Journal of Applied Pharmaceutical Research (JOAPR)
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Correlational study of Hyperbilirubinemia as a diagnostic predictor for perforation in acute appendicitis
Get PDFBackground: Appendicitis is an acute and life-threatening situation if not treated promptly encountered in surgery practice. Even today, most cases of appendicitis are diagnosed by clinical findings and imaging. Scanty information is available to diagnose the perforation of the appendix using serological tests; hence, an attempt is made. The present study aimed to find out the correlation of hyperbilirubinemia as a diagnostic predictor for perforation in acute appendicitis patients. Methods: This prospective observational study was conducted among patients diagnosed with acute appendicitis attending OPD of the general surgery department of Narayana Medical College Hospital. The duration of the study is between January 2023 and December 2023. A total of 400 patients with a diagnosis of either acute appendicitis or perforation were recruited into the study, and they collected blood samples for estimation of hyperbilirubinemia. Results: In the study population of 400 patients, 72 cases were diagnosed as appendicular perforation, and 328 patients had acute appendicitis. The cut-off value of hyperbilirubinemia was taken as serum bilirubin >1.0 mg/dl. Out of 72 cases of appendicular perforations, 64 patients have hyperbilirubinemia (89%), while in the acute appendicitis patients group, 82 of 328 patients have elevated serum bilirubin (25%). The observed mean values of serum bilirubin in the two groups were 1.74 and 0.89, and the difference in the standard error of the mean value of the two groups is statistically significant at a P-value of <0.001. Conclusions: Patients who presented with acute appendicitis symptoms and had serum bilirubin values >1.0 mg/dl had a higher probability of appendicular perforation. Hence, measuring serum bilirubin can be considered an additional diagnostic tool to existing clinical diagnosis and radiological evaluation for more precision in diagnosis
Modulation of mesalamine release from enteric-coated matrix tablets using natural polysaccharides for localized colonic delivery
Get PDFBackground: Inflammatory bowel diseases (IBD) require effective colon-targeted drug delivery for improved therapeutic efficacy and minimized systemic side effects. Objectives: The objective of this research was to develop and evaluate novel colon-targeted matrix tablet formulations of mesalamine (5-aminosalicylic acid) for the treatment of IBD. Materials and Methods: Mesalamine matrix tablets were prepared by wet granulation technique using pH-sensitive polymers (HPMC K4M) and biodegradable natural polysaccharides (pectin, chitosan, and guar gum). Tablets were characterized for physicochemical properties, drug content, and in vitro drug release. Compatibility studies using FTIR and DSC confirmed no interaction between mesalamine and polymers. The optimized formulations were enteric-coated with Eudragit S100 and ethyl cellulose. Drug release kinetics and stability studies were conducted. Results and Discussion: The uncoated formulations (M3, M6, M7) showed adequate protection against drug release in simulated gastric (0-2 h) and intestinal (2-5 h) fluids. The enteric-coated formulations (ME3, ME6, ME7) exhibited a lag time of around 2 hours and restricted drug release (<5%) in simulated gastric and intestinal fluids up to 5 hours. However, in simulated colonic fluid (pH 6.8) containing 4% rat cecal contents, these formulations showed enhanced drug release (71-83% in 12 h) due to biodegradation of polymeric matrices by colonic enzymes. Drug release kinetics indicated anomalous transport or super case-II transport mechanisms. Stability studies at 40°C/75% RH for 3 months revealed no significant changes. Conclusion: The developed colon-targeted mesalamine matrix tablets demonstrated the potential to protect the drug from release in the upper GIT while facilitating targeted drug delivery to the colon, which could improve therapeutic efficacy and minimize systemic side effects in the treatment of IBD
Formulation and evaluation of ointment containing hydroalcoholic extract derived from the bark of Moringa oleifera for wound healing activity in rat model
