Formulation, Development, and Performance Evaluation of Metoclopramide HCl Oro-Dispersible Sustained Release Tablet

Nikhil Kasliwal,Vandana Jugran,Rahul Jain,Jeetendra Singh Negi 대한약학회 2011 Archives of Pharmacal Research Vol.34 No.10

The present study was undertaken to develop and evaluate an oro-dispersible, sustained release tablet of metoclopramide HCl. The technology was comprised of developing sustained release microparticles, and compression of resultant microspheres into a fast dispersible tablet by direct compression. The microspheres of metoclopramide HCl were prepared by an emulsification-solvent evaporation method using ethylcellulose as the matrix polymer. The prepared microspheres were evaluated for morphology, particle size, entrapment efficiency, and in vitro drug release characteristics. Scanning electron microscopy demonstrated spherical particles with a mean diameter of 81.27 ± 5.87 μm and the drug encapsulation efficiency was found to be 70.15 ± 3.06%. The process and formulation variables such as rotation speed, polymer concentration, and drug concentration influenced the drug encapsulation efficiency and in vitro drug release. Optimized microspheres were compressed into tablets which were comprised of metoclopramide HCl microspheres, 53% (w/v) of D-mannitol granules, 7% (w/w) of Polyplasdone XL 10, and 0.5% (w/w) of calcium stearate. The tablets demonstrated a hardness of 59 ± 3 N, friability of 0.21% and disintegration time of 27 ± 3 sec. The formulations were subjected to stability studies as per ICH guidelines and were found to be stable after a 6month study. In vivo experiments conducted in rats demonstrated that a constant level of metoclopramide HCl in plasma could be maintained for up to 20 h at a suitable concentration for antiemetic activity. An appropriate combination of excipients made it possible to obtain orally disintegrating sustained release tablets of metoclopramide HCl using simple and conventional techniques.

Endoscopic ultrasound guided gallbladder drainage by using Lumen apposing metal stent for acute cholecystitis: systematic review

Deepanshu Jain,Bharat Singh Bhandari,Nikhil Agrawal,Shashideep Singhal 대한소화기내시경학회 2018 Clinical Endoscopy Vol.51 No.5

Surgery remains the standard treatment for acute cholecystitis except in high-risk candidates where percutaneous transhepatic gallbladderdrainage (PT-GBD), endoscopic transpapillary cystic duct stenting (ET-CDS), and endoscopic ultrasound-guided gallbladder drainage(EUS-GBD) are potential choices. PT-GBD is contraindicated in patients with coagulopathy or ascites and is not preferred by patientsowing to aesthetic reasons. ET-CDS is successful only if the cystic duct can be visualized and cannulated. For 189 patients whounderwent EUS-GBD via insertion of a lumen-apposing metal stent (LAMS), the composite technical success rate was 95.2%, which increasedto 96.8% when LAMS was combined with co-axial self-expandable metal stent (SEMS). The composite clinical success rate was96.7%. We observed a small risk of recurrent cholecystitis (5.1%), gastrointestinal bleeding (2.6%) and stent migration (1.1%). Cauteryenhanced LAMS significantly decreases the stent deployment time compared to non-cautery enhanced LAMS. Prophylactic placementof a pigtail stent or SEMS through the LAMS avoids re-interventions, particularly in patients, where it is intended to remain in situ indefinitely. Limited evidence suggests that the effcacy of EUS-GBD via LAMS is comparable to that of PT-GBD with the former showingbetter results in postoperative pain, length of hospitalization, and need for antibiotics. EUS-GBD via LAMS is a safe and effcaciousoption when performed by experts.

Demographic Trends in Paddle Lead Spinal Cord Stimulator Placement: Private Insurance and Medicare Beneficiaries

Lawal Labaran,Joshua Bell,Varun Puvanesarajah,Nikhil Jain,Jomar N. Aryee,Micheal Raad,Amit Jain,Jonathan Carmouche,Hamid Hassanzadeh 대한척추신경외과학회 2020 Neurospine Vol.17 No.2

Objective: Although spinal cord stimulators (SCS) continue to gain acceptance as a viable nonpharmacologic option for the treatment of chronic back pain, recent trends are not well established. The aim of this study was to evaluate recent overall demographic and regional trends in paddle lead SCS placement and to determine if differences in trends exist between private-payer and Medicare beneficiaries. Methods: A retrospective review of Medicare and private-payer insurance records from 2007–2014 was performed to identify patients who underwent a primary paddle lead SCS placement via a laminectomy (CPT-63655). Each study cohort was queried to determine the annual rate of SCS placements and demographic characteristics. Yearly SCS implanta�tion rates within the study cohorts were adjusted per 100,000 beneficiaries. A chi-square analysis was used to compare changes in annual rates. Results: A total of 31,352 Medicare and 2,935 private-payer patients were identified from 2007 to 2014. Paddle lead SCS placements ranged from 5.9 to 17.5 (p<0.001), 1.9 to 5.9 (p<0.001), and 5.2 to 14.5 (p<0.001) placements per 100,000 Medicare, private-payer, and overall beneficiaries respectively from 2007 to 2014. SCS placements peaked in 2013 with 19.6, 7.1, and 16.8 placements per 100,000 Medicare, private-payer, and overall patients. Conclusion: There was an overall increase in the annual rate of SCS placements from 2007 to 2014. Paddle lead SCS placements peaked in 2013 for Medicare, private-payer, and over�all beneficiaries. The highest incidence of implantation was in the Southern region of the United States and among females. Yearly adjusted rates of SCSs were higher among Medi�care patients at all time points.

