Open Access Short Research Article

Pediatric Dentistry and Oral Health Features of Children with Certain Genetic Diseases

Uliana Aleksandrovna Khvalevich, Anastasiia Denisovna Planova, Yuri Dorofeev, David Robertovich Pogosyan, Seda Beslanovna Bamatgiriyeva, Vitaly V. Goncharov

Journal of Pharmaceutical Research International, Page 199-205
DOI: 10.9734/jpri/2021/v33i28B31554

Pediatric dentistry provides primary and comprehensive preventive and therapeutic dental care for infants and children in adolescence, as well as provides special medical needs. This specialty includes many skills, disciplines, procedures, and techniques that share a common origin with other dental specialties, but they have been modified and reformed to meet the special requirements of infants, children, adolescents, and special medical needs. However, pediatric dentistry is mainly focused on healthy children, while quite often there are cases when such assistance is required for children with congenital genetic diseases. The prevalence of rare diseases is approximately 65 cases per 100,000 people. This estimate reflects the existence of 7,000 different types of rare diseases, most of which are genetic in nature. Rare diseases of genetic origin are often associated with other comorbidities, which are often characterized by debilitating and chronically degenerative conditions associated with phenotypes. Patients with rare diseases may sometimes exhibit challenging behaviors and often experience physical, mental, and sensory impairments that can affect functioning and participation in daily life. The purpose of the work is to consider the features of pediatric dentistry and the features of oral health of children with certain genetic diseases.

Open Access Original Research Article

Respiratory Morbidity in Neonates at or Near-Term in Relation to Mode of Delivery - A Retrospective Observational Study

Fouzia Rasool Memon, Asma Naz, Nusrat Fozia Pathan, Shahida Baloch, Ameer Ali Jamali, Fareeda Wagan, Arslan Ahmer

Journal of Pharmaceutical Research International, Page 1-6
DOI: 10.9734/jpri/2021/v33i28B31530

Introduction: Antenatal corticosteroids are recommended by Royal College of Obstetrics and Gynaecology for caesarean section planned before thirty-eight plus six weeks gestation. However, these steroids are, not suggested for labour induced electively after thirty four weeks.

Objective: This study’s aim is to enumerate the possibility of respiratory morbidity in neonates for various deliberated approaches of delivery between thirty-five and thirty eight weeks gestation.

Methodology: This study was carried out during June 2018 and December 2020 at a tertiary obstetric unit and analysed 3796 neonates delivered between thirty-five and thirty eight weeks gestation for neonatal admission due to respiratory morbidity.

Results: The risk for respiratory problems in spontaneous labour was 9.9% (16/161), 5.0% (12/238), 1.2% (5/426) and 0.64% (6/930) at thirty five, thirty six, thirty seven and thirty eight weeks of gestation respectively. For induced labour, it was 25% (4/16), 4.8% (5/104), 4.1% (13/318) and 0.82% (4/485) at thirty-five, thirty six, thirty seven and thirty eight weeks respectively. While the risk of respiratory morbidity in elective caesarean section, was 13.8% (4/29), 27.1% (13/48), 4.1% (5/122) and 2.8% (9/318) at thirty-five, thirty six, thirty seven and thirty eight weeks respectively. Overall chance of respiratory morbidity in neonates was 6% after elective caesarean section, 2.8% after labour induction and 2.2% after spontaneous labour (p< 0.0001). The number of neonates with respiratory problems born by elective C-section was only 31 out of total 132 (23.5%). Whereas this risk was 2.8% at 35-38 weeks and 5.0% at 35-37 weeks after induced labour.

Conclusion: Elective delivery at 35-38 weeks is linked to respiratory morbidity in new born babies. More research is required to assess the role of prophylactic corticosteroids preceding elective induction of labour.

Open Access Original Research Article

Topical Delivery of Apremilast Loaded Nanostructured Lipid Carrier Based Hydrogel for Psoriasis Therapy

S. M. Sindhoor, Marina Koland

Journal of Pharmaceutical Research International, Page 7-20
DOI: 10.9734/jpri/2021/v33i28B31531

Background: Apremilast (APR) is an orally administered selective phosphodiesterase 4 inhibitor approved to treat plaque psoriasis and psoriatic arthritis and is available as an oral tablet formulation. However, its systemic side effects limit its application. The low solubility and permeability of apremilast make it difficult to administer it through the skin. Hence an attempt is made to incorporate apremilast into a suitable nanocarrier to facilitate its topical delivery.

Aims: To formulate and characterize Apremilast loaded nanostructured lipid carriers for the management of psoriasis to reduce the systemic side effects.

Methodology: Apremilast loaded Nanostructured Lipid carriers (NLC) were prepared by melt emulsification accompanied by probe sonication. The formulation was prepared using GMS, Sefsol 218, Tween 80 and Transcutol P as Solid Lipid, Liquid lipid, Surfactant and Penetration Enhancer. The NLC was incorporated into carbapol 934 dispersion to convert it into a gel. The NLC formulation was evaluated for size, Polydispersity Index, Zeta Potential, Entrapment efficiency,  Transmission Electron Microscopy. After that, the NLC gel was examined for Spreadability, Extrudabilty, Viscosity, In vitro drug release, Ex vivo permeation, Skin deposition and In vivo studies.

