LITHOTRIPTIC AND ANTI-LITHOGENIC EFFECT OF TILA-DHATRI KSHARA ALONG WITH GOKSHURA KASHAYA IN ETHYLENE GLYCOL-INDUCED NEPHROLITHIASIS IN ADULT MALE CHARLES FOSTER RATS

Objectives: Thirty-five adult Charles Foster rats were taken in the study to assess the lithotriptic and anti-lithogenic activity of the Trial drug. Methods: Thirty-five were divided into seven groups of five animals each. One group was kept as normal control; one group was given ethylene glycol 0.75% alone for 28 days. In the next three groups, Trial drug, kshara with distilled water, and the Standard drug were given, respectively, for 28 days after induction of calculi using ethylene glycol. In the next two groups, to assess the anti-lithogenic activity, simultaneously stone inducing agents and trial/standard drugs were given for 28 days. At the end, blood, urine, and histopathology of rat kidneys were done. Results: Tila-Dhatri kshara with Gokshura Kashaya and standard drug, Potassium Magnesium Citrate B6 showed equal lithotriptic and anti-lithogenic activity as depicted from blood, urine biochemistry, urine microscopy, and histopathology of rat kidneys. Trial drug-treated group showed more diuresis than other groups. Furthermore, serum LDH values were significantly reduced in trial drug-treated group. Conclusion: The trial drug showed significant nephroprotective property when compared to the standard drug as depicted from the serum LDH values and histopathological evaluations

STUDY ON DETERMINANTS OF SUCCESSFUL OUTCOME IN ICSI PREGNANCIES IN A TERTIARY CARE CENTRE

Objectives: A descriptive study was done at the government medical college in Thiruvananthapuram to find out the determinants of the successful outcome of intracytoplasmic sperm injection (ICSI) pregnancies. Methods: The study was done on 60 ART-conceived patients who underwent ICSI and became positive for pregnancy during 1 year. Their pregnancy was followed up, and data was collected in a structured proforma about determinants of successful outcomes. Results: Out of 60 in vitro fertilization (IVF)-conceived subjects (n=60), the maximum age group (40%) that underwent IVF treatment was between 31 and 35 years old, and they belonged to an upper-lower socio-economic status. 45% of patients had a normal body mass index, 46.7% were overweight, and 8.3% were obese. 73.3% were nulliparas.78.3% had primary infertility, and 21.1% had secondary infertility. The prevalence of male infertility was 6.7%, and female infertility was 81.7%. 81.1% had regular menstrual cycles. 8.3% of patients had medical disorders, and 48% of patients had previous surgeries like polypectomy, polycystic ovarian drilling, and laparoscopy for endometriosis. 71.7% were given the GnRH antagonist stimulation protocol for 8–12 days, and 11–15 eggs were obtained in 66.7% of the patients. 91.7% of frozen embryos were transferred. Conclusion: The success of an ICSI pregnancy is determined by the younger age of the female partner, female factor infertility, antagonist stimulation protocol, and the transfer of a frozen embryo

MOLECULAR DOCKING OF SPEARMINT PHYTOCOMPOUNDS AGAINST CYP21A2: IMPLICATIONS FOR PCOS THERAPY

Objectives: In this study, phytocompounds of spearmint that is known to have anti-androgenic activity are docked against a protein CYP21A2. This protein is also known as progesterone complex, one of the member cytochrome P450 enzymes; mutations in the genes encoding these proteins are causative factors of polycystic ovarian syndrome (PCOS). Methods: The study was based on computations using different phytochemicals of spearmint docking to a target protein CYP21A2 which causes hormonal imbalance leading to PCOS and hirsutism. Molecular docking was conducted using PyRx-virtual screening tool and Biovia discovery studio 2.0 to determine binding affinities of different phytochemicals to target protein. Results: The docking result revealed that bicyclogermacrene, cubebol, (-)-beta-bourbonene, alpha-bourbonene, and spathulenol showed highest binding affinities between –8.1 and –8.5 kcal/mol. Further, absorption, distribution, metabolism, excretion, and toxicity properties of these compounds are explored mainly to understand the possibility of developing potential drugs for PCOS. Conclusion: These bioactive compounds can be considered as potential agents that can be used with polyherbal plant extract to reduce the androgen levels in women suffering from PCOS

