Halotherapy is the use of dehumidified oxygen or salt aerosol microparticles attached to a face to treat pulmonary conditions. It was first reported as a substitute to oxygen masks for speleotherapy, a healing technique utilized in saline in Eastern Europe since the early nineteenth century. Micronized NaCl (1-5 m) is effortlessly inhaled by the proximal and distal respiratory tracts. At this juncture, it disintegrates in the mucosal sol layer of the upper airways that coats the respiratory epithelium. The objective of this study was aimed to determine the effectiveness of halotherapy in chronic respiratory disease as an adjuvant to physiotherapy. Literature search engines-PubMed, Google Scholar, and Cochrane were used to select articles that reviewed or used halotherapy as the key point in the publications. Database searches were performed to assess the literature available on halotherapy for chronic respiratory disease. 8 studies were included in the narrative review. Studies included in the review held strong evidence for using halotherapy as an alternative to traditional physiotherapy measures. The synthesis of this study shows fair support for the use of halotherapy as an adjunct to physiotherapy in Chronic Respiratory Disorders (CRD), by including salt rooms, Halogenator and traditional halotherapy managements as accustomed to the patient in relieving and resolving symptoms of the same.
Polygonum plebeium R. Br. (Family: Polygonaceae) is commonly known as “small knotweed”. It is used as a traditional medicine by many cultures across the world. In the rural communities of Shahjahanpur, Uttar Pradesh, it has long been practised to treat intestinal symptoms and pneumonia orally, while leaf powder combined with mishri is offered to treat menstruation disorders. It is abundantly found in the regions of Bangladesh, India, Pakistan, and Sri Lanka. It consists of numerous phytochemicals, such as alkaloids, essential oils, flavonoids, phenols, and tannins , and possesses a variety of pharmacological activities, including anticancer, anti-inflammatory, antioxidant, antinociceptive, cytoprotective, and neuroprotective effects. P. plebeium extract has a wide range of pharmacological properties and is used in the treatment of diarrhoea, eczema, inflammation, liver illness, and ringworm. In this review, a comprehensive and methodical search was performed in several prominent scientific databases, such as the Google Scholar, PubMed, Research Gate, Scopus, Science Direct, and Web of Science.
This review explores the evolution of the concept of Healthcare-Associated Pneumonia (HCAP) in light of the 2016 guidelines from the Infectious Diseases Society of America (IDSA). These updated guidelines prioritize patient-specific risk factors over healthcare system interactions in pneumonia classification. Recent research has revealed that the risk of contracting Multidrug-Resistant (MDR) pathogens is more closely linked to individual patient risk factors than to healthcare system interactions. Consequently, administering empiric antibiotic therapy targeting MDR bacteria for patients meeting HCAP criteria is discouraged unless specific risk factors for MDR infections are identifiable. Hospital-Acquired Pneumonia (HAP) is a significant challenge, particularly in intensive care units, leading to elevated hospitalization costs and extended inpatient care. The review also delves into the emergence and global prevalence of Carbapenem-Resistant Acinetobacter baumannii (CRAB) infections, known for their high mortality rates. In response to the rising threat of CRAB infections, the review introduces Sulbactam-Durlobactam (SUL-DUR) as a promising therapeutic solution. It examines the unique characteristics of Sulbactam and Durlobactam, both individually and in combination, and their potential in treating CRAB infections. Clinical trial data is presented to demonstrate the effectiveness and safety of SUL-DUR in addressing Hospital-Acquired Bacterial Pneumonia (HABP), Ventilator-Associated Bacterial Pneumonia (VABP), and bacteremia caused by the Acinetobacter baumannii-Calcoaceticus complex. The review also covers FDA-approved prescribing guidelines, dosage recommendations, adverse reactions, drug interactions, and usage in specific populations, including pregnant and lactating individuals. The management of renal and hepatic impairment and underscores the importance of monitoring for potential overdosage. While initial clinical evidence is promising, further research is essential to establish the full efficacy and safety profile of SUL-DUR.
Impurities are undesired chemical substances found in pharmaceutical drug products with no therapeutic benefits and, in some cases, can pose a risk to patient safety if their levels exceed a certain limit. Impurities present in the drug substance can affect quality, safety and efficacy of pharmaceutical products causing serious health hazards. Generally, when the pharmaceutical products are free from impurities, they would exert the intended therapeutic response. International Council for Harmonization (ICH) has provided guidelines for impurities in new drug substance (ICH Q3A) that provides guidance on the qualification and control of impurities in new drug substance using different thresholds for their evaluation. The current study provides an overview of ICH Q3A, 3C and M7 guidelines applicable for impurities in drug substances. All these guidelines focuses on safeguarding the safety and quality of drug substances by providing recommendations that address the particular type of impurities involved. The study concludes that by understanding regulations for classification and control of impurities in drug substance it gives an idea for the regulators to prepare and compile the documents required in compliance with standard guidelines.
Studying the immunogenicity of insulin is crucial for managing and treating diabetes and other medical conditions. Although insulin therapy is proven effective for diabetic patients, the presence of insulin antibodies can diminish its effectiveness and lead to adverse immune reactions. Understanding the processes and factors affecting insulin immunogenicity is important to improve treatment outcomes and minimize complications. Research indicates that insulin’s immunogenicity is influenced by various structural characteristics such as size, charge, and hydrophobicity. Additionally, factors like insulin dosage, frequency of administration, patient age, gender, genetic background, and mode of insulin delivery contribute to the likelihood of antibody formation. Therefore, optimizing insulin therapy for diabetic patients requires a comprehensive knowledge of insulin immunogenicity and effective insulin antibody detection assays. The development of advanced point-of-care immunoassays has enabled efficient screening for anti-insulin antibodies and assessment of insulin immunogenicity.
Background
The growing popularity of transdermal patches is attributed to their advantageous characteristics, including the absence of gastric-related problems, prolonged drug release, enhanced safety and stability, and the elimination of the need for punctures during systemic delivery. These features have prompted the exploration of novel techniques and innovations in transdermal delivery systems to optimize drug administration.
Materials and Methods
To address the aforementioned advantages, researchers have focused on incorporating innovative approaches, with a particular emphasis on the utilization of nano-vesicular systems. The nano-vesicular system has gained favour due to its potential to significantly increase drug accumulation at the site of administration, its capacity to easily incorporate a wide range of medications, and its ability to minimize systemic drug absorption. This study undertook an examination of the attempts made in the development and implementation of transdermal nano-vesicular administration.
Results
This study revealed the successful adoption and application of nano-vesicular systems in transdermal drug delivery. The results highlight the efficacy of this approach in enhancing drug accumulation at the administration site and its versatility in accommodating various medications. Additionally, the observed low systemic drug absorption further underscores the potential benefits of transdermal nano-vesicular administration.
