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Objective: To evaluate the bioequivalence of a hybrid pegylated liposomal doxorubicin (PLD) hydrochloride injection with reference product Caelyx®., Methods: This multicenter, open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study was conducted in female patients aged ≥18 years and ≤75 years with ovarian cancer, whose disease progressed or recurred after platinum-based chemotherapy, and who were scheduled to start PLD therapy. Patients were intravenously infused drugs over 1 h at 50 mg/m 2 dose two hours after breakfast on the first day of the chemotherapy cycle in period-I and crossed over to the other arm in period-II (day 29). Pharmacokinetic (PK) analyses were performed using two separate, validated liquid chromatography-mass spectrometry methods for encapsulated and unencapsulated doxorubicin., Results: Both the test and reference formulations were well-tolerated and safe. The pharmacokinetic analysis for both encapsulated and unencapsulated doxorubicin was conducted in 50 patients and PK parameters were found to be comparable between test and reference products. The geometric mean ratios (90% confidence interval) of hybrid PLD/Caelyx® were; maximum measured plasma concentration (C max ): 91.94-97.28%, area under the plasma concentration versus time from time 0 to t (AUC 0-t ): 95.19-103.67% , AUC from time 0 to ∞ (AUC 0-∞ ): 95.13-103.66% for encapsulated doxorubicin and for unencapsulated doxorubicin C max : 92.08-116.46% , AUC 0-t : 91.91-108.28% , AUC 0-∞ : 93.45-110.05%., Conclusion: The PLD formulation was found to be bioequivalent to Caelyx®., (Copyright © 2022. Published by Elsevier B.V.)

Objective: Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) are clinically and biologically diverse phenotypic diseases amongst hematological malignancies. The current study objectives were to diagnose and classify cases of AL as per revised 4th edition of WHO 2016 classification of AL's and study their clinicopathological profiles., Material and Method: This cross-sectional, observational study included 68 patients, diagnosed with AL were recruited. Diagnosis was based on peripheral blood smear examination, bone marrow aspiration, flowcytometry, and cytogenetic and molecular studies., Results: Sixty-eight cases of AL were diagnosed in a period of 2 years, where 25 cases were of ALL and 43 cases were of AML. In the subclassification of AML as per WHO 2016, 20 cases were of AML, RGA, 21 cases were of AML, NOS, and 2 cases were of AML, MRC. In AML, RGA, APL with PML-RARA positive cases were 10 out of 20 cases, AML with (8;21) RUNX1-RUNX1T1 were 7/20 cases; there were two cases of AML with mutated NPM1 gene and one case of AML with biallelic mutation of CEBPA. In AML, NOS subcategory AML with maturation was more common with 9/21cases. In subcategory of ALL, B-ALL was more common than T-ALL. B-ALL, NOS was more common than B-ALL, RGA and we had 1 case of NK cell Leukemia., Conclusion: The application of revised 4th edition WHO 2016 classification confers uniformity in reporting acute leukemia cases that aids in the treatment by using targeted therapies and helps in the prediction of prognosis. The WHO classification for acute leukemias is very objective, therapy oriented and the need of the hour.

Purpose: Composite mesh prostheses incorporate properties of multiple materials for use in open ventral hernia repair (OVHR). This study examines clinical outcomes in patients who underwent OVHR with a polypropylene/expanded polytetrafluoroethylene (ePTFE) composite graft containing a novel polydioxanone (PDO) absorbable ring to facilitate placement and graft positioning., Methods: Data were prospectively collected on consecutive patients undergoing OVHR using a synthetic composite mesh. Seven centers enrolled patients during the study period. All patients underwent a standardized surgical procedure consisting of OVHR with sublay intraperitoneal placement of mesh. Mesh fixation was accomplished with peripheral tacks and transfascial sutures., Results: One hundred and nineteen patients underwent OVHR with the composite mesh. Average age was 55.8 years; there were 71 (59.7 %) females and 48 (40.3 %) males with mean BMI of 33.5 ± 7.1 kg/m(2). One hundred and two (85.7 %) patients presented with primary ventral hernias. Mean defect size was 13.6 cm(2), and mean mesh size was 113.6 cm(2). Most patients (67 %) were discharged the day of surgery. Twelve patients (10.1 %) experienced complications in the perioperative time period primarily consisting of seroma (4.2 %) and ileus (1.7 %). Two patients required reoperation and mesh removal in the early postoperative period for infection and herniorrhaphy site pain, respectively. There was a decline in pain and movement limitation scores between baseline and 1-year follow-up. Six-month (n = 109) and twelve-month (n = 99) follow-up revealed no hernia recurrences (95 % CI 0-3 %, and 0-4 %, respectively)., Conclusions: The use of this second-generation composite mesh was associated with no hernia recurrences and a low complication rate after open ventral hernia repair.