Opioids and Spinal Cord Stimulators: Pre- and Postoperative Opioid Use Patterns and Predictors of Prolonged Postoperative Opioid Use

Lawal Labaran,Jomar N.A. Aryee,Joshua Bell,Nikhil Jain,Varun Puvanesarajah,Michael Raad,Amit Jain,Jonathan Carmouche,Hamid Hassanzadeh 대한척추신경외과학회 2020 Neurospine Vol.17 No.1

Objective: The aim of the study was to compare trends and differences in preoperative and prolonged postoperative opioid use following spinal cord stimulator (SCS) implantation and to determine factors associated with prolonged postoperative opioid use. Methods: A database of private-payer insurance records was queried to identify patients who underwent a primary paddle lead SCS placement via a laminectomy (CPT-C3655) from 2008–2015. Our resulting cohort was stratified into those with prolonged postoperative opioid use, opioid use between 3- and 6-month postoperation, and those without. Multivariate logistic regression was used to determine the effect preoperative opioid use and other factors of interest had on prolonged postoperative opioid use. Subgroup analysis was performed on preoperative opioid users to further quantify the effect of differing magnitudes of preoperative opioid use. Results: A total of 2,374 patients who underwent SCS placement were identified. Of all patients, 1,890 patients (79.6%) were identified as having prolonged narcotic use. Annual rates of preoperative (p=0.023) and prolonged postoperative narcotic use (p<0.001) decreased over the study period. Significant independent predictors of prolonged postoperative opioid use were age <65 years (odds ratio [OR], 1.52; p=0.004), male sex (OR, 1.33; p=0.037), preoperative anxiolytic (OR, 1.55; p=0.004) and muscle relaxant (OR, 1.42; p=0.033), and narcotic use (OR, 15.04; p<0.001). Increased number of preoperative narcotic prescriptions correlated with increased odds of prolonged postoperative use. Conclusion: Patients with greater number of preoperative opioid prescriptions may not attain the same benefit from SCSs as patients with less opioid use. The most significant predictor of prolonged narcotic use was preoperative opioid use.

Is Teriparatide Superior in Treating Osteoporotic Vertebral Compression Fractures in Comparison to Bisphosphonates Treatment Alone: A 2-Year Retrospective Analysis

Nair Vishnu Vikraman,Kundnani Vishal G.,Shetty Abhijith,Anand Manikant,Jain Mukul,Dewnany Nikhil 대한척추외과학회 2023 Asian Spine Journal Vol.17 No.6

Study Design: Retrospective cohort study.Purpose: This study aimed to compare the efficacy of bisphosphonates and teriparatide in the management of osteoporotic vertebral compression fractures with regard to pain management, prevention of nonunion, and radiological as well as clinical outcomes.Overview of Literature: Osteoporosis refers to a skeletal disorder characterized by decreased bone strength caused by poor bone density and quality causing fragility, resulting in long periods of pain-related immobilization.Methods: In a 24-month follow-up retrospective study, 191 patients with osteoporotic vertebral compression fractures were randomly assigned to the bisphosphonate group (n=104) or the teriparatide group (n=87), with patients opting for their treatment between January 2016 and October 2020. Demographic data and patient-reported outcomes scores, including the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), union rates, and kyphosis progression, were assessed at baseline, 6 months, 1 year, and 2 years after treatment.Results: Both groups had a significant decrease in VAS, from 8.38±0.74 to 3.15±1.40 in the bisphosphonate group and from 8.49±0.73 to 1.11±0.31 in the teriparatide group. The ODI scores reduced significantly at 2-year follow-ups, recording 25.02±13.94 and 15.11±2.17 in the bisphosphonate and teriparatide groups, respectively. Risks of nonunion development were slightly higher at 11.53% in the bisphosphonate group and 8.63% in the teriparatide group required operative intervention. The kyphosis progression angles were also significantly lower in the teriparatide group (4.97°±0.78°) than in the bisphosphonate group (8.09°±1.25°).Conclusions: Over time, numerous studies have demonstrated the efficacy of bisphosphonates and teriparatide in ameliorating pain. In this study, the efficacy of teriparatide surpassed that of bisphosphonates in certain aspects, such as the initial 6-month union rates and reduction in the progression of segmental kyphosis. However, bisphosphonates and teriparatide yield similar and favorable union rates at 1 year and final follow-up.