Prof. John Yahya I. Elshimali
Professor of Pathology and Oncology,
UCLA School of Medicine & Charles R. Drew University of Medicine and Science, California, USA.

ISBN 978-93-91595-73-9 (Print)
ISBN 978-93-91595-81-4 (eBook)
DOI: 10.9734/bpi/tipr/v11

This book covers key areas of pharmaceutical research. The contributions by the authors include guaifenesin, stability indicating method, RP-HPLC, analytical method validation, trace elements,   antioxidant, antibacterial properties, Ayurvedic medicinal plants, analytical methods, compounding, high performance liquid chromatography quality control, taxanes, therapeutic drug monitoring, problem based learning, pharmacovigilance, clinical trial, medical science, COVID19, fever pandemic respiratory syndrome, kidney disease, gastrointestinal illnesses, antibody, bioflexi film, risperidone, diabetes mellitus, toxicity, autism, drug utilization studies, WHO prescribing indicators, essential drugs, pyridine, base, azetidinones, pyrazinamide, streptomycin, ciprofloxacin, anti-tubercular activity, antibacterial activity, antiulcer activity, peptic ulcer, neutropenic enterocolitis, amoxicillin, blood culture, visual afterimage, eye movements, field constancy mechanisms, space reference points, proprioceptive signals, finger-nose test, visual illusions. This book contains various materials suitable for students, researchers and academicians in the field of pharmaceutical research.


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Study on Development and Validation of Stability Indicating RP-HPLC Method for Guaifenesin

Sandhya R. Gawai, Kiran Gadge, Sandeep Sonwane

Technological Innovation in Pharmaceutical Research Vol. 11, 9 August 2021, Page 1-15

For the estimation of Guaifenesin in bulk and formulation, a simple, accurate, and exact stability indicating RP HPLC method was developed and validated. The drug and its breakdown products were separated on a Phenomenex C18 column (250 × 4.6 mm, 5\(\mu\)) using a mobile phase of methanol:water (60:40% v/v) under varied forced degradation settings.  Eluents were detected at 230 nm and the flow rate was kept constant at 1.0 mL/min. Guaifenesin degraded in acid, alkali, photolytic, and wet heat settings, but remained stable under H2O2 (oxidative) and dry heat conditions in forced degradation trials.  Linearity was found in the concentration range of 2-12 g/mL in calibration curve experiments, with regression coefficient (R2) 0.999. The equation obtained was y = 102800 x + 24264.

A rapid simple, sensitive and accurate HPLC –UV method has been described for the determination of guaifenesin. From the forced degradation studies it can be concluded that guaifenesin undergoes  acid, alkali, wet heat and  photolytic degradation.

Study on Trace Elemental Analysis in “Jeevanti” (Leptadenia reticulata (Retz.) Wight & ARN.) - An Ayurvedic Medicinal Plant

Rajasamarsen K. Modi, Azra Yasmeen, K. Shivakumar, Somnath Reddy C. Patil

Technological Innovation in Pharmaceutical Research Vol. 11, 9 August 2021, Page 16-27

Leptadenia reticulata (Retz.) Wt. & Arn. (Asclepiadaceae) an endangered medicinal plant known as Jivanti or Jivana in Ayurveda due to its life promoting qualities. Immeasurable healing properties like antioxidant, antibacterial, vasodilator, galactogogue, Jivaniya, etc., Jivanti also used in veterinary practice is remarkable due to its lactogenic effect. Charak used Jivanti as an important Rasayana. Sushruta used it for increasing sperm count, and enhancing breast milk in lactating mothers. Vagabhatta included Jivanti in Jivaniya Gana. It is also known as Shak Shreshtha as it is considered very nutritive as Saag. With all these background, the present investigation has planned to quantify the elemental composition of “Jeevanti”. The quantitative estimations of Fe, Cu, Mn, Zn, Pb and Ni, in leaf, stem and root parts of Jivanti were determined by using Atomic absorption spectrophotometer. The trace elements in leaf, stem and roots of this plant differed significantly but do not exceed the limiting values set by world health organization (WHO). Therefore the use of these plant parts for medicinal purpose is safe and ecofriendly.