A SIMPLE RP-HPLC METHOD DEVELOPMENT AND VERIFICATION OF THE DISSOLUTION OF BROMELAIN-A COMPLEX MIXTURE OF PROTEOLYTIC ENZYMES, IN DELAYED-RELEASE TABLETS

Objective: To develop a simple, accurate, precise and linear Reverse Phase High-Performance Liquid Chromatographic (RP-HPLC) method and verify for the quantitative estimation (Dissolution) of Bromelain in delayed-release tablets. Methods: The optimized RP-HPLC method for both acid and buffer stage dissolutions of delayed-release tablets uses Zorbax 300 SB-C8 column (150 mm X 4.6 mm; 3.5μ), a mobile phase-A of 0.1% trifluoroacetic acid in water and a mobile phase-B of 0.1% Trifluoroacetic acid in Acetonitrile in the gradient proportion, flow rate of 1.0 ml/min, injection volume of 25 µl, detection wavelength of 280 nm using a UV/PDA detector, column temperature of 40 °C, sample tray/compartment temperature of 5 °C and a run time of 20 min. Results: The developed method gave Bromelain eluting at about 6 min. Bromelain exhibited linearity in the range 53.4-800.6 μg/ml (r2=0.99992). The precision is exemplified by relative standard deviation of 1.3 and 2.3% for acid and buffer stages, respectively. Percentage recovery of the drug was found to be between 90.0 and 110.0 during accuracy studies. Conclusion: A simple, accurate, precise, and linear RP-HPLC method was developed and verified for the quantitative estimation (Dissolution) of Bromelain in tablets and hence this method can be explored for the analysis of Bromelain in tablets in various pharmaceutical industries

FORMULATION AND EVALUATION OF CIPROFLOXACIN MICROSPHERES DESIGNED BY USING NATURAL POLYMERS BY IONIC GELATION TECHNIQUE

Objective: A definitive objective for supporting drug discharge is to expand the remedial movement of the medication while limiting its incidental effects. Microspheres have become a unique medicine delivery mechanism for several disorders in this area. The popular fluoroquinolone antibiotic, Ciprofloxacin, is used to treat a variety of bacterial illnesses. This research aims to create Ciprofloxacin microspheres with sustained drug delivery using natural gum polymers. Methods: To choose and assess the ideal formulation, a variety of formulations (F1–F8) were developed. This work was completed using an innovative technology, the Ionic Gelation method. Central Composite Design (CCD) used the quadratic forward regression approach to carry out the optimization. The evaluation tests include Particle size, Scanning Electron Microscopy (SEM), FTIR, Percentage yield, Drug content, Drug Entrapment effectiveness and in vitro dissolution studies. Results: It was discovered that the best formulation was F4. From optimization, the ANOVA was found to be significant. The uneven, spherical structure of microspheres with a rough outer surface is confirmed by SEM investigation. The absence of drug-polymer interaction is confirmed by the FTIR. The formulation F4 was deemed ideal due to its high drug entrapment efficiency, drug content and maximal drug release (89.25% in 12 h). Conclusion: Due to the least plasma half-life, this drug is designed as microspheres thus maximizing the therapeutic activity and minimizing the negative effects. In this regard, microspheres have emerged as novel drug-delivery systems for various diseases. It maintains effective dose concentration, eliminates night-time dosage and decreases side effects, thus optimizing drug therapy

LC-MS/MS-BASED QUANTITATIVE PROFILING OF PAPAIN ENZYME IN CARICA PAPAYA L.: METHOD DEVELOPMENT AND VALIDATION

Objective: To develop & validate a sensitive Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) method for quantifying the Papain enzyme in Carica papaya L. plant extracts. Methods: As an internal standard (IS), Papain was procured. A gradient-based LC-MS/MS method was developed using the Quasar C18, 150mm × 2.1mm, 3µm column, the drug separation was accomplished using a gradient elution mode with a mobile phase consisting of 0.2% formic acid in water (A) & a 98:2% ratio of formic acid in acetonitrile (B). The mobile phase was injected with a volume of 10µl at a flow rate of 0.5 ml/min. Results: Matrix-matched calibration adhering to SANCO guidelines was employed for accurate quantification, covering a concentration range of 1 to 2000 ng/ml. The method's selectivity & linearity were confirmed with an R2 correlation value of 0.990. Limits of detection (LOD) & quantification (LOQ) were determined as 170.5 ng/ml & 516.8 ng/ml, respectively. The developed LC-MS/MS method demonstrated robust analytical performance, providing a solid basis for quantifying Papain enzyme levels in Carica papaya L. plant extracts. The matrix-matched calibration approach, with a well-defined standard calibration curve, showcased the method's selectivity and linearity. The LOD & LOQ values further underscored the method's sensitivity. Conclusion: This study successfully establishes & validates a gradient-based LC-MS/MS method for accurate quantification of Papain enzyme levels in Carica papaya L. plant extracts. The demonstrated precision, accuracy, & sensitivity support the reliability of this analytical approach, offering a valuable tool for future investigations into the biological effects of Papain