Conclusion
In conclusion, the study demonstrates the increasing significance of transdermal patches and the promising role played by nano-vesicular systems in addressing key challenges associated with systemic drug delivery. The successful examination of transdermal nano-vesicular administration by the authors emphasizes the advancements in this field and encourages further exploration of its potential applications in pharmaceutical delivery systems.
Recurrent Aphthous Stomatitis (RAS) is a condition characterized by the development of ulcers and lesions, in the mouth. It affects a wide portion of the population ranging from 5% to 25%. RAS more commonly affects labial mucosa, buccal mucosa, and tongue. Managing RAS involves treatment approaches that can be applied directly to the affected area as well as can be administered internally. Topical therapies involve using anesthetics, corticosteroids, and anti-inflammatory agents to alleviate symptoms. Systemic options include medications like colchicine, dapsone, clofazimine, levamisole, thalidomide and zinc supplements. However, for managing RAS no standardized and curative treatments are available. Thus, the objective of any treatment should be to lessen pain, reduce the duration of ulcers, and inhibit recurrence. Also, this work enlists various cells, receptors and pathways which need to be considered while developing an efficient therapy for RAS. Furthermore, herbal remedies can be beneficial in managing RAS without many side effects as in the case of some synthetic drugs. Some herbal treatments that have shown promise include Punica granatum var. pleniflora, Curcuma longa (turmeric), Hangeshinto and many more are reviewed in this work which will be a promising herbal drug to develop polyherbal dosage form for the same.
Personalized medicine, driven by advancements in pharmacology, is revolutionizing healthcare by tailoring medical treatments to the unique characteristics of individual patients. This paradigm shift from a generalized approach to a patient-centric model holds great promise in improving treatment outcomes, minimizing adverse reactions, and optimizing the cost-effectiveness of drug discovery and development. This article explores the concept of personalized medicine and highlights the pivotal role played by advancements in pharmacology in enabling tailored treatment approaches. We discuss key components of personalized medicine, including genomics, pharmacogenomics, biomarker discovery, targeted therapies, and the integration of technology and data analytics. Furthermore, we examine the potential impact of personalized medicine on various medical specialties and healthcare sectors, such as oncology, cardiology, and mental health. The article concludes by emphasizing the need for continued research, collaboration, and investment in pharmacology to unlock the full potential of personalized medicine in improving patient care.
Objectives
The purpose of this study was to assess the potential synergistic and chemo sensitizing effects of the plant-derived flavonoid EGCG (Epigallocatechin gallate) as an adjuvant therapy with doxorubicin in combating chemoresistance.
Materials and Methods
The evaluation was performed on the NCIH-460 non-small cell Lung cancer cell line, where the cells were treated with both EGCG and doxorubicin simultaneously and successionally at different combination ratios. The viability of the cells was anatomized using the SRB assay, and the quantitative assessment of synergism in the combinations was conducted using the Median effect principle and the combination index-isobologram method with the aid of CompuSyn software. To investigate the role of EGCG in doxorubicin-resistant cells and understand the molecular mechanisms underlying synergy and chemo sensitization, the interaction between EGCG and the protein vimentin was examined through in silico methods and confirmed by western blotting in resistant cells.
Results
The results indicated that simultaneous treatment with EGCG and doxorubicin exhibited synergistic effects, particularly at a combination ratio of 1:3 (EGCG:DOXO), which resulted in up to a seven-fold decrease in the IC50 value of doxorubicin. Additionally, EGCG treatment led to reduced expression of vimentin in Doxorubicin-resistant cells, shedding light on the mechanisms underlying synergy and chemo sensitization.
Conclusion
In conclusion, this study demonstrated the potential schedule-dependent synergism of combining EGCG with doxorubicin, providing a rationale for designing chemotherapeutic combinations in the treatment of Non-Small Cell Lung Cancer (NSCLC).
Background
A heterocyclic hydrocarbon having a 5, 5-diphenylimidazolidine heterocyclic ring that possesses distinctive fundamental structural characteristics. It is a fused ring of aromatic di-benzene and imidazolidine. The flexible heterocyclic molecules in 5, 5-diphenylimidazolidine that have two nitrogen atoms. The biological activity of the 5, 5-diphenylimidazolidine ring and its derivatives is significant and encouraging. We produce a variety of 4-(chloromethoxy)- 3-[2,4-dioxo-5,5-diphenylimidazolidine-1-yl) carbonyl] benzene sulfonic acid and its derivatives in this investigation. In literature survey and molecular docking; it was confirmed that 5, 5-diphenylimidazolidine-2,4-dione gives anticonvulsant effects. The pharmacological samples were examined for their ability to prevent convulsions using the strychnine-induced convulsion method.
Materials and Methods
Benzoin; Benzil; Urea; Glacial Acetic Acid; 4- amino benzoic acid; Con. HNO3; Formic Acid; 2- Nitro Aniline; 4- Nitro Aniline; Aniline; Acetyl Chloride; Formic Acid; 4- amino Phenol are used for the synthesis.IR, NMR and MS are used for interpretation.
Results
Our research led us to the conclusion that a variety of compounds have strong anticonvulsant properties. The compound 4-(2-chloro-N-(2-phenoxymethyl) aniline)-3-[2,4-dioxo-5,5-diphenylimidazolidine-1-yl) carbonyl] sulfonic acid (SSW5)- (scheme II A); 4-(3-chloro-N-(2-phenoxymethyl)aniline)-3-[2,4-dioxo-5,5-diphenylimidazolidine-1-yl) carbonyl] sulfonic acid (SSW6)- (scheme II A); 4-(2,5-dichloro-N-(2-phenoxymethyl)aniline)- 3-[2,4-dioxo-5,5-diphenylimidazolidine-1-yl) carbonyl] sulfonic acid (SSW7) (scheme II A) and 4-(N-(2-phenoxymethyl)aniline)-3-[2,4-dioxo-5,5-diphenylimidazolidine-1-yl) carbonyl] sulfonic acid (SSW3) (scheme II A) gives strong anti-convulsant effects against phenytoin drug.
Conclusion
The title compounds and its derivatives were examined for their ability to treat convulsions. Studies of the relationship between structure and activity revealed that compounds containing 5, 5-diphenylimidazolidine derivatives that have an electron-withdrawing group have higher activity than those that have an electron-donating group.
Background
High Blood Pressure (BP) is a dreadful condition worldwide. Available scientific data confirms the antihypertensive potential of traditional plants. Present study was aimed to assess the blood pressure lowering effect of hexane (MURK-HEX), ethyl acetate (MURK-EA) and methanol (MURK-MeOH) extracts of Murraya koenigii leaves in L-NAME induced hypertensive rats with possible mechanism of action.