Results: The formulated Apremilast loaded showed particle size of less than 200 nm (i.e.170.32nm) with a narrow PDI of 0.267. Entrapment efficiency revealed that 89.26±01.22% of the drug was entrapped. Transmission electron microscopy images confirmed the spherical nature of the nanocarrier. The extended-release pattern of the formulated NLC for 24h was observed in the in vitro release studies and followed the Higuchi model(R2=0.9966). Ex vivo permeability showed a 6.14 fold increase in permeability and 74.05±0.25% deposition of apremilast loaded NLC gel compared to apremilast gel. The formulation was stable for three months without significant changes. In vivo skin studies showed that the prepared NLC did not have any skin irritation potential. The antipsoriatic activity demonstrated by the Apremilast loaded NLC gel in the imiquimod induced psoriasis model in mice was comparable to the standard treatment.

Conclusion: Apremilast loaded NLC demonstrated enhanced permeation, improved skin retention and extended-release compared to conventional gel. The developed formulation can be an alternative for psoriasis therapy after clinical trials in the future.

Open Access Original Research Article

Risk Factors during Pregnancy for Asymptomatic Bacteriuria

Sikander Ali Sial, Amir Bux Detho, Fouzia Rasool Memon, Kousar Parveen, Shabana Memon, Sadia Bukhari, Arslan Ahmer

Journal of Pharmaceutical Research International, Page 21-26
DOI: 10.9734/jpri/2021/v33i28B31532

Introduction: Asymptomatic bacteriuria in pregnancy (ABU) is poorly understood and neglected in developing countries. It causes certain lethal maternal and fetal consequences if left untreated including low weighted births, premature delivery, full-blown urinary tract infection and pyelonephritis.

Objective: Our aim was to explore such factors having bad impact on pregnancy associated with asymptomatic bacteriuria and aware our community about these unspoken perils so that ABU likelihood may be reduced. Prevalence varies country to country. Developing and low economic countries are suffered more than developed so thereby upgrading and providing basic amenities of life the risk factors may be reduced.

Materials and Methods: This was a cross sectional study carried out in department of pathology PUMHSW. Sample size was 377, all selected were 18 years and above. All urinary samples were collected in sterile container and labeled and immediately transported to microbiology laboratory. Dipstick test, wet mount microscopy and Gram's staining were done. Blood, MacConkey's agar was inoculated and streaked with inoculi. Data were analyzed using SPSS version 23.

Results:  Samples found unlabeled (02) and contaminated (03) were dropped from study. A total of 372 were study samples. The most of patients were Gram negative 65(90.20%) predominantly Enterobacteriocae. When cultured, 72 were found growth positive (mixed plus pure) while 300 were negative. Risk factors were assayed in culture positive patients (ABU). A large number of patients (74%) belonged to lower economic class. Most common age group varied from 26-30 years (43%). Third trimester was the most common found in 37 patients ((49.3%). Gravid (G3 or more) were strong risk factors and were 55(73.3%).  Most of patients were illiterate 65 (90.27%). The past history of UTI was a significant risk 46(63.88%) while anemia was found statistically insignificant 17(23.61).

Conclusion: Asymptomatic bacteriuria is frequent in pregnant females and significantly increased when compounded by past history of UTI and low socioeconomic status. Therefore, it is necessary for mothers to be screened for ABU. There is a need of rapid and reliable screening methods so that upcoming disease burden can be reduced.

Open Access Original Research Article

Postoperative Complications of Conventional Polypectomy Versus Endoscopic Sinus Surgery

Arsalan Ahmed Shaikh, Mona Liza Mahesar, Noman Ahmed, Sajjad Yousuf, Akhtar Ali Lakhiar, Farhan Ahmed Shaikh

Journal of Pharmaceutical Research International, Page 27-32
DOI: 10.9734/jpri/2021/v33i28B31533

Objective: To compare the postoperative complications of conventional polypectomy versus Endoscopic sinus surgery.

Study Design: This is cross sectional study.

Setting: Study carried out at E.N.T department, Tertiary care hospital from April 2019 - March 2020.

Materials & Methods:  52 out of which 32 were male and 20 were female. Benign nasal polyps within 14 yrs to 80 years from emergency and out- patient department both were included in our study. Only recurrent and neoplastic lesions were not inclusive of this study. Postoperatively the patient was prescribed with oral antibiotics, nasal decongestants and nasal douche with normal saline, followed by local steroids after 1.5 months. The post operative evaluation (both endoscopic and clinical) was done at 2 weeks, 6 weeks and 3 months post operatively and data was recorded. Statistical package for social sciences (SPSS) software version 20.0.

Results:  A total of 52 patients were recruited for the study with age ranging from 18 to 40 years.  The mean age was 24.65± SD 4.12. There were 32 (61.53%) males and 20 (38.46%) female patients. Two weeks were observed postoperative complications. The intranasal complications after simple intranasal polypectomy i.e. bleeding (SIP 8(30.76%) Versus ESS 5(19.23%)), crusting (SIP 10(38.46%) Versus ESS 6(23.07%)), Synechiae formation (SIP 3(11.53%) Versus ESS 1(3.84%)), recurrence 0% were observed. At upto 6th weeks observed the intranasal complications after simple intranasal polypectomy i.e. bleeding (SIP 5(19.23%) Versus ESS 2(7.69%)), crusting (SIP 6(23.07%) Versus ESS 2(7.69%)), Synechiae formation (SIP 2(7.69%) Versus ESS 1(3.84%)), recurrence 0% were observed. Three months were observed the intranasal complications after simple intranasal polypectomy i.e. bleeding (SIP 1(3.84%) Versus ESS 0%), crusting (SIP 0% Versus ESS 0%), Synechiae formation (SIP 4(15.38%) Versus ESS 3(11.53%)), recurrence 3(11.53%) were observed only in simple intranasal polypectomy group. While the intraorbital and intracranial complications were not observed. 

