Nirma University Journals
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CONCURRENT ESTIMATION OF LOTEPREDNOL ETABONATE AND LEVOFLOXACIN BY UV SPECTROPHOTOMETRIC ABSORBANCE RATIO METHOD FROM THEIR COMBINED EYE DROPS DOSAGE FORM
Full text linkA simple, sensitive, rapid, accurate and precise absorption ratio method (Q value analysis method) has been developed for simultaneous estimation of loteprednol etabonate and levofloxacin in combined dosage form. Ratio of absorbance at two selected wavelengths was calculated. First wavelength is absorption maxima of respective drug and second wavelength is iso-absorptive point at which both drugs give same absorbance. Loteprednol etabonate showed absorbance maxima at 269.29 and levofloxacin showed absorbance maxima at 298.5 nm in methanol. The iso-absorptive point of loteprednol etabonate and levofloxacin was found to be at 269.29 nm. Linearity was constructed in the concentration range of 5-25 μg/mL. Promising values of correlation coefficient for LE (R2 =0.998) and levofloxacin (R2 =0.999) proves that method is linear. Furthermore, the method was successfully validated in terms of various validation parameters as per ICH Q2 (R1) guidelines. The developed method was successfully applied for estimation of both loteprednol etabonate and levofloxacin from its eye drops. Mean % recovery indicated that no interference was observed from excipients present in the formulation. Therefore, developed method can be routinely applied for simultaneous estimation of loteprednol etabonate and levofloxacin from its pharmaceutical dosage form
SOCIO-ECONOMIC IMPACT OF CLINICAL RESEARCH IN VARIOUS COUNTRIES
Full text linkThis article attempts to outline the socio-economic impact of clinical research in sample geographies from around the world. With an attempt, we could sample geographies that largely represent varied population - from developed markets to developing markets, from poor to rich countries, from countries seeing increase in clinical research to countries that are struggling to retain clinical research. In absence of any research/ survey that can map socio economic impact at global level, this article best describes the general trends at least, if not a truly global view. Largely, there are two impacts which are quite visible across all of the sampled geographies. The first one is that the advent of clinical research in any geographies have led to a palpable increase in the standards of medical care in that geographies. This is probably driven by essential training that researchers go through and thereby learning the GCP - Good clinical practice. Another effect is a definite increase in the standards of medical infrastructure, once the clinical research started. This is a reflection of the fact that general population has benefited by investment made by sponsor companies to perform clinical research. The second impact is that the effect of Clinical research activities on economy is also uniformly positive. This results from new job creation that leads to downstream economy. But additionally, it also follows from having healthier humans (those who received medical benefits of clinical trials) who pay more taxes and who further pedals the economy by spending. All in all, the size of these benefits (as measured in various markets) is significant enough not to loose on them and many countries are actively pursuing clinical research to get these benefits
BAMBUSHA: REALM OF INDIAN TRADITIONAL MEDICINE
Full text linkOver the past decades in Indian antiquity, Vanshlochan (Bambusha) is considered as a tonic in treating various ailments. Initial development of such ingredient, predominantly silicon compound, with trace amount of certain elements. A methodological strategy offers to characterize novel candidate bambusha drugs from various bamboo species plants in favor of modern instrumental technique like physico-chemical, X-ray diffraction, fourier transform infra-red spectroscopy, scanning electron microscopy, inductive coupled plasma atomic emission spectroscopy. Bambusha is recommended as a bioavailability enhancer and provide synergistic effect like various well-known medicaments - Sitopaladi, Talisadi, Dadimashtaka, Vilwadichurna and Prabhakar, brambhivati in Ayurveda along with other Unani formulation. The safety and efficacy of this mad stone is not explored scientifically.This review mainly focuses on the traditional, experimental, physico-chemical information of Bamboo manna
ARE GENERIC DRUGS THAT SAFE AND HAVE SAME EFFICACY WITH THAT OF BRAND DRUGS?
Full text linkA drug is a biochemical substance which has biological effects in the body when ingested or otherwise introduced in the body. Its takes many years to discover a new drug as it is has to undergo several operations, several tests and clinical trials leading to huge cost based on expenditure of the research. The drug is to be marketed and manufactured in pharmaceutical industry only if it has passed the USFDA standards. Once the drug passes the USFDA standard the drug is manufactured, and the discoverer is awarded patent for that same drug for certain period of time. As the drug research is much costly the discoverer sets the prices for the drug which is too high, at least not affordable by common community. For this reason, Generic drugs are introduced in the market. In the recent era generic pharmaceutical are the largest contributor of drugs in the market and are in high demand due to cost effective. As all the generic drugs are approved by USFDA and are allowed to be marketed only when the brand drugs discoverer do not hold the patent for the same drug and the brand drugs is in the market for years and well-established safety profile. Although Generic Medication appear to be same as brand drugs, but variation in manufacturing facilities may lead to unseen adverse events. On other side, generic drugs are tested for bioequivalence properties within a certain range compared to brand discoverer drugs, safety and efficacy testing are not required; therefore, it can be said that generic drugs are not therapeutically equivalent to branded innovator drugs the question of requirements of Pharmacovigilance for generic arises when there is plethora of information available for brand drugs regarding safety and adverse effects. [1] [6]
 
