bluuebunny/crossref_metadata_2025_split huggingface dataset:
Process Validation of Highly Potent Antidiabetic Tablets of Voglibose 0.2 Mg
Authors: Tijare Lokesh K. , Deshmukh Lokesh T. , Mohod Abhinay A. , Bhandakkar Vivek M. , Hore Santosh , Padole Nitin N. 
Published: January 2023

Diabetes mellitus is chronic disorder which affecting number of persons worldwide, alpha glycoside inhibitors like Voglibose is a highly potent and tolerant alpha glycoside inhibitor as compare to other diabetic drugs, the main objective of this process validation is to provide documentary evidence that the manufacturing process of Voglibose Tablet IP 0.2 mg will consistently and reproducibly produce a product, which meets predetermined specifications and quality attributes. The critical process parameter was identified with the help of process capability and evaluated by challenging as per in-house specification. Three initial process validation batches (T17L004, T18L003, T19A013) of same size, method, equipment & validation criteria were taken. As per the process validation protocol critical parameter identified like sifting, dry mixing, wet granulation, drying, sifting and milling, blending &lubrication, compression at different stages and blister packing and evaluated as per process validation protocol. Conclusion: Based on evaluation of manufacturing process and analytical data it is concluded that the employed manufacturing process for Voglibose Tablet IP 0.2 mg shall be consistently& reproducibly produce a product which meeting its predetermined specification and quality attributes, hence it is considered to be validated.
The Comorbidities And Clinical Profile Of Chronic Obstructive Lung Disease Patients Attending Tertiary Care Hospital
Authors: Sumathi Dr.Matta , Vani P. , Babitha B. , Basha V.Wazeed , Kumar I Naveen 
Published: January 2023

Background: Chronic pulmonary obstructive disease (COPD) has been responsible for the decreased quality of life as well as increased morbidity and mortality. The objective of the present study was to observe the comorbidities and clinical profile of patients with chronic pulmonary obstructive disease at a tertiary care center.
Methods: The data were collected from 80 COPD patients presenting to OPD of the pulmonary medicine department from August 2021 to January 2022. The data were extracted from a medical case sheet and for statistical analysis, MS Excel was used.
Results: As the age increased the prevalence of COPD increased and the highest was found to be in the age group above 60 years of age. Males were more affected by COPD as compared with females. The smokers were more compared to the nonsmokers. The prevalence of smoking among COPD was noted to be 60% compared to 40% as non-smokers. The most common clinical feature was breathlessness 100% followed by cough 95%. 15% of the cases of copdhad Hypertension as the comorbidity.
Conclusion: Breathlessness was the most common symptom at presentation and hypertension were the most common co-morbidities found.
Phytochemicals of Extract N-Hexane Leaves Bangun-Bangun (Plectranthus Amboinicus) (Lour.) Spreng and Antibacterial Activity Causes Diarrhea
Authors: Singarimbun Nurbaiti Br. , Firmawati Zega Defacto , Firmawati Zega Defacto , Anjelina Simanjuntak Helen , Purba Hermawan , Gurning Kasta 
Published: January 2023

Objective: This research aims to determine the secondary metabolites contained in the n-hexane extract of P. ambionicus leaves and to determine the effective concentration as an antibacterial causing diarrhea.
Methods: The research method was carried out experimentally with the stages of making simplicia, maceration, extract making, phytochemical screening, and antibacterial activity testing.
Results: The results of phytochemical screening showed the presence of flavonoids, saponins, tannins, steroids/triterpenoids. The results of the antibacterial activity test showed that the n-hexane extract of P.amboinicus leaves at all concentrations (50%, 25%, 12.5%) had antibacterial activity in the strong category (10-20 mm).
Conclusion: The n-hexane extract of P.amboinicus leaves has the potential as an antibacterial with a strong category.
A Prospective Study on Hypertension-Revealing it to be a key factor for various Medical Complications, their Management and Prevalence in a Secondary Care Hospital
Authors: Sultana Dr. Amreen , Fatima Shaima , Sultana Arham , Anum Summaya , Ziya Uddin Mohd 
Published: January 2023