Conclusion: We would like to conclude our study in favor of ESS to be superior to other intranasal polypectomy procedures in terms of post operative complications.

Open Access Original Research Article

Estimation of Alanine Transaminase (ALT), Alkaline Phosphate (ALP) and Aspartate (AST) Irrespective of Dietary Supplementation, Body Mass Index and Nature of Exercise

Alamgir Khan, Muhammad Zafar Iqbal Butt, Abdul Manan, Ejaz Asghar, Muhammad Jamil, Samiullah Khan

Journal of Pharmaceutical Research International, Page 33-44
DOI: 10.9734/jpri/2021/v33i28B31536

Purpose: This research study was conducted for the assessment of liver enzymes i.e. Alanine Transaminase (ALT), Alkaline Phosphate (ALP) and Aspartate (AST) irrespective of dietary supplementation, body mass index and nature of the exercise.

Methods: A randomized control trails were taken and thus Sixty (60) subjects ageing 20 to 30 years, (Twenty (20) from low-intensity exercise (EXG-II), Twenty (20) from high-intensity exercise (EXG-III) and Twenty (20) subjects as a control group (CG-III) were included in the study by using International Physical Activity Scale (IPAQ).5ml blood samples were collected from the subjects for the determination of liver functions and blood redox status. Each blood sample was marked with a separate identification mark. After the collection of blood samples, three particular liver enzymes tests i.e. ALT, ALP and AST were performed. The results of the samples test proceeded through the Statistical Package for Social Science (SPSS) Version 23.

Results: The P-Value of the low-intensity exercise group (EXG-II) in term of ALT was less than the high-intensity exercise group ( EXG-III) ( p >.05), The P-Value of the low-intensity exercise group (EXG-II) in term of ALP was less than the high-intensity exercise group ( EXG-III) ( p >.05). The P-Value of low-intensity exercise group (EXG-II) in term of AST was less than high-intensity exercise group (EXG-III) (p >.05).

Conclusion: Based on findings, it was concluded that low-intensity exercise with dietary supplementation positively affects the functions of the liver i.e. Alanine Transaminase (ALT), Alkaline Phosphate (ALP) and Aspartate (AST) as compared to high-intensity exercise. Similarly high-intensity exercise with dietary supplementation also positively influence as compared to performers of high-intensity exercise without dietary supplementation.

Open Access Original Research Article

A Randomized Control Trails for the Assessment of Impact of Moderate Intensity Exercise on Blood Serum Creatinine Concentration among the Male Athletes

Mohibullah Khan, Alamgir Khan, Muhammad Zafar Iqbal Butt, Badar Mohy ud Din, Abdul Manan, Shareen Bhatti, Fakiha Wadiat, Muhammad Jamil

Journal of Pharmaceutical Research International, Page 45-51
DOI: 10.9734/jpri/2021/v33i28B31537

Purpose: The main purpose of the study was to examine the impact of moderate intensity exercise on blood serum creatinine concentration among the male.

Method & Materials: A randomized control trails were conducted for purpose to evaluate the effects of moderate intensity exercise on creatinine level among the subjects (Experimental Group (EG) = 10, Control group (CG). A written informed consent from all the subjects and ethical approval was taken from Gomal University Ethical Review Committee before initiating the study protocols. 5ml blood were taken from all the subjects and each blood sample was marked with separate identification code. Twelve weeks exercise (moderate intensity exercise) protocols was employed on the selected subjects. The collected blood samples were tested and thus the collected results were processed through Statistical Package for Social Sciences (SPSS, Version, 24) by applying Mean and Standard deviation etc.

Results & Conclusion: On the basis of analysis, the researcher concluded that inferentially there is no significant effect of moderate intensity exercise on BMI and Creatinine of the subjects but descriptively the experimental group shows better results in BMI and Creatinine (after the treatment)

Open Access Original Research Article

Assessing the Medication Adherence of Metabolic Disorders in South India

P. Aravinda Swami, R. T. Saravana Kumar, S. Manohar Babu

Journal of Pharmaceutical Research International, Page 52-59
DOI: 10.9734/jpri/2021/v33i28B31538

Aim: The study's main objective was to assess patients' adherence towards treatment and daily practices among Hypertension (HT), Diabetes Mellitus (DM) Type II and hypothyroid participants in South India before and after providing counseling and education based on WHO                      standards.

Study Design: The present study is a prospective open-labeled observational study.

Place and Duration of the Study: The present study was conducted in Vijayawada, South India for six months.

Methodology: A total of 490 participants with Hypertension, Diabetes Mellitus (Type II) and Hypothyroidism were assessed for adherence based on the Morisky medication adherence scale containing 8 points at the starting of the study and 6 months after providing counseling and education.

Results: At the initial point of study, only 12% of the Hypertensive group, 17% of Diabetes Mellitus (Type II) and 15% Hypothyroid group have high adherence. Towards the completion of the study, around 41% in the Hypertensive group, 50% of Diabetes Mellitus (Type II) and 60% Hypothyroid group had high adherence.

Conclusion: The adherence was low at the initial point of the study among all the three groups. After counseling and education provided through the World Health Organization (WHO) specified criteria, we have seen a good increase in the adherence, measured with the MMAS-8 scale. Greater efforts should be made in educating and counseling the patients suffering from such chronic illnesses to improve their quality of life.

Open Access Original Research Article

Awareness of Retinopathy among Sickle Cell Patients

Shahad Alruwaili, Yasser Aleliwi, Shahd Al Mahfud, Mohammad Alshehri, Hamad Al Ghathber, Abdullah Alamri

Journal of Pharmaceutical Research International, Page 73-80
DOI: 10.9734/jpri/2021/v33i28B31540

Background: Sickle cell disease (SCD) is a haemoglobinopathy that is inherited in an autosomal recessive pattern. Retinopathy is a complication of SCD, which varies from mild peripheral retinopathy to severe proliferative retinopathy that can cause loss of vision.

