Volume: 20  Issue: 4 - 2023
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RESEARCH ARTICLE
1.Medication Reconciliation Service in Hospitalized Patients with Infectious Diseases during Coronavirus Disease 2019 pandemic: A Prospective Observational Study
Cüneyd Enver, Buket ERTURK SENGEL, MESUT SANCAR, VOLKAN KORTEN, Betul Okuyan
Pages 210 - 217
INTRODUCTION: To determine the prevalence and type of medication discrepancies and factors associated with unintentional discrepancies, and identify the rate of hospital readmission and emergency service visit within 30 days after discharge among hospitalized patients with infectious diseases and receiving clinical pharmacist-led medication reconciliation during the Coronavirus Disease 2019 pandemic.
METHODS: This observational study was conducted in the internal medicine and infectious diseases wards of a tertiary university hospital between July 2020 and February 2021 among hospitalized adult patients with any infectious diseases. Medication reconciliation service [including patient counseling]) was provided in-person or by telephone. The number and type of medication discrepancies detected during the medication reconciliation services, the acceptance rate of pharmacist’s recommendation, and factors associated with having at least one unintentional medication discrepancy at admission were evaluated. At follow-up, hospital readmission and emergency service visit within 30 days after discharge was assessed by telephone.
RESULTS: Among 146 patients, 84 patients (57.5%) had at least one unintentional discrepancy at admission. Only three unintentional discrepancies were determined in three patients at hospital discharge. All the pharmacist’s recommendations for medication discrepancies were accepted by the physicians. Having COVID-19 (OR=2.25, 95% CI: 1.15-4.40; p<0.05), being high risk for medication error (OR=2.01, 95% CI: 1.03-3.92; p<0.05), and higher number of medications used at home (OR=1.41, 95% CI: 1.23-1.61; p<0.001) were associated with having at least one unintentional discrepancy at admission. The rates of 30-day hospital readmission, and admission to emergency medical service were 12.3% and 15.8%, respectively.
DISCUSSION AND CONCLUSION: Medication reconciliation service provided by in-person or by telephone was useful to detect and solve unintentional medication discrepancies during the COVID-19 pandemic.
Abstract

2.Validated Stability-indicating RP-HPLC Method for Daclatasvir in Tablets
Hemlata Manohar Nimje, Smita Pawar, Meenakshi Deodhar
Pages 218 - 225
INTRODUCTION: The current study goal was to create a precise, sensitive and validated RP-HPLC method for assessing the direct-acting antiviral daclatasvir (DCV) as well as to evaluate the stability of the DCV in both drug and tablet formulations. The current investigation was to perform stability indicating method in different stress conditions, including hydrolysis such as (acidic, basic and neutral), oxidation and photolysis.
METHODS: All the experiment was performed on HPLC Agilent 1100 having stainless steel Hypersil C18 column with a particle size of 5µm and a dimension of 4.6 X 250 mm. The mobile phase chosen was acetonitrile: 0.05% o-Phosphoric acid (50: 50 v/v) in isocratic mode with 0.7 mL/min flow rate and wavelength 315 nm was selected for detection.
RESULTS: This method was validated for linearity and range, accuracy, precision, LOD, LOQ and robustness in accordance with ICH requirements. The results were satisfactory. It was observed that retention time (tR) was 3.760±0.01 min. In acidic condition, DCV degradant shows tR at 3.863, 4.121, 4.783 min and MS/MS spectra scans having m/z 339.1, 561.2 fragment ion. In basic condition, DCV degradant shows tR at 5.188, 5.469 min. and MS/MS spectra scans having m/z 294.1, 339.1, 505.2, 527.2 fragment ions observed. In oxidation conditions, DCV degradant shows tR at 4.038 min and MS/MS spectra scans having m/z 301.1, 339.1 fragment ions were observed.
DISCUSSION AND CONCLUSION: All the mass fragments shows the additional degradation observed for different stress conditions. This will help to identify the structure of degradant and its pathways. No degradation was observed in neutral and photolytic conditions.
Abstract