The present study aims to review the analytical methods for taxanes quantification in diluted formulations and biological samples and their applications in clinical practice . Improvement of the rational use of classic chemotherapeutic drugs is currently a concern for health professionals, as these still constitute an important strategy for cancer treatment. Taxanes are a group of chemotherapeutic agents routinely used in the treatment of a variety of cancers. Their administration to patients is parenteral, which implies dilutions from commercial stock solutions to obtain the final individualized quantity of drug prescribed, that is, however, not usually confirmed. The absence of this post-dilution quality control can contribute to the variability of clinical response. Analysis of these diluted solutions is extremely important to assure an accurate content and, as a result, a safe and effective chemotherapy. On the other hand, therapeutic drug monitoring is essential to optimize individual therapy of drugs with a narrow therapeutic window such as taxanes. Drug quantification in plasma samples is important to establish pharmacokinetic parameters that allow dose adjustment and assess inter- and intra-individual metabolism variability, improving the effectiveness of therapy while minimizing adverse effects. Methods to quantify plasmatic concentrations of taxanes are, therefore, important in clinical practice, contributing to the individualization of treatments. This work made a bibliographic review and comparison of currently available analytical methods for these objectives. High performance liquid chromatography (HPLC), liquid chromatography-tandem mass spectrometry (LC-MS/MS) and micellar electro-kinetic chromatography(MEKC) analytical methods were considered and compared for quantification of taxanes in hospital laboratories and it was concluded that, although LC-MS/MS is an extremely powerful technique, HPLC is versatile and cost-effective for both purposes.

Clinically Oriented Pharmacology Exercises and Innovative Evaluation System

Rakesh Chandra Chaurasia

Technological Innovation in Pharmaceutical Research Vol. 11, 9 August 2021, Page 41-46

Medical science is very vast discipline concerned with the life of human being; Thus, skills, communication and decision-making abilities   are important tools for medical knowledge. In current scenario of modern life, students are pressurized from every corner of society.  Economic burden, lack of friendly environment, senior and peer group pressure, single parents, drug addiction and love affair are common issues during college life. Insecurity of job after completion of education will create future financial fear. Pharmacology is an essential subject of medical science with marked clinical potential. The prescription and pharmacotherapy of any clinical discipline is nothing but Pharmacology. This is the fact that we are always linked with our old tradition, but time has been changed now and needs upgradation of old presentation. This chapter presented some of upgraded and innovative efforts in context to practical, written and oral examination.

A Pandemic Declare by World Health Organization: COVID-19

Ashwini Arun Zanke, Raju R. Thenge, Vaibhav S. Adhao

Technological Innovation in Pharmaceutical Research Vol. 11, 9 August 2021, Page 47-61

A novel coronavirus (SARS-CoV-2, now known as 2019-nCoV) that causes an acute respiratory disease known as the coronavirus disease 2019 (COVID-19) has recently spread throughout the world, first in China and then spreading to other areas of the world. Following its growth in China, the World Health Organization (WHO) declared the COVID-19 outbreak a public health emergency of international concern on January 30, 2020. The development of SARS-CoV-2 in the twenty-first century caused severe acute respiratory syndrome, followed by the Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012, which was also described as the highly pathogenic and large-scale epidemic coronavirus that harmed the human population. According to WHO data issued on March 1, 2020, a total of 87,137 cases were confirmed internationally, with 79,968 cases in China and 2977 deaths (3.4 percent) worldwide. Following that, researchers discovered that SARS-CoV-2 belongs to the b-coronavirus family, which has a genome that is very similar to that of bat coronavirus, indicating that bats are the virus's natural host. The novel coronavirus uses the same receptor as SARS-CoV, angiotensin-converting enzyme 2 (ACE2), and spreads primarily through the respiratory system. This COVID-19 virus has a strong history of sustained human-to-human transmission all across the world. Fever, dry cough, fatigue, difficulty breathing, and, less commonly, gastrointestinal illnesses were the most common clinical symptoms displayed by the majority of the patients. The elderly and those with underlying conditions such as heart disease, diabetes, cancer, or kidney disease are more susceptible to COVID-19 infection, as well as serious outcomes such as acute respiratory distress syndrome (ARDS) and cytokine storm. When it comes to treatment, there are few particular antiviral treatments available right now, but numerous medication regimens and other antibody-based studies are being tested. The current study summarises COVID-19's epidemiology, aetiology, and clinical characteristics, as well as current treatment approaches and prospective scientific advances to battle the epidemic novel coronavirus.

Objective: The purpose of the present study was to formulate and evaluate risperidone loaded bioflexi films for effective treatment of autism. For the preparation of bioflexi films, biopolymer was isolated from seeds of Euryale ferox (family Nymphaeaceae) by an economic method. The biopolymer recovered from the concentrate was subjected for various evaluation parameters such as infrared spectroscopy (IR), differential scanning colorimeter (DSC), scanning electron microscopy (SEM), nuclear magnetic resonance (NMR) and cell line toxicity study.

Methods: The bioflexi films were prepared using this biopolymer, dextrose as flexicizer, and sween 80 as permeation enhancer in methanol and water as solvent system.