Methods: A cross-sectional study was conducted from June 2020 to January 2021 aiming to determine the knowledge of retinopathy among patients with sickle cell disease using a validated self-administered questionnaire.

Result: A total of 166 respondents completed the questionnaire. Females constituted the majority of participants (62.7%). The age group 31–40 years consitituted 28.3% and were associated with higher knowledge scores. The average knowledge score was also significantly higher in respondents from the Eastern region (B = 1.82, P < 0.05) compared to respondents from Riyadh. The main reason for not having an eye check was the perceived lack of importance of visits among 56.8%.

Conclusion: Sickle cell disease patients are prone to complications such as retinopathy which can be detected by frequent follow-up. Almost half of the studied sample showed above average knowledge of retinopathies related to sickle cell disease.

Open Access Original Research Article

Synthesis, Drug Likeness and In-vitro Screening of Some Novel Quinazolinone Derivatives for Anti-Obesity Activity

Pratik G. Modh, Laxman J. Patel

Journal of Pharmaceutical Research International, Page 81-92
DOI: 10.9734/jpri/2021/v33i28B31541

Aim: A series of novel quinazolinone derivates was synthesized and assessed for their ability to inhibitory action on pancreatic lipase. The cyclization of quinazolinone-4(3H)-one derivatives was achieved, whereas carbon-carbon cross coupling reactions were carried out on cyclized quinazolinone-4(3H)-one. This synthesis method afforded corresponding 2, 3 and 6 substituted quinazolin-4(3H)-ones (3a to 3m) with moderate to high yields.

Methods: Benzamide derivatives (1a-1b) were synthesized from anthranilic acid using acid-amine reaction, followed by cyclization using catalytic p-toluene sulfonic acid and oxidation using (diacetoxyiodo)benzene to give bromo substituted quinazolin-4(3H)-ones (2a-2b), which were cross coupled to suitable boronic acid using Suzuki-Miyaura condition to obtain desired compound (3a-3m). All synthesized compounds were characterized by FTIR, proton NMR, LC-MS analysis, checked for their drug likeness, absorption and evaluated for in vitro pancreatic lipase inhibition activity.

Results: Analytical interpretation of all compounds with infrared, proton NMR and LC-MS spectroscopy confirmed their correct structure. All compounds (3a-3m) show good absorption and have reasonably good molecular properties except 3c and 3m which violate two criteria for Lipinski’s rule. Whereas, Compounds 3l and 3m showed IC50 value of 13.13±0.84 µg/mL and 13.80±1.27 µg/mL respectively comparable to the Orlistat (12.72±0.97µg/mL), a US FDA approved drug for the treatment of obesity.

Conclusion: Pancreatic lipase is an important lipolytic enzyme, synthesized and secreted through pancreas, plays an important role in dietary trigycerol absorption and metabolism. Therefore, reducing fat absorption through pancreatic lipase inhibition is a promising strategy to treat obesity. Based upon our findings, compounds 3l and 3m can be further developed as potent anti-obesity agents.

Open Access Original Research Article

Comparative Study of Different Oral Iron Preparations in Females of Reproductive Age Group

Megha Tiwari, Vishal Dubey, Nikita Srivastava

Journal of Pharmaceutical Research International, Page 93-100
DOI: 10.9734/jpri/2021/v33i28B31542

Background: Anemia (anemia) is a decrease in the total amount of red blood cells (RBCs) or hemoglobin in the blood, or a lowered ability of the blood to carry oxygen. The commonness of iron inadequacy is high in all age bunch females. Around 32.4% of ladies have mellow iron deficiency, 14.19% ladies have direct sickliness, 2.2% have serious weakness.

Objective: The aim of the study is to compare the efficacy and safety profile of oral iron formulations in iron deficiency anemia.

Methods: A cross sectional study in patients with anemia receiving oral ferric ammonium citrate, folic acid, vitamin B12and iron hydroxide respectively was included. The patients were followed up once in 0 day, end of week, 1 month, for 3 months and observed for hematological improvement and adverse drug reactions (ADRs). Total 350 anemic patient were included in the study.

Results: The data analyzed in 185 patients received ferric ammonium citrate, folic acid, 165 received, iron hydroxide,folic acid, vitamin B12 have significantly improved mean hemoglobin and anemia indices at the end of study, however, there was no significant differences between the groups when compared. “All four formulations showed similar ADR profile, there was no significant difference in adverse reactions.’’

Conclusion: Ferric ammonium citrate can be considered as best cost-effective choice for treatment of irons deficiency anemia.

Open Access Original Research Article

Prevalence of First Diagnosed Atrial Fibrillation in Patients Admitted with Acute Coronary Syndrome and with Impaired Renal Function with and without Diabetes Mellitus

Nandlal Rathi, Muhammad Zaman Balouch, Shazia Kazi, Salman Ahmed, Abdul mueed, Abdul Ghani Shaikh

Journal of Pharmaceutical Research International, Page 123-128
DOI: 10.9734/jpri/2021/v33i28B31544

Objective: To determine the prevalence of first diagnosed atrial fibrillation in patients admitted with acute coronary syndrome and with impaired renal function with and without diabetes mellitus.

