Development and evaluation of time controlled release tablet of ketoprofen for the treatment of Rheumatoid Arthritis

The aim of present study was to develop and evaluate time controlled release tablet of Ketoprofen intended for rheumatoid arthritis. The cardinal sign of rheumatoid arthritis are stiffness, swelling and pain of one or more joints of the body characteristically most severe in the morning. Rheumatoid arthritis shows a significant circadian variation in its symptoms. Time controlled release tablet delivers the drug at definite time or in controlled rate. It consist of core tablet coated with two layers, the inner swelling layer and outer rupturable. Before compression of core tablet, drug- excipients compatibility study and precompression parameters were investigated. Core tablet was prepared by direct compression method. The core tablets are coated with crosscarmellose sodium as inner swelling layer with different coating level. The prepared tablet again evaluated and coated with rupturable layer of ethylcellulose. The free film of ethylcellulose was evaluated for various parameters. The effect of microcrystalline cellulose and coating level of rupturable layer and swellable layer on lag time were investigated. The results shows as the amount of microcrystalline cellulose increase in core tablet the lag time decreases. The lag time increases with increase in coating level of swelling layer and rupturable layer. The water uptake study shows that higher ethylcellulose levels retards the water uptake and prolongs the lag time

Force‐sensing catheters during pediatric radiofrequency ablation: The FEDERATION Study

Background Based on data from studies of atrial fibrillation ablations, optimal parameters for the TactiCath (TC; St. Jude Medical, Inc) force‐sensing ablation catheter are a contact force of 20 g and a force‐time integral of 400 g·s for the creation of transmural lesions. We aimed to evaluate TC in pediatric and congenital heart disease patients undergoing ablation. Methods and Results Comprehensive chart and case reviews were performed from June 2015 to March 2016. Of the 102 patients undergoing electrophysiology study plus ablation, 58 (57%) underwent ablation initially with a force‐sensing catheter. Patients had an average age of 14 (2.4–23) years and weight of 58 (18–195) kg with 15 patients having abnormal cardiac anatomy. Electrophysiology diagnoses for the + TC group included 30 accessory pathway–mediated tachycardia, 24 atrioventricular nodal reentrant tachycardia, and 7 other. Baseline generator settings included a power of 20 W, temperature of 40°, and 6 cc/min flow during lesion creation with 11 patients (19%) having alterations to parameters. Seventeen patients (30%) converted to an alternate ablation source. A total of 516 lesions were performed using the TC with a median contact force of 6 g, force‐time integral of 149 g·s, and lesion size index of 3.3. Median‐term follow‐up demonstrated 5 (10%) recurrences with no acute or median‐term complications. Conclusions TactiCath can be effectively employed in the treatment of pediatric patients with congenital heart disease with lower forces than previously described in the atrial fibrillation literature. Patients with atrioventricular nodal reentrant tachycardia or atrioventricular reciprocating tachycardia may not require transmural lesions and the TC may provide surrogate markers for success during slow pathway ablation. </jats:sec

Percutaneous pulmonary valve implantation alters electrophysiologic substrate

BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) is first‐line therapy for some congenital heart disease patients with right ventricular outflow tract dysfunction. The hemodynamics improvements after PPVI are well documented, but little is known about its effects on the electrophysiologic substrate. The objective of this study is to assess the short‐ and medium‐term electrophysiologic substrate changes and elucidate postprocedure arrhythmias. METHODS AND RESULTS: A retrospective chart review of patients undergoing PPVI from May 2010 to April 2015 was performed. A total of 106 patients underwent PPVI; most commonly these patients had tetralogy of Fallot (n=59, 55%) and pulmonary insufficiency (n=60, 57%). The median follow‐up time was 28 months (7‐63 months). Pre‐PPVI, 25 patients (24%) had documented arrhythmias: nonsustained ventricular tachycardia (NSVT) (n=9, 8%), frequent premature ventricular contractions (PVCs) (n=6, 6%), and atrial fibrillation/flutter (AF/AFL) (n=10, 9%). Post‐PPVI, arrhythmias resolved in 4 patients who had NSVT (44%) and 5 patients who had PVCs (83%). New arrhythmias were seen in 16 patients (15%): 7 NSVT, 8 PVCs, and 1 AF/AFL. There was resolution at medium‐term follow‐up in 6 (86%) patients with new‐onset NSVT and 7 (88%) patients with new‐onset PVCs. There was no difference in QRS duration pre‐PPVI, post‐PPVI, and at medium‐term follow‐up (P=0.6). The median corrected QT lengthened immediately post‐PPVI but shortened significantly at midterm follow‐up (P<0.01). CONCLUSIONS: PPVI reduced the prevalence of NSVT. The majority of postimplant arrhythmias resolve by 6 months of follow‐up

