Nirma University Journals
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REGULATORY EXCLUSIVITY IN THE UNITED STATES AND EUROPEAN UNION AND ITS IMPACT ON GENERIC ENTRY
Full text linkRegulatory exclusivity is one of strategy apart from an intellectual property rights to get profit and return on investment done by the pharmaceutical industry on development of drugs. The reason of introducing regulatory exclusivity for drug products was that a lot of time would lost during approval of drug product and because of that at the time of approval of drug very little patent protection available to that drug. Pharmaceutical companies usually file patent application at respective countries at the time of an invention related to drug and it will take time more than 10 years to get approval from the authorities (FDA- Food and Drug Authority or EMEA-European Medicines Agency) and that leaves the patent holder with a much lesser duration, and sometimes none, to actually avail a return on the huge investment in R&D
BIOACTIVITY GUIDED ISOLATION OF URSOLIC ACID FROM CLERODENDRUM SERRATUM ROOTS AND EVALUATION OF ITS EFFICACY AGAINST ASTHMA IN GUINEA PIGS
Full text linkPresent study investigated anti-asthmatic activities of ursolic acid isolated from ethyl acetate fraction of crude extract of C. serratum roots along with its anti-inflammatory potential. Methanol extract (70%) was fractionated in to ethylacetate and the fraction was subjected to Gas chromatography-mass spectrum (GC-MS) in order to identify possible phytoconstituents. Column chromatography of the ethyl acetate fraction of C. serratum roots yielded ursolic acid, which was characterized by its FT-IR, mass and NMR spectral data. The effect of ursolic acid on guinea pig was assessed using inflammation of the airway caused by histamine and ovalbumin, inflammatory cell count in blood and broncho-alveolarlavage fluid, quantitative cytokine determination (IL-4, IL-5 and TNF-α) in serum and BALF, and histopathology of lung tissue. The results indicated that ursolic acid has the potential to prevent inflammatory mediators into the local lung and trachea tissues and may be useful in the management of asthma
PARADIGM SHIFT IN PHARMACEUTICAL BUSINESS WITH RESPECT TO IMPORTANCE OF PHARMACEUTICAL DEVELOPMENT
Full text linkCOMPARATIVE IN-VITRO MULTIMEDIA DISSOLUTION STUDY OF CARBAMAZEPINE EXTENDED RELEASE TABLET 400MG AT VARIOUS PH RANGE
No full textDissolution profiles of carbamazepine innovator formulation were evaluated and matched with the test formulation in multiple dissolution medium at various pH. Innovator formulation – Tegretol LP 400 was selected as a reference product. Different batches of innovator and test formulation of 400mg were selected for experiments. During development, the test formulation was formulated with respect to the dissolution profile of Tegretol LP 400 in defined medium – water. After achieving the matched dissolution profile in main medium - water, same test formulation was matched with innovator formulation in various pH medium. The similarity factor (f2) for test and reference product was obtained more than 50 for medium - water, acetate buffer pH 4.5 and phosphate buffer 6.8. During acidic medium at pH 1.2, the innovator formulation represented the typical behavior in dissolution and due to that high variability was observed in the results of intra-run. Same behavior of drug release was also observed for the repeated experiments as well as for other batch of innovator and even in the final test formulation. Hence, to prevent the high variability, surfactant was used for the dissolution in pH 1.2 medium. After various optimization experiments, the minimum optimum concentration of surfactant was achieved and the results of %RSD was found within acceptance criteria for all the formulations. The similarity factor (f2) of 12 units of test and reference product was found above 50. The results were also accepted for the other batch of innovator formulation and during the repetitive experiments
AN EPITOME ON TUBERCULOSIS: A PHASE OF DRUG DISCOVERY TO NANOTECHNOLOGY
Full text linkMycobacterium tuberculosis is a chronic infectious disease. It kills approximately 1.7 million people in the world and also has the highest risk of reactivation in the patients with latent infection. Relapse of the disease and drug resistance (MDR-TB/XDR-TB) are the key parameters of too complex tuberculosis therapy. Due to this varied failure treatment on this globe has asked the researchers to identify novel targets and to intercorrelate its mechanism of action. With an ascending growth of the disease and more specifically drug-resistance has signified its emergence for new anti-tuberculosis drugs. Thus, with the prior knowledge and applying it in the drug discovery has led a convincing opportunity for the modification of current inhibitors or to develop new drugs. With the re-arrangement of recognized scaffolds is applied in its core structure which may help in the improvement of bactericidal, pharmacokinetics and pharmacodynamics activities. Along with the surveys carried out, a large number of compounds are screened against Mycobacterium tuberculosis and can be helpful later in the computer databases. The present drug discovery should include an integrative analysis with computational databases. Nanomedicine also plays an important role in the management of the disease. The nano-sensors which help in the detection of infection rate have provoked its role for the rapid and short term diagnosis. Thus, with the current literature review it can be noted that interconnecting computational chemistry with the nanotechnology diagnosis can be helpful for short term therapy as well as lesser side effects
LIPID MICROSPHERES: EMERGING TRENDS IN PHARAMCEUTICAL TECHNOLOGY