3.LC-MS/MS method development and validation for the determination of favipiravir in pure and tablet dosage forms
Nandeesha Itigimath, Hadagali Ashoka, Basappa C Yallur, Manjunatha Devagondanahalli Hadagali
Pages 226 - 233
INTRODUCTION: The analytical method development and validation for the determination of Favipiravir (FVPR) in pure and tablet dosage forms by LC/MS-MS Technique.
METHODS: A simple LC-MS/MS method was developed for the determination of a new antiviral drug, FVPR in pharmaceutical formulations. The stationary phase employed was Shim pack GISS, C18 (100 mm × 2.1 mm, 1.9 μm) column and mobile phase used in pump A was 10.0 mM ammonium acetate and in pump B methanol was used. The gradient program was used with a fixed mobile phase flow rate at 0.4 mLmin-1. The total run time was 5.0 minutes. The proposed method was validated according to the International Conference on Harmonization (ICH) guidelines. The established method found better outcomes.
RESULTS: The linearity graph was found in the range of 50-200 ngmL-1, and the correlation coefficient value (R2) obtained was found to be 1.0. The limit of detection and limit of quantification were 4.044 ngmL-1 and 12.253 ngmL-1, respectively. Tremendous recovery outcomes were observed and found to be 101%, 99.0% and 99.5% for the FVPR at 150% upper, 100% middle and 50% lower concentrations, respectively.
DISCUSSION AND CONCLUSION: All obtained outcomes were complying with the ICH guidelines. The developed method was simple, unique, accurate, robust, precise, and reproducible for the determination of FVPR in tablet formulation. The method is novel and could be adopted in the formulation industry.
Abstract

4.Development and validation of spectrofluorimetric method for the quantification of Capecitabine in bulk and tablets
Swathi Naraparaju, Ambati Mukti, Durga Panikumar Anumolu, soujanya chaganti
Pages 234 - 239
INTRODUCTION: A new, simple and affordable spectrofluorimetric method was established for the quantification of capecitabine in bulk and in marketed formulation.
METHODS: Native fluorescence of capecitabine in 0.1% w/v cetrimide was measured at 386 nm after excitation at 313 nm.
RESULTS: Linear relationship between fluorescence intensity and the capecitabine concentration was noticed in 0.2-1.0 µg/mL range. The method was supported by checking several validation parameters as stated by ICH guidelines. The limit of detection and quantification values (0.032 and 0.096 µg/mL, respectively) and results of validation parameters demonstrated that the method procedure was sensitive, accurate, precise and reproducible (% relative standard deviation < 2.0). The % assay in commercial formulation was found to be 99.2, which is in agreement with ICH guidelines.
DISCUSSION AND CONCLUSION: As a consequence of the above findings, developed method can be successfully adopted in routine analysis of capecitabine in pharmaceutical dosage forms.
Abstract

5.The role of chitosan-loaded solanine glycoalkaloid from Solanum scabrum Mill. leaf extract as anti-inflammatory and in vitro anticancer agents
Cletus Anes Ukwubile, EMMANUEL OISE IKPEFAN, Ademola Famurewa
Pages 240 - 252
INTRODUCTION: Solanum scabrum Mill. commonly ‘African nightshade’ or ‘’garden huckle berry’’ is a plant whose leaves are used by tribes in Nigeria and Cameroon for making the popular ’kombi’ and ‘njama njama’ soups respectively. This study was aimed at evaluating the anti-inflammatory and anti-cancer activities.
METHODS: Fractions were tested for anti-inflammatory potential and in vitro anti-cancer activity on MCF-7 and HMVII cell lines by carrageenan-induced edema in mice, and cytotoxicity assays such as MTT, transwell migration and invasion assays, apoptosis study by flow cytometry respectively.
RESULTS: Bio-guided isolation yielded a white crystalline compound 3-nitrodibenzofuran (C12H7NO3, m/z; 213.19 g/mol, m.p.; 181.49oC). 1H-NMR showed seven signals at δ (ppm) 2.8 -4.3 consisting of two doublets and five singlets while the 13C showed twelve carbons which are majorly methyl carbons at δ (ppm) between 120-195. All tested samples showed a dose-dependent anti-inflammatory activity in carrageenan induced mice. The isolated compound, solanine and chitosan-loaded drugs showed significant inhibitory activity on the cell lines with an IC50 values of 8.52, 0.82 and 22.1 μg/mL respectively on MCF-7 cell line, and 4.54, 0.08, and 12.1 μg/mL respectively on HMVII cell line, while doxorubicin (Adriamycin) positive control, had an IC50 values of 0.02 and 0.06 μg/mL on MCF-7 and HMVII cancer cells respectively. The selective index of solanine was the lowest from the study, hence, it lacks the ability to differentiate between cancerous and normal cell Vero E6 cell line. Chitosan-loaded drugs quicken early apoptosis and sustained late apoptosis in cells from the study, with much improved selective indices.
DISCUSSION AND CONCLUSION: The results obtained from this study further affirmed the use of chitosan NPs as carrier for anticancer drugs.
Abstract