Get PDFBackground: This study aimed to assess the effectiveness of a hydroalcoholic extract derived from the bark of Moringa oleifera in facilitating the healing process of second-degree burns wounds. Moreover, a comprehensive assessment was carried out on standardized M. oleifera bark to ascertain its physiochemical characteristics, botanical compound layout, and antioxidant activity, all of which play a crucial role in its capacity to facilitate the healing process of burns. Methods: For 14 days, the efficacy of ointments containing a hydroalcoholic extract of M. oleifera bark at concentrations of 5% and 10% was evaluated for treating second-degree burns in rats. Additionally, histological analysis was conducted on skin tissue samples. Results: The M. oleifera bark extract exhibited TPC (52.56 mg/gm of dried extract) and TFC (84.33 mg/gm of dried extract) value along with antioxidant activity (IC50 value of 0.98 µg/ml) for radical scavenging, in the presence of several phytochemicals. The most favorable outcomes were achieved using a 10% ointment composition, demonstrating a wound closure and tissue repair rate of 83.04 ± 0.89%, along with a noteworthy decrease in tissue oxidative stress indicators. Histological investigations have verified the wound-healing properties of M. oleifera bark extract. Conclusion: Due to its significant antioxidant properties and its capacity to create a moist environment for wounds, M. oleifera has the potential to serve as a natural treatment for burns. Additional clinical trials are recommended to validate the efficacy of M. oleifera bark extract as a therapeutic agent for wound healing
Formulation and in-vitro anticancer activity of nilotinib immediate release and ibrutinib sustained release pellets
Get PDFBackground: Blood cancer is a significant contributor to mortality rates worldwide, and its prevalence is projected to rise on a global scale. This trend places considerable strain on healthcare systems and necessitates the expedited development of innovative treatments by pharmaceutical firms to remain competitive. Conventional pellets produce rapid plasma drug levels, but they might cause side effects, decrease effectiveness, and lead to poor therapeutic management. Ibrutinib and Nilotinib are employed to treat leukemia patients. Methodology: The current research aims to formulate, characterize, and anticancer effect of Nilotinib immediate release (NIR) and Ibrutinib sustained release (ISR) seal sugar-coated pellets. Micrometric properties estimated the characterization of the drug pellets, and surface morphology was estimated using scanning electron microscopy. Drug excipient compatibility studies, stability studies, and in-vitro drug release were accessed. Result & Discussion: The results of pellet formulations FNI-1 to FNI-5 showed that FNI-5 formulations showed 100±6.0 µm size and possessed excellent mechanical strength for giving pellets a good self-life; also, due to the higher drug content up to 99%, FNI-5 was the best suited for pellet formulation and because NIR showed 99.18 ± 2.12 drug release at 2h and ISR 99.03±3.74% up to 12h so that anticancer concentration maintained for prolonged period. The standard dose for cytotoxicity against the THP-1 cell line of Nilotinib was found to be 200 mg, and the maintenance oral dose of Ibrutinib was 140mg, with four times the intake of the drug up to 560 mg. In an in vitro study in FNI-5 (final formulation), the dose of Ibrutinib was reduced to 420 mg. Conclusion: A synergistic effect of Ibrutinib and nilotinib drugs was observed in the inhibition of cancer cell growth, with an IC50 value of 4.585 µg/m
Microscopic, pharmacognostic and phytochemical evaluation of Sesbania grandiflora leaves
Get PDFObjective: Sesbania grandiflora is a short-lived and fast-growing edible ornamental plant belonging to the Fabaceae family. Due to its unique therapeutic characteristics such as anti-inflammatory, antitumor, neuroprotective antioxidant, etc., it is utilized as an herbal medication in the Indian traditional medical system to treat various diseases. Therefore, the objective of the current investigation was to offer certain beneficial information regarding the standardization and identification of S. grandiflora leaf, which may be helpful in terms of its validity, purity, and quality. Methods: The micro- and macroscopical study of fresh and dried leaves of Sesbania grandiflora was investigated. Physicochemical parameters were performed according to WHO-recommended parameters. The dried leaves were powdered and extracted with different solvents in a Soxhlet apparatus. The concentrated extract was further