Management of communited patellar fracture with combined Tension Band Wiring Technique and Encirclage

Background: The objective of the study was to evaluate functional results of combined encirclage wiring and tension band fixation in comminuted patellar fractures.Methods: This is a prospective study of 15 patients treated with this method. All fractures described herein were classified as 45-C3 (based on Orthopaedic Trauma Association classification) and were fixed with encirclage wire and tension band wire proximally looped through the quadriceps tendon and distally through the patellar ligament in a figure-of-eight configuration. Knee function was evaluated using the Rasmussen scores at final follow-up.Results: 13 patients gained up to 90 degrees of active flexion at the end of the first week. 4 patients had 10–15 degrees of extensor lag at the end of the first week which improved after vigorous physiotherapy and none of them had any residual extensor lag at the subsequent follow-up. Two patients developed superficial infection. All fractures united at the end of 12 weeks. One patient underwent a second surgery; due to implant related complications. Malunion or non-union was not noted in any of the cases. The average Rasmussen scores was 27.9 out of 30 (range, 27–29).Conclusions: The tension band technique combined with cable encirclage for treatment of communited fractures of patella is a simple and technically less demanding operative technique producing a rigid fixation, stable osteosynthesis and minimal injury to the tendon. It can be done with easily available implants.

Cartridge based nucleic acid amplification test negative in highly suspected case of tuberculosis: a case report

Diagnosis of pulmonary tuberculosis is challenging till today. Smear microscopy is the easiest, commonest and widely employed tool for confirmatory diagnosis of pulmonary tuberculosis, but it has low sensitivity and specificity. Sputum culture can increase the diagnostic yield by 20-40%, but it takes long duration of 2-8 weeks to give result. The role of newly introduced cartridge based nucleic acid amplification test (CBNAAT) in the revised national TB control program (RNTCP) is highly promising with a higher yield of bacteriological diagnosis in sputum negative pulmonary tuberculosis patients with detection of rifampicin resistance rapidly. However, it also has some limitations which may result in false negative results. Case of a 50- year-old-male was reported who was initially managed for community-acquired pneumonia in view of negative sputum and CBNAAT but was later confirmed to have TB but by then he had developed cavities in lung and had transmitted the infection to his son

Evaluation of results of minimally invasive per cutaneous surgeries in management of calcaneal fractures

 Background: To analyze the outcome percutaneous surgeries in fractures of the calcaneum.Methods: 20 patients admitted in a tertiary care center in Ahmedabad were followed up from admission to until 2 years post operatively and functional outcomes in them following operative intervention were analyzed using AOFAS and Maryland scoring system.Results: Majority of patients have excellent or good outcome following percutaneous surgery in fractures of the calcaneum. The results were evaluated for 22 people with intraarticular calcaneum fractures using the Maryland foot score and AOFAS score. The mean AOFAS score was 86. There were 6 excellent, 12 good and 4 fair results.Conclusions: Percutaneous fixation in fractures of the calcaneum is a middle path in treatment of calcaneum fracture having the benefit of better reduction of ORIF plating and lesser soft tissue injury or chances of infection of conservative management

A novel transflectance near infrared spectroscopy technique for monitoring hot melt extrusion

yesA transflectance near infra red (NIR) spectroscopy approach has been used to simultaneously measure drug and plasticiser content of polymer melts with varying opacity during hot melt extrusion. A high temperature reflectance NIR probe was mounted in the extruder die directly opposed to a highly reflective surface. Carbamazepine (CBZ) was used as a model drug, with polyvinyl pyrollidone-vinyl acetate co-polymer (PVP-VA) as a matrix and polyethylene glycol (PEG) as a plasticiser. The opacity of the molten extrudate varied from transparent at low CBZ loading to opaque at high CBZ loading. Particulate amorphous API and voids formed around these particles were found to cause the opacity. The extrusion process was monitored in real time using transflectance NIR; calibration and validation runs were performed using a wide range of drug and plasticiser loadings. Once calibrated, the technique was used to simultaneously track drug and plasticiser content during applied step changes in feedstock material. Rheological and thermal characterisations were used to help understand the morphology of extruded material. The study has shown that it is possible to use a single NIR spectroscopy technique to monitor opaque and transparent melts during HME, and to simultaneously monitor two distinct components within a formulation