Background: High blood pressure or HTN is a heterogeneous group of disorder characterized by a persistent increase in blood pressure due to the force of blood pushing against the blood vessel walls, which develops over time due to unhealthy lifestyle choices, lack of awareness accompanied by low levels of treatment and uncontrolled rates lead to mortality. Globally Hypertension (HTN) affects two-third of the population resulting in 10.4 million deaths annually. Despite several initiatives, the prevalence of HTN and its adverse impact on cardiovascular, renal, and cerebrovascular morbidity and mortality are globally increasing.
Objectives: The objective of the study is to detect the adverse outcomes of uncontrolled hypertension and review the treatment patterns in the management of hypertension to reduce its further complications. To assess whether the higher prevalence of undiagnosed hypertension or poor adherence to antihypertensive therapy or both may explain the higher prevalence of hypertensive complications.
Results: In the study, the prevalence of hypertension was found to be 46% among the patient population with males (52.5%) being more prevalent than females (47.5%). Among all age groups, individuals aged 50-69 years were highly affected. From the study, it was found that a greater number of patients fall in the category of stage-2 hypertension (38.75%) followed by hypertension crisis (28.75%), stage-1 hypertension (25%), and normal (7.5%). More patients with uncontrolled hypertension experienced cardiovascular complications (55%) when compared to cerebrovascular (27.5%) and renal (17.5%) complications. The choice of antihypertensive drugs used in the management were diuretics (43.75%), CCB (41.25%), ARB (37.5%), BB (32.5%), B+A (11.25%), ACEI (6.25%), CS (3.75%), and AAB (2.5%). The most commonly prescribed drugs in the study were Furosemide (11.25%), Telmisartan (11.25%), Amlodipine (7.5%), and Metoprolol (6.25%).
Conclusion: The study concludes that most of the patients with uncontrolled hypertension were suffering from cardiovascular complications with least being affected by renal and cerebrovascular complications. A regular and moderate degree of physical activity in combination with good lifestyle choices may have a good impact on hypertension control thus preventing further complications. However, blood pressure control is obtained in some individuals, while in some blood pressure was still elevated after the drug management due to the presence of co-morbid conditions and poor lifestyle modifications.
Review on process validation of Amoxicillin Potassium Clavulanate Dry Syrup
Authors: Devi Anjana , Kumar Sanjay , Jeet Kamal , Sharma Vikash , Chaudhary Aman 
Published: January 2023

Modern medicines for human use are required to comply with specific standards and regulation set forth by the concerned authorities. A simple and sensitive UV spectrophotometric method was developed and validated for the simultaneous determination of Potassium Clavulanate (PC) and Amoxicillin. As complementary of this work, an assay method for amoxicillin and potassium clavulanate mixtures was developed and validated; stress-testing and stability studies of amox/clav mixtures was carried out under specified conditions according to ICH and analyzed by using validated stability-indicating assay and related substances methods. Aim of this study was to test the validation of derivative spectrophotometric method in simultaneous determination the content amoxicillin and clavulanate potassium in dry syrup by derivative spectrophotometric method with zero crossing technique, in buffer phosphate pH 4,4-methanol (91:9) mixture.
Review on Collagen as a wound healer.
Authors: G.S Tribhuvan , B Velhal A , D Jadhav. P , K Redasani V 
Published: January 2023

In reaction to the tissue injury, normal wound healing process goes through inflammatory, proliferative, and remodeling stages. Impairments any one of these stages cause the wound to become chronic and non-healing, necessitating intervention to bring returning the process to its original state. Collagen, a fundamental has a role in the matrix extracellular an important function in wound healing regulation, whether in its native fibrillar form or in the wound as soluble components environment. Collagen has been used as an additional wound treatment to aid healing since it is involved in the control a combination of a few of these processes. The importance of collagen in various biological processes related to wound healing is discussed in this paper, additionally to a survey of the existing research in regards to the utilization of collagen-based wound care. There are several techniques to developing recommendations, but no gold standard has emerged so till now.
Simultaneous Estimation of Metoprolol and Telmisartan in Combined Tablet Dosage Form by Using RP-HPLC and UV Spectrophotometry
Authors: Gandu Sravanthi , . Parameshwari , M Ravinder , Gandla Kumaraswamy , Narmada Gade 
Published: January 2023