Materials and Methods
Air dried leaves of “ Murraya koenigii” were extracted with different organic solvents namely methanol (MURK-MeOH), Hexane (MURK-HEX) and ethyl acetate (MURK-EA). Wistar rats of either sex were used in the study. Hypertension was developed by L-NAME and then data was collected after jugular vein cannulation using Oscillograph and powerlab data acquisition system. For possible mode of action muscarinic pathway was chosen. Data was analysed using SPSS-20 by applying independent sample t-test.
Results and Discussion
The invasive method revealed that “MURK-HEX”, “MURK- EA” and “MURK- MeOH” extracts exhibited significant dose dependent (18.8-50.1) % fall in MABP at the log doses (1,3, 5, 10 and 30 mg/kg) in normotensive rats. Except, “MURK-HEX”, the “MURK-EA” and “MURK-MeOH” altered the BP lowering effect, when these extracts followed by “Atropine” (Atr 10-4M) via intravenous route. Results demonstrate that MURK- EA and MURK-MeOH showed the involvement of muscarinic receptors while hypotensive effect of MURK-HEX may mediate via another pathway. In L-NAME induced hypertensive rats, MURK-HEX, MURK- EA and MURK- MeOH exhibited an immediate (18.37-51.93% falls) in MABP but it did not persist for longer time.
Conclusion
Murraya koenigii caused a significant decrease in MABP by the stimulation of muscarinic receptor in activation of EDRF which release nitric oxide to produce vasorelaxation.
Background
The development of micro-organism resistance in humans and the environment has been linked to the inadequacy of conventional treatment methods in completely eliminating antibiotics. The purpose of this research is to look at the potential for eliminating Amoxicillin (AMO) from aqueous environments using Nickel (II) Oxide Nanoparticles (NiO nanoparticles).
Materials and Methods
In order to determine how successful NiO nanoparticles are in eliminating AMO, the impact of many important adsorption process factors, such as the initial concentrations of AMO (10-50 mg/L), pH (3-10), adsorbent dose (0.1-1 g/L), mixing rate (50-300 rpm), contact time (10-100 min), and temperature (15-45°C) was examined.
Results
The greatest AMO removal efficiency was 99.48% at pH=7, 0.8 g/L of adsorbent, and contact time of 60 min. The endothermic nature of the adsorption process was suggested by the positive value of ΔHo. The observed physical adsorption was consistent with the ΔHo evolved during adsorption, which was less than 40 KJ/mol. The negative value of ΔGo demonstrated that AMO absorbed on the NiO nanoparticles was a spontaneous process.
Conclusion
Accordingly, NiO nanoparticles could be employed as a successful adsorbent to eliminate AMO from pharmaceutical wastewater.
Background
The most prevalent lifestyle diseases are Diabetes Mellitus type 2 (DM2) and Hypertension (HTN), especially in older age groups, which leads to Chronic Kidney Disease (CKD) as the most possible comorbidity. Management of HTN involves various drugs with fixed doses and combinations, while specialized regimens are implemented for patients with other comorbidities like DM2 and CKD. Treatment of blood pressure in diabetics is complicated and requires combinational therapy with regular monitoring of both blood pressure and blood glucose to prevent diabetic nephropathy. Chronic Kidney Disease (CKD) describes the gradual loss of kidney function, and it is the major complication of DM and HTN. Management of CKD involves determining the cause of disease and eliminating or controlling it, with most CKD cases intensified by HTN, DM, infections, hypovolemic conditions, and salt intake. Despite the fact that lifestyle modifications and pharmacological interventions are frequently necessary to achieve the best blood pressure goals in patients with diabetes and CKD.
Materials and Methods
This cross-sectional study collected data on 300 patients, of whom 200 had type 2 diabetes and 100 had CKD as concomitant diseases and were regularly using anti-hypertensives.
Results
The results of our study are astonishing because minimizing or avoiding risk factors like alcohol and smoking have improved the patient condition significantly in both DM2 and CKD, along with HTN. Starting with ACEi and ARBs initially had a great impact on achieving the blood pressure goal in DM2. Specific beta blockers are recommended in patients with CVD risk. Salt restriction, using antihypertensives like ARBs, and CCBs are used predominantly to treat blood pressure and proteinuria in CKD patients. Diuretics are implemented to treat symptoms like edema and low urine output, to reduce fluid overload on the heart, and to prevent heart failure.
Conclusion
The clinical pharmacist plays an important role in designing the therapeutic regimen and lifestyle changes for the best patient outcome.
Background
Ureteric stones, characterized by the crystallization of mineral particles in stagnant urine, cause considerable discomfort and pain. Alpha-blockers are employed in the management of ureteric stones to alleviate symptoms by dilating the ureter and facilitating stone passage. Alpha-blockers have proven to be effective in improving the clinical outcomes of patients with ureteric stones, with Silodosin, Alfuzosin, and Tamsulosin emerging as promising options.
Aim and Objectives
This study aims to evaluate the effectiveness and safety of Silodosin, Alfuzosin, and Tamsulosin in treating ureteric stones. It assesses their performance in patients at a Tertiary Care Hospital, aiming to identify the most suitable alpha-blocker for optimum outcomes.
Materials and Methods
The study involved 60 patients with ureteral stones treated at the Urology Department of Dhiraj Hospital. Patients’ responses to a structured questionnaire assessing variables related to ureteric stone development were collected. Physical examinations, along with radiological confirmation through X-ray, Ultrasound (USG), and CT-scan, were conducted. A 15-day follow-up assessed the efficacy of alpha-blockers. Statistical analysis and paired t-tests were employed to compare the drugs’ effectiveness.
Results
Silodosin demonstrated the highest stone expulsion rate at 95%, whereas Tamsulosin exhibited a 50% rate, and Alfuzosin recorded a 10% rate. Minimal side effects were observed, such as nausea, vomiting, and diarrhea, which were typical for patients with ureteric stones.
Conclusion
Silodosin emerged as the most effective alpha blocker for promoting stone expulsion and ameliorating ureteric stone symptoms when compared to Tamsulosin and Alfuzosin. It is considered a pharmacologically superior choice for patients with ureteric stones, making it a valuable option in clinical practice.
Background
Geriatric populations have at high probability of getting drug-related issues due to age-related pharmacokinetic and pharmacodynamic changes. Ageing populations are more prone to have DRPs due to age, drug characteristics, polypharmacy, and multiple comorbidities. The study aimed to assess the DRP in geriatric patients attended a tertiary care teaching hospital.
