Open Access Short Communication

Evaluation of Physicochemical Properties and Chemical Constituents of Rasam, a Traditional South Indian Soup

Ayush Sharma, Muthu Kumaradoss Mohan Maruga Raja, Ravi Manne

Journal of Pharmaceutical Research International, Page 18-25
DOI: 10.9734/jpri/2021/v33i1731302

Aims: To evaluate the physical and chemical properties of rasam, a traditional south Indian soup. Each ingredient present in rasam are known for their medicinal value individually. Moreover, rasam has being suggested as a general control measure in the treatment of SARS-CoV-2 by Ministry of AYUSH. For formulation designing the properties of material under study is generally determined. Hence, this study was carried out to evaluate the physiochemical properties of rasam so that it would be convenient to chose a suitable dosage form.

Study Design: The physical and chemical studies was carried simultaneously in order to achieve the confirmatory results.

Place and Duration of Study: Study was performed at Parul Institute of Pharmacy & Research, Parul University, Vadodara, Gujarat, India. The study took about 45 days.

Methodology: The physical parameters evaluated were pH, viscosity, density, boiling range, surface tension, miscibility, refractive index and loss on drying. The chemical evaluation included preliminary qualitative phytochemical screening.

Results: The pH of rasam was 3.916 ±0.0133, viscosity was 0.956 cp, density was 0.993 g/mL, relative density was 0.995, boiling point was 110.3333 ± 0.333, surface tension was 107.093 N/m, refractive index was 1.37, and loss on drying was 80%. It contains several chemical constituents like alkaloids, glycosides, saponins, etc.

Conclusion: The evaluated physical and chemical properties of rasam would provide a gateway for the formulation researchers to follow-up with various dosage forms designing.

Open Access Minireview Article

Considerations in Real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) for the Detection of SARS-CoV-2 from Nasopharyngeal Swabs

Priyadharshini Sekar, Godfred Antony Menezes, Pooja Shivappa, Biji Thomas George, Ashfaque Hossain

Journal of Pharmaceutical Research International, Page 68-78
DOI: 10.9734/jpri/2021/v33i1731309

Coronavirus Disease 2019 (COVID-19) was first reported in December 2019, in the City of Wuhan, China. Within the span of a few weeks, the disease had spread to other regions of China and eventually to different parts of the world. COVID 19 has affected 221 countries and territories around the world, with a total of 121,290,697 positive cases and 2,682,554 deaths as on March 17, 2021. Accurate disease diagnosis (for the SARS-Cov-2 virus and variants), coupled to patient isolation are currently critical strategies in restricting disease spread. Due to lack of time during this pandemic the diagnostics assays were not adequately validated. Infected individuals at times could potentially be missed by real-time reverse transcription polymerase chain reaction (rRT-PCR) for SARS-CoV-2 tests due to incorrect/inefficient sampling procedure, low limit of detection and epidemiology of the virus. rRT-PCR test results should be interpreted in conjunction with clinical examination and Computed Tomography (CT), particularly in suspected symptomatic individuals or those with epidemiological history of contact with known COVID-19 cases. Considering the above-mentioned constraints, the current scenario demands rapid and point-of-care tests for detection of SARS-CoV-2 in remote locations. To date, there is no reliable commercially available antigen detection kit. The infected subjects reveal low levels of antibodies against SARS-CoV-2 through the early period of infection. In addition, techniques such as, Digital RT-PCR technology and isothermal RNA amplification with electrochemical biosensors are some of the new technologies currently being developed to provide sensitive and specific SARS-Cov-2 antigen detection. The newly reported variant, SARS-CoV-2 VUI 202012/01 may not influence diagnostic outcomes as worldwide most PCR assays use two or more (including RdRp/ E/ N) reliable gene targets, besides S gene.

Open Access Original Research Article

Efficacy of Fine Needle Aspiration and Cytology in Solitary Thyroid Nodule

Shahzad Asfandyar Haider, Samar Memon, Muhammad Saleem Laghari, Ahsan Ali Laghari, Mujeeb-Ur- Rehman Laghari, Usama Feroz Daudpota

Journal of Pharmaceutical Research International, Page 1-6
DOI: 10.9734/jpri/2021/v33i1731300

Objective: To determine the efficacy of fine needle aspiration and cytology (FNAC) in the solitary thyroid nodules at tertiary care Hospital.