Continuous manufacturing of high quality pharmaceutical cocrystals integrated with process analytical tools for in-line process control

A continuous manufacturing process for pharmaceutical indomethacin–saccharine cocrystals was achieved by extrusion processing with high throughput. Down-stream milling and blending of the extrudates was followed by feeding the formulated cocrystals in a capsule-filling machine. By applying a quality by design approach, the process was optimized and scaled up to produce 3000 capsules/h of pharmaceutical cocrystals. Process analytical tools such as near infrared reflectance and spatial filter velocimetry probes were coupled at various process stages for in-line monitoring and quality control. Further physicochemical characterization of extruded batches confirmed the manufacturing of high quality cocrystals. A fully integrated continuous process starting from raw materials to produce a finished product was assembled with only six unit operations and a small footprint. The study is a paradigm of continuous manufacturing of pharmaceutical cocrystals

Near infra red spectroscopy as a multivariate process analytical tool for predicting pharmaceutical co-crystal concentration

YesThe use of near infra red spectroscopy to predict the concentration of two pharmaceutical co-crystals; 1:1 ibuprofen – nicotinamide (IBU-NIC) and 1:1 carbamazepine – nicotinamide (CBZ-NIC) has been evaluated. A Partial Least Squares (PLS) regression model was developed for both co-crystal pairs using sets of standard samples to create calibration and validation data sets with which to build and validate the models. Parameters such as the root mean square error of calibration (RMSEC), root mean square error of prediction (RMSEP) and correlation coefficient were used to assess the accuracy and linearity of the models. Accurate PLS regression models were created for both co-crystal pairs which can be used to predict the co-crystal concentration in a powder mixture of the co-crystal and the active pharmaceutical ingredient (API). The IBU-NIC model had smaller errors than the CBZ-NIC model, possibly due to the complex CBZ-NIC spectra which could reflect the different arrangement of hydrogen bonding associated with the co-crystal compared to the IBU-NIC co-crystal. These results suggest that NIR spectroscopy can be used as a PAT tool during a variety of pharmaceutical co-crystal manufacturing methods and the presented data will facilitate future offline and in-line NIR studies involving pharmaceutical co-crystals

Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

Currently, because globalization, the pharmaceutical industry is facing enormous challenges to comply with regulatory matters. Reduced patent life and overall decreased profitability of newly discovered drugs are also forcing the pharmaceutical industry to shorten the drug development time with maximum throughput. Therefore, continuous manufacturing (CM) processes via hot melt extrusion (HME) can be a promising alternative for achieving these goals. HME offers solvent-free green technology with a process that is easy to scale up. Moreover, CM provides better product quality assurance compared with batch processes, with fewer labor costs and shorter time to development. In this review, we primarily focus on various aspects of CM and the emerging application of HME to bridge the current manufacturing gap in pharmaceutical sphere

