Open Access Study Protocol

Evaluation of Repeated Dose (Sub Chronic) Toxicity Study of Shilasindur Prepared by Two Different Methods Along with Its Characterization and Antimicrobial Activity

Barkha Tirpude, Bharat Rathi, Renu Rathi, Swapnali Khabade

Journal of Pharmaceutical Research International, Page 26-35
DOI: 10.9734/jpri/2022/v34i9A35494

Introduction: Rasaushadhies (metal and mineral) preparations are unique preparations that include Bhasma, herbo-mineral preparations and Kupipakwa rasayana hold a significant place in Ayurvedic pharmaceutics. Nearly 70 % of formulations include a combination of one or more metallic/mineral with several herbs which have a supporting role in improving efficacy, relieving symptoms of the disease and to achieve long and healthy life. Shilasindur is a one of the Kupipakwa rasayana containing mercury, sulphur and arsenic disulphide and indicated in skin disorders, respiratory tract disorders and other infectious diseases.

Aim and Objectives: Evaluation of repeated dose (Sub chronic) toxicity study of Shilasindur along with its characterization and antimicrobial activity.

Materials & Methods: Shilasindur will be prepared in three batches as per classical reference and by using Electric Muffle furnace. The prepared formulation will be assessed with Organoleptic characters, physicochemical parameters and ICP – AES (Inductively coupled plasma atomic emission spectroscopy), FTIR (Fourier-transform infrared spectroscopy), XRD (X-Ray Diffraction). Sub chronic toxicity study will be carried out according to the OECD guidelines 408 and 452 as well as CCRAS guidelines of safety and toxicity.  Epsilometer test (E-test) will be used to check antimicrobial activity of Shilasindur.

Results: The analytical parameters will be assessed to establish the pharmaceutical standardization. Toxicity study will be done in three doses to ensure its safety. Statistical analysis will be done by applying unpaired t-test and ANOVA test.

Conclusion: If significant positive results obtained in this work then it will be a valuable contribution and evidence that the drug Shilasindur is safe for consumption at treatment doses.

Open Access Original Research Article

Antibacterial, Antioxidant and Cytotoxic Studies of the Essential Oil and Ethanol Extract of Aerial Parts of Artemisia rutifolia Steph.ex. Spreng

Amarjargal Ayurzana, Irekhbayar Jambal, Nandintsetseg Boldkhuu, Bayarhuu Batbayar, Elena P. Romanenk, Altantsetseg Shatar

Journal of Pharmaceutical Research International, Page 1-8
DOI: 10.9734/jpri/2022/v34i9A35489

Mongolia is rich in medicinal plants. In recent years, interest in plant-derived food additives has grown. This study was aimed to evaluate antioxidant, cytotoxic activities of aerial parts ethanol extracts from Artemisia rutifolia Steph.ex Spreng grown in Mongolia. The essential oil composition variability of A.rutifolia Steph.ex Spreng aerial parts collected from three different slopes of Kharkhiraa mountain was assessed by gas chromatography mass spectrometry (GC/MS). Chromatographic analysis of A.rutifolia Steph.ex Spreng essential oils showed the predominance of monoterpene hydrocarbons represented mainly by santolina triene, β-myrcene. The antioxidant and cytotoxic activities of the essential oil and ethanol crude extracts were determined by using DPPH and MTT assays. The antioxidant activity of A.rutifolia Steph.ex Spreng ethanol extract is 2.12 times higher than the antioxidant activity of the essential oil. The essential oil of A.rutifolia Steph.ex Spreng with a concentration of 150 mg/ml or 3μg/disk inhibits the growth of S.enterica 9.3 ± 0.76 mm, B.subtillus 10.3 ± 0.58 mm, S.aureus 9.6 ± 1.5 mm and has a moderate bacterial activity. The results clearly showed that the essential oil presented satisfactory cytotoxic activity against two human tumor cell lines HepG2 (human liver cancer cell line); AGS (human stomach cancer cell line). Our work revealed that the ethanol extracts and essential oil of Artemisia ritifolia Steph.ex Spreng grown in Mongolia has potential as sources of new antioxidant, and cytotoxic compounds, respectively. Essential oil of A.rutifolia Steph.ex Spreng contains caryophylline-7.19% and caryophylline oxide-5.82%, so the essential oil at a dose of 25 mg/ ml inhibits the growth of human stomach cancer cell (AGS). The results of the study were certified by the utility model certificate of “Soap Fragrance Elixir” with the registration number 20-003068.

Open Access Original Research Article

Comparative Evaluation of the Relationship between Different Anthropometric Measurements on the Face with the Mesiodistal Width of the Maxillary Central Incisor in Males and Females in Local Population in Pune, India

G. Thatte Shruti, K. Jagtap Amit

Journal of Pharmaceutical Research International, Page 9-17
DOI: 10.9734/jpri/2022/v34i9A35492

Aims: To compare the width of the central incisor obtained by the given formulae with the actual width of the central incisor in males and females and assess whether the interpupillary , interalar ,intercommisural and interlateral canthus widths are reliable anthropometric measurements to give an accurate value of the width of the central incisor in local population.

Study Design: Original Research.

Place and Duration of Study: Department Of Prosthodontics and Crown and Bridge, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune. Dr. D. Y. Patil Vidyapeeth, Pune – 411018, between June 2009 and July 2010.