An accurate, precise and reproducible RP-HPLC and UV Spectrophotometric method was developed and validated for the simultaneous estimation of Metoprolol and Telmisartan in tablet dosage form. The chromatographic separation was carried out on X-tera C8 column (100mm*4.6mm*5µ), by using the mobile phase (0.05M Sodium phosphate buffer pH 2.8 and methanol) in the ratio 35:65, at a flow rate 1.2ml/min. The detection was carried out at a wave length of 226nm. The retention time for Metoprolol and Telmisartan was found to be 2.338 and 5.559 respectively. UV method involves solving simultaneous equations based on measurement of absorbance at two wavelengths 223nm and 296nm λmax of Metoprolol and Telmisartan respectively. Beer’s law was obeyed in the concentration range of 1.25-6.25μg/ml and 2-10μg/ml for Metoprolol and Telmisartan respectively. The developed methods were validated according to ICH guidelines.
Review: Drug Discovery and Development of Warfarin
Authors: Manao Tirsa Ami , Asra Ridho , Chandra Boy 
Published: January 2023

Background: The history of the discovery of Warfarin started from the plains of North America in Canada in 1920. Livestock in that area died from bleeding. Warfarin was first used in 1948 as a rodenticide, and in 1954 the US Food and Drug Administration (FDA) approved it for medical use as an anticoagulant.
Purpose: This review article aims to discuss the history of the discovery of warfarin starting from the presence of blood clotting disorders to the point that researchers worked to find drugs that can inhibit blood clotting, namely the anticoagulant group.
Research Methods: The method used is the study of relevant literature which is accessed through online sites such as Google Scholar, Research Gate, Science Direct, Springer Link, and NCBI.
Conclusion: In its development, several trials such as in silico, preclinical, and clinical trials have shown significant results but are always associated with bleeding.
Anti Inflammatory and Antioxidant Activity of Ziziphus Jujuba Extract
Authors: Singh Bhawana , Gautam Sandra , Dubey B K , Basedia Deepak Kumar 
Published: January 2023

The antioxidant activity of the leaves and fruits of Ziziphus jujuba and contribution in some phytochemical characteristics was obtained. Phytochemical analysis was found that Ziziphus jujuba leaves and Fruits were loss on drying 0.85%, 0.65%, total ash values were 5.3%, 7.6% , Acid insoluble ash value were 2.9%, 4.4%, Water soluble ash value were 0.7%, 1.1% and Foaming index were 13ml, 12ml. Phytochemical screening was found that carbohydrate present in JFE and JFA, alkaloids were present in JLE, JLA and JFE, glycosides were present in JFA, flavonoids were present in all type of extracts, steroids were present in only JLE and protein and amino acids were present in JFE and JFA. JFE possessed higher antioxidant activity with IC50 value of < 300 µg/ml among all extracts for both methods and higher inhibition found in DPPH method 96.32% and in ABTS method it is 98.68 %. Aqueous extract of Ziziphus Jujuba fruit (JFA) was exhibited excellent anti-inflammatory activity against COX-1 & Cox-2 with IC50 value less than <0.2mg/ml. Ethanolic extract of leaf (JLE) & Ethanolic extract of fruit (JFE) possessed moderate activity (< 0.3) against both COX-1 & Cox-2. Aqueous extract of leaf (JLA) exhibited poor activity against both COX-1 & Cox-2. Overall conclusion of anti-inflammatory study of different extracts of Ziziphus Jujuba leaves and fruit were possessed anti inflammatory activity and inhibition was increased with concentration of samples increased.
Imunomodulatory Effect of Red Tip Leaf’s (Syzygiummyrtifolium Walp.) Ethanol Extract on Male Rat
Authors: Sinulingga Rony Andreas Harka , Hasibuan Poppy Anjelisa Z , . Yuandani , . Rosidah , Dalimunthe Aminah 
Published: January 2023

