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 study on outcome of various K-wire fixations in paediatric supracondylar humerus fractures

Background: The ideal pin geometry for treatment of paediatric supracondylar humerus fracture is still debated. Various studies have been carried out comparing medial-lateral pinning (MLP) and lateral only pinning (LOP), but none have compared all three individually i.e. MLP, lateral divergent pinning and Lateral Trans olecranon fossa four cortex purchase pinning (TOF-FCP). This study aims to compare the cosmetic and functional outcome of these three pinning methods.Methods: 54 children with supracondylar humerus (Gartland type 2 or 3) meeting inclusion criteria were treated operatively and followed up till 6 months postoperatively. At 6 months the cosmetic and functional outcomes were assessed using the modified Flynn criteria.Results: All fractures united within 3 to 6 weeks duration. The mean duration of fracture union was 4.05 weeks. Functional outcome was satisfactory (i.e. excellent or good) at 6 months according to Flynn criteria in 95% of cases in cross pinning, 100% cases in TOF-FCP construct and 89% cases in lateral entry divergent pinning. cosmetic outcome was satisfactory (i.e. excellent or good) at 6 months according to Flynn criteria in 95% of cases in cross pinning, 100% cases in TOF-FCP construct and 89% cases in lateral entry divergent.Conclusions: Functional and cosmetic outcome of all three pinning geometries after operative intervention of paediatric supracondylar humerus fracture is similar in expert hands. The incidence of complications with TOF-FCP construct is less amongst the lateral only pinning

Functional and radiological outcome of proximal femoral nailing versus dynamic hip screw in unstable intertrochanteric femur fractures

Background: Intertrochanteric femur fractures account half of the hip fractures in elderly, the other majority being neck of femur fracture. 35-40% of intertrochanteric are unstable (Tronzo’s classification type 3, 4 and 5). The dynamic hip screw (DHS) has achieved widespread acclaim in the last few years and is currently considered to be the standard device for outcome assessment. Though, the DHS has been shown to produce good results, but complications are frequent, particularly in unstable inter-trochanteric fracture. The advantage of Proximal Femur Nailing fixation is that it provides a more biomechanically stable construct by reducing the distance between hip joint and implant. The goal of this study is to assess the clinical and radiographical outcomes of the DHS (load bearing implant) and PFN (load sharing implant) for the treatment of Intertrochanteric hip fractures.Methods: We assessed the same in 52 cases of unstable femur fracture 26 operated with DHS and 26 with PFN and followed up with sequential radiographs for radiological union and sequential interview with Harris hip score calculation for functional outcome assessment.Results: Patients operated for unstable intertrochanteric femur fracture with Proximal femoral nailing had better Harris hip scores (excellent 4, good 14) compared to dynamic hip screw group (Excellent 6, good 5) and earlier weight bearing (At 18 weeks, 100% in PFN compared to 65.5% in DHS). PFN has lesser incidence of postoperative complications (15% in PFN compared to 38% in DHS).Conclusions:The proximal femoral nail has better functional outcome in terms of Harris hip score and early radiologic union in unstable intertrochanteric fractures of femur. 

Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension: UPLC-TQ-ESI-MS/MS and NMR

A novel stability-indicating, reversed-phase, high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of favipiravir in an oral suspension. The effective separation of favipiravir and its degradation products was achieved on a Zorbax Eclipse Plus C18 column (5 μm particle size, 150 mm length × 4.6 mm diameter). The mobile phase was prepared by mixing 5 mM of phosphate buffer (pH 3.5) and methanol in a 75:25 v/v ratio delivered at a 1.0 mL/min flow rate. The eluents were monitored using a photodiode array detector at a wavelength of 322 nm. The stability-indicating nature of this method was evaluated by performing force degradation studies under various stress conditions, such as acidic, alkali, oxidative, thermal, and photolytic degradation. Significant degradation was observed during the alkali stress degradation condition. The degradation products generated during various stress conditions were well separated from the favipiravir peak. In addition, the major degradation product formed under alkali stress conditions was identified using UPLC-ESI-TQ-MS/MS and NMR. Method validation was performed according to the ICH Q2 (R1) guideline requirements. The developed method is simple, accurate, robust, and reliable for routine quality control analysis of favipiravir oral suspensions

Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension: UPLC-TQ-ESI-MS/MS and NMR