used for physiochemical and phytochemical studies. Result: The fresh leaves of S. grandiflora were examined for their organoleptic characteristics. The leaves are regular compound and pari-pinnate with an average length of 15–30 cm long with green color. The transverse section of the leaf demonstrated the presence of spongy and palisade type of mesophyll cells. Stomata are anxiolytic and anisocytic stomata. Furthermore, Powder microscopy revealed the presence of simple epidermal hairs, dark yellowish-brown tannin fragments, light yellowish resinoids, oil globules, mucilage cells, and spiral vessels. Phytochemical screening revealed the presence of triterpenes, glycosides, tannins, flavonoids, gallic acid, biotin, and rutin. Conclusion: This study adds to the body of knowledge regarding the standardization and identification of the subject matter and facilitates future research on the Ayurvedic medical system
Design, development, and optimization of sumatriptan loaded ethosomal intra-nasal nanogel for brain targeting
Get PDFBackground: Sumatriptan is one of the most essential drugs for treating migraine. However, dosage-related side effects are still a worry despite its 14 % oral bioavailability and recurrence of migraine-associated diseases. Methodology: The fundamental focus of the study is to develop the sumatriptan intra-nasal nano-ethsomal gel by film hydration technique with the aid of QbD principles that govern the varied compositions and blends of polymers like HPMC K100M and Phospolipon 90G to develop a sustained release dosage form. Results and discussion: The preliminary FT-IR and DSC studies revealed no interactions between the drug and their physical mixtures. The present study considered three observable responses: vesicle size, zeta potential, and percent drug release after 24 h, taken into consideration during the optimization of the ethosomal formulations utilizing 32 central composite designs (CCD). The vesicle size (122.23 nm), zeta potential (-40.2 mV), and drug release percentage (92.61 %) for all formulations were seen in the F12 batch after 24h. The p-XRD and SEM studies indicated that the nano-ethosomal gel was stable. The stability studies indicated the preparation of a more stable formulation for the parameters under the study protocol. Conclusion: Using a novel intra-nasal brain targeting approach by adapting the film hydration technique, the current issues might be addressed, and the drug's duration of residence at the absorption site uptake substantially increase. To efficiently modify the drug's residence through the intra-nasal route, this work focuses on developing a nano-ethosomal gel loaded with sumatriptan
Comprehensive review of breast cancer risk factors, diagnosis, screening, and treatment methods
Get PDFBackground: Breast cancer is one of the leading causes of cancer-related deaths among women, accounting for 11.7% of all cancer cases and approximately 685,000 deaths worldwide in 2020. Its multifactorial etiology includes genetic, hormonal, and lifestyle-related risk factors with significant implications for diagnosis and treatment. Understanding these factors and the latest advancements in screening and therapeutic approaches is essential for improving patient outcomes. Methodology: This review synthesizes findings from peer-reviewed articles, clinical trials, and meta-analyses. The focus is on identifying key risk factors for breast cancer, evaluating the effectiveness of current diagnostic methods, and examining the latest treatment strategies, including personalized medicine. Data were collected from PubMed, Scopus, and Google Scholar databases. Results and Discussion: The review highlights major risk factors, including BRCA1/BRCA2 mutations, which contribute to a 45-65% lifetime risk, as well as hormonal influences and lifestyle factors like obesity and alcohol consumption. Targeted therapies, such as HER2 inhibitors (e.g., trastuzumab) and hormone therapies (e.g., tamoxifen), have significantly improved survival rates. Emerging treatments like immunotherapy and PARP inhibitors are also promising for aggressive and metastatic cases. Conclusion: Breast cancer continues to pose a significant health challenge, but advancements in risk assessment, early detection, and personalized treatment offer hope for better outcomes. Continued research and refining diagnostic and therapeutic approaches are essential for reducing breast cancer mortality and enhancing patient quality of life.