Materials and Methods
The study was a prospective observational study which was carried out for a duration of 6 months involving inpatients of Vivekananda General Hospital. PCNE classification V 9.1 was used to assess the drug-related problems.
Results
In this study, 210 geriatric patients were analysed, among which 161 were males and 49 were females. The mean age of study participants was 69.5 (±5.0) years. Among overall population, 193 (91.9%) subjects were reported with comorbidities. The most common chronic disease was hypertension (43.4%), and the least was found to be Hypothyroidism (1.6%). Comorbidities were assessed based on charlson comorbidity index, where the mean score of comorbidities was 3.86 with 54% survival rate in 10 years. The subjects were analysed for DRPs using PCNE classification V9.1, among which 132 prescriptions contain 299 DRPs. Drug-drug interactions were the highest observed DRPs (107). Other DRPs were found within the Problem domain (23.07%), Cause domain (43.47%), planned interventions (16.72%), Intervention acceptance (11.70%) followed by Outcome domain (5.01%) of PCNE classification.
Conclusion
Our study highlights that importance of pharmaceutical care among the geriatric patients. Special emphasized care must be given to elderly population to avoid DRPs due to presence of comorbidities, polypharmacy and illiteracy.
Background
Staphylococcus aureus is an adaptive and versatile microorganism that can cause a wide range of ailments, from intense and short-lived infections to persistent infections that are difficult to cure. Even though S. aureus infections could once be treated with ordinary antibiotics, the rise of drug-resistant organisms is currently a major issue. Numerous antibiotics were used to treat Staphylococcus aureus infections, but over time, the bacteria eventually developed resistance to multiple drugs. Since then, Methicillin-resistant Staphylococcus aureus (MRSA) strain-related nosocomial infections have increased in frequency. Recent advances in bioinformatics and silico screening have boosted our rate and chances of discovering medicinal metabolites.
Objectives
In this study, we understand and analyse the binding efficiency of Staphylococcus aureus C0673 with three existing antibiotics employing molecular docking studies.
Materials and Methods
The genomic sequence of Staphylococcus aureus C0673 is retrieved from the Ensemble bacteria database (GCA_00 0638495) and docked with three currently prescribed antibiotics, i.e., Gentamicin, Linezolid and Norfloxacin using HDOCK server.
Results and Discussion
In the present study Gentamicin, Linezolid and Norfloxacin effectively bind with Staphylococcus aureus C0673. Based on the docking score, the efficiency of the compound against the bacterial protein was assessed. Gentamicin shows higher binding affinity when compared to the other two compounds. Hence, Gentamicin can be considered an eligible candidate by combining with novel medicines to treat the Multi-Drug Resistant protein of Staphylococcus aureus.
Conclusion
From this research investigation, we conclude that multidrug resistant antibiotics efficiently bind with Staphylococcus aureus C0673. The results obtained from this study play a major role in the field of current bacterial informatics studies.
Background
Nyctanthes arbortristis Linn., popularly referred to as Parijat or Night-flowering Jasmine, has garnered significant attention in traditional medicinal practices owing to its wide-ranging array of phytochemical constituents. The focus of this study lies in the molecular docking investigations conducted on a specific phytoconstituent isolated from this plant.
Materials and Methods
The phytoconstituent was extracted from Nyctanthes arbortristis Linn. through rigorous isolation and purification techniques. Its chemical structure and purity were characterized using state-of-the-art spectroscopic and analytical methods, including UV, 1H NMR, IR, and HPLC. The molecular docking analysis of phytoconstituent with (target) proteins was carried out using Schrodinger (V5.0).
Results and Discussion
Crocetin, a carotenoid compound, was derived from the ethanolic extract of Nyctanthes arbortristis Linn. seeds. In the molecular docking analysis, the binding scores of the compound with the binding sites of PDB ID: 2FGI, 1ERE, 3K23 and 2GHM were -7.956, -8.246, -7.530, and -5.625 kcal/mol, respectively. Conclusion: The isolated chemical, crocetin, has the potential to be an effective anticancer agent, according to computational analyses.
Background
Olanzapine causes alterations in lipid and glucose metabolism, indicated by weight gain, and altered metabolic profiles. Hesperidin has been related to numerous positive health benefits including improvements in cardiovascular and metabolic function making it a potentially suitable candidate to counteract the negative effects of olanzapine treatment. Hence the purpose of the study is to investigate the effect of hesperidin on olanzapine-induced weight gain, and associated lipid and glucose metabolic dysfunctions in female Sprague Dawley rats.
Materials and Methods
Olanzapine (2 mg/kg b.i.d. i.p.) was administered for 28 days to induce weight gain, dyslipidemia and insulin resistance in rats. Hesperidin was tested at doses of 50, 100, 200 mg/kg p.o. over 28 days. Body weight, food intake, and water intake were noted daily. Locomotor activity was recorded weekly. Novel object recognition test, Oral glucose tolerance test, and Homeostatic Model Assessment for Insulin Resistance and antioxidant biomarkers were measured followed by histopathological examination.
Results and Discussion
Treatment with hesperidin notably reduced the weight gain and hyperphagia brought on by olanzapine administration. Significant improvement in locomotor activity was observed upon hesperidin administration. Further, hesperidin resulted in a significant improvement in the discrimination ratio in the Novel object recognition test. Administration of hesperidin significantly reduced the glucose intolerance, insulin resistance and dyslipidemia induced by olanzapine treatment. Furthermore, leptin and adiponectin levels were significantly improved upon hesperidin administration. Additionally, there was a significant improvement in anti-oxidant biomarkers followed by amelioration of histological examination.
Conclusion
In conclusion, it was found that hesperidin reduced weight gain, and improved lipid, and glucose dysregulation caused by olanzapine administration. Additionally, it mitigates olanzapine-induced changes in plasma levels of leptin, and adiponectin. Hesperidin also improved cognitive behavior in olanzapine-treated rats.
Background
Clinical Pharmacy Services (CPSs) is a branch of health sciences which render patient care by optimizing pharmaceutical therapy and providing guidance to patient regarding health, medications and disease prevention. The implementation of CPSs is required to provide safe, effective and economical drug therapy.
Objectives
The aim of our study is to assess the knowledge and attitude of HCPs and students towards CPSs in Southern India.
Materials and Methods
A cross-sectional study was conducted in selected pharmacy, nursing, medical and ayurvedic colleges and selected tertiary care hospital located in Southern India. The pre and post-test questionnaires were used as a tool to gather the data for the study. The frequency, percentage, mean and standard deviation were calculated for continuous variables and the categorical variables were calculated as frequency and percentage.