Methodology: A total of 434 patients were selected from two different hospitals, 361 from NICVD, Tando Muhammad Khan and 73 from Isra University Hospital, Hyderabad. Both males and females, aged between 18 years to 70 years, first ever presented & admitted with acute coronary syndrome (ACS) and renal impairment were included and whereas, patients with atrial fibrillation (AF) other than first diagnosed, previous history of myocardial infarction/coronary artery bypass grafting (CABG), known case of chronic kidney disease/on dialysis, history of cerebrovascular accident (CVA), patient with valvular heart disease, and pregnant women were excluded from this study. Baseline and clinical data was collected to determine the association with the prevalence of first diagnosed AF through chi-square test and a p value of <0.05 was considered as statistically significant.

Results: The mean age ± SD was 49.32±12.47 years. Among them majority were males 66.35% and rural residents 51.15% respectively. The most common risk factor observed in our study was presence of hypertension (N = 231, 53.22%) and among all ACS patients, most common type of ACS was unstable angina (N = 195, 44.93%). The overall prevalence of first diagnosed atrial fibrillation was 12.44% (N = 54) and the overall prevalence of diabetes mellitus was 39.63% (N = 172). Mean random blood sugar levels in diabetic patients was 203.32±105.60 mg/dL, hypertensive patients with DM (48.14%), and patients with STEMI with DM (12.96%) were significantly associated with increased prevalence of first diagnosed atrial fibrillation, p value <0.05.

Conclusion: Prevalence of first diagnosed AF is comparatively higher in our study because of the underlying renal impairment. Modifiable risk factor like uncontrolled blood sugar levels has significance association with first diagnosed AF.

Open Access Original Research Article

Efficacy of Treatment of Diabetic Macular Edema through Frequency-Doubled ND:YAG Laser (532NM) Green Laser

Zakaullah Gopang, Shabeer Ahmed Bhutto, Safder Ali Abbasi, Fayaz Ali Abbasi, Vijay Nagdev

Journal of Pharmaceutical Research International, Page 129-134
DOI: 10.9734/jpri/2021/v33i28B31545

Objective: To determine the efficacy of Frequency-doubled Nd: YAG laser (532 nm) green laser in treatment of diabetic macular edema

Study Design: This is a descriptive case series study.

Setting: Study carried out at Ophthalmology Department, Shaheed Mohtarma Benazir Bhutto Medical University Larkana, from 01-10-2019 to 31-03-2020 (06 months).

Materials and Methods: The patients with diabetic macular edema and were advised focal laser photocoagulation with help of frequency doubled Nd: YAG laser (532 nm) green laser. Improvement in visual acuity >2 lines after 3 months on snellen’s chart from the baseline was labeled as efficacy positive.

Results: The total of 150 patients were included to assess efficacy of frequency doubled Nd: YAG laser (532 nm) green laser in treating diabetic macular edema as a result improvement in visual acuity of 98 (65.33%) and no improvement or same vision in 52 (34.67%) patients was observed.

Conclusion: It is to be concluded that frequency doubled Nd: YAG laser (532 nm) green laser is an effective, useful and non-invasive diagnostic tool in treating diabetic macular edema.

Open Access Original Research Article

Effect of Katakakhadiradi Kashayam on Lipid Profile and Pancreatic Damage in Type II Diabetes Mellitus

Angelie Jessica Subbiah, M. Kavimani, Mukilan Ramadoss, Mudiganti Ram Krishna Rao, K. Prabhu

Journal of Pharmaceutical Research International, Page 135-141
DOI: 10.9734/jpri/2021/v33i28B31547

The lipid pattern and levels in diabetic patient are the same as those for subjects with cardiovascular disease. The tactic underlying the oral hypoglycemic agent is to adjust the lipid profile; which can be achieved by herbal therapy. The use of herbs and formulations for attenuation of hyperglycemia and to aid protection against the pancreatic damage is clinically very important. This study was intended to find the efficacy of Katakakhadiradi Kashayam(KKK)on lipid profile and pancreatic tissue damage in streptozotocin-nicotinamide (SN) induced diabetic rats. The diabetic rats were treated with Katakakhadiradi Kashyam orally at doses of 100, 200 and 300 mg/kg/bw. For 28 days and compared with the standard drug Glibenclamide. After the kashayam treatment triglyceride, HDL-cholesterol and total cholesterol level were assayed and pancreatic tissue damage caused by streptozotocin was analysed by histology study.Katakakhadiradi kashayam could restore the serum lipid profile by controlling the blood glucose level and reduce the pancreatic injury in diabetic rats. Supplementation of Katakakhadiradi kashayam showed a significant improvement in the serum lipid profile thus helping in retarding the secondary complications.

Open Access Original Research Article

Results of Anterior Cruciate Ligament Injuries by Arthroscopic Reconstruction Using Semitendinosus Tendon

Nuresh Kumar Valecha, Niaz Hussain Keerio, Masood Ahmed Qureshi, Syed Sajid Hussain, Hassan Amir us Saqlain, Ghazanfar Ali Shah, Syed Shahid Noor

Journal of Pharmaceutical Research International, Page 142-148
DOI: 10.9734/jpri/2021/v33i28B31548

Objectives: This study was designed to evaluate the surgical management of anterior cruciate ligament injuries by arthroscopic reconstruction using semitendinosus grafts.

Methodolgy: This study was conducted by Dibba Hospital Fujairah, United Arab Emirates from March 2017- to March 2020. A total of 40 patients were selected for this research.   In our study, we used arthroscopy assisted ACL reconstruction technique with single bundle quadrupled semitendinosus tendon autograft. This autograft was inserted from the ipsilateral limb with the help of endobutton femoral side of graft was fixed and with bioabsorbable screw tibial side of graft was stabilized. A single surgeon performed all the surgeries.