Formulation and development of Commiphora myrrha based polyherbal nanoemulsion mouthwash and assessment of its anti-oxidant and cytotoxicity activity
Get PDFBackground: A Commiphora myrrha (CM)-based polyherbal mouthwash with enhanced stability and oral bioavailability was developed using a high-energy homogenization method. Methodology: The formulations primarily consist of herbal extracts from CM, ginger, and white tea, optimized based on various parameters, including organoleptic properties, pH, Dynamic Light Scattering (DLS), and Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy (ATR- FTIR). Stability studies were also conducted on each formulation. Results and Discussion: The particle sizes ranged from 77 to 216 nm, with zeta potential values between -0.92 and -2.09 ± 0.38 mV, indicating stability. ATR- FTIR studies confirmed no interaction between the ingredients. Antioxidant activity was significant, with IC50 values for pure extracts of CM, white tea, and ginger being 0.071 ± 0.003, 0.073 ± 0.004, and 0.066 ± 0.004 mg/ml, respectively. For formulations M1 and M2, IC50 values were 1.030 ± 0.901 and 0.495 ± 0.496 mg/ml, respectively, showing a concentration-dependent increase in antioxidant activity. The MTT cytotoxicity assay showed high cell viability for M1 (96.1%) and M2 (133.3%) at 0.002 mg/ml, suggesting low cytotoxicity, though variability in results indicated further assay optimization. High standard deviations, 0.06 and 0.208, indicated limitations in experimental conditions emphasizing the need for improved assay parameters for accuracy. Conclusion: The mouthwash formulations, M1 and M2 Show promise, with future work focusing on increasing CM concentration and refining cytotoxicity testing methods to ensure reliable data for subsequent antibacterial and in vivo studies
Knowledge, attitudes and practices of Materiovigilance among physicians in a rural tertiary care teaching hospital in Puducherry- a cross sectional study
Get PDFBackground: In India, medical devices are considered as drugs. A medical device may lead to problems either due to a defect during manufacture or transport, improper handling by health care professionals or patients, or failure to comply with recommendations. Aim & Objective: To evaluate the knowledge, attitude, and practice of Materiovigilance among health professionals at the Tertiary Care Hospital. Methods: This was a Cross-Sectional Questionnaire Based study. The questionnaires were circulated among 100 medical professionals. The structured survey tool comprised of two parts. The first part contains demographic data, and the second part consists of 15 questions, with 5 each pertaining to the awareness, attitude, and practice domains. All the data were entered into a Microsoft Excel sheet and analyzed using GraphPad Instat software version 5.0. Results: Medical professionals with above-average knowledge scores were 57 %, and the practice percentage of Materiovigilance was 60%, but there is a positive attitude (72%) towards Materiovigilance. A significant difference was noted Between the knowledge scores of professors and residents (p-value - 0.0491). There was no significant difference in knowledge scores between medical, surgical, and pre/para specialties. However, there was a positive correlation between the knowledge and attitude scores of the medical professionals. Conclusion: We conclude that the Knowledge aspect and also the practice of Materiovigilance among Physicians in our tertiary care hospital is lacking. However, their positive attitude to reporting adverse events is reassuring
Design and evaluation of cost-effective oro-dispersible tablets of venlafaxine hydrochloride by effervescent method
Get PDFBackground: Venlafaxine hydrochloride (VFH) is an antidepressant drug with poor bioavailability due to extensive first-pass metabolism. Objective: In the present study, oro-dispersible VFH tablets were prepared using an effervescent method to enhance patient compliance using a design of experiment (DoE) approach. Methods: A two-factor, three-level 32 full factorial design was applied to investigate the combined effect of two formulation variables: the amount of treated agar and effervescent material (mixture of sodium bicarbonate, citric acid and tartaric acid) on disintegration time and %drug release (Critical quality attributes). Treated agar (12-18%w/w) was used as a disintegrant, and a mixture of sodium bicarbonate, citric acid and tartaric acid (12-16%w/w) was used as effervescent material along with directly compressible excipients to enhance mouth feel. The association between the factors and responses was established by plotting response surfaces and contour plots. A 3D surface plot was used further to evaluate the responses to the factors. Prepared tablets were evaluated for wetting time, hardness, friability, thickness, drug content uniformity, and disintegration time. In vitro, drug release studies and stability studies were also performed. Results: The tablet formulation containing 17.5% w/w treated agar and 16%w/w mixture of sodium bicarbonate, citric acid and tartaric acid was found to be a promising formulation with a disintegration time of 27 seconds and in vitro drug release of 97.38% (in phosphate buffer of pH 6.8). Conclusion: The use of effervescent material was found to be useful for taste masking as well as patient compliance