Results
A total of 632 questionnaires were responded out of 663 handed out with a response rate of 95.3%. Most of the respondents (441; 69.7%) are between the age 17 and 20 years, with a mean age of 21.1±5.88. Most of the students (507; 85.2%) and HCPs (34; 91.8%) heard about the services and the majority of them responded that they have clinical pharmacist in the hospital in which they are currently practicing. After conducting the awareness session, the major part of students (557; 93.6%) and HCPs (35; 94.5%) responded that they knew CPs were the integral part of medical team.
Conclusion
The study found that students and HCPs had shallow knowledge and positive attitude regarding CPSs and an incremental response was observed after the awareness session. Thus more and more educational programs should be conducted in healthcare settings to clearly define the scope of CPs.
Background
Mesalamine produces many side effects through oral route such as stomach cramps, throat irritation, back ache and muscle pain. Furthermore, it failed to yield maximum drug release and also not able to produce the drug release for over a period of time at the target site. To overcome these disadvantages, the current research proposed to develop microspheres with pH-dependent bio-resorbable polymers to obtain site-specific controlled drug release at the target site.
Materials and Methods
Microspheres were prepared by two methods as ionic gelation and solvent evaporation methods using copolymers such as Eudragit S 100 and PLGA.
Results
The prepared formulations were characterized for multiple parameters and the particle size ranges were found in between 5.52 to12.56 μm whereas percentage entrapment efficiency was found in the range of 32 to 98% respectively. Apart from other formulations, PLGA microspheres showed the maximum cumulative percentage drug release through in vitro and ex vivo and the results were found as 96±0.1% and 90.8±0.8% respectively. As compared to Pentasa®, PLGA microspheres showed two folds increase in drug release. The PLGA biodegradability was observed as maximum in the caecal content than other formulations.
Conclusion
Compared to Pentasa®, the prepared PLGA microspheres showed the best results and the obtained result was verified with a p-value which is shown <0.005. Based on the results, it was concluded that the prepared PLGA microspheres showed better-controlled drug release than other test formulations.
Background
Antimicrotubule agents effectively block cancer spread and are routinely employed as front-line chemotherapeutics. But patients, who receive Paclitaxel, suffer from peripheral neuropathy, which not only lowers quality of life but also can lead to treatment termination. Therefore, it is essential to identify novel microtubule inhibitors that can act as future front-line chemotherapeutics. In our previous study, we synthesized a cohort of 23 benzothiazolo[3,2-a] quinazoline derivatives employing a tandem copper catalyzed regioselective N-Arylation and aza-michael additions. However, the bioactive potential of the benzothiazolo-quinazoline derivatives are unknown. The synthesized benzothiazolo-quinazoline derivatives structurally resemble the microtubule inhibitors colchicine and CA-4. Therefore in this study; we asked whether benzothiazolo-quinazoline congeners act as microtubule inhibitors.
Materials and Methods
To answer the question, we treated benzothiazolo-quinazoline congeners in a panel of four cancer cell lines and elucidated the molecular mechanism of action of the hit compounds in vitro and in vivo.
Results
We found that benzothiazolo-quinazoline derivatives: 1-3, 6, 10, and 21-23 exhibited superior inhibitory effects with IC50 values ranging from 4.2-12.1 μM in HeLa cells. We observed that 1-3, 6, 10, and 21-23 arrest cells in G2/M phase and disrupt microtubule network. In addition, we found that the selected congeners increase transcript and protein levels of mitotic markers. As part of mechanism, we observed that the congeners 1-3, 6, 10, and 21-23 promote tubulin depolymerisation similar to nocodazole, a microtubule depolymerising agent. Further, molecular modelling studies have shown that the congeners occupy the colchicines binding pocket in microtubule. We observed that the congeners 1-3, 6, 10, and 21-23 disrupt blood vessel formation in chick eggs and arrest Zebrafish embryo development.
Conclusion
We conclude that the congeners 1-3, 6, 10, and 21-23 function as antimicrotubule agents. Based on observations, we suggest that the congeners can be lead-optimized to generate next generation of frontline chemotherapeutics.
Background
Cardiovascular Disease (CVD) commonly known as disease of heart blood vessels and is typically composed of fatty deposits. The WHO estimates that approximately 17.3 million people worldwide die each year from CVD.
Purpose
To identify DRPs, and assess the Health Related Quality of Life in the study population.
Materials and Methods
A Prospective observational study was carried out on 210 patients in the cardiology department over 6 months. DRPs were identified by using the PCNE tool 9.1 version. The Health-Related Quality of Life was measured by using the SF-36 questionnaire in cardiac patients.
Results
Among 210 subjects, 205 subject profiles were identified with 520 DRPs, which included 166 drug interactions, 37 problems related, and 147 causes related, a total of 50 interventions were found and accepted, so the outcome of the intervention is 50. significant correlation was observed in the physical function domain of HRQoL, age in Physical functioning, Role limitation due to physical health, and General health and also reported significant correlation of age in Energy/fatigue, Emotional well-being and Role limitation due to emotional problems.
Background
Mucoadhesive buccal tablets are well established, widely used, and commonly accepted oral dosage forms that, by virtue of their adhesiveness, allow the drug to be released gradually over an extended period. Various parameters of the polymers being used in the formulation affect their adhesiveness. This includes the molecular weight, concentration, chain length, flexibility, hydration, and hydrogen bonding.
Materials and Methods
Ondansetron, an antiemetic drug that is a selective 5-HT3 serotonin receptor antagonist, was formulated as a mucoadhesive buccal tablet consisting of guar gum, xanthan gum, Locust bean gum, microcrystalline cellulose, magnesium stearate, and silicon dioxide. The formulation consisted of nine batches with batch codes ranging from F1 to F9, which involved the use of various polymer combinations and concentrations to create a homogenous powder mixture. The tablets were formed in a single-punch tablet compression machine.
Results and Discussion
The study analyzed the physicochemical characteristics of Ondansetron and its excipients, revealing a melting point of 232°C and high solubility in various solvents. The formulation’s pH was found to be within acceptable range for saliva, and the weight variation test showed average percentage variation within limits. The highest mucoadhesive strength was found in tablets with increased amounts of mucoadhesive polymers like guar gum, xanthan gum, and locust bean gum F7-F9. The release studies showed that F9 followed Fickian drug release transport, while F1 to F8 followed non-Fickian drug release transport, resulting in sustained or controlled release effects.
Conclusion
The study uses sustained-release polymers like guar gum, xanthan gum, and locust bean gum to create mucoadhesive ondansetron tablets for treating emesis in chemotherapy. The transmucosal buccal route is optimal for oral administration, with formulations extending drug release for up to 24 hr without local irritant effects. The formulation is successfully synthesized, having optimal drug release to produce desired therapeutic outcomes.
