Open Access Study Protocol

A Phase II Open-Label Multi-center Trial of Isotoxic Hypofractionated Radiotherapy for NSCLC

Chunmei Liu, Qiang Lin, Huandi Zhou, Xiaohui Ge, Chaoxing Liu, Dongxue Gao, Yufeng Zhang, Xiaoying Xue

Journal of Pharmaceutical Research International, Page 1-11
DOI: 10.9734/jpri/2022/v34i32A36102

Background: The standard treatment for advanced unresectable non-small cell lung cancer (NSCLC) is concurrent chemoradiotherapy. However, many poor Karnofsky score or elderly patients cannot tolerate it due to heir serious side effects. For patients who cannot tolerate concurrent chemoradiotherapy, conventional treatment is sequential chemoradiotherapy or radiotherapy alone. But the median survival time of sequential chemoradiotherapy and radiotherapy alone is 11-16 months. In order to improve curative effect, radiotherapy, as an important treatment method, has been tried, innovated and improved continuously. The goal of this trial is to evaluate feasibility and safety of isotoxic hypofractionated radiotherapy in patients with NSCLC.

Methods: This is a phase Ⅱ open-label multi-center two-step non-randomised Trial. In the first stage, 12 patients will be included in the trial with radiotherapy of 3Gy per fraction. If more than 3 patients have serious side effects of radiotherapy, the trial will be terminated. Otherwise, the second phase will continue, and the total number of participants will be 30. All patients eventually will be followed up for 5 years.

The primary endpoint is the safety of isotoxic hypofractionated radiotherapy. The secondary outcomes are time to progression (TTP), progression free survival (PFS), overall survival (OS), local control (LC).

Discussion: In clinical practice, the local control rate of conventional fractionated radiotherapy for NSCLC is very low. We hope that this trial can verify the safety of isotoxic hypofractionated radiotherapy.

Trial Registration: NCT03606291, REGISTERED JULY, 30, 2018.

Open Access Original Research Article

Etravirine Lipid Nanoparticles: Development and Validation Using Specific RP-HPLC Technique

Kunal Badrinarayan Banode, Veena Shailendra Belgamwar, Suchitra Shitla Mishra

Journal of Pharmaceutical Research International, Page 12-21
DOI: 10.9734/jpri/2022/v34i32A36103

Introduction: A common, exact & economical reverse phase-high performance liquid chromatographic approach for coinciding measurement of anti-retroviral medicine, Etravirine in the formulation of nanoparticle has been devised. This approach is a revolutionary analytical methodology for detecting substance at the same time.

Methods: Validation & optimization chromatographic conditions were completed as per the guidelines of ICH. The disconnection was done on a column measuring (150mm x 4.6mm, 5μ) using the mobile phase consisted of acetonitrile and 10mM ammonium acetate buffer in the ratio of 90:10 v/v of pH 2.7 as the mobile phase in the ratio 85:15 at a flow rate of 1ml/min for a short run time of 13 minutes. The wavelength was 310nm & the column temperature was kept at 26°C.

Results: The devised technique was linear at 10, 20, 30, 40, as well as 50 g/ml, with a regression coefficient of 0.999 for each of these concentrations. For etravirine, the LOD readings were 0.514 g/ml, whereas the LOQ readings were 1.713 g/ml. Etravirine was shown to have a recovery rate of 98.8%.

Conclusion: The approach was, precise, accurate & rapid with excellent inter- & intra-day accuracy. The approach was also useful for characterization & coinciding measurement of medicines in formulation of nanoparticles.

Open Access Original Research Article

Quality Assessment of Extemporaneously Compounded Carvedilol Oral Suspension for Pediatric Patients at the Hospital Pharmacy

Iman M. Alfagih, Alanood Almurshedi, Basmah Aldosari, Bushra Al Quadeib, Enas Zakaria, Eram Eltahir, Khadijh Alnakhli

Journal of Pharmaceutical Research International, Page 22-31
DOI: 10.9734/jpri/2022/v34i32A36104

Aims: The aim of this study was to evaluate different quality control parameters and the stability of the carvedilol compounded extemporaneous suspensions over three months at room temperature.