Results: In our observations, we reported that the majority of the patients had exposure of ACL injury in their middle adult age (32-38 years old) due to high engagement in physical activities (67.8%) like biking, playing sports and many others. The ratio of right knee injury site was comparatively high (53.5%) than the left one (46.4%).

Conclusion: From the results, we concluded that the younger age group is more prone to anterior Cruciate ligament injury. ACL reconstruction with Semitendinosus tendon autograft helps in maintaining knee movement and assist in early knee stability.

Open Access Original Research Article

Comparative Effects of Solvents on the Herbal Extraction of Antidiabetic Phytochemicals

Samuel C. Iwuji, Chidimma V. Ogbonna, Chinonye I. Iwu, Wilson C. Okafor, Emmanuel C. Chibuike

Journal of Pharmaceutical Research International, Page 149-159
DOI: 10.9734/jpri/2021/v33i28B31549

Aims: The study determined and compared the herbal extraction yields using water, ethanol and hydromethanol solvent and the solvent extracting the highest antidiabetic constituents.

Place: The study took place in the Department of Chemistry (Organic Laboratory), Federal University of Technology Owerri, Nigeria.

Methodology: The antidiabetic contents of Moringa oleifera (Moringa) and Vernonia amygdalina (bitter leaf) were extracted by soaking using water, ethanol and hydromethanol (1:1) as solvents. The phytochemicals analysis was done both qualitatively and quantitatively (using Spectrophotometer (UV-V15)). Data collected were statistically analysed using SPSS version 10 tools.

Results: The crude ethanolic extraction was found to give the highest extract yield of 46.06% and 38.91% from Moringa and bitter leaf, respectively. There were more phytochemicals obtained from Moringa (28+) than from Vernonia crude extracts (21+). The antidiabetic phytochemicals identified in both plants included Steroids, Phenols, Cardiac glycosides and Terpenoids. Ethanol extracted the Glycosides, Terpenoids and Phenols in relative abundance.. Hydromethanol solvent extraction yielded the highest concentrations of Steroids from Moringa (59.87mg/100g) and bitter leaves (75.43mg/100g) as well as highest extraction of Cardiac glycosides from both plants. Water extracted the highest concentrations of Phenols from both Moringa (0.32mg/g); bitter leaf (0.25mg/g) and Terpenoids from Moringa.

Conclusion: This study suggests that the choice of solvent (s) for phytochemical extraction (s) should consider factors such as the plant material (s) and the phytochemical (s) involved. So, Water > Hydromethanol > ethanol could be used for extracting phytochemicals for diabetes therapy.

Open Access Original Research Article

Endoscopic Pilonidal Sinus Treatment (EPSIT): Is a New Minimally Invasive Treatment in Pilonidal Sinus

Nawaz Ali Dal, Arshad Hussain Abro, Muhammad Anwar Memon, Ahmer Akbar Memon, Muhammad Qasim Mallah, Danish Haider Khoso, Ubedullah Shaikh

Journal of Pharmaceutical Research International, Page 193-198
DOI: 10.9734/jpri/2021/v33i28B31552

Objective: To determine the outcome of endoscopic pilonidal sinus treatment (EPSIT): Is a new minimally invasive treatment in pilonidal sinus.

Study Design: This is a observational study.

Setting: Study carried out at General Surgery department, Liaquat University of Medical and Health Sciences Jamshoro, form March 2020 to Feb 2021.

Materials and Methods:  Patients aged between 20-40 years, both gender having sinus in the cleft of the buttocks on clinical examination with associated symptoms like pain when sitting or standing, reddened, sore skin around the area, pus or blood draining from sinus, hair protruding from the lesion and formation of more than one sinus tract, or holes in the skin were included in this study. Patients with abscess and recurrent pilonidal sinus were excluded. Outcome measurements were postoperative pain, return to normal daily activities and complication rates including infection, recurrence.

Results: 44 patients with Pilonidal Sinus were included in this study.  15 to 40 years with mean age ± SD (range) was 26.56±4.1 years. 40(90.90%) were male where as 4(9.09%) were females. Mostly patients have single external openings in 37(84.09%) patients with midline opening location in 26(59.09%) patients. The mean operative time±SD (range) was 21.09±3.62 minutes (15 to 45 min). According to the visual analog scale (VAS) score for postoperative pain assessment after 48 hours of surgery, 36 patients (81.81%) reported a VAS between 1 to 3, and 8(18.18%) reported a score between 4 to 6. Postoperative wound infection was seen in one case 2.27% while recurrence was observed in two cases 4.54%. The overall healing rate was 93.18%. The mean time to return to normal daily activities was 6.1±11 (range, 2–15) days. 

Conclusion: To conclude that the EPSiT is safe, effective, simple, repeatable and very welcomed by the patients if explained correctly. We can say that EPSiT can be labeled as a day surgery, with fast post-operative recovery and early return to work.

Open Access Original Research Article

Saponins from the Pericarp of Albizia lebbeck (Benth) L. and Their Biological Screening on Laboratory Animals

Basma G. Eid, Nadia M. Sokkar

Journal of Pharmaceutical Research International, Page 183-192
DOI: 10.9734/jpri/2021/v33i28B31553

Aim: Albizia lebbeck L. is widely used to treat many diseases. Saponins are one of the major constituents that are found in the tissues of the tree. The purpose of this study was aimed at the phytochemical and biological investigation of the saponins of the pericarp.

Methodology: 50% ethanol extract of the dried powdered pericarp of A. lebbeck was fractionated with different organic solvents and examinated for their oxidative stress radical, anticonvulsant and analgesic effects. The highly potent fraction was subjected to chromatographic and spectroscopic analysis of its saponins.