Purpose
The study aimed to formulate and evaluate an ocular effective prolonged release cubogel formulation of Moxifloxacin Hydrochloride (MX-Cubogel) to treat conjunctivitis.
Materials and Methods
Initially, a Moxifloxacin-loaded cubosome (MX-Cubosome) was prepared using a top-down technique using glyceryl monooleate and poloxamer 407 in different concentrations. The optimized MX-Cubosome was selected based on the physicochemical characteristics and was used to prepare MX-Cubogel by dispersing the cubosome into an in situ gelling system using the cold method. Physicochemical characterization, drug-polymer interaction studies, and histopathological studies were performed.
Results
Twelve MX-Cubosomal dispersions were prepared. The cubosomes were consistent, aggregate-free, and milky white. Particle sizes ranged from 306.5 to 714.2 nm, with a uniform size distribution. Zeta potentials were between -27.9 and -39.8 mv and encapsulation efficiencies ranged from 69% to 85%. Electron microscopy confirmed the nano-sized structure of the cubosomes. The MX-Cubogels were clear, with no visible impurities. Four formulations (MB11, MB12, MB15 and MB16) gelled immediately and remained stable over time. The gelation temperatures of the majority of formulations were between 28°C and 43°C. MX-Cubogels had a drug content of 92.5% to 97.7%. Four formulations (MB4, MB7, MB10 and MB13) released more than 95% of the drug over 12 hr. The antibacterial activity of the MX-Cubogels was demonstrated by an inhibition zone of 32 mm, which was greater than the standard (27 mm). Histological examination of goat corneas treated with selected formulations (MB4, MB7, MB10 and MB13) showed normal structures, with no changes in the epidermal layer after cubosomal formulation penetration.
Conclusion
The study demonstrates that MX-Cubosome dispersions can be successfully formulated as in situ gels (MX-Cubogel) with sustained release and antibacterial activity. The gels are also non-irritating to the cornea. MX-Cubogel might be a good alternative to conventional eye drops.
Background
The present study deals with the detailed pharmacognostic investigation of Sidhha single drug, the stem of Cissus vitiginea L. It is a climber that belongs to the family ‘Vitaceae’ with a pantropical distribution throughout India and Sri Lanka. In dried form, identification of the specific plant is difficult at present due to the lack of authentic pharmacognostic data related to this specific plant part.
Materials and Methods
In order to prevent the adulteration of medicinal components, the stem of C. vitiginea was subjected to different pharmacognostic studies, physicochemical analysis, FT-IR and HPTLC fingerprinting.
Results and Discussion
In the microscopical studies, the unique and elaborated anatomical structure is detailed with evidence of powder microscopic characters like trichomes, elongated fibres, raphide sacs, acicular crystals and different arrangements like xylem vessels with perforation plates observed. The results from the HPTLC fingerprint scanned at wavelengths 254 nm, 366 nm, and 575 nm for alcohol extract of stem of C. vitiginea L. confirmed the presence of different phytoconstituents revealed by the FT-IR analysis.
Conclusion
All the pharmacognostic characters and physicochemical parameters of stem of C. vitiginea L. could be useful in the identification and standardization of a crude drug.
Background
Fumaria parviflora (FP) is a medicinal herb that is used in several traditional medicines to treat diseases like folliculitis, erysipelas. Fumaria parviflora Lam. belonging to the family Papaveraceae is used widely in traditional and folkloric medicine. It is known as ‘Pittapapra’ in Ayurveda, and ‘Shahtaraa’ in Unani is used to treat various ailments like indigestion, vomiting, fever, and fatigue. It is showing properties like anthelminthic, diuretic, diaphoretic, and blood-purifying properties. The present study is done to evaluate the antibacterial and antifungal properties of the extract.
Materials and Methods
The plant extract was isolated by using a Soxhlet apparatus by using ethanol as the solvent. The extract was filtered using filter paper and heated in the oven to obtain the plant extract concentrate. The o/w emulsion-based cream was evaluated for pH, viscosity, thermal stability, spreadability, antibacterial (S. aureus and E. coli) and antifungal (C. albicans and A. niger) activity.
Results
The o/w emulsion-based cream formulations were found to be stable, found to have pH compatible to human skin, no skin irritancy and also have good spreadability properties, and found to be effective against bacterial cells but no considerable effect on fungal cells.
Conclusion
The o/w emulsion-based cream formulations were examined for both antibacterial and antifungal activities but from the results we concluded that Fumaria parviflora Lam. is found to be effective against bacterial cells and useful in treating bacterial skin infections.
Background
The need of developing a vaccine on emergency basis to COVID-19 has captured the attention of the regulator during the recent pandemic. There is no comprehensive regulatory pathway for the development of a novel candidate provided in India.
Materials and Methods
The COVID-19 vaccines were developed and approved in a short duration when compared to the historical timelines. A questionnaire was sent to the manufacturers of COVID-19 vaccine and collected the information of various regulatory approvals obtained for the development of the vaccine, clinical trials conducted along with the details on their design, conduct and assessment.
Results and Discussion
Based on the data collected the time to approval and the innovative measures such as application of adaptive clinical trial design, comparator, rolling review by the regulator, end point, functional antibody, animal challenge study etc were tabulated. The details of the expert review were collected from the NRA website. The approval was based on the totality of evidence from all the parameters.
Conclusion
Based on the data obtained from the questionnaire and the gaps and best practices collected from the manufacturers an algorithm for the approval of the novel candidate vaccine during an epidemic is proposed. This algorithm if adopted, would expedite the development of Novel Candidate Vaccine in India.
Background
This study investigated the biosynthesis of Copper Oxide Nanoparticles (CuONPs) using an environmentally safe and sustainable approach based on Amaranthus tricolor extract.
Materials and Methods
The synthesized CuONPs were characterized using various analytical techniques, including X-ray Diffraction (XRD), scanning electron microscopy (SEM), and Fourier-Transform Infrared Spectroscopy (FTIR). The antioxidant activity of the CuONPs was assessed using different in vitro assays, including the (2,2-diphenyl-1-picrylhydrazyl) radical scavenging assay and cytotoxicity against MCF7 breast cancer cells.