Materials and Methods: This study was conducted in department of general surgery at Liaquat University Hospital Jamshoro/ Hyderabad during one year from June 2015 May 2016. The study included all subjects of any gender and age who had a solitary nodule that was confirmed clinically or through thyroid scan. To achieve a tissue diagnosis before surgery, the study participants experienced fine needle aspiration cytology (FNAC). The resected specimens were submitted for histopathology investigation postoperatively. Diagnostic accuracy of FNAC was assessed by cross tabulation by taking histopathology as gold standard. The data was gathered by using a self-made proforma and analyzed with SPSS version 20.

Results: Total fifty solitary thyroid nodules (STN) patients were studied. Mean age of the patients was 34.54+10.3 years. Of 50 patients, 46(92%) & 4(8%) were females and males respectively with male & female ratio of 1:11.5. 28(56%) STN were on right lobe, left side in 19(38%) cases; on isthmus in 3 (6%) cases. As per FNAC results, nodular colloid goiters were seen in 66% cases, follicular neoplasm in 10%, papillary carcinoma in 10%, Hurthle cell variation in 6%, benign cystic lesion in 4% of cases, neoplastic cystic lesion in only 1 case, and also only 1 study subject was suspected for malignancy. Thyroid function tests were normal in all patients. FNAC showed a significant efficacy with 83.3% sensitivity, 86.8% specificity, 86% diagnostic accuracy, 66.6% PPV and 94.28% NPV when histopathology was taken as a gold standard.

Conclusion: In the conclusion of this study the FNAC observed to be a simple, safe and effective diagnostic tool in detecting the thyroid malignancies as solitary thyroid nodules with 83.3% and 86.8% sensitivity and specificity respectively.

Open Access Original Research Article

Method Development and Validation of Anabasine and Nornicotine in Human Plasma by LC-MS/MS

P. Rajagopaludu, N. Saritha, N. devanna, M. Srinivas

Journal of Pharmaceutical Research International, Page 7-17
DOI: 10.9734/jpri/2021/v33i1731301

Aim: For the Method development and validation of Anabasine and Nornicotine in human plasma LC-MS/MS technique is used.

Methodology: Operated in positive electron spray ionization which removes the hardness in ions. Metoprolol is used as an internal standard. Mass analyzers are used to determine the mass to charge ratio. Liquid chromatography separates mixture components in the basis of differences in affinity for stationary and mobile phase. It removes undesired impurities. It increases reproducibility, sensitivity, robustness, detection of low-level proteins.  C18 Column (Phenomenex Luna C18, 5 μm, 50*4.6mm ID) is used to for high resolution and peak area. Calibration curve is constructed with the help of linear regression. During the entire process no instability is found.

Results: m/z values of Anabasine are 162.84(Q1), 134.68(Q3) and for Nornicotine are 148.90(Q1), 79.82(Q3). Back calculated curve is calculated at different concentrations from 1-1000ng/ml and their accuracy range from 97-105% for Anabasine and 93-108% for Nornicotine. In Anabasine and Nornicotine the precision and accuracy are calculated by Intra-batch and inter-batch. In the process of multi-step preparation, consider n=6 for intra-batch and n=18 for inter-batch the values obtained are between the nominal concentrations i.e., 90-110%. For each analyte the coefficients of variation are below nominal criteria <15%.  For Anabasine and Nornicotine the average recovery rate is 98.3% and 94.3%.

Open Access Original Research Article

The Effect of Single Bout of Competitive Training on Muscle Damage and Liver Enzymes in University Student Wrestling and Taekwondo Athletes

Muhammed Emre Karaman, Cengiz Arslan, Ayşe Eda Kinaci

Journal of Pharmaceutical Research International, Page 26-30
DOI: 10.9734/jpri/2021/v33i1731304

Aims: The effects of exercise/training on biochemical parameters may vary according to the characteristics of individuals, physical conditions, duration and intensity of exercise, and different lipid values. The purpose of this study was to investigate the alterations in muscle damage and liver enzyme parameters of male university student wrestling and taekwondo athletes after single bout of competitive training.