ENHANCING THE PHYSICAL CHARACTERISTICS AND SHELF LIFE OF RICE WATER (ORYZA SATIVA L.) GEL SHAMPOO: THE ROLE OF PROPYLENE GLYCOL CONCENTRATION

Objective: This study aims to determine the effect of variations in propylene glycol concentration on the physical properties and physical stability of rice water shampoo gel and the physical strength of rice water shampoo gel preparation. Methods: The active ingredient was rice water which was prepared by washing rice with water at the proportion of 1:1. The rice water then was applied to HPMC K4M-based gel preparations and further designed to prepare shampoo gel with varying concentrations of propylene glycol 8%, 10%, and 12%. The rice water shampoo gel was evaluated for its organoleptic properties, pH, viscosity, spreadability, flowability test, softness test, and physical stability test. Results: The results of the physical properties test on the three formulas produced an organoleptic clear pale yellow color, lemon odor, and semi-solid shape. The pH test results obtained by F1 was 7.24 ± 0.08, F2 was 5.89 ± 0.01, and F3 was 6.02 ± 0.01. The viscosity test results obtained by F1 amounted to 2082 ± 80.07 cP, F2 amounted to 4987 ± 883.88 cP, and F3 amounted to 6531 ± 232.79 cP. The foam height test results obtained by F1 amounted to 4.6 ± 2.11 cm, F2 amounted to 1.46 ± 0.05 cm, and F3 amounted to 1.7 ± 0.17 cm. Variations in propylene glycol levels affect the physical properties of shampoo gel preparations at pH, viscosity, and foam height but do not affect the organoleptic practice. The stability test that was conducted at weeks 0, 1, 2, 3, and 4 with varying levels of propylene glycol showed significant changes on viscosity and foam height stability. Conclusion: Variations in the concentrations of propylene glycol in the three formulations affect the physical but have no effects on the pH stability of the rice water shampoo gel preparation

A COMMUNITY-BASED SURVEY TO ASSESS THE PREVALENCE AND ETIOLOGICAL FACTORS FOR TYPE II DIABETES MELLITUS IN THE TWO REGIONAL STATES OF SOUTHERN INDIA – A PILOT STUDY

Objective: The concurrent study aimed to assess and analyse the prevalence and etiological factors responsible for the occurrence of Type 2 diabetes mellitus among the labour population. A cross-sectional study was conducted among the labour in the two regional states of southern India. This study was conducted for 6 months in the two states of the southern region of India. Methods: A questionnaire was designed with various questions to study the prevalence and scrutinize the causes responsible for the occurrence of type 2 diabetes among the labour population. A total number of n=104 respondents participated, out of which 57 were diabetic and were further analysed. The results were compiled and subjected to the statistical analysis (Chi square test). Results: In the demographics, the majority of the participants were females (n=33), while the remaining were males. 75% of the participants were with age groups between 31-60 y, about 50% were uneducated and belonged to lower income category. Etiological factors like family history (>50%) and comorbid conditions (n=43) were more responsible for the prevalence of Type 2 diabetes. In the food habits assessment, carbohydrates and non-vegetarian consumption were more in majority (>45%) of the respondents. 86% of the participants were on medication, along with only 57.8% were recorded with HbA1c.  Diet restrictions, and timely intake of food were up to the level after the diagnosis of the disease. Nearly 50% of diabetics were confident about the management of the disease and 54 respondents were spotted to have a keen interest in acquiring knowledge further.  Conclusion: The findings concluded that the diabetic participants followed the necessary diet requirements and were on medication for the treatment of Type 2 diabetes mellitus