The pattern of modern life demands that everything must be done very fast and instant. The quality of the consumed food, air pollution, lack of exercise and stress can cause the body’s endurance to decline continuously. The Red Tip (Syzigium myrtifolium Walp.) has been researched to have a flavonoid compound that has benefits as an anti-inflammatory and have potentially as an immunomodulator. The purpose of this study is to prove the effect of immunomodulator on the activity of phagocytosis, the total number and the differential of leukosit, the antibody titer value, and delayed type hypersensitivity response. Group treatment to test the clearance of carbon divided into 7 groups, each consisting of 5 male mice including the group of CMC-Na 0.5 %, Imboost ® dose 22.5 mg/ kgBB, the red tip leaf’s ethanol extract with dose of 50, 100, 200, 400, and 800 mg/kg orraly distributed for 7 days, and on the 8th day the carbon suspension was given using i.v. The blood intake were done in certain times and then the absorbance was measured using UV-Vis spectrophotometer. The liver and spleen of the rats were taken and weighed. The treatment group for antibody titer was divided into 7 groups with each consisting of 5 male mice using the same treatment as above except positive control that has been used levamisole on 25 mg/kgBB dose that has been distributed orraly for 14 days. The non spesific immune respond utilizing carbon cleanses method by measuring the carbon elemination speed and total amount and leukocyte differential. The specific immune response testing using antibody titers was done based on glutination which was formed and the delayed type hypersensitivity testing based on the mice swollen foot. The research outcome shows that the distribution of the red tip leaf’s ethanol extract with dose of 100, 200, 400, and 800 mg/kgBB is increasing the phagocytosis activity significantly compared to CMC-Na 0.5% (p < 0.05). The of the red tip leaf’s ethanol extract is increasing the total of leukocytes and neutrophils of the segment. The distribution of the red tip leaf’s ethanol extract with dose of 50, 100, 200, 400, and 800 mg/kgBB is increasing the formation of rat’s immune cell antibodies significantly compared to CMC-Na 0,5% (p < 0,05).This research prove that the red tip leaf’s ethanol extract has an effect of imunostimulator againts the phagocytosis activity, the total sum and leukocytes differential along with antibody titer value and the delayed type hypersensitivity.
Regulatory perspective of Drug Repurposing: Methods, Regulatory pathways and Hurdles
Authors: Verma Sonal , Vaghela Khushboo , Zaveri Maitreyi 
Published: January 2023

Drug repurposing is a phenomenon that aims at utilising an established and approved drug product or drug substance for an additional clinical indication apart from the one that it was intended for. The reprofiling of drug formulations creates an extensive arsenal of therapeutic options for drug products, thus making the practice a desirable and forthcoming procedure. There are several techniques and methods that have been adopted over the years to evaluate the various possibilities for the repurposing of drugs in search of a wider range of chemical therapeutics.
The repurposing of drug products has provided, over the course of time several different advantages to the pharmaceutical industry, and yet remains an uncomprehended and over-looked procedure. The following paper attempts to identify the different benefits that are to be gained from the repurposing of drug products along with the approaches that have been used for the same. Additionally, the paper also discusses the regulatory perspective of drug repurposing, emphasising on the incentives that are available for various pharmaceutical sponsors as well the hurdles that are to be faced during the repurposing of a drug product or drug substance.
AI models predicting Risk of Cardio Vascular Diseases - The Limitations, Challenges and Necessity for Regulatory Framework
Authors: Belidhe Vyshnavi , Maryam Suha , Siddala Srivani , Chinthamalla Divya , Garela Chandrakanth , Venkata Jithan Aukunuru , Jenugu Vidya Sagar 
Published: January 2023

