media and the number of base pairs (bp) which were then compared with positive controls. From the research conducted, it was found that there were 4 samples B, C, D, and E detected positive for containing pork DNA at 132 bp. Meanwhile, the jamu capsule shell preparation in sample A was negative for pork DNA.

Exploring graph capsual network and graphormer for graph classification

Graph Neural Networks (GNNs) have achieved significant success in many scenarios. However, scalar-based features in GNN may be insufficient for the generation of graph representation via node representation, resulting in a lack of graph properties. Furthermore, the message aggregation operation of the original GNN suffers from not only a lack of global and structural information in graph but also the over-smoothing problem. As a result, we make efforts to alleviate the above problems of the original GNN. Inspired by the idea of capsule, we convert the node features into the form of capsules and utilize dynamic routing mechanism to generate the graph capsules from various perspectives and attention mechanism to highlight important graph capsules. Additionally, to empower the graph capsules with the ability to capture global and structural information in graph and semantic information between nodes, we introduce the Transformer architecture specific to graph data with GraphNorm to enhance the expressiveness of graph capsules and perform the interpretability analysis for the message passing between capsules and the generation process of capsules by visualization technology. Finally, we conduct extensive experiments on six common graph datasets to demonstrate CapsTrans superiority on the graph classification task over existing State-of-the-Art (SOTA) methods.

Two different molecularly imprinted polymeric coating techniques for creating sensitive and selective electrochemical sensors for the detection of Ribavirin

Herein, we successfully designed two separate imprinting strategies for the selective and sensitive detection of ribavirin (RIB) based on electropolymerization (EP) with para-aminophenyl boronic acid (p-APBA) functional monomer and photopolymerization (PP) with uracil methacrylate (UraM) functional monomers. For this purpose, firstly, poly(Py-co-p-APBA)]/RIB@MIP/GCE was successfully synthesized by co-polymerization of p-APBA monomer with pyrrole (Py) in the presence of RIB on a glassy carbon electrode (GCE) surface via EP process. Secondly, the PP based UraM/RIB@MIP sensor was fabricated by the co-polymerization of UraM and 2-hydroxyethyl methacrylate (HEMA) using polyvinyl pyrrolidone (PVP) as a sacrificial agent. The modifications of electrode surface are assessed at the molecular and electronic levels by quantum chemical calculations. Under optimum experimental conditions, the dynamic linear range of the developed sensors was found as 1.0 × 10−11-5.0 × 10−10 M and 1.0 × 10−12-2.5 × 10−11 M for EP and PP, respectively. The developed electrochemical sensors shows satisfactory recovery for the determination RIB in capsule form and commercial serum samples as 99.55–101.18% and 99.17% and 101.09% for poly(Py-co-p-APBA)/RIB@MIP/GCE and UraM/RIB@MIP/GCE sensors, respectively.

Adult attention deficit hyperactivity disorder: a comprehensive review.

Attention deficit hyperactivity disorder (ADHD) is a common childhood disorder, with only 2-3% prevalence into adulthood. The epidemiology and proposed causes of ADHD are multifactorial, including genetic, prenatal and environmental influences. The diagnosis of ADHD is often complicated by masking coping mechanisms, an overlap of symptoms with other, more commonly diagnosed disorders. Traditionally, it has been treated with stimulant medications. Non-stimulant options often target norepinephrine and dopamine regulation and are preferred in cases of comorbid substance use disorder, anxiety and other complicating factors, due to an improved side-effect profile and patient preference. They include atomoxetine and viloxazine. The latter, Viloxazine, in the form of extended-release capsules, is the first novel, non-stimulant option approved for adults with ADHD, in the past two decades. Its therapeutic effects are predominantly produced by its action as a norepinephrine reuptake inhibitor and may also modulate the serotonergic system. Viloxazine is relatively safe and effective in treating other disorders such as depression, anxiety, epilepsy and substance use disorder. Its pharmacokinetics includes metabolization by CYP enzymes. As antiepileptics inhibit CYP1A2, therefore, a special consideration would be needed, when co-administering with anti-epileptic drugs. Similarly, individuals with liver or cardiovascular disease and a personal or family history of bipolar disorder require close monitoring, while on this medication. A thorough review of the history, mechanism of action, pharmacokinetics and drug-drug interactions has been presented here, with special attention on treatment in adults with comorbid conditions. This study conducted an all-language literature search on Medline, Cochrane, Embase, and Google Scholar until December 2022. The following search strings and Medical Subject Headings (MeSH) terms were used: "Viloxazine," "ADHD," "Stimulants," and "adult ADHD." We explored the literature on the growing knowledge of Viloxazine. A thorough review of the history, mechanism of action, pharmacokinetics, and drug-drug interactions are reviewed here with special attention on treatment in adults with comorbid conditions.