Full text linkRecent advances in the isolation techniques, medicinal chemistry, biotechnology and the capacity for screening new drug compounds have been able to produce several lead molecules. More than likely many potential drugs have lost because of inadequate formulation strategies during different stages of evaluation. In many cases, the loss could have been due to solubility problems. To maximize the drug potential of all molecules, there has been a renewed effort to find formulation strategies for compounds inadequately soluble in water. Many different drug delivery systems for lipid soluble compounds have been suggested, but lipid microsphere (LM) drug delivery system has great potential. The system is time tested, safe and stable at room temperature, easily mass- produced yet cheaper. The drug distribution and targeting can be achieved by manipulating size, surface charge and surface legands of LM. At present, commercially available lipid microsphere formulation are few but in future this system will find considerable share in the market
INHALED FLUTICASONE PROPIONATE DRY POWDER FOR THE EFFECTIVE MANAGEMENT OF ASTHMA
Full text linkDry powder inhaler has become an attractive platform for pulmonary drug delivery. Dry powder inhalers are commonly used to treat asthma and other pulmonary diseases. Dry powder inhalers chiefly consist of micronized drug admixed with the carrier particles which aid in the flow of the drug in the respiratory tract. The dry powder formulations of fluticasone propionate were prepared with different coarse and fine lactose grades such as Respitose® SV003, Respitose® SV010, Respitose® ML001, Respitose® ML006 and Lactohale® LH 230, Inhalac® 230 and Inhalac® 400 and evaluated for flow properties, emitted and fine particle dose, content and blend uniformity. The final coarse and fine lactose grades were Inhalac® 230 and Inhalac® 400 based on the flow properties. 32 factorial design was applied for the formulation optimization. The final device used was Breezhaler®. The optimized batch showed a fine particle fraction of 8.99 ± 3.71 with a mass median aerodynamic diameter of 3.40 ± 0.02 thus showing the efficiency of dry powder inhalers in the delivery of fluticasone propionate deep into the lungs
HYDROGELS AS NOVEL ALTERNATIVE FOR THE MANAGEMENT OF VARIOUS DISEASES OF CENTRAL NERVOUS SYSTEM
Full text linkThe word \u27Hydrogel\u27 includes \u27Hydro\u27 and \u27Gel\u27 indicating gel like property and water solubility. Hydrogel formation includes combining together of monomer units to form cross linked structure which provides water insolubility. Hydrogel as a delivery system has gained wide acceptability due to its various applications. Based on the monomer used, hydrogel possess different properties and can be used for various diseases and disorders. Materials used for hydrogel formulation include Polyvinyl alcohol (PVA), Polyethylene oxide (PEO)and polysaccharides such as Chitosan, Cellulose, Agarose, Carragenan. Depending on the swelling behaviour, hydrogel can be used for different applications including controlled relase formulations The classification of hydrogel is based on the its physical, chemical, swelling, and source. Hydrogel based delivery system has application in effective management of various diseases of central nervous system like Alhzeimer; Parkinson\u27s; Tumor of spinal cord; Down\u27s syndrome and brain stroke. Different materials used in the formulation of the hydrogel provide different property thus making it suitable for management of different diseases and disorders besides central nervous system
NUTRITIONAL STATUS ASSESSMENT OF PRESCHOOL CHILDREN ATTENDING ANGANWADI CENTERS OF AHMEDABAD CITY
Full text linkPreschool children age group is a vulnerable population which seeks more attention and care on nutritional status. For the present study 142 children aged two year to five year were purposively selected. The data were collected by pre-prepared questionnaires. Anthropometric measurement was done by weight, height, Middle Upper Arm Circumference (MUAC), Head and chest circumference, BMI. Severity of malnutrition was assessed by Weight for age, height for age and weight for height. The study revealed 36.6 percent children were stunting and 16.9 percent were severe stunting, 23.9 percent children were underweight while 30.3 percent children were severely underweight, 5.6 percent children were fall under severe wasting category while 19 percent children were fall under wasting category. The results of the study indicates that under nutrition is still an important public health problem among children in Isanpur area of Ahmedabad and was significantly associated with gender, family income, education of mother, as well as dietary intake. Personal hygiene and sanitation, dietary intake might help to improve nutritional status of children
ETHICAL PRINCIPLES AND PRACTICES IN CLINICAL RESEARCH: A BRIEF HISTORY AND GUIDELINES OF CURRENT RELEVANCE
Full text linkEthics is the science of moral values and standards. Scientific experiments, especially those in human subjects, need to be guided by specific ethical values in several aspects. Human experiments of newly discovered medicines or medicines under development, the clinical trials, have a fairly healthy ethical history in ancient and medieval times. However, between World War I and 1970s, the history of clinical trials is very disappointing and has often violated the ethical principles. As a result, several guidelines on ethical conduct of clinical trials have been formulated by various stakeholders covering more or less the same principles of ethics. The Nuremberg code, Declaration of Helsinki, the Belmont report, the ICH GCP guidelines, and the ICMR Guidelines on Ethics are some of the examples. All these documents have covered mainly three aspects of ethics of conducting research in human patients or subjects: a) the patient related aspects (protection, justice and beneficence); b) scientific standard and quality related aspects and c) documentation, publication and promulgation related aspects