Proizvodne varijable koje utječu na svojstva peleta u peletiranju taljenjem sa smjesom voskova u sferonizatoru za laboratorijsku proizvodnju

The purpose of the study was to evaluate the suitability of laboratory scale spheronizer for the production of spherical pellets loaded with diltiazem hydrochloride by wax combination. The 1:1 combination of cetyl alcohol and hydrogenated castor oil, as low and high melting point waxes, were used. The various production variables affecting the different characteristics of pellets and the process efficiency were evaluated. Drug loaded pellets were evaluated for drug release in distilled water. Bowl temperature primarily affects the sphericity and adhesion of pellets to the bowl. Mass temperature has a pronounced effect on size, size distribution and sphericity of pellets. Wax concentration affects all characteristics of pellets but adhesion was least affected. The effect of these three variables can be compensated by optimizing the friction plate speed. It has been found that the highest yield of pellets (8501400 m) with maximum sphericity can be produced by using 45 C bowl temperature, 52 C mass temperature and 1400 rpm friction plate speed.Cilj rada bio je pripraviti sferične pelete u laboratorijskom sferonizatoru koristeći smjesu voskova. Cetilni alkohol kao vosak niskog tališta i hidrogenirano ricinusovo ulje kao vosak visokog tališta, upotrebljeni su u omjeru 1:1. Proučavan je utjecaj proizvodnih varijabli na svojstva peleta i efikasnost proizvodnje te brzinu oslobađanja ljekovite tvari iz peleta u destiliranoj vodi. Na sferičnost i adhezivnost peleta najviše utječe temperatura peletiranja. Temperatura mase ima i značajan utjecaj na veličinu, raspodjelu veličine peleta i sferičnost. Koncentracija voska utječe na sva svojstva peleta, ali najmanje na adhezivnost. Učinak tih triju varijabli može se kompenzirati optimiziranjem brzine ploče za trenje. Pronađeno je da najveće iskorištenje peleta (8501400 microm) s najboljom sferičnošću ako je temperatura peletiranja 45 oC, temperatura mase 52 oC, a brzina ploče za trenje 1400 rpm

IV sotalol use in pediatric and congenital heart patients: A multicenter registry study

Background There is limited information regarding the clinical use and effectiveness of IV sotalol in pediatric patients and patients with congenital heart disease, including those with severe myocardial dysfunction. A multicenter registry study was designed to evaluate the safety, efficacy, and dosing of IV sotalol. Methods and Results A total of 85 patients (age 1 day-36 years) received IV sotalol, of whom 45 (53%) had additional congenital cardiac diagnoses and 4 (5%) were greater than 18 years of age. In 79 patients (93%), IV sotalol was used to treat supraventricular tachycardia and 4 (5%) received it to treat ventricular arrhythmias. Severely decreased cardiac function by echocardiography was seen before IV sotalol in 7 (9%). The average dose was 1 mg/kg (range 0.5-1.8 mg/kg/dose) over a median of 60 minutes (range 30-300 minutes). Successful arrhythmia termination occurred in 31 patients (49%, 95% CI [37%-62%]) with improvement in rhythm control defined as rate reduction permitting overdrive pacing in an additional 18 patients (30%, 95% CI [19%-41%]). Eleven patients (16%) had significant QTc prolongation to \u3e465 milliseconds after the infusion, with 3 (4%) to \u3e500 milliseconds. There were 2 patients (2%) for whom the infusion was terminated early. Conclusions IV sotalol was safe and effective for termination or improvement of tachyarrhythmias in 79% of pediatric patients and patients with congenital heart disease, including those with severely depressed cardiac function. The most common dose, for both acute and maintenance dosing, was 1 mg/kg over ~60 minutes with rare serious complications

Developed in collaboration with and endorsed by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American Heart Association (AHA), and the Association for European Paediatric and Congenital Cardiology (AEPC). Endorsed by the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and the Latin American Heart Rhythm Society (LAHRS).