Complete Blood Profile after administration of Hydrocotyle sibthorpioides Lam. extract in capsule form

Complete Blood Profile after administration of Hydrocotyle sibthorpioides Lam. extract in capsule form

Fecal transplantation for treatment of inflammatory bowel disease.

Fecal transplantation for treatment of inflammatory bowel disease.

Trial of a Novel Oral Cannabinoid Formulation in Patients with Hypertension: A Double-Blind, Placebo-Controlled Pharmacogenetic Study.

Cannabidiol (CBD) is a non-psychoactive cannabinoid, and available evidence suggests potential efficacy in the treatment of many disorders. DehydraTECH™2.0 CBD is a patented capsule formulation that improves the bioabsorption of CBD. We sought to compare the effects of CBD and DehydraTECH™2.0 CBD based on polymorphisms in CYP P450 genes and investigate the effects of a single CBD dose on blood pressure. In a randomized and double-blinded order, 12 females and 12 males with reported hypertension were given either placebo capsules or DehydraTECH™2.0 CBD (300 mg of CBD, each). Blood pressure and heart rate were measured during 3 h, and blood and urine samples were collected. In the first 20 min following the dose, there was a greater reduction in diastolic blood pressure (p = 0.025) and mean arterial pressure MAP (p = 0.056) with DehydraTECH™2.0 CBD, which was probably due to its greater CBD bioavailability. In the CYP2C9*2*3 enzyme, subjects with the poor metabolizer (PM) phenotype had higher plasma CBD concentrations. Both CYP2C19*2 (p = 0.037) and CYP2C19*17 (p = 0.022) were negatively associated with urinary CBD levels (beta = -0.489 for CYP2C19*2 and beta = -0.494 for CYP2C19*17). Further research is required to establish the impact of CYP P450 enzymes and the identification of metabolizer phenotype for the optimization of CBD formulations.

Liquid-filled hard capsule formulation of choline alfoscerate: preparation and in vitro/in vivo evaluation

Liquid-filled hard capsule formulation of choline alfoscerate: preparation and in vitro/in vivo evaluation

Two green spectrofluorimetric methods for the assay of atomoxetine hydrochloride in pure form and commercial capsules with application to content uniformity testing.

Atomoxetine hydrochloride (ATX) is a potent and non-stimulant drug which was approved for the treatment of attention-deficit hyperactivity disorder. Owing to its importance, two green, simple and validated spectrofluorimetric methods were developed for its sensitive assay in pure and capsule forms. The first method (Method I) relied on measuring the enhanced fluorescence of ATX by the use of sodium dodecyl sulfate in alkaline medium at λ ex 227 nm/λ em 298 nm. The second method (Method II) involved complex formation of ATX with Erythrosine B (EB) in aqueous acidic solution resulting in quantitative quenching of the EB naive fluorescence. This complex was formed in the presence of Britton-Robinson buffer (pH 4.0). The difference in fluorescence intensity was measured at λ ex 527/λ em550 nm. The calibration curves were linear through the ranges of 0.2-2.0 µg ml-1 for Method I, 0.2-4.0 µg ml-1 for Method II with good correlation coefficient (r = 0.9998) for both methods. The suggested methods were perfectly applied for determination of ATX in its commercial capsules and content uniformity test. The greenness of the proposed methods was confirmed by three different assessment tools and it was found that both methods were green, eco-friendly and environmentally safe.