Results: The formulations were characterized including uniformity of weight, drug content, folding endurance, and thickness. To study the stability of the formulations and in vitro dissolution of the experimental formulations were performed to determine the amount of risperidone present in the patches and scanning electron microscopy of the prepared bioflexi films was taken to see the drug distribution pattern. Drug-excipient interaction studies were carried out using Fourier transform infrared spectroscopic technique. In vitro dissolution studies showed that the drug distribution in the bioflexi film was homogeneous and it was found that the maximum drug release in 24 h was 99.81% with formulation EF3. In vitro skin permeation study was also conducted in a modified Franz’s diffusion cell which shows that the maximum permeation with the formulation EF3 and it was 768.50 \(\mu\)g/cm2 after 24 h.

Conclusion: Optimized formulations were found to be suitable for formulating in terms of physicochemical characteristics and there was no significant interaction noticed between the drug and biopolymer used.

Determination of Cost of Illness of Type 2 Diabetes Mellitus in Tertiary Care Setting

Usha Adiga, Sachidananda Adiga, Tirthal Rai

Technological Innovation in Pharmaceutical Research Vol. 11, 9 August 2021, Page 78-97

Diabetes mellitus imposes a considerable burden on health systems and societies. The cost implications of diabetes to society are multifold: direct costs to people with diabetes, their families and to the health care sectors, indirect costs to society and government, which are the productivity costs; and intangible costs, which means adverse effects on quality of life. Very little is known about the economic impact of diabetes in the developing world where predicted increases in prevalence are highest. The total annual medical costs is significantly higher in complicated diabetics as compared to those without complications. Awareness creation on primary and secondary prevention of diabetes and its complications is the need of the hour, alongside capacity strengthening of medical and paramedical professionals involved in diabetes care.

Assessment of Prescription Pattern at Outpatient Department in a Tertiary Care Hospital at Central Maharashtra, India

Shruti Chandra, Deepak Bhosle, Amol Ubale

Technological Innovation in Pharmaceutical Research Vol. 11, 9 August 2021, Page 98-104

Introduction: Drug utilization studies are powerful tools to ascertain the role of drug in society. They create a sound socio-medical and health economic basis for healthcare decision making. DUS are conducted to facilitate the rational use of drugs in populations. The indicators of prescription in practice measure the performances of health care provider in several key dimensions related to appropriate use of drug. Therefore, the present study was undertaken to analyze the prescription written by doctors in a Tertiary Care teaching Hospital.

Materials and Methods: Present study was a cross sectional, prospective and observational study. The study was conducted in MGM Medical College & Research centre, Aurangabad from July 2018 to March 2019 for duration of 9 months. Data was obtained from 850 prescriptions. Data was analysed as per WHO prescribing indicators.

Results: Total 850 prescriptions were analysed, including 490 (57.6%) males and 360 (42.3%) females. The maximum numbers of prescriptions were from the age group of 18-40 (53.6%) years of age. Average number of drugs in the present study was found to be (3.1). Percentage of drugs prescribed by generic name is 16.0%. Percentage of encounters with an antibiotic prescribed was 59.1%. Percentage of encounters with an injection prescribed was 4.9%. Percentage of drugs prescribed from essential drugs list was 68.4%.

Conclusion: There is need of improving the prescribing pattern by keeping the number of medicines as low as possible, prescribing medicines by generic names, using medicines appropriately after selecting and consciously keeping the cost of therapy low. Health professionals have a responsibility to ensure that the right drug is prescribed, dispensed and taken.

Role of Pyridine Containing Azetidinone Derivatives as Privileged Scaffolds in Anti Tubercular Agents

N. Pramod, C. Bharath Kumar, P. Sri Lekha, B. Mayuri

Technological Innovation in Pharmaceutical Research Vol. 11, 9 August 2021, Page 105-112

In search of potential therapeutics for Tuberculosis, in the present research we described herein a novel series of 3-Chloro-1-phenyl-4-(pyridine-4yl-)azetidin-2-one derivatives were synthesized by forming of Schiff base as intermediate. The resulted Schiff base further undergoes elimination to give titled Azetidinone derivatives. The Mechanism Involved in the formation of Schiff base is Nucleophilic addition followed by elimination. The formed Schiff base undergoes further cyclization to give novel Azetedinone derivatives. The titled compounds were characterized physically and analyzed structurally by spectroscopic methods (IR, 1H-NMR, MASS). The compounds Azt-1 to Azt-6 were screened for selected In vitro anti-tubercular activity. In vitro anti-tubercular activity was performed by using the Micro plate Alamar Blue Assay (MABA) method. The most active compounds of the series were Azt-1(H), Azt-2(Cl), Azt-5 (O-OH) and Azt-6 (P-OH) than standards. The Potent anti tubercular activity might be the presence of Electron withdrawing group -Cl, (Azt-2) and Electron Donating substituents -OH at ortho and para position in the phenyl ring of (Azt-5) and (Azt-6) respectively.