The goal of diabetes therapy today is to achieve and maintain as near normal glycemia as possible to prevent the long-term microvascular and macrovascular complications of an elevated blood glucose. A newly developed inlay osmotic pump tablet (IOPT) can deliver glipizide (GLZ) and metformin HCl (MET) gradually in controlled manner. The aim of present investigation was to prepare the IOPT that can deliver >75% of GLZ in 2 h, whereas MET released after 2 h and sustained up to 12 h. In the present work, HP-β-CD was used to modify the solubility of GLZ before incorporating in the osmotic system and MET was spray-dried with HPMC A15C to modify its release profile, flow property, and compressibility. Various parameters mainly G(75%) (75% GLZ release), t(LMET) (lag time of MET release from device), Q(10 h) (percent of MET released within 10 h), and RSQ(ZERO) (R(2) of release data fitted to zero-order equation) were used to compare different formulations. The effects of different formulation variables, that is, osmagents, concentration of hydrophilic polymer, diameter of drug releasing orifice, and coating composition on the drug release profile were investigated. The release rate of GLZ could be effectively modified by the addition of sodium carbonate and sodium chloride, whereas the release rate of MET was adjusted by dual-coating system and by addition of hydrophilic polymer. The developed inlay osmotic system could be effective in the multidrug therapy of diabetes by delivering both drugs in a controlled manner.

Background: Fast-track surgery has been described as a plan to facilitate early recovery. We present one surgeon's modifications to fast-track surgery for laparoscopic colectomy patients., Methods: We performed a retrospective review of 48 consecutive patients undergoing elective laparoscopic colectomy treated by a modified fast-track plan between 2004 and 2008. Elements included preoperative education, pre-anesthesia dexamethasone, immediate postoperative general diet, no urinary catheter, no epidural anesthesia, and no flatus or bowel movement as a discharge requirement. Data collected included the following: age, sex, body mass index, resection indications, surgical time, blood loss, pain score, time to ambulation, time to bowel function, length of stay, complications, and mortality., Results: The mean length of stay was 37 hours (1.5 d), with 29 of 48 patients discharged without passage of flatus or stool. Only 1 patient required readmission., Conclusions: Our modified fast-track plan achieved significant improvement in length of stay for laparoscopic colectomy compared with previous results., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)

Radiation sensitive films are standard dosimetric tools in radiation therapy. Films are used for machine quality assurance (QA) and treatment planning software evaluation. With the advent of intensity modulated radiation therapy (IMRT), simple and fast imaging technology is needed for patient-specific verification of radiation fields. Conventional radiographic films are often used. Radiochromic films, e.g. Gafchromic films, were recently introduced to the market. But these films have some disadvantages. JP Laboratories have developed a prototype radiochromic film, called SIFID (self-developing, instant film for imaging and dosimetry) with superior performance such that SIFID is unaffected by ambient light for months, stable up to 90 degrees C and can be archived. SIFID is made of polymerisable diacetylene. The film develops blue colour instantly upon absorbing radiation. We evaluated the film for radiation therapy applications. Our preliminary data demonstrate its feasibility as a dosimetric tool for IMRT QA as well as for other applications.

We developed an analog very large-scale integrated system of two mutually inhibitory silicon neurons that display several different stable oscillations. For example, oscillations can be synchronous with weak inhibitory coupling and alternating with relatively strong inhibitory coupling. All oscillations observed experimentally were predicted by bifurcation analysis of a corresponding mathematical model. The synchronous oscillations do not require special synaptic properties and are apparently robust enough to survive the variability and constraints inherent in this physical system. In biological experiments with oscillatory neuronal networks, blockade of inhibitory synaptic coupling can sometimes lead to synchronous oscillations. An example of this phenomenon is the transition from alternating to synchronous bursting in the swimming central pattern generator of lamprey when synaptic inhibition is blocked by strychnine. Our results suggest a simple explanation for the observed oscillatory transitions in the lamprey central pattern generator network: that inhibitory connectivity alone is sufficient to produce the observed transition.