A novel stability-indicating, reversed-phase, high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of favipiravir in an oral suspension. The effective separation of favipiravir and its degradation products was achieved on a Zorbax Eclipse Plus C18 column (5 μm particle size, 150 mm length × 4.6 mm diameter). The mobile phase was prepared by mixing 5 mM of phosphate buffer (pH 3.5) and methanol in a 75:25 v/v ratio delivered at a 1.0 mL/min flow rate. The eluents were monitored using a photodiode array detector at a wavelength of 322 nm. The stability-indicating nature of this method was evaluated by performing force degradation studies under various stress conditions, such as acidic, alkali, oxidative, thermal, and photolytic degradation. Significant degradation was observed during the alkali stress degradation condition. The degradation products generated during various stress conditions were well separated from the favipiravir peak. In addition, the major degradation product formed under alkali stress conditions was identified using UPLC-ESI-TQ-MS/MS and NMR. Method validation was performed according to the ICH Q2 (R1) guideline requirements. The developed method is simple, accurate, robust, and reliable for routine quality control analysis of favipiravir oral suspensions

Trends, Characteristic, and Outcomes of Preterm Infants Who Received Postnatal Corticosteroid: A Cohort Study from 7 High-Income Countries

INTRODUCTION Our objective was to evaluate the temporal trend of systemic postnatal steroid (PNS) receipt in infants of 24-28 weeks' gestational age, identify characteristics associated with PNS receipt, and correlate PNS receipt with the incidence of bronchopulmonary dysplasia (BPD) and BPD/death from an international cohort included in the iNeo network. METHODS We conducted a retrospective study using data from 2010 to 2018 from seven international networks participating in iNeo (Canada, Finland, Israel, Japan, Spain, Sweden, and Switzerland). Neonates of 24 and 28 weeks' gestational age who survived 7 days and who received PNS were included. We assessed temporal trend of rates of systemic PNS receipt and BPD/death. RESULTS A total of 47,401 neonates were included. The mean (SD) gestational age was 26.4 (1.3) weeks and birth weight was 915 (238) g. The PNS receipt rate was 21% (12-28% across networks) and increased over the years (18% in 2010 to 26% in 2018; p < 0.01). The BPD rate was 39% (28-44% across networks) and remained unchanged over the years (35.2% in 2010 to 35.0% in 2018). Lower gestation, male sex, small for gestational age status, and presence of persistent ductus arteriosus (PDA) were associated with higher rates of PNS receipt, BPD, and BPD/death. CONCLUSION The use of PNS in extremely preterm neonates increased, but there was no correlation between increased use and the BPD rate. Research is needed to determine the optimal timing, dose, and indication for PNS use in preterm neonates

Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension : UPLC-TQ-ESI-MS/MS and NMR

A novel stability-indicating, reversed-phase, high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of favipiravir in an oral suspension. The effective separation of favipiravir and its degradation products was achieved on a Zorbax Eclipse Plus C18 column (5 mu m particle size, 150 mm length x 4.6 mm diameter). The mobile phase was prepared by mixing 5 mM of phosphate buffer (pH 3.5) and methanol in a 75:25 v/v ratio delivered at a 1.0 mL/min flow rate. The eluents were monitored using a photodiode array detector at a wavelength of 322 nm. The stability-indicating nature of this method was evaluated by performing force degradation studies under various stress conditions, such as acidic, alkali, oxidative, thermal, and photolytic degradation. Significant degradation was observed during the alkali stress degradation condition. The degradation products generated during various stress conditions were well separated from the favipiravir peak. In addition, the major degradation product formed under alkali stress conditions was identified using UPLC-ESI-TQ-MS/MS and NMR. Method validation was performed according to the ICH Q2 (R1) guideline requirements. The developed method is simple, accurate, robust, and reliable for routine quality control analysis of favipiravir oral suspensions.Peer reviewe

UHPLC-APCI-TQ-MS analytical method to quantify nitrosamine impurities in the commercial formulation of metformin and glipizide

As per the ICH M7 guideline nitrosamine impurities are referred to as cohort of concern which are having a potential significant carcinogenic risk and for the safe human consumption of drug products, the levels of nitrosamine impurities need to be controlled as per respective permissible daily exposures (PDE). An accurate, precise, sensitive, and robust UPLC-APCI-TQ-MS/MS method has been developed for the quantification of eight nitrosamine impurities in the marketed formulation of metformin and glipizide Tablets. Chromatographic separation was achieved using Kinetex® 150 × 3.0 mm Biphenyl 100 Å, 2.6 µm column with mobile phase A (0.1% w/v formic acid dissolved in water) and mobile phase B (0.1% w/v formic acid dissolved in methanol) with a flow rate of 0.4 mL per minute having run time of 20 min with gradient mode of elution. As per ICH Q2(R1) guideline the method had been validated which demonstrates the sensitivity of the developed method with a good linearity range of 1–5 ng/mL for all eight nitrosamine impurities. The validation parameters suggest that the developed method for the simultaneous quantification of eight nitrosamine impurities in the marketed formulation of metformin hydrochloride and glipizide can be routinely applied in the quality control laboratory. </p