AbstractIn view of the increasing complexity of both cardiovascular implantable electronic devices (CIEDs) and patients in the current era, practice guidelines, by necessity, have become increasingly specific. This document is an expert consensus statement that has been developed to update and further delineate indications and management of CIEDs in pediatric patients, defined as ≤21 years of age, and is intended to focus primarily on the indications for CIEDs in the setting of specific disease categories. The document also highlights variations between previously published adult and pediatric CIED recommendations and provides rationale for underlying important differences. The document addresses some of the deterrents to CIED access in low- and middle-income countries and strategies to circumvent them. The document sections were divided up and drafted by the writing committee members according to their expertise. The recommendations represent the consensus opinion of the entire writing committee, graded by class of recommendation and level of evidence. Several questions addressed in this document either do not lend themselves to clinical trials or are rare disease entities, and in these instances recommendations are based on consensus expert opinion. Furthermore, specific recommendations, even when supported by substantial data, do not replace the need for clinical judgment and patient-specific decision-making. The recommendations were opened for public comment to Pediatric and Congenital Electrophysiology Society (PACES) members and underwent external review by the scientific and clinical document committee of the Heart Rhythm Society (HRS), the science advisory and coordinating committee of the American Heart Association (AHA), the American College of Cardiology (ACC), and the Association for European Paediatric and Congenital Cardiology (AEPC). The document received endorsement by all the collaborators and the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and the Latin American Heart Rhythm Society (LAHRS). This document is expected to provide support for clinicians and patients to allow for appropriate CIED use, appropriate CIED management, and appropriate CIED follow-up in pediatric patients

Development and Evaluation of TIME Controlled Release Tablet of Ketoprofen for the Treatment of Rheumatoid Arthritis

The aim of present study was to develop and evaluate time controlled release tablet of Ketoprofen intended for rheumatoid arthritis. The cardinal sign of rheumatoid arthritis are stiffness, swelling and pain of one or more joints of the body characteristically most severe in the morning. Rheumatoid arthritis shows a significant circadian variation in its symptoms. Time controlled release tablet delivers the drug at definite time or in controlled rate. It consist of core tablet coated with two layers, the inner swelling layer and outer rupturable. Before compression of core tablet, drug- excipients compatibility study and precompression parameters were investigated. Core tablet was prepared by direct compression method. The core tablets are coated with crosscarmellose sodium as inner swelling layer with different coating level. The prepared tablet again evaluated and coated with rupturable layer of ethylcellulose. The free film of ethylcellulose was evaluated for various parameters. The effect of microcrystalline cellulose and coating level of rupturable layer and swellable layer on lag time were investigated. The results shows as the amount of microcrystalline cellulose increase in core tablet the lag time decreases. The lag time increases with increase in coating level of swelling layer and rupturable layer. The water uptake study shows that higher ethylcellulose levels retards the water uptake and prolongs the lag time

The B-vitamins in malnutrition with alcoholism- a model of intervitamin relationships

1. The B-vitamin status of fifty-nine patients, mainly from the lower socio-economic classes in Bombay, with a history of chronic malnutrition, and of alcoholism of 1-5-20 years' duration, was studied before and during treatment, and in relation to their clinical, especially neurological, condition. These patients were divided into two neurological categories: (I) those with peripheral neuropathy (mainly sensory and distal) alone, (2) those with mental changes (mainly confusion and disorientation) also. Both categories frequently showed pellagrous pigmentation and mucocutaneous signs of B-vitamin deficiency. 2. Thiamin and erythrocyte transketolase (EC 2.2.1.1) activity, riboflavin, nicotinic acid, pantothenic acid, total and pyridoxal fraction of vitamin B6, folate and total vitamin B12 were estimated in the blood and the cerebrospinal fluid (CSF) of these patients, and also in the blood of sixty-nine control subjects and in the CSF of some of them. The concentrations of all the vitamins, except vitamin B12, were highly significantly lower in the blood of patients of category I compared to the controls, and erythrocyte transketolase activity and pyridoxal concentration in patients of category 2 were significantly lower than those of category I patients. Blood pantothenic acid and folate concentrations were reduced less consistently. 3. Serum vitamin B12 concentration was significantly increased (though within normal range) in the patients compared to the control group, probably because of the moderate hepatic insufficiency (as assessed by liver function tests) in the former. 4. The concentrations of thiamin, riboflavin, nicotinic acid and total vitamin B6 were also highly significantly lower in the CSF in patients of category I compared with controls. Furthermore, thiamin, nicotinic acid and total vitamin B6 concentrations were significantly lower in patients of category 2 than those of category I patients, indicating that CSF levels reflect better the neurological status of these patients. 5. There was a moderate increase in the blood concentration of all the vitamins tested, after a relatively poor hospital diet alone. There was a concurrent increase in the blood levels of thiamin, riboflavin, nicotinic acid and pantothenic acid after parenteral treatment with either thiamin or nicotinic acid. The administration of pyridoxine resulted in a significant increase in the blood levels of riboflavin and the pyridoxal fraction of vitamin B6