Updating the Antibacterial & Antiulcer Activity of Aegle Marmelos Linn

Tapan Kumar Mahato, Komal Sharma

Technological Innovation in Pharmaceutical Research Vol. 11, 9 August 2021, Page 113-123

Antimicrobial drugs are those drugs which are used to treat diseases caused by microorganisms. These disease causing microorganisms are called pathogenic microorganisms. To treat the diseases,antimicrobial medicines are used e.g. antibiotic, antiviral, antifungal and antiparasitic medicines. These microbes produces diseases not only in humans but in animals and plants too. Antimicrobial resistance (AMR) occurs when disease producing microbes gets resistant against the medications, so that the medications becomes ineffective which makes common infections difficult to treat and hence leads to increased risk of severe illness, disease spreading and death. According to the report of World Health Organization (WHO), the cases of AMR is continuously going upwards and it creates trouble in effective treatment and prevention of infections caused by microorganisms like bacteria, viruses, fungi and parasites. AMR makes the medicines ineffective so that the infections remains in the body and enhances the chances of spread to others. WHO recommends to minimize the  use of synthetic antibiotics and to increase the use of herbal antimicrobial drugs. Using these recommended ways only, the AMR can be controlled or eliminated. Herbal drugs are considered to be therapeutically effective and free from side effects. In this chapter, a very potent herbal drug, Aegle Marmelos Linn. (Bael in hindi) has been discussed. Aegle marmelos Linn. is useful in treating many health ailments. Scientific studies reveals that It possess many pharmacological activities like anticonvulsant, antioxidant, antihyperglycemic, anxiolytic, antidepressant, antihistaminic, antimicrobial, hepatoprotective, analgesic, immune modulatory, cardio protective and antithyroid activity. Because of  its antibacterial and antiulcer activity it is used to treat peptic ulcer patients. The bacteria which is responsible for peptic ulcer is Helicobacter pylori. This chapter discusses about the effect of Aegle Marmelos on bacterias including Helicobacter pylori.

Study on Confirmed Case of Neutropenic Enterocolitis in Armenia

Tatevik Grigoryan, Petros Ghazaryan, Samvel Danielyan, Gevorg Tamamyan

Technological Innovation in Pharmaceutical Research Vol. 11, 9 August 2021, Page 124-126

Neutropenic enterocolitis (NE) also known as typhlitis is a severe condition usually affecting immunocompromised patients. This is a first documented case of NE in Armenia. 12-years old girl who was diagnosed with Hodgkin Lymphoma IIA in September of 2019 was hospitalized and chemotherapy was initiated with prednisolone, vincristine, doxorubicin and etoposide. On the 9th day of chemotherapy she had abdominal pain, cramps, constipation. Laboratory findings were unremarkable. Empiric Helicobacter Pylori (HP) eradication was prescribed (regimen with amoxicillin and clarithromycin) by gastroenterologist. 2 days later she had fever and CBC showed profound neutropenia (WBC -0.34 neutrophil counts 0.06*103/\(\mu\)L). Meropenem was started for febrile neutropenia. Despite the treatment symptoms were persistent. Based on the symptoms (fever, neutropenia, abdominal pain, diarrhea) NE was suspected and CT scan of abdomen was performed. It revealed the width of the intestinal mucosa 0.5-1.0 cm. Consequently, the diagnosis of NE was confirmed and clarithromycin was switched to metronidazole accordingly. Pseudomonas aeruginosa was detected in blood culture and Proteus vulgaris was detected in stool culture. After 10 days of antibacterial therapy and diet the patient was recovered. CONCLUSION: Awareness of typhlitis and possible risk factors at local institutions might help to modify the incidence and consequences of typhlitis.

In the paper It has been shown, that with using a complex 3-D configuration of reference points in the presence of structural rich afterimage (rAI) of the entire visual scene, eye movements lead to transformation of the 3-D visual field, representing a complex rotation and scale transformation of the near extrapersonal space with a center somewhere in the region of a hypothetical "cyclopean eye". Experiments have shown that this also results in the recalculation of the coordinates of the observer's gaze direction, entirely based on inflow information, independent on the signals of the oculomotor and even proprioceptive efferent systems. Three types of rAI illusions are described under different kinds of eye movements. A model is again (after 1976) expressed that these phenomena reflect the work of the "contextually" independent Screen Constancy Mechanisms (SCM), whitch operate at the hypothetical Constant Visual Screen (CVS) level. This level can still be considered as "pseudo-sensory" one of the visual system, located before the formation (appearance) of the object-structured visual field. In experiments, certain conditions affecting the degree of afterimage structural “richness” have been also investigated.