Results: The n-butanol fraction expressed the best results regarding the biological activities. Chromatographic and spectroscopic analysis of this fraction revealed the identification of three oleanane-type saponins.

Conclusion: The present study constituted the first phytochemical analysis of the bioactive saponins content in the pericarp of A. lebbeck.

 

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Open Access Original Research Article

Enhancement of Dissolution Rate and Bioavailability of Nifedipine by Chitosan Based Cocrystallization Technique

. Reetu, Ashutosh Yadav, Anita Singh, Arun Garg

Journal of Pharmaceutical Research International, Page 206-219
DOI: 10.9734/jpri/2021/v33i28B31555

The objective of present study was to enhance solubility and dissolution behaviour of nifedipine by using cocrystallization method. A significant increase in solubility and dissolution rate of nifedipine has been demonstrated by solvent change method using chitosan. In this method, chitosan was precipitated on nifedipine crystals using sodium citrate as a salting out agent. An accurately weighed chitosan was dissolved in 1% acetic acid and drug was added in the chitosan solution. This resulting solution was added drop wise into 1% sodium citrate solution with continuous stirring. Sodium citrate precipitate polymer on drug crystals. FTIR, DSC, XRD, SEM, In-vitro dissolution studies, were studied for characterization of prepared cocrystals. Stability studies showed a good stability character of prepared cocrystals. Design Expert® software version 10.0 was used to develop polynomial models which were analysed to delineate the main effects for each CQA (critical quality attributes) through Box-Bhenken design expert. Pharmacokinetic study clearly showed the enhancement of dissolution rate of cocrystals. The above investigation concluded that the significant dose reduction is possible for nifedipine with cocrystal formulation which leads to improve patient compliance.

Open Access Original Research Article

Design, Synthesis, Characterization, Computational Study and In-vitro Antioxidant and Anti-inflammatory Activities of Few Novel Pyrazol-3-one Derivatives

Aziz Unnisa, B. Anupama, Humera Banu, Syeda B. Fatima, K. N. V. Chenchu Lakshmi, Rahamat Unissa

Journal of Pharmaceutical Research International, Page 220-231
DOI: 10.9734/jpri/2021/v33i28B31556

Aim: To design, synthesize and perform computational study on a few Novel pyrazol-3-one derivatives.

Study design:  Experimental study.

Methodology: A series of 6-aryl substituted pyrimidine azodyes were synthesized by coupling phenyl pyrimidine 2-amine with different aromatic amines. The synthetic compounds were screened for their in-vitro antioxidant and anti-inflammatory activities. The Computational study of designed compounds was done by OCHEM, Molinspiration cheminformatics, Datawarrior, and Swiss ADME. DPPH assay was used to determine the antioxidant activity and heat hemolysis method for anti-inflammatory activity.

Results: Molinspiration, Data Warrior, Ochem which are helpful to predict molecule general properties, bioactive scores, toxicity, and drug-likeness. Data Warrior results inferred that the compounds possess moderately active towards mutagenic (compound 2, 11), reproductive (compound 6, 7, 8), and highly active towards Tumorogenic (compound 2) toxicities. OCHEM results showed that most of the synthesized compounds were found to be non-inhibitors of all the subtypes of cytochrome P450 except compound 8. All compounds under this study were effective scavengers of free radicals except the compounds 1, 2, 6, 10. Invitro Anti-inflammatory studies have shown that the compounds (6, 7, 8, 9, 13) active toward heat hemolysis.

Conclusion: The synthesized compounds were comprehensively studied and targets were identified rendering them as lead molecules for further development of newer agents with greater efficacy and safety.

Open Access Original Research Article

Circulating Level of Soluble Leptin Receptor and its Association with Cardiometabolic Risk Factors among Obese Subjects in Kerala, South India

K. S. Manju, K. B. Leena, L. Vijayalekshmi, K. T. Shenoy

Journal of Pharmaceutical Research International, Page 232-239
DOI: 10.9734/jpri/2021/v33i28B31557

Background and Aims: Leptin, the peptide hormone secreted mainly by adipose tissue is reported to play the central role in the pathogenesis of obesity. Leptin exerts its biological effects through specific receptor molecules present in target tissues. Among the different isoforms of leptin receptor, the Soluble Leptin Receptor (SLR) is the major leptin binding protein seen in circulation which modulates the bioavailability of leptin. Our objectives were to analyse the level of circulating SLR among obese subjects and its association with biomarkers of obesity, serum leptin, insulin and cardiometabolic risk factors in comparison with healthy age and sex matched control subjects.

Methods: About 173 study participants of both genders were selected and grouped as case (n=102) and control (n=71) with a cut off point of BMI 25kg/m2. Waist to hip ratio (WHR) and body fat percentage (BF%) were calculated from anthropometric measurements. Leptin, insulin, soluble leptin receptor were estimated in fasting blood samples by sandwich ELISA method. Fasting plasma glucose and lipid profile were measured by standard enzymatic methods in autoanalyzer. Homeostasis Model Assessment of Insulin resistance (HOMA-IR) was calculated. Comparison between groups was done by independent sample ‘t’ test. P values <.05 were considered statistically significant.

Results: The SLR level was found to be increased in obese group in comparison with control group(P =.001). A significant increase in serum leptin and insulin level was observed in obese group when compared to control (P =.001). Obese group showed more than two fold increase in insulin resistance expressed as HOMA-IR when compared to control subjects (P =.001). But no significant difference in the synthesis of insulin expressed as HOMA-beta between the groups. No significant difference in serum lipoprotein levels was observed between the two groups.