Methodology: The participants of the present study, sampled voluntarily. The research sample consists of 6 elite level male wrestlers (age=17.33 ± 0.54) and 6 elite level male taekwondo (age=17.66 ± 0.54) athletes. First of all, blood samples from all athletes were taken to evaluate the pre-test levels of serum AST, ALT and CK. After 15 minutes of warm-up, in accordance with the competition conditions of the relevant sports branch, the match was made in a total of 6 minutes, with appropriate loading intensity and rest interval. After at least 15 minutes of training blood samples were taken again to evaluate the post-test levels of AST, ALT and CK. Serum samples were studied in an auto analyzer.

Results: The results showed that after single bout of competitive training, serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatine kinase (CK)  significantly increased  in both groups (p<0.05).

Conclusion: As a conclusion; acute load of exercise caused an increase in both muscle damage and liver enzyme parameters. When this increase is compared between the two combat sports, it was seen that the parameters of the wrestlers were higher. If these biomarkers increase so much during competition, this will negatively affect the athletic performance of the athletes. In order to prevent this, success can be achieved by ensuring that the athletes are trained sufficiently and prepared for the competition during the pre-competition preparation period.

Open Access Original Research Article

One Factor SEM and Multilevel SEM Model for Patient Satisfaction Data

Rehan Ahmad Khan Sherwani, Sajjad Ali Gill, Shaukat Ali Raza, Shumaila Abbas, Muhammad Farooq, Sana Saeed, Hira Shahid

Journal of Pharmaceutical Research International, Page 39-49
DOI: 10.9734/jpri/2021/v33i1731306

Structural equation models are very common in medical, social, management and behavioral sciences where researchers established some causal relations between observed variables and latent variable. In structured populations the assumption of independence of observations is often violated and had been ignored by the researchers. As a result with the correlated structure of the error terms, biased estimates of the parameters have been produced that leads towards incorrect statistical inference. Multilevel structural equation model under one factor model has been proposed, estimated and compared with the traditional structural equation model on patient satisfaction data. Multilevel structural equation model produced better estimates than the structural equation models.

Open Access Original Research Article

A Comparative Study on In-vitro Quality Control Parameters of Different Brands of Loratadine Tablets Commercially Available in Bangladesh

Rosy Fatema, Sumaiya Khan, A. S. M. Roknuzzaman, Ramisa Anjum, Nishat Jahan

Journal of Pharmaceutical Research International, Page 50-58
DOI: 10.9734/jpri/2021/v33i1731307

Loratadine, a second generation H1-receptor antagonist, works by blocking the action of histamine and is widely prescribed for itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergic conditions. To ensure quality the main requirements for a medicinal product are safety, potency, efficacy and stability. This research work aimed to compare and assess the quality levels of different local brands of loratadine tablets available in the drug market of Bangladesh. Six different brands of loratadine 10 mg tablet manufactured by the local companies were used for the analysis. The evaluation was performed through the determination of weight variation, hardness, friability, percent potency, disintegration time, and dissolution profile in accordance with USP-NF specifications. All brands showed acceptable weight variation and % friability. The percent potency for tested samples by UV method ranges from 97.02%-108%, showing none of the brands contains less than 90% of the active principle as per the specification. The result of the physical and chemical studies, such as in-vitro dissolution, disintegration, hardness, etc., has been found to differ but lie within the specified limit. After analyzing the data obtained from the tests, it can be claimed that loratadine 10 mg tablets manufactured and marketed by several local companies in Bangladesh meet the quality standard required to achieve the desired therapeutic outcomes.

Open Access Original Research Article

Prevalence and Risk Factor of Gastro-esophageal Reflux Disease among Hail Population, Saudi Arabia

Mohammed Kuddus, Hadi Abdulaziz Aldarwish, Ali Ahmed Al Tufaif, Mohammed Ahmed Al-Tufaif, Ali Howaidi Alharbi

Journal of Pharmaceutical Research International, Page 59-67
DOI: 10.9734/jpri/2021/v33i1731308

Aims: Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder that develops when the contents of the stomach reflux into the esophagus due to large hiatal hernia or lower esophageal sphincter dysfunction. The common symptoms of the disease include heartburn and regurgitation. It takes place mainly among youngers, females, and obese people. The aims of the study include GERD prevalence among Hail population and the related risk factors.

Study Design: Cross-sectional study.