Results
The presence of several functional groups such as amides, hydroxyl groups, alcohols, and alkenes was verified by Fourier-Transform Infrared (FTIR) analysis. Scanning Electron Microscopy (SEM) was used to analyze the morphology of the CuONPs produced from Amaranthus tricolor, which exhibited spherical CuONPs with distinct cell-spreading patterns. The elemental composition of the CuONPs was validated by X-ray Diffraction (XRD), which revealed typical peaks related to Copper (Cu) and Oxygen (O2). CuONPs demonstrated dose-dependent cytotoxicity against MCF7 breast cancer cells, with Inhibitory Concentration (IC50) values of 84.24 g/mL and 76.85 g/mL, respectively. These findings emphasize the potential of CuONPs as selective anticancer agents.
Conclusion
This work demonstrates the effective synthesis and diverse characteristics of CuONPs obtained from Amaranthus tricolor. These discoveries have broad implications in nanomedicine, antibacterial methods, and antioxidants. Furthermore, this study emphasizes the specific cytotoxicity of CuONPs against cancer cells, stressing their potential in targeted cancer therapy.
Background
The bioavailability of the drug is influenced by the solubility of the drug in the biological fluids. Solubility and dissolution are the rate-limiting steps for the absorption and bioavailability of BCS class II drugs.
Materials and Methods
In the current work, Efavirenz (EFV) has been selected as a model drug for the development and assessment of Solid Dispersion (SD) by solvent evaporation and fusion methods using sugar-based carriers like xylitol, Sorbitol, lactulose, and one nonsugar carrier surplus. First, the drug was assessed for solubility in various solvents. EFV Solid Dispersions (S.D.s) have been produced by solvent evaporation and fusion at different carrier ratios (1:0.5, 1:1, 1:1.5, 1:2, and 1:3). The prepared SDs were subjected to drug content uniformity, saturation solubility studies, and in vitro dissolution studies.
Results
Preformulation investigations, such as FT-IR, proved that the excipient and drug molecules are binding with intermolecular hydrogen bonds. EFV was found to be more soluble in 7.4 pH phosphate buffer than in the other solvents. The saturation solubility of EFV was affected by carrier concentration and %yield, and in vitro drug dissolution studies were performed on the S.D.s. Pure EFV released 54.78% of the drug, whereas SDs by solvent evaporation method released 85.28± 1.84%-100.74±1.69% drug, and SDs prepared by fusion method released 76.65±0.98%- 99.28±1.95% of the drug in 60 min.
Conclusion
SDs of EFV prepared by solvent evaporation and fusion methods have improved the aqueous solubility of EFV, and, in turn, improved the in vitro drug release, and formulation with 1:1.5 drug-to-carrier ratio has been selected as an optimized formulation.
Background
Hypertension is a chronic long-stay disease that requires proper treatment management and regular medication assessment, which ensure that the disease does not progress into a disorder. Medication Adherence is an easy access and assessable tool that provides insights about patient compliance to medications and effectiveness of therapy. This helps the physicians to improve patient treatment outcomes and quality of life by addressing the factors that influence medication adherence.
Objectives
To assess patient compliance to antihypertensive medications and factors that influence medication adherence.
Materials and Methods
A prospective Observational study was conducted in a tertiary care teaching hospital in Hubli among 200 hypertensive patients, the study subjects were selected based on inclusion and exclusion criteria, data was collected and sorted from patient data collection forms. Medication adherence rating scale was used to assess medication adherence among patients. The association between variables such as age, social status, co-morbidities and polypharmacy with medication adherence was determined using Pearson chi-square in SPSS version 25.
Results
Our study included 200 hypertensive patients, most of them were males 64%. On assessing Medication adherence rating scale, we found that majority 62.8% of the study subjects adhere to their antihypertensive medication. The association between various factors that influence medication adherence was determined by Pearson Chi-square, we observed that age, social status, co-morbidities and polypharmacy were statistically significant at p=<0.05 with medication adherence.
Conclusion
Medication adherence plays a significant role in assessing the patient’s response to a treatment and improving their quality of life. Similarly, our study highlights the importance of assessing medication adherence, especially in study subjects with existing co-morbidities and polypharmacy, thus reducing hospital stays and unnecessary side effects.
Background
Wound healing is a complex physiological process that involves a cascade of events, from inflammation to tissue remodeling. Impaired wound healing can lead to chronic wounds, which are painful and susceptible to various infections, including fungal ones. Candida and Cryptococcus infections are particularly troublesome due to their resistance to conventional treatments. In this context, hydrogels have emerged as promising drug delivery and wound management vehicles.
Materials and Methods
The hydrogel, made from 5-flucytosine, chitosan, and pectin, provides a moist environment for wound healing and creates a barrier against infections. In this study, four hydrogel formulations containing 5-FC, chitosan, pectin, and 0.1 M HCl were developed and. they were optimized for various parameters, including drug concentration, polymer ratio, and crosslinking density. Dependent variables maximize drug release, gel stability, and other desired properties. Hydrogel Base includes natural and synthetic material that exhibits desirable properties, such as high water absorption capacity and gel stability.
Results
Formulations evaluated for their compatibility, Physical properties, Spreadability, Viscosity, Rheological studies, pH, Ex vivo Skin Permeation Study, Structural and Morphological Analysis, Swelling Index, Anti-fungal Activity Studies, the hydrogel’s effectiveness against C. albicans was demonstrated in an experiment, with the F-3 formulation showing the most effective anti-fungal properties.
Conclusion
The 5-FC hydrogel presented a significant step towards addressing the challenges posed by chronic wounds and fungal infections.
Background
The Advent of the COVID -19 pandemic has necessitated the quick exploration of new drugs. Synthetic approach is time consuming and expensive with uncertainty. The natural products can be explored as this approach is cost effective and takes less time to investigate. The ethnic significance of Grewia hirsuta has given clues of Immunomodulator potential. Hydro ethanolic extract of Grewia hirsuta was explored and compared with established levamisole.
Materials and Methods
In vitro, immunomodulator models on human lymphocytes and In vivo carbon clearance model in Swiss albino mice were studied by lymphotoxicity and lymphocyte proliferation.
Results
Hydro ethanolic extract of Grewia hirsuta has shown similar results of immunomodulation comparable with levamisole in statistically significant studies assessed by Dunnett’s test.
Conclusion
Hydro ethanolic extract has shown decreased lymphocyte toxicity and increased lymphocyte proliferation.
Background
Magnetic nanoparticles are valued in medical applications for their distinctive properties. In this study, we synthesized magnetic nanoparticles with the aim of employing them for drug delivery.
Materials and Methods
The nanoparticles were synthesized through the co-precipitation of ferric and ferrous salts. Subsequently, these nanoparticles were incorporated into a sodium alginate-gellan gum polymeric matrix and prepared into microbeads by the ionotropic gelation method. The microbeads underwent characterization through various techniques.