6.Evaluation of Marketed Rosemary Essential Oils (Rosmarinus officinalis L.) in Terms of European Pharmacopoeia 10.0 Criteria
Timur Hakan Barak, Elif Bölükbaþ, Hilal Bardakcý
Pages 253 - 260
INTRODUCTION: Various pure rosemary essential oil containing commercial products are in demand for their health-promoting and cosmetic claims in Turkey. Although they are regarded as natural and harmless, they should be in compliance with European Pharmacopoeia (EP) criteria. Therefore, in this study, 15 rosemary oil samples sold in pharmacies, herbal shops and in online platforms in Turkey were investigated in terms of “Rosemary Oil” EP 10.0. monograph criteria. In the current study, it was aimed to evaluate current quality status of the rosemary essential oils in the Turkish market.
METHODS: Appearance, fatty oils and resinified essential oils, relative density, refractive index, optical rotation, acid value tests were performed according to EP 10.0 and compared with the given standards. In addition, TLC and GC-MS analysis were conducted to all samples for advanced understanding of their phytochemical profile and harmony with EP standards.
RESULTS: 15 pure rosemary oil containing product from Turkish market were evaluated. All of the samples were licensed as cosmetic products in Turkey via ministry of Health. 83.1 to 96.9% of the ingredients of all samples were determined via GC-MS analysis. Results demonstrated that none of the samples from Turkish rosemary essential oil market fully complied the EP rosemary oil monograph standards.
DISCUSSION AND CONCLUSION: In the light of these information, it was revealed that enhanced regulations and auditing mechanisms are needed to improve quality of the products. When the difference between the sources of purchase assessed, pharmacies are still better locations to obtain such products nevertheless improvements are yet needed.
Abstract

7.Formulation, characterization and optimization of a topical gel containing tranexamic acid to prevent superficial bleeding: In vivo and in vitro evaluations
Sara Daneshmand, farideh shiehzadeh, Daryosh Mohebi, omid chavoshian
Pages 261 - 269
INTRODUCTION: Tranexamic acid (TXA) is used systemically to stop bleeding, but it can lead to thromboembolism. Trials showed the efficacy of topical TXA on local hemorrhages. However, there is a need for an efficient delivery system that can keep the drug at the site of action
METHODS: To develop a gel containing TXA 3% optimized in terms of viscosity and dispersibility, the Central Composite Design (CCD) based on two factors-three levels (Carbopol 940 and HPMC, 1-1.5% and 1-2% respectively) was applied. The spreadability and viscosity were assessed using the glass slide and rheometer, respectively. To confirm the compatibility of TXA with gel, FTIR spectroscopy was performed. Drug content uniformity was analyzed by a spectroscopy method. An ex vivo mice model, using Franz cells was applied to evaluate the permeation of TXA through the skin. To investigate the effect of topical TXA gel on bleeding time, the IVY human method was performed.

RESULTS: Results: HPMC/carbopol 940 (1: 1w/w) gel has shown the highest quality in terms of viscosity and dispersibility (3.982 ± 17.6 and 6.052 ± 3562 respectively). The FTIR absorption spectrum showed that all of the TXA index peaks appeared without displacement. The complete encapsulated TXA content was uniformly dispersed throughout the gel. In vitro TXA cumulative release reached 90% in 4 hours. In vivo, the bleeding time for the TXA gel was significantly lower than the TXA solution and control.


DISCUSSION AND CONCLUSION: The results confirm the importance of further studies on this formulation as a potential medication to stop acute superficial bleeding.
Abstract

SHORT COMMUNICATION
8.Exploration of Structure Activity Relationship Using Integrated Structure and Ligand Based Approach: Hydroxamic Acid Based HDAC inhibitors and Cytotoxic Agents
Ekta Shirbhate, Jaiprakash Pandey, VIJAY KUMAR PATEL, RAVICHANDRAN VEERASAMY, Harish Rajak
Pages 270 - 284
INTRODUCTION: The present study aimed to establish significant and validated quantitative structure activity relationship (QSAR) models for HDAC inhibitors and correlate their physicochemical, steric, and electrostatic properties with their anti-cancer activity.
METHODS: We have selected a dataset from the earlier research findings. The target and ligand molecules were procured from recognized databases, were incorporated into pivotal findings such as molecular docking (XP Glide), e-pharmacophore study and 3D QSAR model designing study (Phase).
RESULTS: The docking studies revealed molecule 39 with better docking score and well binding contact with protein. The significant interaction between ligand and receptor were (i) metallic bond interaction with Zinc (Zn2451) of receptor 1ZZ1 and keto group of ligand (ii) hydrogen bond formation between NH- moiety of hydroxamic acid group of ligand with GLY151 and TYR312 amino acids (iii) Hydrogen bonding is also visible between NH- moiety of indole ring and ASP98 amino acid (iv) hydrophobic interaction of PHE208 with five membered ring B of indole and benzene ring of compound 39.The 3D QSAR analysis performed for PLS factor 5, reported good 0.9877 and 0.7142 as R2and Q2values, respectively and low standard of deviation SD = 0.1049 for hypothesis AADRR.139.
DISCUSSION AND CONCLUSION: Based on the computational outcome, it has been concluded that molecule 39 is an effectual and relevant candidate for inhibition of HDAC activity. Moreover, these computational approaches motivate to discover novel drug candidates in the pharmacological and healthcare sectors.
Abstract