SIGNALLING PATHWAYS AND MOLECULAR TARGETS FOR SKIN CANCER: INVOLVEMENT OF CDK2 INHIBITION
Full text linkPresently, accessible drugs in the market for the management of basal cell carcinoma include Fluorouracil, Imiquimod, Vasodegib and for melanoma, drugs are Dacarbazine, Vemurafenib. Impartial of contemporary training was to improve novel sequences of molecules which would turn on the CDK2 receptors and which might support in the preclusion of the skin malignancy. Malignancy triggering environmental exposures contains substances, such as the elements in tobacco smoke, besides radiation, such as ultraviolet rays from the sun. Skin cancer is one of the malignancies which happens due to the exposure to UV radiation and can prime to very hazardous effects in normal healthy body. Presently, a predictable 9,320 persons will expire due to melanoma in the U.S. in 2018: of persons, 5,990 will be Male and 3,330 will be Female. Only 20 to 30 percent of melanomas remain originate now present moles, although 70 to 80 percent ascend on outwardly regular skin. There are numerous molecular pathways for skin cancer such as, hedgehog pathway, PI3K/Akt pathway, p53 pathway, CDK4/CYCLIN pathway and MAPK pathway, have FDA affirmed medications accessible. Just about 10% of all melanomas are hereditary, and genetic analyses have linked the susceptibility of melanoma to the CDKN2A gene. There are numerous novel targets on origin of melanoma treatment such as Arginine Depletion and Laminins as a novel target. CDKs show significant parts in controller of cell-division then restrained transcript now answer toward numerous intracellular also extracellular signals. There are three kinds of CDK inhibitors such as, ATP competitive inhibitors, ATP noncompetitive inhibitor and Allosteric inhibitor
STUDY ON PERCEPTION OF PHYSICIANS TOWARDS ADVERSE DRUG REACTION REPORTING: A SURVEY IN INDIA
Full text linkOngoing assessment for a positive risk–benefit profile of any medicinal product is an important aspect of lifecycle management; it is also a regulatory requirement. Important stakeholders in this process of pharmacovigilance (PV) are the patients, healthcare practitioners, pharmaceutical companies and regulatory agencies. Despite the regulations for post-marketing drug safety monitoring being well-defined, the rate of reporting of adverse drug reaction (ADR) by the healthcare community continues to be inordinately low.
ADVANCES IN Tau PROTEIN INHIBITORS FOR ALZHEIMER\u27S DISEASE: A REVIEW
No full textAlzheimer\u27s disease was originally defined as presenile dementia which has no an antecedent cause, for example alcohol, stroke on brain or a trauma on brain. It is neurodegenerative disease which is chronic in nature which starts slowly and as time passes get worsen. Neurofibrillary tangles composed primarily of tau proteins aggregates which are hyperphosphorylated forms of the microtubules associated protiens. The main reason of aggregation is an imbalance in phosphates and kinase activities leading to an abnormal phosphorylation of tau and its further aggregation. A wide range of therapeutic approaches for this specific tau kinase inhibition or to enhance the phosphate activity, which will indeed promote the stability of microtubule and thus will in turn reduce the aggregation of tau proteins and their clearance is also enhance its clearance by small molecule drugs or by means of immunotherapy. Most of the drugs which are promising in their activities are still in preclinical trails and some of them are: Crenezumab (a monoclonal antibody which is passive); ACI-24 & -35 (targets aβ and p-tau actively as an immunotherapy), Anti- tau antibody and Morphomer tau (compound which is small for the treatment). Thus this therapy improves current situation of patient and blocks tau protein aggregation leading cause of AD.
 
CHEWING GUM: A BOON FOR ORAL DRUG DELIVERY
Full text linkDifferent types of formulations including; mouth wash, lozenges, gargles, mouth dissolving films and pellets, chewing gums, etc. are being used to combat bad breath. Chewing gums have been used as a means of cleansing teeth and for removing bad breath odor, since a very long time. The prevalent use of chewing gums by people of all age groups has prompted interest of formulations scientist towards manufacturing of chewing gums for different purposes. Chewing gums are preferred for delivering drugs for localized effect as medicated chewing gums. Herbal ingredients are known to have a very pleasant and persistent mouth feel, however their use in the form of chewing gums is least explored. In this review authors have tried to compile the basic concept of formulating chewing gum, its method of production, characterizing parameters, various applications in different areas, future scope.
 
SKILL GAP ANALYSIS IN LIFE SCIENCES SECTOR
Full text linkLife Sciences Sector Skill Development Council (LSSSDC) is an autonomous and not for profit organization with financial support from National Skill Development Corporation (NSDC). Life Sciences Sector comprises of industries in the areas of Pharmaceutical, Bio-Pharmaceuticals, Medical Devices and Contract Research. Life Science Sector required highly skilled personnel as it is connected with research and development. This sector relates with development, delivery and evaluation of life care products, which needs collaboration skills of academia, industry and government. If these issues are not addressed effectively, it may hamper the number of products in the market. The key objective of the LSSSDC is to create a robust and vibrant eco-system for quality education and skill development in the Life Sciences Sector in the country. LSSSDC works as an apex body in Life Sciences Sector for Skill Development Initiative in India. Three important missions of LSSSDC are:
To carry out a functional and occupational mapping and to develop a catalogue of Industry Occupations/Job Roles in Life Sciences Sector.
To develop and set National Occupational Standards for different job and its roles in the sector.
To develop and put in place an Assessment & Certification mechanism for Accreditation of Training Institutes/Trainees and Trainers.
 
EMA EXPECTATION WITH THE REVISED GUIDELINE OF RISK MANAGEMENT PLAN [GVP MODULE V]
Full text linkThe European Medicines Agency (EMA) has revised the guideline of Risk Management Systems (Revision 02). This article provides the expectation of EMA with recently published revised guideline of Risk Management Systems (Revision 02).