SD-CapsNet: A Siamese Dense Capsule Network for SAR Image Registration with Complex Scenes

SAR image registration is the basis for applications such as change detection, image fusion, and three-dimensional reconstruction. Although CNN-based SAR image registration methods have achieved competitive results, they are insensitive to small displacement errors in matched point pairs and do not provide a comprehensive description of keypoint information in complex scenes. In addition, existing keypoint detectors are unable to obtain a uniform distribution of keypoints in SAR images with complex scenes. In this paper, we propose a texture constraint-based phase congruency (TCPC) keypoint detector that uses a rotation-invariant local binary pattern operator (RI-LBP) to remove keypoints that may be located at overlay or shadow locations. Then, we propose a Siamese dense capsule network (SD-CapsNet) to extract more accurate feature descriptors. Then, we define and verify that the feature descriptors in capsule form contain intensity, texture, orientation, and structure information that is useful for SAR image registration. In addition, we define a novel distance metric for the feature descriptors in capsule form and feed it into the Hard L2 loss function for model training. Experimental results for six pairs of SAR images demonstrate that, compared to other state-of-the-art methods, our proposed method achieves more robust results in complex scenes, with the number of correctly matched keypoint pairs (NCM) at least 2 to 3 times higher than the comparison methods, a root mean square error (RMSE) at most 0.27 lower than the compared methods.

Effect of bhavitha churna of Mandukaparni (Centella asiatica Linn. Urban) in Hyperuricemia associated with Gouty arthritis of elbow joints - A case report

Hyperuricemia is a condition caused by inadequate protein metabolism resulting exceed of serum uric acid level. According to a recent survey, hyperuricemia affects 28.94% of people worldwide. Treatment of hyperuricemia is typically based on long-term administration of hypouricemic modern medications, which can lead to additional complications. Hyperuricemia can be referred as Amaja roga in Ayurveda. To correct metabolism through treatment with an efficient, treatable, and safe Ayurvedic drug is preferable because Ayurveda places a high value on understanding metabolic disorders. Previous studies has reported hypouricemic activity of leaf and anti-inflammatory effect of methanolic extract of whole plant of Centella asiatica Linn. Urban. A clinical case of hyperuricemia with arthritis involving both the elbow joints along with right toe and ankle joint is being presented for the effect of bhavitha churna (processed powder) of whole plant of the drug Mandukaparni. Medicine was given at a dose of 2gm/day in the capsule form (2 capsules twice a day - 500mg/capsule). Bhavana involves churna being processed with liquid extracts to boost its potency. The treatment was conducted for three months along with one month follow-up without medicine. After the treatment, there was reduction in symptoms as patient reported with mild pain and no more swelling, tenderness and stiffness. Serum uric acid level was also reduced up to the upper limit of its normal range.

Field Efficacy of Biocapsules of Entomopathogenic Fungi for the Management of Amaranthus Leaf Webber Spoladea recurvalis (Fabricius) Crambidae: Lepidoptera