MODIFYING FRACTION EXTRACTED FROM SESEWANUA (CLERODENDRUM FRAGRANS WILD) LEAVES IN SNEDDS PREPARATIONS: CHARACTERIZATION AND BIOAVAILABILITY TEST

Objective: This study aimed to determine the effect of compound modification using acyl chloride derivatives on n-hexane:ethyl acetate fraction of sesewanua leaves, focusing on the characteristics, and pharmacokinetics profile in Self-Nano-emulsifying Drug Delivery System (SNEDDS) preparations. Methods: A quasi-experimental method was used with six SNEDDS formulas, namely F0 (without active substance), F1 (acetyl chloride fraction), F2 (propanoyl chloride fraction), F3 (butyryl chloride fraction), and F4 (pentanoyl chloride fraction) and F5 (piperine compound). The fractions were subjected to characterization tests including particle size, polydispersity index, and zeta potential as well as determination of pharmacokinetics profile using the modified crane and Wilson method. Results: The results showed that the characterization tests of particle size using Particle Size Analyzer (PSA) for F0-F5 on gastric fluid, included 15.8, 17,367, 20,367, 15.8, 28.233, and 21.533 nm. The polydispersity index values were 0.211, 0.438, 0.311, 0.383, 0.394, and 0.397, while the Zeta Potential values were -22,267, -22.2, -23.5, -24,033, -22,967, and -21.6 mV, respectively. The pharmacokinetics profile of AUC0-∞ was as follows: F0 0 μg, F1 492.83, F2 492.83, F3 245.98, F4 492.94, and F5 843.38 μg. Fraction five (F5) as a control had a higher AUC0-∞ value than compared to the fractions modified with acyl chloride derivatives. The T1/2 elimination values were F0 0 h, F1 22.5 h, F2 10.811 h, F3 35.54 h, F4 231.01 h, and F5 15.469 h. Conclusion: Based on the results, the addition of acetyl, propanoyl, butyryl, and penthanoyl chloride affected Particle Size Characterization Analysis and pharmacokinetics profile of SNEDDS preparation of n-hexane:ethyl acetate fraction. Structural modification showed the ability to alter the bioavailability of the active ingredient according to the desired therapeutic goal

QUALITY AND EFFICACY OF GENERAL ANESTHESIA VERSUS SEGMENTAL THORACIC SPINAL ANESTHESIA IN MODIFIED RADICAL MASTECTOMY SURGERY: A SINGLE-CENTER OBSERVATIONAL STUDY

Objective: Surgical resection remains the most important treatment modality for breast cancers. Recent research suggests that the choice of anesthesia technique might also have a role in the recurrence of the disease. We compared quality and efficacy of the conventional general anesthesia technique with segmental thoracic spinal (STS) anesthesia technique used in modified radical mastectomy. Methods: 60 American Society of Anesthesiologists II/III patients were divided into two groups Group C (Control group) and Group S (Study group). Group C patients were induced with standard anesthesia regimen while Group S patients were given STS at T4–T5 inter space with 1.5 mL of 0.5% hyperbaric levobupivacaine along with 15 µg of fentanyl with conscious sedation. Hemodynamics, pain score, time for first rescue analgesia, experience of anesthesiologist, surgeon, and patients were recorded. Results: Time for induction in group S is significantly longer (Group C 17.4±3.8 vs. 36.2±7.2 min, in Group S). The duration of surgery (56±13.6 min vs. 76.4±15.9 min) was also significantly longer, while reversal period was shorter in Group S (9.2±6.2 and 6.3±5.7 min). Modified Aldrete’s recovery score achieved quickly in Group C (16.8±4.9 vs. 29.7±9.8 min), but postoperative analgesia was better in Group S as first rescue analgesic sode required after 6.2±1.9 h in Gr. S while in Gr. C time duration was 4.9±1.3 h. Length of stay in hospital was more in Group S, (Group C 45.4±4.8 vs. Group S 56.3±8.5 [h]) while ease and comfort of surgeon anesthesiologist and patient satisfaction score were more in Group C. Conclusion: STS anesthesia is feasible for breast carcinoma surgeries but it is easier for surgeon and anesthesiologist to manage patient under general anesthesia. STS anesthesia has advantage in terms of early post-operative analgesia and will definitely be helpful in cases where patient is not fit for general anesthesia