Place and Duration of Study: Hail, Kingdom of Saudi Arabia. Between July to December 2020.

Methodology: A cross-sectional study conducted with 704 subjects aged more than 15 years, through self-administered questionnaire consisting of 22 questions. The questionnaire included demographic data, GERD clinical symptoms, and individual behaviour. Statistical data analyzed by using SPSS version 22.

Results: Out of 704 subjects, nearly half of the participants were males (51.7%). GERD was found in 408 (58%) participants among them 276 (39.2%) had mild symptoms, 9.9%, had moderate symptoms and 62 (8.8%) had severe condition. Most significant predictors of GERD (P <0.05) were Females with chronic health problems, anxiety, and having Spicy food. The participants with sports activity had less risk to develop GERD.

Conclusion: The results showed high prevalence of GERD among Hail population with many significant predictors. Public health providers should increase awareness about GERD and its significant effects on community.

Open Access Original Research Article

Pharmacokinetics Evaluation of Acamprosate Tablets in Healthy Human Volunteers

Kiran S. Chaudhari, Milind Bagul, Ketan Shah

Journal of Pharmaceutical Research International, Page 79-88
DOI: 10.9734/jpri/2021/v33i1731310

Pharmacokinetic data of acamprosate tablets was not accessible on large number of human. Rationale to examine the pharmacokinetic properties of acamprosate calcium in healthy male subject, on single or multiple dosage administration, to evaluate the bioequivalence of two formulations of acamprosate calcium tablets in fast or fed environment. This work engross the study of pharmacokinetic property of Acamprosate calcium tablets in single dosing under fasting condition.

Methods: Bioequivalence study of delayed release acamprosate tablets 333 mg for a randomized, single dose, open label, two treatment, two periods, two sequences and crossover design in 12 healthy, adult human subjects under fasting condition was conducted. The wash out period within the each treatment and each stage was 1 week. The quantification of acamprosate was done by LCMS/MS method. Accessibility was evaluated by monitoring adverse events, physical examinations and ECG and laboratory tests.

Results: The entire study was conducted by using 12 male subjects to fulfill all stages in the study. The pharmacokinetic calculations for test and reference formulations are as follows: single dosing, Tmax 8.54 ± 5.24 and 10.71 ± 5.41 h, Cmax 146.06 ± 99.73 and 115.01 ±86.26 ng · mL−1, AUC0-t 1391.95 ± 731.24 and 1557.03 ± 960.98 ng·mL−1·h, AUC0–∞ 1987.40 ± 962.84 and 2720.21 ± 1931.79 ng·mL−1·h, respectively. In all three stages, 90% CIs for the test/reference ratio of AUC0–t and AUC0–∞ was to be found within 80% –125% of acamprosate calcium.

Conclusions: As per regulatory guidelines, pharmacokinetics parameters for acamprosate calcium were found to be within the acceptance criteria.

Open Access Review Article

Improvement of Biomedical Structural Polymers by Synthetic Biology Methods

Vyacheslav Gennad'evich Malyutin, Valentina Olegovna Sevagina, Viktor Anatolevich Kokotov, Vitaly V. Goncharov, Alexander Markov, Karina Nikolaevna Shalneva

Journal of Pharmaceutical Research International, Page 31-38
DOI: 10.9734/jpri/2021/v33i1731305

Materials that have a biological origin find many applications in both Biomedicine and other Sciences. However, the properties of these materials are difficult to change, since natural biosynthetic mechanisms are difficult to explain, simulate, or adjust. Thus, many materials of biological origin are isolated from natural tissues or their substitutes are produced recombinantly, and then modified in the process of experimental application.

A major shift in this paradigm is caused by the emerging field of synthetic biology, which introduces innovations in the "tool kit" of methods for tuning biomolecules and biosynthetic mechanisms. Relative to materials, this led to higher product titers due to reprogrammed natural biosynthesis and allowed the development of new materials by combining the desired domains. Here we can focus on recent applications of synthetic biology to bio-derived ribosomal and non-ribosomal polymer materials for biomedical applications. It is also interesting to describe modern methods that will affect the production and design of biomaterials in the near future. Continuous innovation at the intersection of synthetic biology and materials science promises to usher in a new era of biomaterial design and synthesis.