INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES

5-17

Authors: J. Balasubramanian*1 , T. Muthukumaran1 , S. Hariram2 , G. A. Nandhini2 , K. Saisugathri2

In this retrospective study which deals about the rules & regulations which are required for drug approval process in Europe. Developing a new drug requires great amount of research work in pharmaceutical sciences and pharmacological basics. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This retrospective provides clear information on list of EU member countries, EEA, EFTA, and EMA. Different types of submission procedure for regulatory approvals were explained clearly. The European Medicines Agency is responsible for the centralized authorization procedure for human and veterinary medicines. This procedure results in a single marketing authorization that is valid in all EU countries, as well as in the European Economic Area (EEA) countries. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. Key Words: EU – European Union, EMA – European Medical Agency, EEA - European Economic Area.

22-30

Authors: Naresh Kshirasagar* 1 Srilatha Malvey1 , K.Senthil Kumar 2 , C.Vijaya2 , M.Venkata Reddy3

Orodispersible Tablets (ODT) of Naratriptan a typical anti migraine is highly appropriate, as it has ease of administration for patients who are mentally ill, disabled and uncooperative. It has better patient’s acceptance and compliance and other improved biopharmaceutical properties and efficiency compared with conventional oral dosage forms. In the present research work an attempt was made to design ODT by using sublimation method by addition of camphor as subliming agent, followed by effect of lubricants were resulted. The experiment was run with six batches containing different concentrations of subliming agents. On comparing all the batches of sublimation method SF4 shows higher dissolution rate was resulted due to rapid diffusion or porous nature of tablet. Among them camphor 5% is better subliming agent for formulation of ODT of Naratriptan. Vacuum drying employed to remove sublime salts at low temperature 40ºC for 2 hr. From the results of study we concluded that formulation SF4 (Mannitol, lactose monohydrate, Crospovidone, Aspartame Sodium starch glycolate, Magnesium stearate, Orange flavor Camphor) possesses good disintegration and dissolution rate profile. An FTIR studies reveal that there is no interaction of drug with excipients. The sublimation method can be used to prepare ODTs of several categories of drugs, which need rapid onset of action. Hence sublimation method of preparing tablet with a view of obtaining faster action of drug and would be advantageous in comparing to the currently conventional forms. Keywords: Orodispersible tablets, Naratriptan, FTIR.

37-43

Authors: A. Prabhu1 , K. Shankar*2 , P. Muthukrishnan3 , A. Kathiresan4 & P.Prakash

Novel utilization of weed synthesized nanoparticles plays major role in treatment against many cancer cells and pathogenic microbes. Green synthesis is more economical, ecofriendly and large scale production of nanoparticles. This study investigates on cytotoxic and apoptotic effect of setaria verticillata synthesized silver nanoparticles against Breast cancer cell (MCF-7) and Lung cancer cell (A549) lines. The synthesized silver nanoparticles were characterized by High resolution-transmission electron microscopy (HR-TEM). The optical property of silver nanoparticles was determined by selected area electron diffraction (SAED). The invitro cytotoxicity and apoptotic effect of synthesized silver nanoparticles was evaluated against Breast cancer cells (MCF-7) and lung cancer cells (A549) by MTT assay, Trypan blue dye assay and DNA fragmentation assay. The size of silver nanoparticles was spherical with average size of 12±4 nm. Electron diffraction pattern shows the silver nanoparticles were crystalline in nature with Face centered cubic (FCC) structure. The MTT assay shows the % CTC50 is 897.05µg/ml for MCF-7 and 402.75 µg/ml for A549 cell lines respectively. Trypan blue dye assay indicates cytotoxic effects increased with increase in concentration of silver nanoparticles upto 1000 µg/ml. The DNA fragmentation assay of silver nanoparticles treated MCF-7 and A549 shows the double strand breaks shows formation of DNA ladders. The invitro cytotoxic effect of setaria verticillata synthesized silver nanoparticles was toxic against Breast cancer cell (MCF-7) and lung cancer cell (A549). Keywords: Silver nanoparticles, MCF-7, A549, HR- TEM, MTT assay

52-56

Authors: Ibel C Fredy 1*, Santosh Chandrashekar 1 , R Srinivasan

Pharmacovigilance also known as drug safety is defined as the science and activities relating to the collection, detection, assessment, monitoring and prevention of adverse effects or any other drug- related problems. The World Health Organization (WHO) defines an ADR as ‘a response to a drug that is noxious, unintended and occurs at doses normally used in man for the prophylaxis, diagnosis, therapy of disease, or for modification of physiological function’. The study conducted was a cross sectional retrospective study using modified ADR form from Central Drugs Standard Control Organization (CDSCO) and assessment was performed using different scales. This is a retrospective observational study, conducted on reported ADRs at a quaternary care hospital from 2009 – 2014. The main aim of this study is to assess the incidence, pattern of ADRs, causality, offending drugs, and to prevent the occurrence. Each reported ADR was assessed for its causality by using Naranjo’s scale. The severity of each reported ADR was assessed using modified Hartwig & Siegel scale and preventability of ADRs by modified Schumock & Thornton scale. The adverse drug reactions which occur in this quaternary care hospital reaction had a large number of reactions but most of which were in mild to moderate range. The prescribing of large number of medications causing low intensity of ADRs indicates the use of cautious responsibility due to direct liability and awareness.