Results and Discussion
In vitro release studies were conducted to assess the release of amikacin sulfate from the microbeads, and to examine the influence of crosslinking agents and polymer concentrations. Our findings suggest that the microbeads effectively control the release of amikacin sulfate.
Conclusion
Our study demonstrates the potential of magnetic nanoparticles in drug delivery, particularly through sodium alginate-gellan gum microbeads as controlled-release carriers, offering promising prospects for medical applications.
Background
Amoebiasis, caused by the human pathogen Entamoeba histolytica is one of the most common parasitic diseases. The existing anti-amoebic drugs show significant side effects in humans. Therefore, for effective control of this parasite, an alternative strategy is required. Microorganisms having probiotic potential are gaining global importance due to their health-promoting effects along with the safety aspects. Therefore, the present study aimed to isolate new lactic acid bacterial strains having anti-amoebic activity as well as probiotic potential from a traditional fermented beverage consumed by an Indian tribal community.
Materials and Methods
Twenty bacterial isolates have been selected based on their tolerance ability towards acid and bile salt. Their biofunctional aspects and anti-amoebic potential are studied. The most potential one was chosen through heatmap visualization and principal component analysis based on probiotic attributes. Finally, the opted isolate was studied for its in vivo safety evaluation using mouse model.
Results and Discussion
The isolates were found as Gram positive, catalase negative and able to ferment different carbohydrates. They showed significant killing activity against Entamoeba histolytica. They were found to have a high tolerance to gastrointestinal stresses, antioxidant activity, sensitivity to various antibiotics, high auto-aggregation activity (up to 28.78%), cell-surface hydrophobicity (up to 78.75%) and antibacterial activity. Their negative activity in gelatin hydrolysis and haemolysis assay indicates that they are safe. From 16s rDNA sequencing, they were found to be Limosilactobacillus sp. Among the isolates, B-51 was considered as the best probiotic strain by heatmap visualization and principal component analysis. Importantly, the strain B-51 showed beneficial effects in mice when supplemented through oral gavage.
Conclusion
The isolated strains from rice fermented beverage showed anti-amoebic activity along with interesting probiotic traits. The in vivo study findings of the best one proved its potential for therapeutic application in humans.
Background
With a high incidence and prevalence of Diabetes and an increase in population of elderly, reports project the number of diagnosed diabetes cases among people 65 years and older will grow more than 4-fold from 2005 to 2050. Diabetes has been identified as a potential risk factor requiring hospitalisation for SARS-CoV-2, Due to mechanisms like chronic inflammation, impaired immune response, etc. Madhumeha (Diabetes) is a condition with depletion of Ojus. Thus, Rasayana Chikitsa is an imperative requirement to manage the disease and to prevent the complications. Increased awareness amongst large population groups should be a major determinant for the prevention of diabetes and its complications. Therefore, Knowledge, Attitude, and Practice were chosen to study as the principal markers of awareness among patients.
Materials and Methods
An cross sectional pilot study was planned to assess the Knowledge, Attitude and Practices related to Rasayana Chikitsa among Elderly Diabetic subjects during the COVID 19 Pandemic. Non-probable convenient sampling was done to enroll 50 subjects, by using an interviewer-based questionnaire.
Results
Gender, Educational status and socioeconomic status were strong positive indicators of Knowledge and practice. Females had better Knowledge (16.10 vs 10.9), Attitude (6.9 vs 6) and Practice (5.4 vs 3.2) scores compared to males. One in two respondents knew about Ayurvedic immunomodulators (50%) and 64% of them came to know it during the pandemic, but nearly half (46% responded “Don’t know”) did not have a definite positive attitude that Ayurvedic immunomodulators would control the infection.
Conclusion
Even though there is good knowledge about the disease and moderate knowledge about the Rasayana Chikitsa, there is a considerable gap when it comes to practice. Hence, there is an urgent need for coordinated educational campaigns with a prioritized focus on poorer, rural and less educated groups to combat negative attitude and poor practices about uses of Ayurvedic immunomodulators.
Objectives
To develop and validate a sensitive, accurate, simple, precise and cost-effective UHPLC method for the simultaneous determination of Teneligliptin and Pioglitazone in pure and its tablet formulation form and validating this developed method as per Guidelines of ICH (
Materials and Methods
The chromatographic separation was done by using column Agilent C18 (2.5 μm; 4.6x100 mm ID), isocratic mobile phase consists of Methanol: 0.1% TEA (PH-6 WITH OPA) 60: 40%v/v. The flow rate of mobile phase is 0.9 mL/min. The separation was carried out at 241 nm wavelength. The current method for accuracy, precision, linearity, specificity, robustness and ruggedness was validated as per ICH guidelines.
Results
Teneligliptin and Pioglitazone retention time observed at 2.382 and 3.315 min respectively. The graphs showing peak area against concentration demonstrated linear between 2-10 μg/mL for Teneligliptin and 1.5-7.5 μg/mL for Pioglitazone. This relationship exhibited a high level of linearity with a Regression coefficient (R2) of 0.999. The determined limit of detection is 0.0843 and 0.0084 μg/mL while the limit of quantification was found to be 0.255 and 0.025 μg/mL for Teneligliptin and Pioglitazone respectively. The assay percentage of the available formulation was found to be 99.72 and 100.51 for Teneligliptin and Pioglitazone.
Conclusion
The Validation parameters indicate the effective separation of the drug substance from their degradants effectively. This developed method shows the` suitability for the routine quantitative analysis of Teneligliptin and Pioglitazone in its pure and their available pharmaceutical formulations for quality control purpose.
Background
Teneligliptin is a new drug recently approved by FDA for treatment of type 2 Diabetes Mellitus (DMT 2). Very few methods have been reported for analysing its degradation products and their impact on human health.
Materials and Methods
A precise, specific, and sensitive gradient UHPLC technique was developed and validated to analyze Teneligliptin using an Agilent C18 column (4.6x100 mm ID) with 2.5 μm particle size. The method employs a flow rate 0.9 mL/min and detects the teneligliptin at a wavelength 241 nm. This method comprises a mobile phase consists a mixture of Methanol with 0.1% TEA (60:40%v/v), along with a 20 μL injection volume for duration of 20 min.
Results
Linearity was found in the range of 2-10 μg/ mL having a correlation coefficient of 0.999. The retention time for Teneligliptin was found to be 2.382. Furthermore, the precision and robustness of the method were validated with a remarkable RSD (Relative Standard Deviation) below 2%.
Conclusion
The method’s stability under various stress conditions was confirmed through forced degradation studies conducted on both bulk substances and pharmaceutical dosage forms. Validation of the method followed the guidelines outlined by the ICH for assessing the validation parameters like specificity, linearity, accuracy, precision, robustness, LOQ and LOD.
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