Artificial intelligence (AI) algorithms have changed the landscape of Cardio Vascular Disease (CVD) risk assessment and demonstrated a better performance mainly due to its ability to handle the input nonlinear variations. Further, it has the flexibility to add risk factors derived from medical imaging modalities using Computer Vision (CV). Most commonly used algorithms in CVD risk predications were classification and regression tress (CART).
Though most of the developed models have shown good accuracy but have not considered risks factors or dependent variables related to specific population which plays an integral role in predicting the risk of CVDs. This Include gender specific clinical risk factors (hormonal changes, bone density etc.), metrological, chronological data, exposure to environmental pollutants, race, genotype, hereditary, dietary intake, physical inactivity, psychological stress etc. Secondly the existing models have not included the weighing and grading of the risks, as all factors won’t contribute equally to the Cardiac Risk. Importantly predictive models can be readily used within the populations in which they were developed but practically they often give a less than satisfactory performance, when applied to another population because of the Inter genetic variations especially in CVDs.
India accounts for one-fifth of these deaths worldwide especially in younger population. The results of Global Burden of Disease study state age-standardized CVD death rate of 272 per 100000 populations in India, which is much higher than that of global average of 225. CVDs strike Indians a decade earlier than the western population. For Indians, particular causes of concern in CVD are early age of onset, rapid progression and high mortality rate. Indians are known to have the highest coronary artery disease (CAD) rates, and the conventional risk factors fail to explain this increased risk.
In Indian context, aggressive screening tests should begin at an early age and will be beneficial for early detection and treatment to reduce the mortality. Hence there is necessity to develop upgraded AI models specific to a subset of population (Indian, Caucasoid, Dravidian etc.) inclusive of the risk factors in that specific population. Secondly allotting weighing, grading of risk factors in the model will provide accurate cardiac risk prediction compared to other approaches.
The regulatory and policy landscape for AI is an emerging issue in jurisdictions globally, including in the European Union and in supra-national bodies like the IEEE, OECD and others. Since 2016, a wave of AI ethics guidelines has been published in order to maintain social control over the technology.
Clinical Trial Agreement – Eliminate legal problems when conducting clinical trials in Germany
Authors: Gerst Christoph , Geringer Christina , Voigt Thomas , Ahmed Raees 
Published: January 2023

The possibilities of structuring clinical trial agreement are far reaching. Especially regarding the question, who the contract partner will be, an initial, also liability-related, positioning is possible; by either including or not including the respective examining physician in the agreement. The agreement has in large parts a clarifying function regarding the contractual obligations of both parties, as the AMG, the ICH-GCP guideline and various european regulations and directives stipulate a wide range of requirements for the performance of clinical trials. Inclusion in the agreement allows for a clear division of responsibilities and liability in the event of non-compliance with the requirements. It is also necessary that the sponsor is obligated to carry out quality assurance measures and the modalities of their implementation, including the remuneration of the time spent for this purpose.
A central question is also, who is entitled to the results of the clinical trial or to inventions based on them, whereby the ArbnErfG also must be taken into account. Whether there are at least rights of use for non-commercial purposes for the other party, should also be regulated. Also relevant is the agreement of confidentiality agreements and the answer to the question, when and to which extent publications on the results of the tests in question are permissible, in order to ensure an appropriate balance of the parties' interests.
In terms of data protection law, special attention must be paid to the question which party is the controller within the meaning of the GDPR - depending on the answer to this question, complicated and extensive regulations must be made. In addition to the regulation of the remuneration and its payment modalities, regulations regarding the liability, at least within the legal ramifications are possible and necessary. Conclusively – as always - general cancellation rights and other possibilities of terminating the agreement can be added.
The preceding explanations show how complex and comprehensive the aspects to be taken into account are. Numerous possibilities have been highlighted above, in order to provide an overview and to simplify the drafting, in hope that the contribution may aid as an orientation.