Methodology: The carvedilol compounded extemporaneous suspensions were prepared in our lab in a manner consistent with how they are prepared for pediatric patients at the hospital pharmacy. The suspensions were stored at room temperature and analyzed immediately and at 1, 2 and 3 months. Suspensions were monitored for changes in organoleptic properties, pH, particle size, zeta potential, viscosity, sedimentation volume, drug content and drug dissolution.

Results: The results demonstrated that the carvedilol compounding protocol used in this study was reliable and able to prepare 1.67 mg/mL of carvedilol suspension by using carvedilol commercially available tablets and Ora-blend as a suspending vehicle. Also, the extemporaneously compounded suspension maintained acceptable quality attributes when stored for three months at room temperature.

Conclusion: The extemporaneously compounded suspension enables pediatricians to administer a variable dose, which adapts to every patient’s needs, and gives the possibility of treatment when the liquid dosage form is not available.

Open Access Original Research Article

Evaluation of the Effectiveness of the Use of “Hepa-Merz” in Burn Disease

B. M. Shakirov, R. R. Muradova, M. M. Haydarov

Journal of Pharmaceutical Research International, Page 32-36
DOI: 10.9734/jpri/2022/v34i32A36105

Introduction: A burn affects the structure and function of almost every organ including the liver.

Material and Methods: This study received approval from Samarkand Centre of Emergency Medical Care (RCSUMA), Uzbekistan. The research program included complex treatment and examination of 82 patients with IIIAB-IV (deep burns) degree burns from 30% to 60% of the body surface and included: a general clinical and instrumental examination, biochemical and clinical blood tests.

Results: The results of the study showed the effectiveness of the use of Hepa-Merz in the complex treatment of severely burned patients. Conclusions: The use of Hepa-Merz allows to enhance the targeted therapeutic effect on the functional and morphological state of the liver and is indicated for the prevention and treatment of post-burn intoxication hepatitis.

Open Access Original Research Article

Knowledge, Attitudes, and Practices Regarding Ocular Manifestations of COVID 19 among Students in a Medical College in Saudi Arabia- A Cross Sectional Study

Bayan S. Alshuhayb, Abdullah F. Alwadani, Kaberi Biswas, Aqeel Y. Alhumaid, Norah S. Alshuhayb, Ali R. Bushajea

Journal of Pharmaceutical Research International, Page 37-47
DOI: 10.9734/jpri/2022/v34i32A36106

Background: The coronavirus pandemic has forced governments of different countries to implement measures to control the spread of the virus and improve health awareness. Medical students are thought to have a significant role in public health promotion. Although there are studies assessing the level of knowledge of COVID-19 among medical students, there are very few assessing the level of knowledge about the ocular manifestations of COVID-19. Therefore, this study aims to assess the level of knowledge, attitudes, and practices regarding the ocular manifestations of COVID-19 among medical students a medical college in Saudi Arabia.

Methods: An online, questionnaire based cross sectional study was conducted to assess the knowledge, attitudes, and practices regarding the ocular manifestations of COVID 19 among medical students.

Results: The level of knowledge about COVID-19 was adequate. However, there was a deficient knowledge regarding some aspects of ophthalmological involvement in coronavirus disease. Female students and those of higher academic years demonstrated significantly higher knowledge. Attitudes and practices regarding prevention of infection and personal protective measures were satisfactory. The main source of information about COVID-19 was social media and internet.

Conclusions: This is probably the first study investigating the ophthalmological knowledge of COVID-19 among medical students in this region. The level of knowledge about COVID-19 was adequate but knowledge about some ophthalmological aspects was insufficient. Students had adequate knowledge about COVID prevention and personal protective measures. It is suggested to include knowledge of COVID-19 in the curriculum to fill gaps in the knowledge, especially in the preclinical years. Seminars and training programmes could also add to the same.

Open Access Original Research Article

The Impact of Maturity on Role of Head and Eye on Ocular Motions to Intersection Scanning Conduct

Ateeq Rehman, Maqbool Ahmed Jamali, Nisar Ahmed Jandan, Muhammad Ashfaque Abbasi, Abbas Ali Ghoto, Arslan Ahmer

Journal of Pharmaceutical Research International, Page 48-53
DOI: 10.9734/jpri/2022/v34i32A36107

Objectives: The Objectives of researchers of this study are to find out if there was a relationship between age and the input of head and hand actions on scanning conduct at crossings. Impending junctions necessitates scanning a broad region, which necessitates big lateral head turns and eye movements.