Conclusion: Increased level of circulating soluble leptin receptor has been observed in obese subjects in comparison with control subjects and is associated with hyperleptinemia, hypertension and insulin resistance.

Open Access Original Research Article

The COVID-19 Pandemic and the Public Health System Challenges in India

Kesavan Sreekantan Nair

Journal of Pharmaceutical Research International, Page 169-182
DOI: 10.9734/jpri/2021/v33i28B31551

This paper attempts to provide an overview of the Covid-19 pandemic situation in India and highlights various public health system challenges faced by the country in its efforts to control the pandemic. This paper is based on extensive review of literature conducted to stimulate pertinent descriptive information on Covid-19 pandemic and public health system challenges in India. The Covid-19 pandemic has created unprecedented challenges on India’s public health system. India has implemented several strategies to mitigate the pandemic, but the rapid spread of the virus poses huge challenges of hitherto unseen scale on multiple fronts. India’s public health system is chronically underfunded, leading to a shortage of Covid-19 treatment facilities. Even the available health resources are unevenly distributed across states resulting in huge disparities in emergency preparedness and management of the pandemic. Due to lack of robust primary health care system and effective public health strategies, vulnerable population in most states are prone to the pandemic and risk of severe complications. The findings can draw attentions of health policy makers to develop appropriate policy for future pandemic preparedness and management.

Open Access Review Article

Regulatory Prototype for Biological Products in the United States

G. M. Pavithra, N. Venugopal

Journal of Pharmaceutical Research International, Page 60-72
DOI: 10.9734/jpri/2021/v33i28B31539

Biological products are used for the treatment of many disease, so the biological application submitted for the approval of products are also increasing. The progress of a biosimilarproduct is more difficult and expensive than a small molecule generic product. Biosimilars are not true generic drugs, but demonstrate a high degree of similarity to the reference biological product. In order to improve access to costly biological treatments, a biosimilar pathway in the US was established under the Biologics Price Competition and Innovation Act of 2009. The study highlighted the “Regulatory prospective for the registration of Biological products in US” and a brief description about the development, Manufacturing and approval process of biosimilar products. This article is also focused on the regulatory framework, Biological License Application, Purple book, and Pharmacovigilance of biological products.

Open Access Review Article

Impact of Natural Products on Developing New Treatments for Corona Virus Disease (COVID-19): Review

Amna A. Saddiq, Enas N. Danial, Iman A. Saraf

Journal of Pharmaceutical Research International, Page 101-122
DOI: 10.9734/jpri/2021/v33i28B31543

COVID-19 is dominatingly considered as an unavoidable pandemic, and researchers are exceptionally inquisitive about how to give the best assurance to people in general before an immunization can be made accessible. Normal items have consistently assumed an essential part in drug advancement measure against different illnesses, which brought about screening of such specialists to battle emanant freaks of infections. Contingent upon the construction, component of activity and hazard elements of Covid-19, this audit centers around those normal mixtures that showed promising outcomes against Corona infections. Although restraint of viral replication is frequently considered as an overall component for antiviral action of many of the characteristic items, contemplates have shown that some regular items can connect with key viral proteins that are related with destructiveness. Supplementation of natural products might be a affect to reduce risk through different mechanisms.

In this unique circumstance, a portion of the regular items have antiviral action in the nanomolar fixation and could be leads for additional medication advancement all alone or as a format for drug plan. Also, a decent number of normal items with against Covid action are the significant constituents of some regular dietary enhancements, which can be abused to improve the resistance of everyone in specific scourges The candidate compounds identified by us may help to speed up the drug development against COVID-19.

Open Access Review Article

Evaluation of Sensitivity, Specificity, and Cost-Effectiveness of Paper-Based Microfluidics for DNA Diagnostics of Malaria versus Nucleic Acid Test (NAT) Versus Rapid Diagnostic Tests (RDT) in Resource-Limited Settings: A Protocol

Usha Adiga, Tirthal Rai

Journal of Pharmaceutical Research International, Page 160-168
DOI: 10.9734/jpri/2021/v33i28B31550

Objective: The objective of the study is to compare three techniques, routinely used rapid diagnostic tests (lateral flow immune chromatography) versus nucleic acid amplification test (NAT)  versus Paper-based microfluidics for DNA diagnostics of Malaria, in terms of their sensitivity and specificity as diagnostic tests in detecting malarial infection among febrile illnesses, suspected of malaria, as well as to compare their cost-effectiveness.

Methodology: Three seventy febrile cases suspected of malaria with negative results with RDT will be screened by real-time PCR and DNA microfluidics techniques, sensitivity and specificity of these as screening tests will be compared. The number of extra positive cases detected by NAT gives us the yield. Cost-effectiveness analysis will be done by calculating the incremental cost-effectiveness ratio (ICER) and average cost-effectiveness ratio (ACER) for the tests.

Statistical Analysis: Statistical analysis will be done using SPSS version 21. Sensitivity, specificity, Positive predictive values will be computed. Comparison of sensitivity and specificity of NAT, a paper microfluidic technique for DNA diagnostics and RDT will be carried out using McNemar’s test. Receiver operating curves will be generated separately to assess the utility of the NAT.

Conclusion: The Implications of this study from the patient's perspective would mean early diagnosis which forms the tenet of control of the disease by increasing the yield. Early diagnosis at the community level would translate into the application of efficient prevention mechanisms to spread the infection. The cost-effectiveness analysis would provide a scientific basis for the adoption of the best test for the diagnosis, given the economic feasibility of the study.