There are many insecticides are being available for pest control in the market, but traditionally focused on killing insect pests using a variety of insecticides may lead to insecticide resistance in insect pests. Biological control methods are promising alternative methods to the chemical method. In the evaluation of the efficacy of biocapsules of Beauveria bassiana (Balsamo) Vuillemin and Metarhizium anisopliae (Metschnikoff) Sorokin, for the management of amaranthus leaf webber, Spoladea (Hymenia) recurvalis F., it was revealed that Metarhizium and Beauveria capsules @ three L-1 sprayed twice (at weekly intervals) was effective reducing the larval population of S. recurvalis (83.6 and 69.9 % respectively). Lower doses of two and one capsule L-1 were less effective (47.3 to 66.5 % reductions). Spraying spore suspensions of these fungi @ 108 mL-1 resulted in 91.2 to 100 per cent reduction, while in flubendiamide 39.35 SC, it was 89.8 per cent. Treatment with Metarhizium and Beauveria capsules did not affect the natural enemy population significantly with 2.33 to 3.67 plant-1, while the corresponding population was 1.4 in flubendiamide 39.5 SC and 3.6 in the untreated control. The yield in the plots treated with Metarhizium and Beauveria capsules @ three L-1 was higher when compared to that in the untreated plot. Therefore, Need-based production of biocontrol formulations in the form of capsules, tablets, powder, etc. should be broadcasted.

Virtual Bioequivalence Assessment of Elagolix Formulations Using Physiologically Based Pharmacokinetic Modeling.

In lieu of large bioequivalence studies and exposing healthy postmenopausal women to additional drug exposure for elagolix coadministered with hormonal add-back therapy, physiologically based pharmacokinetic (PBPK) modeling was used with in vitro dissolution data to test for virtual bioequivalence. For endometriosis, elagolix is approved at doses of 150mg once daily and 200mg twice daily as a tablet. As a combination therapy, two individual tablets, consisting of an elagolix tablet and an estradiol/norethindrone acetate 1/0.5mg (E2/NETA) tablet, were utilized in Phase 3 endometriosis trials. However, the commercial combination drug products consist of a morning capsule (containing an elagolix tablet and E2/NETA tablet as a fixed-dose combination capsule, AM capsule) and an evening capsule (consisting of an elagolix tablet, PM capsule). In vitro dissolution profiles were dissimilar for the tablet and capsule formulations; thus, in vivo bioequivalence studies or a bioequivalence waiver would have been required. To simulate virtual cross-over, bioequivalence trials, in vitro dissolution data was incorporated into a previously verified PBPK model. The updated PBPK model was externally validated using relevant bioequivalence study data. Based on results of the virtual bioequivalence simulations, the commercial drug product capsules met the bioequivalence criteria of 0.80-1.25 when compared to the reference tablets. This was a novel example where PBPK modeling was utilized along with in vitro dissolution data to demonstrate virtual bioequivalence in support of a regulatory bioequivalence waiver.

Olaparib in an ovarian cancer patient with end-stage renal disease and hemodialysis

PurposeFor patients with severe renal impairment (CrCl ≤ 30 ml/min) or end-stage renal disease (ESRD), olaparib intake is not recommended as the pharmacokinetics and safety of olaparib have not been evaluated in this patient group. Therefore, this valuable patient group is generally excluded from poly(ADP-ribose) polymerase inhibitor (PARPi) therapy. Here we report the pharmacokinetics (PK), efficacy, safety and tolerability of olaparib capsules 200 mg BID in a patient with recurrent epithelial ovarian cancer (EOC) and ESRD requiring hemodialysis.MethodsBlood and dialysate samples of the patient were collected on a dialysis and non-dialysis day. Olaparib total plasma concentrations were determined through high-performance liquid chromatography with tandem mass spectrometric detection. Actual scheduled sample times were used in the PK analysis to determine multiple dose PK parameters at steady state.ResultsMaximum concentration was achieved 1.5 h after drug administration on non- dialysis and after 1 h on dialysis day. The steady-state trough concentration and the maximal plasma concentration were similar on dialysis and non- dialysis day. On non-dialysis day, the AUCss was 30% higher (24.0 µg.h/mL vs. 16.9 µg.h/ml) than on dialysis day. The plasma clearance CLss/F was lower on non-dialysis day. Olaparib was not detectable in the dialysate samples.ConclusionA total dose of olaparib 200 mg BID capsule formulation was well tolerated by our patient with ESRD and hemodialysis. Moreover, this maintenance therapy led to 16 months of progression free survival. Further trials on PARPi therapy in patients with hemodialysis are warranted.