Methodology: We selected 53 participants in two age sets: 27 older (14 females and 19 males; 62-82 years) and 25 youngers (11 females and 14 males; 23-42 years) with visual acuity that fulfilled MA driver's license standards (minimum 21/41 modified or unmodified). Randomized control data, as well as vehicle position, speed, and heading, and info regarding other programmed automobiles, remained gathered at a rate of 32 cycles per second (rpm). With the help of a six-camera remote digital authentication scheme operating at 60 Hz, data on head and eye movements were acquired. This research was conducted at People Medical College Hospital, Nawabshah from April 2020 to March 2021.

Results: When driving in a simulator, 29 drivers over the age of 28 were monitored to see how their eyes and heads moved as they drove. It was determined that there were two types of scans for each of the city's 19 four-way intersections: eye-only scans (which contained only eye actions) and head-plus-eye scans (head and eye movements). Experienced drivers' head-eye scans (47.7% vs. 55%), as well as eye-only scans, were lower than expected (9.3 percent vs. 11.2 percent). In head-eye scans, skilled drivers showed the lower head and visual attention percentage compared to younger drivers. Among senior drivers, more eye-only scans (7 vs. 6) were performed, even though there were lesser head-eye scans (just 2). If you look at all-gaze scans, you won't see any ageing effects. According to our results, eye and head motions have a significant influence in development of cognitive deficits. Our findings show that eye and head motions both contribute to age-related impairments in intersection scanning, emphasizing the necessity of evaluating both eye and head movements.

Conclusion: To evaluate head motions, and to highlight the necessity for training programmed for senior drivers this can emphasize before approaching the junction.

Open Access Original Research Article

Inflammatory Markers and the Metabolic Syndrome in Pakistan

Kinza Zafar, Hafiza Maryam Mushtaq, Zaryab Ali

Journal of Pharmaceutical Research International, Page 54-58
DOI: 10.9734/jpri/2022/v34i32A36108

The metabolic disorder has been conceptualized as a bunching of metabolic syndrome, including insulin obstruction, dyslipidemia, focal adiposity, and raised circulatory strain (BP) that increment risk for cardiovascular infection (CVD) and type 2 diabetes. The main objective of the study is to analyse the relationship between inflammatory markers and the metabolic syndrome In Pakistani population. This descriptive study was conducted in DHQ Hafizabad during July 2021 to December 2021. This study was finished with the consent of moral board of emergency clinic. The information was gathered from 150 patients of the two sexual orientations. The information was gathered from 150 patients from which 50 females and 100 males. In the second gathering C-receptive protein is higher than in the principal bunch with measurable importance (p = 0.02). Leukocytes have a less significant worth in laying out proinflammatory and cardiovascular gamble commitment in patients with metabolic disorder contrasted and C-responsive protein. It is presumed that corpulence is the principle element of metabolic condition. Patients determined to have metabolic condition present an enacted fiery status. Provocative disorder is communicated by the quantity of metabolic condition parts.

Open Access Original Research Article

Effects of Low Level Laser Therapy Vs Ultrasound Therapy in the Management of Active Trapezius Trigger Points

Abin Abraham Mammen, Deepak S Hegde, K. U. Dhanesh Kumar

Journal of Pharmaceutical Research International, Page 59-70
DOI: 10.9734/jpri/2022/v34i32A36109

Background: Trigger point is a extremely irritable local spot of exquisite tenderness in the nodule within the tangible taut muscle band. The prevalence studies have shown that the occurrence of myofascial trigger point in the general population.

Objective: The aim of the study was compare the effects of low level laser therapy( LLLT) Vs ultrasound therapy in the management of active trapezius trigger point.

Methodology: The participants will be allocated into two groups using simple random sampling. One group has to be given Low level laser therapy (LLLT) and Moist Heat and other group treated with US and Moist Heat. Both group receive treatment for 3 times a week. Total number of 9 session has to be given in 21 days. The outcome measure has to be taken at the first day and end of the day. 

Conclusion: Based on the above results we conclude that Low Level Laser Therapy can be used as a therapeutic device in the management of Active Trapezius Trigger points.