Methodology: A total of 160 participants [Males=80; Females=80] were selected in the age group of 18-25 yrs which fulfilled the selection criteria. Informed consent was obtained from each student before participation. The following anthropometric measurements were performed: CW which is the mesiodistal width of the maxillary central incisor, interpupillary width (IPW) and the interalar width (IAW), intercommisural width (ICW) and interlateral canthus width (LCW) which were calculated using a digital vernier calliper. The differences and variables were studied by sex and the differences in the expected mesiodistal width of the central incisor by IPW/CW=6.6 and CW=IAW/4 with the real value was evaluated. The values were evaluated and the differences helped in determining whether these anthropometric measurements can be used as a guide for selection of artificial teeth in males and females in local population.

Results: As per this study conducted, in males & females there was statistically significant correlation between the width of the central incisors (CI) and the interalar width IAW (P value =0.043) and the interpupillary width IPW (P value =0.003) when calculated by formula CI=IAW/4 and CI=IPW/6.6. There was no statistically significant correlation between the width of the central incisor and the interlateral canthus width (LCW) and the intercommisural width (ICW).

Conclusion: There was significant correlation between the interalar width and interpupillary width and the width of the central incisor. Thus, interalar width, when divided by 4, and the interpupillary width when divided by 6.6 was a reliable predictor of the selection of the maxillary central incisor width in females and males in local population.

Open Access Original Research Article

Implication of Estimated Glomerular Filtration Rate for an Effective Management in Type 2 Diabetes Mellitus

Nithya Panneerselvam, Hemanthkumar Shanmugam

Journal of Pharmaceutical Research International, Page 18-25
DOI: 10.9734/jpri/2022/v34i9A35493

Introduction: Diabetic patients are at early risk of developing deterioration in renal function. The pharmacokinetics of antidiabetic drugs may get altered depending on the Glomerular filtration rate.

Aim: The aim is to study the estimated glomerular filtration rate eGFR appropriateness in the management of type 2 DM.

Materials and Methods: The study was conducted in the private diabetic care centre, Chennai. Serum urea, Serum creatinine, GFR and routine blood glucose investigations were measured for all the participants. Based on the report, the therapeutic modalities were analyzed for their nephroprotection. Descriptive statistics was used & values were expressed in numbers and percentage.

Results: Out of 148 patients, 87 diabetic patients were selected based on inclusion criteria. In which 55% were males & 45% females. Diabetes was observed to be highest 58.62% in the age group 40-59 years followed by 22.99% in 20-39 years and 18.39% in ≥60 years. 66 patients had creatinine level ≤1.1 and 21 patients had increased serum creatinine (>1.1). From the 87 study participants, 24 patient’s treatment regimens were modified based on eGFR and HbA1C.

Conclusion: Rationality in the management could be improved by including eGFR values in addition to glucose levels and HbA1C for type 2 diabetes mellitus.

Open Access Original Research Article

A Study to Assess the Effect of an IB (Information Bundle) on Physiological Parameters among Patients Undergoing Upper GI Endoscopy

Sushma Pandey, Seema Singh

Journal of Pharmaceutical Research International, Page 36-45
DOI: 10.9734/jpri/2022/v34i9A35497

Background: Upper gastrointestinal (GI) endoscopy is a common diagnostic procedure that plays central role in the practice of gastroenterology. It remains the first line of diagnostic modality for evaluation of Gastrointestinal (GI) disorders. It is a safe, commonly used investigation for the evaluation of wide range of upper GI lesions. Any type of surgery or an invasive procedure can cause stress to an individual. Whenever, exposed to such procedures, stress would definitely occur. Stress is expressed through altered physiological functions such as changes in blood pressure, pulse rate, respiratory rate. Information Bundle helps to minimize stress and stabilize physiological parameters during procedure among endoscopy patients.

Aim: Of this study is to evaluate the effect of information bundle on physiological parameters among upper Gastrointestinal endoscopy patients.

Methods: Two group pretest posttest research design was used. Sample was selected through convenient purposive sampling technique and total number of samples were equally divided in experimental and control group. 

Results and Discussion: The majority of the patients were from age group 39 years and above. The post intervention means cores showed an improvement in the physiological parameters in experimental group and calculated ‘t’ values were statistically significant at 0.05 level of significance(p<0.05).

Conclusion: The Information Bundle was found effective in stabilizing the physiological parameters of patients during endoscopy.

Open Access Original Research Article

A Study of Stability Indicating Development and Validation of a Method for Simultaneous Estimation of Brigatinib and Alectinib Using Reverse Phase Ultra Performance Liquid Chromatography in Active Pharmaceutical Ingredient Form

Gunturu Raviteja, Kantipudi Rambabu

Journal of Pharmaceutical Research International, Page 46-55
DOI: 10.9734/jpri/2022/v34i9A35498

Aims: New validated method for the simultaneous estimation of Brigatinib and Alectinib using UPLC and study of its degradation.

Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between March 2021 and April 2021.

Methodology: Using Luna C18 100 x 2.6 mm, 1.6 µm column, acetonitrile, and 0.1 percent Tri ethyl amine (TEA) (80:20 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 260 nm. The Braginib and Alectinib peaks were resolved within 5 minutes of elution time, with the Brigatinib peak eluting at 3.208 minutes and the Alectinib peak eluting at 1.757 minutes.

Results: The proposed method displays excellent linearity in the concentration ranges of 1.0 µg/ml to 15 µg/ml for Brigatinib and 5.0 µg/ml to 75 µg/ml for Alectinib. The RSD of robustness levels has a maximum of just 2 percent.

Conclusion: The accuracy, specificity, and sensitivity of the method were all found to be in line with ICH guidelines, when the procedure was developed and tested.