Approaches in biotechnological applications of natural polymers

Natural polymers, such as gums and mucilage, are biocompatible, cheap, easily available and non-toxic materials of native origin. These polymers are increasingly preferred over synthetic materials for industrial applications due to their intrinsic properties, as well as they are considered alternative sources of raw materials since they present characteristics of sustainability, biodegradability and biosafety. As definition, gums and mucilages are polysaccharides or complex carbohydrates consisting of one or more monosaccharides or their derivatives linked in bewildering variety of linkages and structures. Natural gums are considered polysaccharides naturally occurring in varieties of plant seeds and exudates, tree or shrub exudates, seaweed extracts, fungi, bacteria, and animal sources. Water-soluble gums, also known as hydrocolloids, are considered exudates and are pathological products; therefore, they do not form a part of cell wall. On the other hand, mucilages are part of cell and physiological products. It is important to highlight that gums represent the largest amounts of polymer materials derived from plants. Gums have enormously large and broad applications in both food and non-food industries, being commonly used as thickening, binding, emulsifying, suspending, stabilizing agents and matrices for drug release in pharmaceutical and cosmetic industries. In the food industry, their gelling properties and the ability to mold edible films and coatings are extensively studied. The use of gums depends on the intrinsic properties that they provide, often at costs below those of synthetic polymers. For upgrading the value of gums, they are being processed into various forms, including the most recent nanomaterials, for various biotechnological applications. Thus, the main natural polymers including galactomannans, cellulose, chitin, agar, carrageenan, alginate, cashew gum, pectin and starch, in addition to the current researches about them are reviewed in this article.. }To the Conselho Nacional de Desenvolvimento Cientfíico e Tecnológico (CNPq) for fellowships (LCBBC and MGCC) and the Coordenação de Aperfeiçoamento de Pessoal de Nvíel Superior (CAPES) (PBSA). This study was supported by the Portuguese Foundation for Science and Technology (FCT) under the scope of the strategic funding of UID/BIO/04469/2013 unit, the Project RECI/BBB-EBI/0179/2012 (FCOMP-01-0124-FEDER-027462) and COMPETE 2020 (POCI-01-0145-FEDER-006684) (JAT)

Development of cocrystals of water insoluble active substances with inactive excipients by using hot melt extrusion

The major aim of the research reported herein was to develop and optimise hot melt extrusion (HME) as a robust technique for the cocrystallisation of poorly water soluble drugs and their coformers. Two pairs of cocrystals of a poorly water soluble drug, carbamazepine, with saccharin and trans-cinnamic acid, were produced by using single (SSE) and twin screw (TSE) hot melt extrusion. The optimum barrel temperature for TSE was chosen from various temperature profiles applied in the SSE experiments. Physicochemical characterisation of extrudates was undertaken by using differential scanning calorimetry (DSC) and X-ray powder diffraction (XRPD); it was found that the screw configuration in TSE plays an important role in the production of high quality cocrystals compared to cocrystals produced using SSE. Furthermore, samples collected from the three zones of the barrel of the extruder during CBZ-TCA extrusion, confirmed the gradual formation of cocrystals in TSE. The TSE extruded cocrystals exhibited faster dissolution rates compared to bulk CBZ, the prototype cocrystals and those produced by SSE. In a further study, a hydrophilic carrier, D-glucono--lactone (DGL) was extruded with CBZ, at various molar ratios, by using HME processing. XRPD and HSM characterisation of extrudates revealed polymorphic transformation of bulk carbamazepine (form III) into polymorphic form I. DGL was shown to be a suitable carrier for CBZ in order to enhance its dissolution rate. The extrudates showed faster dissolution rates compared to the physical mixtures in the ascending order: 2:1<1:1<1.5:1 (CBZ:DGL molar ratio). Different HME variables were examined in order to optimise the formation of indomethacin-saccharin cocrystals by using TSE. Important HME processing parameters-screw speed and extruder barrel temperature -were found to have an influence on the production of the cocrystals. Indomethacin-saccharin cocrystals improved the dissolution performance of indomethacin. In-line NIR (near infrared spectroscopy) was used as a process analytical tool during the continuous manufacture of the cocrystals for further insight into the HME process. Scale-up of cocrystals was performed by increasing the throughput rate in the laboratory scale extruder without compromising the quality of the extrudates. Whilst scaling-up the HME process, the downstream process was operated in continuous mode in order to prepare the final dosage (capsule) form of the indomethacin-saccharin cocrystals. In-line particle size monitoring was performed during the extrusion and milling processes. Particle size had a significant influence on the dissolution properties of the milled compared to the non-milled cocrystals